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MDedge conference coverage features onsite reporting of the latest study results and expert perspectives from leading researchers.
Rising viral load on dolutegravir? Investigators try fix before switch
Brisbane, Australia – , according to new data from the ADVANCE trial.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” said Andrew Hill, MD, from the department of pharmacology and therapeutics at the University of Liverpool, England.
The new data was presented here at the International AIDS Society conference on HIV Science. The ADVANCE trial is a three-arm randomized study involving 1,053 treatment-naive individuals comparing two triple-therapy combinations — dolutegravir, emtricitabine, and one of two tenofovir prodrugs – with a standard care regimen of tenofovir disoproxil fumarate, emtricitabine, and efavirenz.
Although the usual approach for someone in a clinical trial who experiences elevations in HIV RNA levels while on a dolutegravir-based treatment is to switch them to another therapy, the ADVANCE investigators opted for a different strategy.
“We actually continued treatment despite high viral load, and we didn’t have standard discontinuation preferences,” Dr. Hill said at the meeting. They instead provided counseling about adherence, which gave an opportunity to examine viral resuppression rates in participants in both the dolutegravir and efavirenz arms.
This revealed that 95% of patients in the two dolutegravir arms of the study were able to achieve resuppression of their viral load – defined as below 50 viral RNA copies per mL – without any emergence of resistance.
The guidelines
Current World Health Organization guidelines recommend that anyone whose viral load goes above 1,000 copies per mL who is on a non-nucleoside reverse transcriptase inhibitor such as efavirenz should be switched to an appropriate regimen.
Those who experience viremia on an integrase inhibitor such as dolutegravir should receive adherence counseling, have a repeat viral load test done in 3 months, and – if their viral load is still elevated – be switched to another regimen.
Dr. Hill and his team were examining how this might play out in a clinical trial setting and they found that there were a similar number of episodes of initial virologic failure in both the dolutegravir and efavirenz groups.
But after adherence counseling, testing for resistance and – if no resistance was evident – continuation with treatment, they saw differences emerge between the two groups.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” he said.
Time to viral resuppression
At 24 weeks after restarting treatment, 88% of people in the dolutegravir group had resuppressed their viral RNA, compared with 46% of people in the efavirenz group. At 48 weeks, those figures were 95% and 66%, respectively.
Dr. Hill pointed out that a significant number of people were lost to follow-up after virologic failure, and genotyping was not performed at baseline.
We addressed the question of how much adherence counseling should be undertaken in people who experienced viremia while on dolutegravir therapy, Dr. Hill said, particularly as there were often very good reasons for lack of adherence, such as homelessness.
“If you can get through those difficult phases, people can go back on their meds,” he said in an interview. “It’s almost a sociological problem rather than a clinical issue.”
And with efavirenz and the lower rates of resuppression observed in the study, Dr. Hill said it was a more fragile drug, so viremia therefore provided the opportunity for resistance to emerge, “and then once the resistant virus is there, you can’t get virus undetectable.”
Laura Waters, MD, a genitourinary and HIV medicine consultant at the Mortimer Market Centre in London, who was not involved in the study, said the results support recommendations to give people on drugs such as dolutegravir, which have a high genetic barrier to resistance, more time to improve their adherence before switching to another therapy.
“Although it provides that reassuring proof of concept, it doesn’t negate the importance of having to continue to monitor, because nothing is infallible,” she told this news organization. “We’ve talked about high-barrier drugs in the past, and you do start seeing resistance emerge.”
A version of this article first appeared on Medscape.com.
Brisbane, Australia – , according to new data from the ADVANCE trial.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” said Andrew Hill, MD, from the department of pharmacology and therapeutics at the University of Liverpool, England.
The new data was presented here at the International AIDS Society conference on HIV Science. The ADVANCE trial is a three-arm randomized study involving 1,053 treatment-naive individuals comparing two triple-therapy combinations — dolutegravir, emtricitabine, and one of two tenofovir prodrugs – with a standard care regimen of tenofovir disoproxil fumarate, emtricitabine, and efavirenz.
Although the usual approach for someone in a clinical trial who experiences elevations in HIV RNA levels while on a dolutegravir-based treatment is to switch them to another therapy, the ADVANCE investigators opted for a different strategy.
“We actually continued treatment despite high viral load, and we didn’t have standard discontinuation preferences,” Dr. Hill said at the meeting. They instead provided counseling about adherence, which gave an opportunity to examine viral resuppression rates in participants in both the dolutegravir and efavirenz arms.
This revealed that 95% of patients in the two dolutegravir arms of the study were able to achieve resuppression of their viral load – defined as below 50 viral RNA copies per mL – without any emergence of resistance.
The guidelines
Current World Health Organization guidelines recommend that anyone whose viral load goes above 1,000 copies per mL who is on a non-nucleoside reverse transcriptase inhibitor such as efavirenz should be switched to an appropriate regimen.
Those who experience viremia on an integrase inhibitor such as dolutegravir should receive adherence counseling, have a repeat viral load test done in 3 months, and – if their viral load is still elevated – be switched to another regimen.
Dr. Hill and his team were examining how this might play out in a clinical trial setting and they found that there were a similar number of episodes of initial virologic failure in both the dolutegravir and efavirenz groups.
But after adherence counseling, testing for resistance and – if no resistance was evident – continuation with treatment, they saw differences emerge between the two groups.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” he said.
Time to viral resuppression
At 24 weeks after restarting treatment, 88% of people in the dolutegravir group had resuppressed their viral RNA, compared with 46% of people in the efavirenz group. At 48 weeks, those figures were 95% and 66%, respectively.
Dr. Hill pointed out that a significant number of people were lost to follow-up after virologic failure, and genotyping was not performed at baseline.
We addressed the question of how much adherence counseling should be undertaken in people who experienced viremia while on dolutegravir therapy, Dr. Hill said, particularly as there were often very good reasons for lack of adherence, such as homelessness.
“If you can get through those difficult phases, people can go back on their meds,” he said in an interview. “It’s almost a sociological problem rather than a clinical issue.”
And with efavirenz and the lower rates of resuppression observed in the study, Dr. Hill said it was a more fragile drug, so viremia therefore provided the opportunity for resistance to emerge, “and then once the resistant virus is there, you can’t get virus undetectable.”
Laura Waters, MD, a genitourinary and HIV medicine consultant at the Mortimer Market Centre in London, who was not involved in the study, said the results support recommendations to give people on drugs such as dolutegravir, which have a high genetic barrier to resistance, more time to improve their adherence before switching to another therapy.
“Although it provides that reassuring proof of concept, it doesn’t negate the importance of having to continue to monitor, because nothing is infallible,” she told this news organization. “We’ve talked about high-barrier drugs in the past, and you do start seeing resistance emerge.”
A version of this article first appeared on Medscape.com.
Brisbane, Australia – , according to new data from the ADVANCE trial.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” said Andrew Hill, MD, from the department of pharmacology and therapeutics at the University of Liverpool, England.
The new data was presented here at the International AIDS Society conference on HIV Science. The ADVANCE trial is a three-arm randomized study involving 1,053 treatment-naive individuals comparing two triple-therapy combinations — dolutegravir, emtricitabine, and one of two tenofovir prodrugs – with a standard care regimen of tenofovir disoproxil fumarate, emtricitabine, and efavirenz.
Although the usual approach for someone in a clinical trial who experiences elevations in HIV RNA levels while on a dolutegravir-based treatment is to switch them to another therapy, the ADVANCE investigators opted for a different strategy.
“We actually continued treatment despite high viral load, and we didn’t have standard discontinuation preferences,” Dr. Hill said at the meeting. They instead provided counseling about adherence, which gave an opportunity to examine viral resuppression rates in participants in both the dolutegravir and efavirenz arms.
This revealed that 95% of patients in the two dolutegravir arms of the study were able to achieve resuppression of their viral load – defined as below 50 viral RNA copies per mL – without any emergence of resistance.
The guidelines
Current World Health Organization guidelines recommend that anyone whose viral load goes above 1,000 copies per mL who is on a non-nucleoside reverse transcriptase inhibitor such as efavirenz should be switched to an appropriate regimen.
Those who experience viremia on an integrase inhibitor such as dolutegravir should receive adherence counseling, have a repeat viral load test done in 3 months, and – if their viral load is still elevated – be switched to another regimen.
Dr. Hill and his team were examining how this might play out in a clinical trial setting and they found that there were a similar number of episodes of initial virologic failure in both the dolutegravir and efavirenz groups.
But after adherence counseling, testing for resistance and – if no resistance was evident – continuation with treatment, they saw differences emerge between the two groups.
“What we saw was a faster time to resuppression in the people followed-up long term on dolutegravir and also a higher percentage of people becoming suppressed when they remained on dolutegravir,” he said.
Time to viral resuppression
At 24 weeks after restarting treatment, 88% of people in the dolutegravir group had resuppressed their viral RNA, compared with 46% of people in the efavirenz group. At 48 weeks, those figures were 95% and 66%, respectively.
Dr. Hill pointed out that a significant number of people were lost to follow-up after virologic failure, and genotyping was not performed at baseline.
We addressed the question of how much adherence counseling should be undertaken in people who experienced viremia while on dolutegravir therapy, Dr. Hill said, particularly as there were often very good reasons for lack of adherence, such as homelessness.
“If you can get through those difficult phases, people can go back on their meds,” he said in an interview. “It’s almost a sociological problem rather than a clinical issue.”
And with efavirenz and the lower rates of resuppression observed in the study, Dr. Hill said it was a more fragile drug, so viremia therefore provided the opportunity for resistance to emerge, “and then once the resistant virus is there, you can’t get virus undetectable.”
Laura Waters, MD, a genitourinary and HIV medicine consultant at the Mortimer Market Centre in London, who was not involved in the study, said the results support recommendations to give people on drugs such as dolutegravir, which have a high genetic barrier to resistance, more time to improve their adherence before switching to another therapy.
“Although it provides that reassuring proof of concept, it doesn’t negate the importance of having to continue to monitor, because nothing is infallible,” she told this news organization. “We’ve talked about high-barrier drugs in the past, and you do start seeing resistance emerge.”
A version of this article first appeared on Medscape.com.
AT IAS 2023
Results from halted islatravir antiretroviral trial presented
Brisbane, Australia – , according to investigators.
The nucleoside reverse transcriptase translocation inhibitor hit a roadblock in December 2021 when the U.S. Food and Drug Administration put a hold on investigational new drug applications for both the oral and implant formulations of islatravir after some patients in clinical trials showed decreases in total lymphocyte and CD4+ cell counts.
A phase 3, double-blind, randomized, controlled trial was underway at the time of once-daily islatravir (0.75 mg) in combination with 100 mg doravirine, compared with bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) as initial therapy for HIV infection in treatment-naïve individuals. Recruitment was stopped, 83 participants short of the planned 680, but the trial could continue the full 48 weeks.
Jürgen Rockstroh, MD, professor of medicine and head of the HIV Outpatient Clinic at the University of Bonn, Germany, presented the latest results from that trial of 597 patients at the International AIDS Society conference on HIV Science.
At week 48 after starting therapy, 88.9% of participants in the islatravir and doravirine arm and 88.3% of patients in the B/F/TAF arm achieved the primary outcome of HIV-1 RNA levels below 50 copies/mL.
One patient treated with islatravir and doravirine and four patients taking B/F/TAF experienced virologic failure.
Dr. Rockstroh told the conference the patient who developed viremia with the new islatravir combination had very high viral load at baseline but showed a rapid response to treatment, which reduced his viral load down to around 1,200 copies/mL by week 4.
However, by week 24, his islatravir concentration had reduced below detectable levels, suggesting a problem with adherence. His viral load increased again, and three treatment-resistant mutations were detected.
While both arms of the study showed a significant increase in CD4+ T cell counts, Dr. Rockstroh pointed out that some individuals in the islatravir and doravirine arm had a lower absolute increase in lymphocyte counts at week 48.
Overall, the mean change in CD4+ T cell counts was 182 cells/mL in the islatravir and doravirine group, compared with 234 cells/mL in the B/F/TAF group.
More patients in the islatravir combination arm discontinued treatment due to a decrease in CD4+ T cell or total lymphocyte counts – 5.4%, compared with 2% in the B/F/TAF arm, however.
“These changes in lymphocyte counts did not lead to any difference in the amount of infection-related adverse events, which happened in both arms in relatively comparable percentages,” Dr. Rockstroh said at the conference.
New lower dose
Because of persistent concerns about the impact on CD4+ T cells and total lymphocytes, Dr. Rockstroh said another phase 3 trial is now underway using a lower 0.25 mg dose of islatravir, again combined with 100 mg doravirine, in people who are treatment-naïve and virologically suppressed.
The study also examined the impact of both treatments on weight gain and found the mean change in weight was similar between both arms – 3.45 kg gain in those on islatravir with doravirine and 3.32 kg gain in those on B/F/TAF, which was not significantly different.
There are several important reasons it is a good idea to have more treatment options available for people with HIV, Dr. Rockstroh said in an interview.
With integrase inhibitors potentially interfering with metabolic health, weight gain, hypertension, insulin resistance, and possible diabetes, “I think it’s wise that we at least have alternative strategies,” he said.
James McMahon, MD, PhD, an infectious diseases physician and head of the Infectious Diseases Clinical Research Unit at the Alfred Hospital and Monash University in Melbourne, said there is always a need for new HIV treatments, particularly ones that are more powerful.
“Whenever you get a drug that’s potent at low dose, it means you can have smaller pills, [and] you can then consider giving more of it in long-acting formulations,” Dr. McMahon said.
He pointed out that the study did not show any signal of increased infections with the lower CD4+ T cell counts in the islatravir and doravirine arm, “but that difference is enough to raise that concern that it’s not ideal, and it should be moved forward with a lower dose, which is what they’ve done.”
A version of this article first appeared on Medscape.com.
Brisbane, Australia – , according to investigators.
The nucleoside reverse transcriptase translocation inhibitor hit a roadblock in December 2021 when the U.S. Food and Drug Administration put a hold on investigational new drug applications for both the oral and implant formulations of islatravir after some patients in clinical trials showed decreases in total lymphocyte and CD4+ cell counts.
A phase 3, double-blind, randomized, controlled trial was underway at the time of once-daily islatravir (0.75 mg) in combination with 100 mg doravirine, compared with bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) as initial therapy for HIV infection in treatment-naïve individuals. Recruitment was stopped, 83 participants short of the planned 680, but the trial could continue the full 48 weeks.
Jürgen Rockstroh, MD, professor of medicine and head of the HIV Outpatient Clinic at the University of Bonn, Germany, presented the latest results from that trial of 597 patients at the International AIDS Society conference on HIV Science.
At week 48 after starting therapy, 88.9% of participants in the islatravir and doravirine arm and 88.3% of patients in the B/F/TAF arm achieved the primary outcome of HIV-1 RNA levels below 50 copies/mL.
One patient treated with islatravir and doravirine and four patients taking B/F/TAF experienced virologic failure.
Dr. Rockstroh told the conference the patient who developed viremia with the new islatravir combination had very high viral load at baseline but showed a rapid response to treatment, which reduced his viral load down to around 1,200 copies/mL by week 4.
However, by week 24, his islatravir concentration had reduced below detectable levels, suggesting a problem with adherence. His viral load increased again, and three treatment-resistant mutations were detected.
While both arms of the study showed a significant increase in CD4+ T cell counts, Dr. Rockstroh pointed out that some individuals in the islatravir and doravirine arm had a lower absolute increase in lymphocyte counts at week 48.
Overall, the mean change in CD4+ T cell counts was 182 cells/mL in the islatravir and doravirine group, compared with 234 cells/mL in the B/F/TAF group.
More patients in the islatravir combination arm discontinued treatment due to a decrease in CD4+ T cell or total lymphocyte counts – 5.4%, compared with 2% in the B/F/TAF arm, however.
“These changes in lymphocyte counts did not lead to any difference in the amount of infection-related adverse events, which happened in both arms in relatively comparable percentages,” Dr. Rockstroh said at the conference.
New lower dose
Because of persistent concerns about the impact on CD4+ T cells and total lymphocytes, Dr. Rockstroh said another phase 3 trial is now underway using a lower 0.25 mg dose of islatravir, again combined with 100 mg doravirine, in people who are treatment-naïve and virologically suppressed.
The study also examined the impact of both treatments on weight gain and found the mean change in weight was similar between both arms – 3.45 kg gain in those on islatravir with doravirine and 3.32 kg gain in those on B/F/TAF, which was not significantly different.
There are several important reasons it is a good idea to have more treatment options available for people with HIV, Dr. Rockstroh said in an interview.
With integrase inhibitors potentially interfering with metabolic health, weight gain, hypertension, insulin resistance, and possible diabetes, “I think it’s wise that we at least have alternative strategies,” he said.
James McMahon, MD, PhD, an infectious diseases physician and head of the Infectious Diseases Clinical Research Unit at the Alfred Hospital and Monash University in Melbourne, said there is always a need for new HIV treatments, particularly ones that are more powerful.
“Whenever you get a drug that’s potent at low dose, it means you can have smaller pills, [and] you can then consider giving more of it in long-acting formulations,” Dr. McMahon said.
He pointed out that the study did not show any signal of increased infections with the lower CD4+ T cell counts in the islatravir and doravirine arm, “but that difference is enough to raise that concern that it’s not ideal, and it should be moved forward with a lower dose, which is what they’ve done.”
A version of this article first appeared on Medscape.com.
Brisbane, Australia – , according to investigators.
The nucleoside reverse transcriptase translocation inhibitor hit a roadblock in December 2021 when the U.S. Food and Drug Administration put a hold on investigational new drug applications for both the oral and implant formulations of islatravir after some patients in clinical trials showed decreases in total lymphocyte and CD4+ cell counts.
A phase 3, double-blind, randomized, controlled trial was underway at the time of once-daily islatravir (0.75 mg) in combination with 100 mg doravirine, compared with bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) as initial therapy for HIV infection in treatment-naïve individuals. Recruitment was stopped, 83 participants short of the planned 680, but the trial could continue the full 48 weeks.
Jürgen Rockstroh, MD, professor of medicine and head of the HIV Outpatient Clinic at the University of Bonn, Germany, presented the latest results from that trial of 597 patients at the International AIDS Society conference on HIV Science.
At week 48 after starting therapy, 88.9% of participants in the islatravir and doravirine arm and 88.3% of patients in the B/F/TAF arm achieved the primary outcome of HIV-1 RNA levels below 50 copies/mL.
One patient treated with islatravir and doravirine and four patients taking B/F/TAF experienced virologic failure.
Dr. Rockstroh told the conference the patient who developed viremia with the new islatravir combination had very high viral load at baseline but showed a rapid response to treatment, which reduced his viral load down to around 1,200 copies/mL by week 4.
However, by week 24, his islatravir concentration had reduced below detectable levels, suggesting a problem with adherence. His viral load increased again, and three treatment-resistant mutations were detected.
While both arms of the study showed a significant increase in CD4+ T cell counts, Dr. Rockstroh pointed out that some individuals in the islatravir and doravirine arm had a lower absolute increase in lymphocyte counts at week 48.
Overall, the mean change in CD4+ T cell counts was 182 cells/mL in the islatravir and doravirine group, compared with 234 cells/mL in the B/F/TAF group.
More patients in the islatravir combination arm discontinued treatment due to a decrease in CD4+ T cell or total lymphocyte counts – 5.4%, compared with 2% in the B/F/TAF arm, however.
“These changes in lymphocyte counts did not lead to any difference in the amount of infection-related adverse events, which happened in both arms in relatively comparable percentages,” Dr. Rockstroh said at the conference.
New lower dose
Because of persistent concerns about the impact on CD4+ T cells and total lymphocytes, Dr. Rockstroh said another phase 3 trial is now underway using a lower 0.25 mg dose of islatravir, again combined with 100 mg doravirine, in people who are treatment-naïve and virologically suppressed.
The study also examined the impact of both treatments on weight gain and found the mean change in weight was similar between both arms – 3.45 kg gain in those on islatravir with doravirine and 3.32 kg gain in those on B/F/TAF, which was not significantly different.
There are several important reasons it is a good idea to have more treatment options available for people with HIV, Dr. Rockstroh said in an interview.
With integrase inhibitors potentially interfering with metabolic health, weight gain, hypertension, insulin resistance, and possible diabetes, “I think it’s wise that we at least have alternative strategies,” he said.
James McMahon, MD, PhD, an infectious diseases physician and head of the Infectious Diseases Clinical Research Unit at the Alfred Hospital and Monash University in Melbourne, said there is always a need for new HIV treatments, particularly ones that are more powerful.
“Whenever you get a drug that’s potent at low dose, it means you can have smaller pills, [and] you can then consider giving more of it in long-acting formulations,” Dr. McMahon said.
He pointed out that the study did not show any signal of increased infections with the lower CD4+ T cell counts in the islatravir and doravirine arm, “but that difference is enough to raise that concern that it’s not ideal, and it should be moved forward with a lower dose, which is what they’ve done.”
A version of this article first appeared on Medscape.com.
Studies link GLP-1 agonists to progression of diabetic retinopathy
SEATTLE – A family of blockbuster drugs for managing blood glucose – and now for promoting weight loss – has been linked to exacerbation of macular disease that frequently accompanies diabetes, new data show.
Two studies presented at the annual meeting of the American Society of Retina Specialists (ASRS) have found that
Clinicians should be aware of these effects of GLP-1 inhibitors to ensure appropriate monitoring of patients for the possibility that retinopathy may accelerate, according to Ehsan Rahimy, MD, an adjunct clinical professor at Stanford (Calif.) University, and colleagues.
Dr. Rahimy presented results of a retrospective study of retinopathy progression in patients taking either GLP-1 agonists or sodium-glucose transporter-2 (SGLT-2) inhibitors, also known as gliflozins. “When we looked at the conversion to proliferative disease, you can see it was statistically higher in the GLP-1 group at all time points,” he said.
GLP-1 agonists can promote considerable weight loss in patients with and without diabetes. Moreover, the finding that gliflozins improve cardiovascular and renal function in patients with type 2 diabetes has accelerated the use of these agents for blood glucose control.
Using a repository of data from more than 13,500 people taking either of the two kinds of medication, the researchers looked for conversion of diabetic eye disease to proliferative diabetic retinopathy (PDR) or DME. Secondary outcomes were the need for intravitreal injections, panretinal photocoagulation (PRP), or pars plana vitrectomy (PPV).
Propensity score matching for age, sex, race, ethnicity, and baseline hemoglobin A1c resulted in the inclusion of 5,446 participants in each treatment group. After matching, the mean age of participants in either group was 64 years, and the mean A1c was 8.5%. Slightly more than half the participants were insulin-dependent.
Patients taking GLP-1 inhibitors had higher rates of conversion to PDR than those taking gliflozins at 3 years (6% vs. 4%; P < .01), the researchers found. Nearly 25% of those taking a GLP-1 agonist had progressed to DME after 3 years, compared with 18% of those taking a gliflozin.
People in the group taking GLP-1 inhibitors also had a greater need for interventions than those on a gliflozin; 8% vs. roughly 6%, respectively, required intravitreal injections, Dr. Rahimy reported. Similar trends were noted for need for PRP and PPV, he added, although the absolute numbers of patients were small.
Albiglutide the key culprit?
In other research reported at the meeting, a meta-analysis of data collected in 93 randomized clinical trials of the seven currently available GLP-1 agonists found only albiglutide was associated with diabetic retinopathy to a statistically significant degree. Compared with placebo, albiglutide more than doubled the risk for early-stage diabetic retinopathy (relative risk 2.18; 95% confidence interval, 1.01-4.67; P = .05).
Other GLP-1 agonists evaluated in the meta-analysis included semaglutide, tirzepatide, dulaglutide, exenatide, liraglutide, and lixisenatide. These findings were reported in a poster presented at the meeting by Ishani Kapoor, MD candidate, Drexel University, Philadelphia.
“The strength of these effects depends on the specific GLP-1 receptor agonist used, patient-specific clinical characteristics, and demographics,” Ms. Kapoor and coauthors reported. “Further studies are needed to clarify the patient populations that would benefit from GLP-1 receptor agonists and those at risk for [the] development of additional ocular damage.”
What causes progression?
Whether worsening of retinopathy stems from rapid weight loss and acute reductions in concentrations of blood glucose or is a direct effect of GLP-1 agonists on the eye is unclear.
“That rapid reduction is thought to play some role,” Dr. Rahimy said. “But if you actually look out there in the basic science literature, it’s suggested that there are direct effects of these medications on the retina too. That being said, it’s suggested that they may be protective to the retina. And I think that’s where we’ve gotten a lot of mixed signals in our community between what we’ve seen on the basic science side vs. what we’re seeing on the real-world side.”
The study was independently funded. Dr. Rahimy reports consultancies or speakerships with AbbVie, Allergan, Apellis, Carl Zeiss, Genentech, and Google, and research support from Regeneron. Ms. Kapoor reports no relevant financial relationships.
A version of this article appeared on Medscape.com.
SEATTLE – A family of blockbuster drugs for managing blood glucose – and now for promoting weight loss – has been linked to exacerbation of macular disease that frequently accompanies diabetes, new data show.
Two studies presented at the annual meeting of the American Society of Retina Specialists (ASRS) have found that
Clinicians should be aware of these effects of GLP-1 inhibitors to ensure appropriate monitoring of patients for the possibility that retinopathy may accelerate, according to Ehsan Rahimy, MD, an adjunct clinical professor at Stanford (Calif.) University, and colleagues.
Dr. Rahimy presented results of a retrospective study of retinopathy progression in patients taking either GLP-1 agonists or sodium-glucose transporter-2 (SGLT-2) inhibitors, also known as gliflozins. “When we looked at the conversion to proliferative disease, you can see it was statistically higher in the GLP-1 group at all time points,” he said.
GLP-1 agonists can promote considerable weight loss in patients with and without diabetes. Moreover, the finding that gliflozins improve cardiovascular and renal function in patients with type 2 diabetes has accelerated the use of these agents for blood glucose control.
Using a repository of data from more than 13,500 people taking either of the two kinds of medication, the researchers looked for conversion of diabetic eye disease to proliferative diabetic retinopathy (PDR) or DME. Secondary outcomes were the need for intravitreal injections, panretinal photocoagulation (PRP), or pars plana vitrectomy (PPV).
Propensity score matching for age, sex, race, ethnicity, and baseline hemoglobin A1c resulted in the inclusion of 5,446 participants in each treatment group. After matching, the mean age of participants in either group was 64 years, and the mean A1c was 8.5%. Slightly more than half the participants were insulin-dependent.
Patients taking GLP-1 inhibitors had higher rates of conversion to PDR than those taking gliflozins at 3 years (6% vs. 4%; P < .01), the researchers found. Nearly 25% of those taking a GLP-1 agonist had progressed to DME after 3 years, compared with 18% of those taking a gliflozin.
People in the group taking GLP-1 inhibitors also had a greater need for interventions than those on a gliflozin; 8% vs. roughly 6%, respectively, required intravitreal injections, Dr. Rahimy reported. Similar trends were noted for need for PRP and PPV, he added, although the absolute numbers of patients were small.
Albiglutide the key culprit?
In other research reported at the meeting, a meta-analysis of data collected in 93 randomized clinical trials of the seven currently available GLP-1 agonists found only albiglutide was associated with diabetic retinopathy to a statistically significant degree. Compared with placebo, albiglutide more than doubled the risk for early-stage diabetic retinopathy (relative risk 2.18; 95% confidence interval, 1.01-4.67; P = .05).
Other GLP-1 agonists evaluated in the meta-analysis included semaglutide, tirzepatide, dulaglutide, exenatide, liraglutide, and lixisenatide. These findings were reported in a poster presented at the meeting by Ishani Kapoor, MD candidate, Drexel University, Philadelphia.
“The strength of these effects depends on the specific GLP-1 receptor agonist used, patient-specific clinical characteristics, and demographics,” Ms. Kapoor and coauthors reported. “Further studies are needed to clarify the patient populations that would benefit from GLP-1 receptor agonists and those at risk for [the] development of additional ocular damage.”
What causes progression?
Whether worsening of retinopathy stems from rapid weight loss and acute reductions in concentrations of blood glucose or is a direct effect of GLP-1 agonists on the eye is unclear.
“That rapid reduction is thought to play some role,” Dr. Rahimy said. “But if you actually look out there in the basic science literature, it’s suggested that there are direct effects of these medications on the retina too. That being said, it’s suggested that they may be protective to the retina. And I think that’s where we’ve gotten a lot of mixed signals in our community between what we’ve seen on the basic science side vs. what we’re seeing on the real-world side.”
The study was independently funded. Dr. Rahimy reports consultancies or speakerships with AbbVie, Allergan, Apellis, Carl Zeiss, Genentech, and Google, and research support from Regeneron. Ms. Kapoor reports no relevant financial relationships.
A version of this article appeared on Medscape.com.
SEATTLE – A family of blockbuster drugs for managing blood glucose – and now for promoting weight loss – has been linked to exacerbation of macular disease that frequently accompanies diabetes, new data show.
Two studies presented at the annual meeting of the American Society of Retina Specialists (ASRS) have found that
Clinicians should be aware of these effects of GLP-1 inhibitors to ensure appropriate monitoring of patients for the possibility that retinopathy may accelerate, according to Ehsan Rahimy, MD, an adjunct clinical professor at Stanford (Calif.) University, and colleagues.
Dr. Rahimy presented results of a retrospective study of retinopathy progression in patients taking either GLP-1 agonists or sodium-glucose transporter-2 (SGLT-2) inhibitors, also known as gliflozins. “When we looked at the conversion to proliferative disease, you can see it was statistically higher in the GLP-1 group at all time points,” he said.
GLP-1 agonists can promote considerable weight loss in patients with and without diabetes. Moreover, the finding that gliflozins improve cardiovascular and renal function in patients with type 2 diabetes has accelerated the use of these agents for blood glucose control.
Using a repository of data from more than 13,500 people taking either of the two kinds of medication, the researchers looked for conversion of diabetic eye disease to proliferative diabetic retinopathy (PDR) or DME. Secondary outcomes were the need for intravitreal injections, panretinal photocoagulation (PRP), or pars plana vitrectomy (PPV).
Propensity score matching for age, sex, race, ethnicity, and baseline hemoglobin A1c resulted in the inclusion of 5,446 participants in each treatment group. After matching, the mean age of participants in either group was 64 years, and the mean A1c was 8.5%. Slightly more than half the participants were insulin-dependent.
Patients taking GLP-1 inhibitors had higher rates of conversion to PDR than those taking gliflozins at 3 years (6% vs. 4%; P < .01), the researchers found. Nearly 25% of those taking a GLP-1 agonist had progressed to DME after 3 years, compared with 18% of those taking a gliflozin.
People in the group taking GLP-1 inhibitors also had a greater need for interventions than those on a gliflozin; 8% vs. roughly 6%, respectively, required intravitreal injections, Dr. Rahimy reported. Similar trends were noted for need for PRP and PPV, he added, although the absolute numbers of patients were small.
Albiglutide the key culprit?
In other research reported at the meeting, a meta-analysis of data collected in 93 randomized clinical trials of the seven currently available GLP-1 agonists found only albiglutide was associated with diabetic retinopathy to a statistically significant degree. Compared with placebo, albiglutide more than doubled the risk for early-stage diabetic retinopathy (relative risk 2.18; 95% confidence interval, 1.01-4.67; P = .05).
Other GLP-1 agonists evaluated in the meta-analysis included semaglutide, tirzepatide, dulaglutide, exenatide, liraglutide, and lixisenatide. These findings were reported in a poster presented at the meeting by Ishani Kapoor, MD candidate, Drexel University, Philadelphia.
“The strength of these effects depends on the specific GLP-1 receptor agonist used, patient-specific clinical characteristics, and demographics,” Ms. Kapoor and coauthors reported. “Further studies are needed to clarify the patient populations that would benefit from GLP-1 receptor agonists and those at risk for [the] development of additional ocular damage.”
What causes progression?
Whether worsening of retinopathy stems from rapid weight loss and acute reductions in concentrations of blood glucose or is a direct effect of GLP-1 agonists on the eye is unclear.
“That rapid reduction is thought to play some role,” Dr. Rahimy said. “But if you actually look out there in the basic science literature, it’s suggested that there are direct effects of these medications on the retina too. That being said, it’s suggested that they may be protective to the retina. And I think that’s where we’ve gotten a lot of mixed signals in our community between what we’ve seen on the basic science side vs. what we’re seeing on the real-world side.”
The study was independently funded. Dr. Rahimy reports consultancies or speakerships with AbbVie, Allergan, Apellis, Carl Zeiss, Genentech, and Google, and research support from Regeneron. Ms. Kapoor reports no relevant financial relationships.
A version of this article appeared on Medscape.com.
FROM ASRS 2023
Time-restricted eating gains for weight and glycemic control
Time-restricted eating (TRE) can be a practical, easy-to-follow way for some people to control their daily food intake and lose weight. It precludes a person’s need to pay close attention to how much they eat as long as they confine consumption to a limited time window. Plus, results from several recent studies show TRE can further benefit people with type 2 diabetes as well as obesity via mechanisms beyond weight loss.
The most tested and recommended eating window is 8 hours long, although periods up to roughly 10 hours may provide some benefits. Results from multiple studies document that TRE produces modest but consistent weight loss of less than 5% in many people. A recent meta-analysis of 17 randomized controlled studies involving 899 people showed an overall incremental weight loss, compared with controls of 1.60 kg on a TRE regimen.
The more limited data collected so far in people with type 2 diabetes show additional metabolic benefits from TRE, including improved beta-cell responsiveness, increased insulin sensitivity, nonoxidative glucose disposal, increased time in glycemic range, and virtually no hypoglycemic events, Courtney Peterson, PhD, said at the annual scientific sessions of the American Diabetes Association.
said Dr. Peterson, a researcher in the department of nutrition sciences at the University of Alabama, Birmingham.
‘Eating earlier is better’
An advantage of TRE is that it is “agnostic to food preferences and quality,” said Lisa S. Chow, MD, during a separate session at the meeting. TRE “may have benefits beyond calorie restriction” that appear related to “the timing of eating and the extent of the eating window restriction. Eating earlier [in the day] is better” for markers of metabolic health regardless of how much weight a person may lose on a TRE regimen, noted Dr. Chow, an endocrinologist and professor at the University of Minnesota Medical School, Minneapolis.
But the TRE paradigm seems amenable to some flexibility on the timing for the eating window while still having benefit.
“Self-selected eating windows are usually late,” Dr. Chow observed, and because compliance with a constrained eating window matters, it may be worth allowing people to choose whichever time window for eating works best for them.
“If you let people pick their eating window, they typically include dinner,” said Dr. Chow, who has run a small TRE study that showed this.
“To maximize the effects [of TRE] people should use the eating window that best fits their life,” agreed Kelsey Gabel, PhD, who also gave a TRE talk during the meeting. “Eating most of your [daily] calories first thing in the morning would have the best cardiometabolic benefit, but reduced adherence would mitigate the benefit,” said Dr. Gabel, a nutrition researcher at the University of Illinois.
‘Meeting people where they’re at’
“We can have a larger public health impact by meeting people where they’re at. People should position their eating window where it best fits so they can achieve calorie restriction without even knowing it,” Dr. Gabel advised.
She cited a report as evidence that most people prefer a later eating window. The report reviewed observational data from nearly 800,000 people who used either of two different TRE phone apps. The data showed that most people opted to start their daily eating during 11:00 AM-1:00 PM, and then stop during 6:00 PM-8:00 PM.
“TRE will not solve all of our obesity problems, but it’s a good place to start,” Dr. Gabel declared.
For people who include dinner at a typical evening time in their TRE window, a key message is that “dinner is your last food of the day. There’s no snacking later,” said Dr. Chow.
“The biggest challenge is adherence,” said Dr. Peterson. “Fewer people want to do TRE than you think. We know that calorie restriction works. We just need a way for people to do it,” and for at least some people, TRE is that way. While no evidence clearly shows that 8 hours is the best eating-window duration, “we think 8 hours is a good sweet-spot for motivated people,” she said.
Sparser data on TRE in people with T2D
Fewer studies have examined the impact of TRE on glycemic control, insulin sensitivity, and related effects in people with type 2 diabetes. According to Dr. Peterson, published reports currently include two randomized controlled studies and three single-arm studies in people with type 2 diabetes and an additional two studies in people with prediabetes.
The largest of these reports randomized 120 adults in China with type 2 diabetes and overweight to TRE using a 10-hour eating window (8:00 AM-6:00 PM) or unrestricted eating for 12 weeks. By the end of the study, those on the TRE regimen had an average reduction in their hemoglobin A1c from baseline that was 0.88 percentage points greater than among the controls, and the TRE arm had also lost an average of nearly 2.15 kg more from baseline than the controls.
Dr. Peterson highlighted the importance of expanding research using TRE in people with type 2 diabetes.
Dr. Peterson and Dr. Gabel report no relevant financial relationships. Dr. Chow has received research support from Dexcom.
A version of this article first appeared on Medscape.com.
Time-restricted eating (TRE) can be a practical, easy-to-follow way for some people to control their daily food intake and lose weight. It precludes a person’s need to pay close attention to how much they eat as long as they confine consumption to a limited time window. Plus, results from several recent studies show TRE can further benefit people with type 2 diabetes as well as obesity via mechanisms beyond weight loss.
The most tested and recommended eating window is 8 hours long, although periods up to roughly 10 hours may provide some benefits. Results from multiple studies document that TRE produces modest but consistent weight loss of less than 5% in many people. A recent meta-analysis of 17 randomized controlled studies involving 899 people showed an overall incremental weight loss, compared with controls of 1.60 kg on a TRE regimen.
The more limited data collected so far in people with type 2 diabetes show additional metabolic benefits from TRE, including improved beta-cell responsiveness, increased insulin sensitivity, nonoxidative glucose disposal, increased time in glycemic range, and virtually no hypoglycemic events, Courtney Peterson, PhD, said at the annual scientific sessions of the American Diabetes Association.
said Dr. Peterson, a researcher in the department of nutrition sciences at the University of Alabama, Birmingham.
‘Eating earlier is better’
An advantage of TRE is that it is “agnostic to food preferences and quality,” said Lisa S. Chow, MD, during a separate session at the meeting. TRE “may have benefits beyond calorie restriction” that appear related to “the timing of eating and the extent of the eating window restriction. Eating earlier [in the day] is better” for markers of metabolic health regardless of how much weight a person may lose on a TRE regimen, noted Dr. Chow, an endocrinologist and professor at the University of Minnesota Medical School, Minneapolis.
But the TRE paradigm seems amenable to some flexibility on the timing for the eating window while still having benefit.
“Self-selected eating windows are usually late,” Dr. Chow observed, and because compliance with a constrained eating window matters, it may be worth allowing people to choose whichever time window for eating works best for them.
“If you let people pick their eating window, they typically include dinner,” said Dr. Chow, who has run a small TRE study that showed this.
“To maximize the effects [of TRE] people should use the eating window that best fits their life,” agreed Kelsey Gabel, PhD, who also gave a TRE talk during the meeting. “Eating most of your [daily] calories first thing in the morning would have the best cardiometabolic benefit, but reduced adherence would mitigate the benefit,” said Dr. Gabel, a nutrition researcher at the University of Illinois.
‘Meeting people where they’re at’
“We can have a larger public health impact by meeting people where they’re at. People should position their eating window where it best fits so they can achieve calorie restriction without even knowing it,” Dr. Gabel advised.
She cited a report as evidence that most people prefer a later eating window. The report reviewed observational data from nearly 800,000 people who used either of two different TRE phone apps. The data showed that most people opted to start their daily eating during 11:00 AM-1:00 PM, and then stop during 6:00 PM-8:00 PM.
“TRE will not solve all of our obesity problems, but it’s a good place to start,” Dr. Gabel declared.
For people who include dinner at a typical evening time in their TRE window, a key message is that “dinner is your last food of the day. There’s no snacking later,” said Dr. Chow.
“The biggest challenge is adherence,” said Dr. Peterson. “Fewer people want to do TRE than you think. We know that calorie restriction works. We just need a way for people to do it,” and for at least some people, TRE is that way. While no evidence clearly shows that 8 hours is the best eating-window duration, “we think 8 hours is a good sweet-spot for motivated people,” she said.
Sparser data on TRE in people with T2D
Fewer studies have examined the impact of TRE on glycemic control, insulin sensitivity, and related effects in people with type 2 diabetes. According to Dr. Peterson, published reports currently include two randomized controlled studies and three single-arm studies in people with type 2 diabetes and an additional two studies in people with prediabetes.
The largest of these reports randomized 120 adults in China with type 2 diabetes and overweight to TRE using a 10-hour eating window (8:00 AM-6:00 PM) or unrestricted eating for 12 weeks. By the end of the study, those on the TRE regimen had an average reduction in their hemoglobin A1c from baseline that was 0.88 percentage points greater than among the controls, and the TRE arm had also lost an average of nearly 2.15 kg more from baseline than the controls.
Dr. Peterson highlighted the importance of expanding research using TRE in people with type 2 diabetes.
Dr. Peterson and Dr. Gabel report no relevant financial relationships. Dr. Chow has received research support from Dexcom.
A version of this article first appeared on Medscape.com.
Time-restricted eating (TRE) can be a practical, easy-to-follow way for some people to control their daily food intake and lose weight. It precludes a person’s need to pay close attention to how much they eat as long as they confine consumption to a limited time window. Plus, results from several recent studies show TRE can further benefit people with type 2 diabetes as well as obesity via mechanisms beyond weight loss.
The most tested and recommended eating window is 8 hours long, although periods up to roughly 10 hours may provide some benefits. Results from multiple studies document that TRE produces modest but consistent weight loss of less than 5% in many people. A recent meta-analysis of 17 randomized controlled studies involving 899 people showed an overall incremental weight loss, compared with controls of 1.60 kg on a TRE regimen.
The more limited data collected so far in people with type 2 diabetes show additional metabolic benefits from TRE, including improved beta-cell responsiveness, increased insulin sensitivity, nonoxidative glucose disposal, increased time in glycemic range, and virtually no hypoglycemic events, Courtney Peterson, PhD, said at the annual scientific sessions of the American Diabetes Association.
said Dr. Peterson, a researcher in the department of nutrition sciences at the University of Alabama, Birmingham.
‘Eating earlier is better’
An advantage of TRE is that it is “agnostic to food preferences and quality,” said Lisa S. Chow, MD, during a separate session at the meeting. TRE “may have benefits beyond calorie restriction” that appear related to “the timing of eating and the extent of the eating window restriction. Eating earlier [in the day] is better” for markers of metabolic health regardless of how much weight a person may lose on a TRE regimen, noted Dr. Chow, an endocrinologist and professor at the University of Minnesota Medical School, Minneapolis.
But the TRE paradigm seems amenable to some flexibility on the timing for the eating window while still having benefit.
“Self-selected eating windows are usually late,” Dr. Chow observed, and because compliance with a constrained eating window matters, it may be worth allowing people to choose whichever time window for eating works best for them.
“If you let people pick their eating window, they typically include dinner,” said Dr. Chow, who has run a small TRE study that showed this.
“To maximize the effects [of TRE] people should use the eating window that best fits their life,” agreed Kelsey Gabel, PhD, who also gave a TRE talk during the meeting. “Eating most of your [daily] calories first thing in the morning would have the best cardiometabolic benefit, but reduced adherence would mitigate the benefit,” said Dr. Gabel, a nutrition researcher at the University of Illinois.
‘Meeting people where they’re at’
“We can have a larger public health impact by meeting people where they’re at. People should position their eating window where it best fits so they can achieve calorie restriction without even knowing it,” Dr. Gabel advised.
She cited a report as evidence that most people prefer a later eating window. The report reviewed observational data from nearly 800,000 people who used either of two different TRE phone apps. The data showed that most people opted to start their daily eating during 11:00 AM-1:00 PM, and then stop during 6:00 PM-8:00 PM.
“TRE will not solve all of our obesity problems, but it’s a good place to start,” Dr. Gabel declared.
For people who include dinner at a typical evening time in their TRE window, a key message is that “dinner is your last food of the day. There’s no snacking later,” said Dr. Chow.
“The biggest challenge is adherence,” said Dr. Peterson. “Fewer people want to do TRE than you think. We know that calorie restriction works. We just need a way for people to do it,” and for at least some people, TRE is that way. While no evidence clearly shows that 8 hours is the best eating-window duration, “we think 8 hours is a good sweet-spot for motivated people,” she said.
Sparser data on TRE in people with T2D
Fewer studies have examined the impact of TRE on glycemic control, insulin sensitivity, and related effects in people with type 2 diabetes. According to Dr. Peterson, published reports currently include two randomized controlled studies and three single-arm studies in people with type 2 diabetes and an additional two studies in people with prediabetes.
The largest of these reports randomized 120 adults in China with type 2 diabetes and overweight to TRE using a 10-hour eating window (8:00 AM-6:00 PM) or unrestricted eating for 12 weeks. By the end of the study, those on the TRE regimen had an average reduction in their hemoglobin A1c from baseline that was 0.88 percentage points greater than among the controls, and the TRE arm had also lost an average of nearly 2.15 kg more from baseline than the controls.
Dr. Peterson highlighted the importance of expanding research using TRE in people with type 2 diabetes.
Dr. Peterson and Dr. Gabel report no relevant financial relationships. Dr. Chow has received research support from Dexcom.
A version of this article first appeared on Medscape.com.
FROM ADA 2023
Pandemic blamed for failed trial of inhaled antibiotic
NEW YORK – When data were combined from two parallel phase 3 bronchiectasis treatment trials, inhaled colistimethate sodium failed to significantly reduce the rate of exacerbations associated with Pseudomonas aeruginosa infection, but the disparity in the findings from the two trials, presented at the 6th World Bronchiectasis & NTM Conference (WBC) 2023, strongly suggests that this therapy is effective after all.
“The totality of the evidence supports a consistent and clinically meaningful benefit [of this therapy] outside of pandemic conditions,” reported Charles Haworth, MD, director, Cambridge Centre for Lung Infection, Royal Papworth Hospital, Cambridge, England.
The key phrase is “outside of pandemic conditions.” PROMIS I, which was fully enrolled before the COVID-19 pandemic descended, associated the inhaled therapy with highly significant benefits. PROMIS II, which was initiated later and enrolled 40% of its participants during the pandemic, did not.
The difference between these two trials, which were essentially identical, was the timing, according to Dr. Haworth. By starting later, PROMIS II caught the onset of the pandemic, which he believes introduced numerous problems that defeated the opportunity to show an advantage for the inhaled antibiotic.
Injectable colistimethate sodium, a decades-old formulation of colistin, is already approved in the United States for gram-negative infections and is considered helpful even in challenging diseases, such as cystic fibrosis. Positive results from a phase 2 trial with inhaled colistimethate sodium in bronchiectasis patients with P. aeruginosa infection provided the rationale for the phase 3 PROMIS program.
The key entry criterion of PROMIS I and PROMIS II, each with nearly 90 participating study sites, was a history of bronchiectasis and ≥ two P. aeruginosa infections requiring oral therapy or ≥ 1 infection requiring intravenous therapy in the prior 12 months. Patients were randomly assigned to receive colistimethate sodium delivered in the proprietary I-neb nebulizer (CMS I-neb) or a matching placebo.
On the primary endpoint of annualized rate of exacerbations, the figures per year were 0.58 for CMS I-neb and 0.95 for placebo in the PROMIS I trial. This produced a rate ratio of 0.65, signaling a significant 35% (P = .00101) reduction in risk. In PROMIS II, the annualized rates of exacerbation were essentially identical in the experimental and control arms (0.089 vs. 0.088; P = .97).
With “no signal of benefit” in the PROMIS II trial, the numerical advantage of CMS I-neb for the combined data did not reach statistical significance, Dr. Haworth reported.
Other endpoints told the same story. For example, the time to first exacerbation was reduced by 41% in PROMIS I (HR, 0.59; P = .0074) but was not reduced significantly (P = .603) in PROMIS II. In PROMIS I, there was a nearly 60% reduction in the risk of severe exacerbations associated with CMS I-neb, but the risk ratio of severe infections was slightly but not significantly higher on CMS I-neb in PROMIS II.
There were signals of benefit in PROMIS II. For example, the reductions in P. aeruginosa density were similar in the two studies (P < .00001 in both), and assessment with the Severe Exacerbations and Quality of Life (SQOL) tool associated CMS I-neb with end-of-study improvement in QOL for the experimental arm in both studies.
While Dr. Haworth acknowledged that he recognizes the “issues of post hoc analysis with any data,” obscuring a benefit that would have been otherwise shown.
Besides the dramatic reduction in rates of hospitalization during the pandemic, an obstacle for showing differences in exacerbations, and other COVID-related factors with the potential to skew results, Dr. Haworth also provided several sets of objective data to make his point.
Most importantly, Dr. Haworth and his coinvestigators conducted a meta-analysis that combined data from the phase 2 trial, data from PROMIS I, and data from the patients enrolled in PROMIS II prior to the COVID pandemic. In this analysis the rate ratio for annualized exacerbations was a “pretty impressive” 0.65 favoring CMS I-neb. Moreover, in contrast to data from the PROMIS II patients enrolled during the COVID pandemic, the other three sets of data were “remarkably consistent.”
If PROMIS II data collected from patients enrolled during COVID are compared with the other sets of data, they are “the clear outlier,” he asserted.
Many guidelines in Europe, including those from the European Respiratory Society and the British Thoracic Society, already recommend inhaled colistin in patients with bronchiectasis for the treatment of P. aeruginosa. Although Dr. Haworth believes that the preponderance of controlled data now argue that CMS I-neb is effective as well as safe (adverse events in the experimental and placebo arms of PROMIS I and II were similar), he is not sure what steps will be taken to confirm a benefit to regulatory authorities. According to Dr. Haworth, there are no approved inhaled antibiotics in the United States.
Referring to Zambon, which funded the trials and is developing CMS I-neb, Dr. Haworth said, “This will be a company decision. There are some logistical hurdles to doing another trial.”
Not least of these hurdles is that clinicians and patients already consider inhalational antibiotics in general and inhaled colistin specifically to be effective for several types of infections, including P. aeruginosa, according to Eva Polverino, MD, PhD, a pulmonologist associated with the Hospital Clinic of Barcelona. She said that these drugs are already a standard of care in her own country as well as in many other countries in Europe.
“There has been a loss of equipoise needed to conduct a randomized placebo-controlled trial,” Dr. Polverino said. In her opinion, the U.S. FDA “should start thinking of other pathways to approval.” She thinks that enrollment in a placebo-controlled trial is no longer appropriate.
Dr. Haworth and Dr. Polverino have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
NEW YORK – When data were combined from two parallel phase 3 bronchiectasis treatment trials, inhaled colistimethate sodium failed to significantly reduce the rate of exacerbations associated with Pseudomonas aeruginosa infection, but the disparity in the findings from the two trials, presented at the 6th World Bronchiectasis & NTM Conference (WBC) 2023, strongly suggests that this therapy is effective after all.
“The totality of the evidence supports a consistent and clinically meaningful benefit [of this therapy] outside of pandemic conditions,” reported Charles Haworth, MD, director, Cambridge Centre for Lung Infection, Royal Papworth Hospital, Cambridge, England.
The key phrase is “outside of pandemic conditions.” PROMIS I, which was fully enrolled before the COVID-19 pandemic descended, associated the inhaled therapy with highly significant benefits. PROMIS II, which was initiated later and enrolled 40% of its participants during the pandemic, did not.
The difference between these two trials, which were essentially identical, was the timing, according to Dr. Haworth. By starting later, PROMIS II caught the onset of the pandemic, which he believes introduced numerous problems that defeated the opportunity to show an advantage for the inhaled antibiotic.
Injectable colistimethate sodium, a decades-old formulation of colistin, is already approved in the United States for gram-negative infections and is considered helpful even in challenging diseases, such as cystic fibrosis. Positive results from a phase 2 trial with inhaled colistimethate sodium in bronchiectasis patients with P. aeruginosa infection provided the rationale for the phase 3 PROMIS program.
The key entry criterion of PROMIS I and PROMIS II, each with nearly 90 participating study sites, was a history of bronchiectasis and ≥ two P. aeruginosa infections requiring oral therapy or ≥ 1 infection requiring intravenous therapy in the prior 12 months. Patients were randomly assigned to receive colistimethate sodium delivered in the proprietary I-neb nebulizer (CMS I-neb) or a matching placebo.
On the primary endpoint of annualized rate of exacerbations, the figures per year were 0.58 for CMS I-neb and 0.95 for placebo in the PROMIS I trial. This produced a rate ratio of 0.65, signaling a significant 35% (P = .00101) reduction in risk. In PROMIS II, the annualized rates of exacerbation were essentially identical in the experimental and control arms (0.089 vs. 0.088; P = .97).
With “no signal of benefit” in the PROMIS II trial, the numerical advantage of CMS I-neb for the combined data did not reach statistical significance, Dr. Haworth reported.
Other endpoints told the same story. For example, the time to first exacerbation was reduced by 41% in PROMIS I (HR, 0.59; P = .0074) but was not reduced significantly (P = .603) in PROMIS II. In PROMIS I, there was a nearly 60% reduction in the risk of severe exacerbations associated with CMS I-neb, but the risk ratio of severe infections was slightly but not significantly higher on CMS I-neb in PROMIS II.
There were signals of benefit in PROMIS II. For example, the reductions in P. aeruginosa density were similar in the two studies (P < .00001 in both), and assessment with the Severe Exacerbations and Quality of Life (SQOL) tool associated CMS I-neb with end-of-study improvement in QOL for the experimental arm in both studies.
While Dr. Haworth acknowledged that he recognizes the “issues of post hoc analysis with any data,” obscuring a benefit that would have been otherwise shown.
Besides the dramatic reduction in rates of hospitalization during the pandemic, an obstacle for showing differences in exacerbations, and other COVID-related factors with the potential to skew results, Dr. Haworth also provided several sets of objective data to make his point.
Most importantly, Dr. Haworth and his coinvestigators conducted a meta-analysis that combined data from the phase 2 trial, data from PROMIS I, and data from the patients enrolled in PROMIS II prior to the COVID pandemic. In this analysis the rate ratio for annualized exacerbations was a “pretty impressive” 0.65 favoring CMS I-neb. Moreover, in contrast to data from the PROMIS II patients enrolled during the COVID pandemic, the other three sets of data were “remarkably consistent.”
If PROMIS II data collected from patients enrolled during COVID are compared with the other sets of data, they are “the clear outlier,” he asserted.
Many guidelines in Europe, including those from the European Respiratory Society and the British Thoracic Society, already recommend inhaled colistin in patients with bronchiectasis for the treatment of P. aeruginosa. Although Dr. Haworth believes that the preponderance of controlled data now argue that CMS I-neb is effective as well as safe (adverse events in the experimental and placebo arms of PROMIS I and II were similar), he is not sure what steps will be taken to confirm a benefit to regulatory authorities. According to Dr. Haworth, there are no approved inhaled antibiotics in the United States.
Referring to Zambon, which funded the trials and is developing CMS I-neb, Dr. Haworth said, “This will be a company decision. There are some logistical hurdles to doing another trial.”
Not least of these hurdles is that clinicians and patients already consider inhalational antibiotics in general and inhaled colistin specifically to be effective for several types of infections, including P. aeruginosa, according to Eva Polverino, MD, PhD, a pulmonologist associated with the Hospital Clinic of Barcelona. She said that these drugs are already a standard of care in her own country as well as in many other countries in Europe.
“There has been a loss of equipoise needed to conduct a randomized placebo-controlled trial,” Dr. Polverino said. In her opinion, the U.S. FDA “should start thinking of other pathways to approval.” She thinks that enrollment in a placebo-controlled trial is no longer appropriate.
Dr. Haworth and Dr. Polverino have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
NEW YORK – When data were combined from two parallel phase 3 bronchiectasis treatment trials, inhaled colistimethate sodium failed to significantly reduce the rate of exacerbations associated with Pseudomonas aeruginosa infection, but the disparity in the findings from the two trials, presented at the 6th World Bronchiectasis & NTM Conference (WBC) 2023, strongly suggests that this therapy is effective after all.
“The totality of the evidence supports a consistent and clinically meaningful benefit [of this therapy] outside of pandemic conditions,” reported Charles Haworth, MD, director, Cambridge Centre for Lung Infection, Royal Papworth Hospital, Cambridge, England.
The key phrase is “outside of pandemic conditions.” PROMIS I, which was fully enrolled before the COVID-19 pandemic descended, associated the inhaled therapy with highly significant benefits. PROMIS II, which was initiated later and enrolled 40% of its participants during the pandemic, did not.
The difference between these two trials, which were essentially identical, was the timing, according to Dr. Haworth. By starting later, PROMIS II caught the onset of the pandemic, which he believes introduced numerous problems that defeated the opportunity to show an advantage for the inhaled antibiotic.
Injectable colistimethate sodium, a decades-old formulation of colistin, is already approved in the United States for gram-negative infections and is considered helpful even in challenging diseases, such as cystic fibrosis. Positive results from a phase 2 trial with inhaled colistimethate sodium in bronchiectasis patients with P. aeruginosa infection provided the rationale for the phase 3 PROMIS program.
The key entry criterion of PROMIS I and PROMIS II, each with nearly 90 participating study sites, was a history of bronchiectasis and ≥ two P. aeruginosa infections requiring oral therapy or ≥ 1 infection requiring intravenous therapy in the prior 12 months. Patients were randomly assigned to receive colistimethate sodium delivered in the proprietary I-neb nebulizer (CMS I-neb) or a matching placebo.
On the primary endpoint of annualized rate of exacerbations, the figures per year were 0.58 for CMS I-neb and 0.95 for placebo in the PROMIS I trial. This produced a rate ratio of 0.65, signaling a significant 35% (P = .00101) reduction in risk. In PROMIS II, the annualized rates of exacerbation were essentially identical in the experimental and control arms (0.089 vs. 0.088; P = .97).
With “no signal of benefit” in the PROMIS II trial, the numerical advantage of CMS I-neb for the combined data did not reach statistical significance, Dr. Haworth reported.
Other endpoints told the same story. For example, the time to first exacerbation was reduced by 41% in PROMIS I (HR, 0.59; P = .0074) but was not reduced significantly (P = .603) in PROMIS II. In PROMIS I, there was a nearly 60% reduction in the risk of severe exacerbations associated with CMS I-neb, but the risk ratio of severe infections was slightly but not significantly higher on CMS I-neb in PROMIS II.
There were signals of benefit in PROMIS II. For example, the reductions in P. aeruginosa density were similar in the two studies (P < .00001 in both), and assessment with the Severe Exacerbations and Quality of Life (SQOL) tool associated CMS I-neb with end-of-study improvement in QOL for the experimental arm in both studies.
While Dr. Haworth acknowledged that he recognizes the “issues of post hoc analysis with any data,” obscuring a benefit that would have been otherwise shown.
Besides the dramatic reduction in rates of hospitalization during the pandemic, an obstacle for showing differences in exacerbations, and other COVID-related factors with the potential to skew results, Dr. Haworth also provided several sets of objective data to make his point.
Most importantly, Dr. Haworth and his coinvestigators conducted a meta-analysis that combined data from the phase 2 trial, data from PROMIS I, and data from the patients enrolled in PROMIS II prior to the COVID pandemic. In this analysis the rate ratio for annualized exacerbations was a “pretty impressive” 0.65 favoring CMS I-neb. Moreover, in contrast to data from the PROMIS II patients enrolled during the COVID pandemic, the other three sets of data were “remarkably consistent.”
If PROMIS II data collected from patients enrolled during COVID are compared with the other sets of data, they are “the clear outlier,” he asserted.
Many guidelines in Europe, including those from the European Respiratory Society and the British Thoracic Society, already recommend inhaled colistin in patients with bronchiectasis for the treatment of P. aeruginosa. Although Dr. Haworth believes that the preponderance of controlled data now argue that CMS I-neb is effective as well as safe (adverse events in the experimental and placebo arms of PROMIS I and II were similar), he is not sure what steps will be taken to confirm a benefit to regulatory authorities. According to Dr. Haworth, there are no approved inhaled antibiotics in the United States.
Referring to Zambon, which funded the trials and is developing CMS I-neb, Dr. Haworth said, “This will be a company decision. There are some logistical hurdles to doing another trial.”
Not least of these hurdles is that clinicians and patients already consider inhalational antibiotics in general and inhaled colistin specifically to be effective for several types of infections, including P. aeruginosa, according to Eva Polverino, MD, PhD, a pulmonologist associated with the Hospital Clinic of Barcelona. She said that these drugs are already a standard of care in her own country as well as in many other countries in Europe.
“There has been a loss of equipoise needed to conduct a randomized placebo-controlled trial,” Dr. Polverino said. In her opinion, the U.S. FDA “should start thinking of other pathways to approval.” She thinks that enrollment in a placebo-controlled trial is no longer appropriate.
Dr. Haworth and Dr. Polverino have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM WBC 2023
Offering HPV vaccine at age 9 linked to greater series completion
BALTIMORE – , according to a retrospective cohort study of commercially insured youth presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The research was published ahead of print in Human Vaccines and Immunotherapeutics.
Changing attitudes
“These findings are novel because they emphasize starting at age 9, and that is different than prior studies that emphasize bundling of these vaccines,” Kevin Ault, MD, professor and chair of the department of obstetrics and gynecology at Western Michigan University Homer Stryker MD School of Medicine and a former member of the CDC’s Advisory Committee on Immunization Practices, said in an interview.
Dr. Ault was not involved in the study but noted that these findings support the AAP’s recommendation to start the HPV vaccine series at age 9. The Centers for Disease Control and Prevention currently recommends giving the first dose of the HPV vaccine at ages 11-12, at the same time as the Tdap and meningitis vaccines. This recommendation to “bundle” the HPV vaccine with the Tdap and meningitis vaccines aims to facilitate provider-family discussion about the HPV vaccine, ideally reducing parent hesitancy and concerns about the vaccines. Multiple studies have shown improved HPV vaccine uptake when providers offer the HPV vaccine at the same time as the Tdap and meningococcal vaccines.
However, shifts in parents’ attitudes have occurred toward the HPV vaccine since those studies on bundling: Concerns about sexual activity have receded while concerns about safety remain high. The American Academy of Pediatrics and the American Cancer Society both advise starting the HPV vaccine series at age 9, based on evidence showing that more children complete the series when they get the first shot before age 11 compared to getting it at 11 or 12.
“The bundling was really to vaccinate people by the age of 13, thinking that onset of sexual activity was after that,” study author Sidika Kajtezovic, MD, a resident at Boston Medical Center and Boston University Obstetrics and Gynecology, said in an interview. But Dr. Kajtezovic said she delivers babies for 13-year-old patients. “Kids are having sex sooner or sooner.” It’s also clear that using the bundling strategy is not making up the entire gap right now: Ninety percent of children are getting the meningococcal vaccine while only 49% are getting the HPV vaccine, Dr. Kajtezovic pointed out. “There’s a disconnect happening there, even with the bundling,” she said.
Debundling vaccines
Dr. Kajtezovic and her colleagues used a national database of employee-sponsored health insurance to analyze the records of 100,857 children who were continuously enrolled in a plan from age 9 in 2015 to age 13 in 2019. They calculated the odds of children completing the HPV vaccine series based on whether they started the series before, at the same time as, or after the Tdap vaccination.
Youth who received the HPV vaccine before their Tdap vaccine had 38% greater odds of completing the series – getting both doses – than did those who received the HPV vaccine at the same time as the Tdap vaccine. Meanwhile, in line with prior evidence, those who got the first HPV dose after their Tdap were less likely – 68% lower odds – to complete the two- or three-dose (if starting above age 14) series.
The researchers identified several other factors that were linked to completing the HPV vaccine series. Females had greater odds than did males of completing the series, as did those living in urban, rather than rural, areas. Other factors associated with completing the series included living in the Northeast United States and receiving primary care from a pediatrician rather than a family medicine physician.
Timing is important
“I am encouraged by the findings of this study,” Dr. Ault said in an interview. “However, I would have liked the authors to expand the age range a bit higher. There are data that continuing to discuss the HPV vaccine with parents and teens will increase uptake into the later teen years.”
One challenge is that research shows attendance at primary care visits declines in older adolescence. Since there is no second Tdap or meningitis shot, families need to return for the second HPV vaccine dose after those shots, though they could get the second dose at the same time as other two vaccines if they receive the first dose before age 11. There’s also evidence suggesting that providers find conversations about the HPV vaccine easier when sexual activity is not the focus.
“I often feel that, before a child reaches adolescence, they’re almost, in a way, not sexualized yet, so talking about cancer prevention for an 8- or 9-year-old sometimes sounds a little different to patients versus protecting your 12-year-old, who’s starting to go through adolescence and developing breasts” and other signs of puberty, Dr. Kajtezovic said. Keeping the focus of HPV vaccine discussions on cancer prevention also allows providers to point out the protection against anal cancer, vulvar cancer, vaginal cancer, and head and neck cancer. “They are horrible, and even if they’re treatable, they’re often very hard to treat at an advanced stage,” Dr. Kajtezovic said. “The surgery required is so life disabling and disfiguring.”
The HPV Roundtable advises continuing bundling at practices having success with it but encourages practices to consider earlier vaccination if their uptake is lagging. Quality improvement initiatives, such as earlier electronic medical record prompts and multi-level interventions in pediatric practices, have shown substantial increases in HPV vaccine uptake at 9 and 10 years old. One survey in 2021 found that one in five primary care providers already routinely recommend the HPV vaccine at ages 9-10, and nearly half of others would consider doing so.
“My hope is in the next few years, when [the CDC] refreshes their vaccine recommendations, that they will either unbundle it or move the bar a few years earlier so that you can initiate it to encourage earlier initiation,” Dr. Kajtezovic said.
Dr. Ault had no other disclosures besides prior service on ACIP. Dr. Kajtezovic had no disclosures.
BALTIMORE – , according to a retrospective cohort study of commercially insured youth presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The research was published ahead of print in Human Vaccines and Immunotherapeutics.
Changing attitudes
“These findings are novel because they emphasize starting at age 9, and that is different than prior studies that emphasize bundling of these vaccines,” Kevin Ault, MD, professor and chair of the department of obstetrics and gynecology at Western Michigan University Homer Stryker MD School of Medicine and a former member of the CDC’s Advisory Committee on Immunization Practices, said in an interview.
Dr. Ault was not involved in the study but noted that these findings support the AAP’s recommendation to start the HPV vaccine series at age 9. The Centers for Disease Control and Prevention currently recommends giving the first dose of the HPV vaccine at ages 11-12, at the same time as the Tdap and meningitis vaccines. This recommendation to “bundle” the HPV vaccine with the Tdap and meningitis vaccines aims to facilitate provider-family discussion about the HPV vaccine, ideally reducing parent hesitancy and concerns about the vaccines. Multiple studies have shown improved HPV vaccine uptake when providers offer the HPV vaccine at the same time as the Tdap and meningococcal vaccines.
However, shifts in parents’ attitudes have occurred toward the HPV vaccine since those studies on bundling: Concerns about sexual activity have receded while concerns about safety remain high. The American Academy of Pediatrics and the American Cancer Society both advise starting the HPV vaccine series at age 9, based on evidence showing that more children complete the series when they get the first shot before age 11 compared to getting it at 11 or 12.
“The bundling was really to vaccinate people by the age of 13, thinking that onset of sexual activity was after that,” study author Sidika Kajtezovic, MD, a resident at Boston Medical Center and Boston University Obstetrics and Gynecology, said in an interview. But Dr. Kajtezovic said she delivers babies for 13-year-old patients. “Kids are having sex sooner or sooner.” It’s also clear that using the bundling strategy is not making up the entire gap right now: Ninety percent of children are getting the meningococcal vaccine while only 49% are getting the HPV vaccine, Dr. Kajtezovic pointed out. “There’s a disconnect happening there, even with the bundling,” she said.
Debundling vaccines
Dr. Kajtezovic and her colleagues used a national database of employee-sponsored health insurance to analyze the records of 100,857 children who were continuously enrolled in a plan from age 9 in 2015 to age 13 in 2019. They calculated the odds of children completing the HPV vaccine series based on whether they started the series before, at the same time as, or after the Tdap vaccination.
Youth who received the HPV vaccine before their Tdap vaccine had 38% greater odds of completing the series – getting both doses – than did those who received the HPV vaccine at the same time as the Tdap vaccine. Meanwhile, in line with prior evidence, those who got the first HPV dose after their Tdap were less likely – 68% lower odds – to complete the two- or three-dose (if starting above age 14) series.
The researchers identified several other factors that were linked to completing the HPV vaccine series. Females had greater odds than did males of completing the series, as did those living in urban, rather than rural, areas. Other factors associated with completing the series included living in the Northeast United States and receiving primary care from a pediatrician rather than a family medicine physician.
Timing is important
“I am encouraged by the findings of this study,” Dr. Ault said in an interview. “However, I would have liked the authors to expand the age range a bit higher. There are data that continuing to discuss the HPV vaccine with parents and teens will increase uptake into the later teen years.”
One challenge is that research shows attendance at primary care visits declines in older adolescence. Since there is no second Tdap or meningitis shot, families need to return for the second HPV vaccine dose after those shots, though they could get the second dose at the same time as other two vaccines if they receive the first dose before age 11. There’s also evidence suggesting that providers find conversations about the HPV vaccine easier when sexual activity is not the focus.
“I often feel that, before a child reaches adolescence, they’re almost, in a way, not sexualized yet, so talking about cancer prevention for an 8- or 9-year-old sometimes sounds a little different to patients versus protecting your 12-year-old, who’s starting to go through adolescence and developing breasts” and other signs of puberty, Dr. Kajtezovic said. Keeping the focus of HPV vaccine discussions on cancer prevention also allows providers to point out the protection against anal cancer, vulvar cancer, vaginal cancer, and head and neck cancer. “They are horrible, and even if they’re treatable, they’re often very hard to treat at an advanced stage,” Dr. Kajtezovic said. “The surgery required is so life disabling and disfiguring.”
The HPV Roundtable advises continuing bundling at practices having success with it but encourages practices to consider earlier vaccination if their uptake is lagging. Quality improvement initiatives, such as earlier electronic medical record prompts and multi-level interventions in pediatric practices, have shown substantial increases in HPV vaccine uptake at 9 and 10 years old. One survey in 2021 found that one in five primary care providers already routinely recommend the HPV vaccine at ages 9-10, and nearly half of others would consider doing so.
“My hope is in the next few years, when [the CDC] refreshes their vaccine recommendations, that they will either unbundle it or move the bar a few years earlier so that you can initiate it to encourage earlier initiation,” Dr. Kajtezovic said.
Dr. Ault had no other disclosures besides prior service on ACIP. Dr. Kajtezovic had no disclosures.
BALTIMORE – , according to a retrospective cohort study of commercially insured youth presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The research was published ahead of print in Human Vaccines and Immunotherapeutics.
Changing attitudes
“These findings are novel because they emphasize starting at age 9, and that is different than prior studies that emphasize bundling of these vaccines,” Kevin Ault, MD, professor and chair of the department of obstetrics and gynecology at Western Michigan University Homer Stryker MD School of Medicine and a former member of the CDC’s Advisory Committee on Immunization Practices, said in an interview.
Dr. Ault was not involved in the study but noted that these findings support the AAP’s recommendation to start the HPV vaccine series at age 9. The Centers for Disease Control and Prevention currently recommends giving the first dose of the HPV vaccine at ages 11-12, at the same time as the Tdap and meningitis vaccines. This recommendation to “bundle” the HPV vaccine with the Tdap and meningitis vaccines aims to facilitate provider-family discussion about the HPV vaccine, ideally reducing parent hesitancy and concerns about the vaccines. Multiple studies have shown improved HPV vaccine uptake when providers offer the HPV vaccine at the same time as the Tdap and meningococcal vaccines.
However, shifts in parents’ attitudes have occurred toward the HPV vaccine since those studies on bundling: Concerns about sexual activity have receded while concerns about safety remain high. The American Academy of Pediatrics and the American Cancer Society both advise starting the HPV vaccine series at age 9, based on evidence showing that more children complete the series when they get the first shot before age 11 compared to getting it at 11 or 12.
“The bundling was really to vaccinate people by the age of 13, thinking that onset of sexual activity was after that,” study author Sidika Kajtezovic, MD, a resident at Boston Medical Center and Boston University Obstetrics and Gynecology, said in an interview. But Dr. Kajtezovic said she delivers babies for 13-year-old patients. “Kids are having sex sooner or sooner.” It’s also clear that using the bundling strategy is not making up the entire gap right now: Ninety percent of children are getting the meningococcal vaccine while only 49% are getting the HPV vaccine, Dr. Kajtezovic pointed out. “There’s a disconnect happening there, even with the bundling,” she said.
Debundling vaccines
Dr. Kajtezovic and her colleagues used a national database of employee-sponsored health insurance to analyze the records of 100,857 children who were continuously enrolled in a plan from age 9 in 2015 to age 13 in 2019. They calculated the odds of children completing the HPV vaccine series based on whether they started the series before, at the same time as, or after the Tdap vaccination.
Youth who received the HPV vaccine before their Tdap vaccine had 38% greater odds of completing the series – getting both doses – than did those who received the HPV vaccine at the same time as the Tdap vaccine. Meanwhile, in line with prior evidence, those who got the first HPV dose after their Tdap were less likely – 68% lower odds – to complete the two- or three-dose (if starting above age 14) series.
The researchers identified several other factors that were linked to completing the HPV vaccine series. Females had greater odds than did males of completing the series, as did those living in urban, rather than rural, areas. Other factors associated with completing the series included living in the Northeast United States and receiving primary care from a pediatrician rather than a family medicine physician.
Timing is important
“I am encouraged by the findings of this study,” Dr. Ault said in an interview. “However, I would have liked the authors to expand the age range a bit higher. There are data that continuing to discuss the HPV vaccine with parents and teens will increase uptake into the later teen years.”
One challenge is that research shows attendance at primary care visits declines in older adolescence. Since there is no second Tdap or meningitis shot, families need to return for the second HPV vaccine dose after those shots, though they could get the second dose at the same time as other two vaccines if they receive the first dose before age 11. There’s also evidence suggesting that providers find conversations about the HPV vaccine easier when sexual activity is not the focus.
“I often feel that, before a child reaches adolescence, they’re almost, in a way, not sexualized yet, so talking about cancer prevention for an 8- or 9-year-old sometimes sounds a little different to patients versus protecting your 12-year-old, who’s starting to go through adolescence and developing breasts” and other signs of puberty, Dr. Kajtezovic said. Keeping the focus of HPV vaccine discussions on cancer prevention also allows providers to point out the protection against anal cancer, vulvar cancer, vaginal cancer, and head and neck cancer. “They are horrible, and even if they’re treatable, they’re often very hard to treat at an advanced stage,” Dr. Kajtezovic said. “The surgery required is so life disabling and disfiguring.”
The HPV Roundtable advises continuing bundling at practices having success with it but encourages practices to consider earlier vaccination if their uptake is lagging. Quality improvement initiatives, such as earlier electronic medical record prompts and multi-level interventions in pediatric practices, have shown substantial increases in HPV vaccine uptake at 9 and 10 years old. One survey in 2021 found that one in five primary care providers already routinely recommend the HPV vaccine at ages 9-10, and nearly half of others would consider doing so.
“My hope is in the next few years, when [the CDC] refreshes their vaccine recommendations, that they will either unbundle it or move the bar a few years earlier so that you can initiate it to encourage earlier initiation,” Dr. Kajtezovic said.
Dr. Ault had no other disclosures besides prior service on ACIP. Dr. Kajtezovic had no disclosures.
AT ACOG 2023
Roflumilast cream appears safe, effective for children with psoriasis, researchers report
In patients aged 2-11 years, roflumilast cream was well tolerated and improved signs and symptoms of psoriasis over 4 weeks, according to results from a pair of phase two studies.
“Limited topical treatments are approved for children younger than 12 years old with psoriasis,” researchers led by Adelaide A. Hebert, MD, wrote in their abstract. The results were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.
Roflumilast cream 0.3% (Zoryve) is a once-daily, topical nonsteroidal treatment from Arcutis Biotherapeutics. A phosphodiesterase-4 inhibitor, it was approved by the Food and Drug Administration in 2022 for mild, moderate and severe psoriasis in individuals aged 12 and older, including intertriginous psoriasis.
For the analysis, Dr. Hebert, chief of pediatric dermatology at the University of Texas, Houston, and colleagues conducted two 4-week, phase 2, open-label safety studies of roflumilast cream 0.3%.
One, study 216, enrolled 10 children aged 2-5, and all but one were Black. The other, study 215, enrolled 20 children aged 6-11, and half were Black and nearly half were White. At baseline, patients had 2% or greater body surface area (BSA) involvement and an Investigator Global Assessment (IGA) score of at least mild.
Caregivers applied roflumilast cream to all affected areas once daily for 28 days. The researchers collected pharmacokinetic samples at week 2 and week 4. The primary endpoints were pharmacokinetic, safety, and tolerability.
Efficacy was evaluated as exploratory endpoints: An IGA of clear or almost clear plus a 2-grade or more improvement from baseline, a 50% or greater improvement and a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI-50 and PASI-75), a 4-point or greater reduction in the Worst Itch–Numeric Rating Scale (WI-NRS) in patients with a baseline score of 4 or greater, a mean change from baseline in BSA, and improvement in the Children’s Dermatology Life Quality Index (CDLQI).
At baseline, the mean BSA was similar for patients enrolled in studies 216 and 215 (9.6% and 8.8%, respectively), and 80% of all patients had baseline IGA of moderate. By week 2, the mean roflumilast and N-oxide predose plasma concentrations among patients in the younger group were 2.15 and 22.4 ng/mL, compared with 3.15 and 28.9 ng/mL among those in the older group. At week 4, the mean roflumilast and N-oxide predose concentrations were 2.04 and 15.8 ng/mL in the younger group (study 216), compared with 1.68 and 15.7 ng/mL in the older group (study 215).
As for efficacy, 90% and 40% of patients in studies 216 and 215 achieved IGA success at week 4, respectively, while 90% and 50% achieved PASI-75, 90% and 40% achieved WI-NRS success, and the mean BSA reductions at week 4 were 79.1% and 44.4%. Meanwhile, one younger patient in study 216 reported a treatment-emergent adverse event (TEAE) of headache, which was considered mild, while four older patients in study 215 reported 8 TEAEs, which were considered mild and ranged from back pain to nasal congestion.
“The rapid onset of action was surprising but exceedingly rewarding for the subjects enrolled in the study,” Dr. Hebert told this news organization after the meeting. “The PASI scores and itch scores were markedly improved at the end of the 4-week clinical trial. Patient and parents alike were pleased to use a steroid-free option with once-daily application and rapid onset of action to help control plaque psoriasis.”
In the poster abstract, she and her coauthors concluded that “under maximal use conditions in children aged 2-11 years, roflumilast cream 0.3% was well tolerated and improved signs and symptoms of psoriasis with measured improvements in IGA score, PASI score, BSA involvement, CDLQI, and WI-NRS. Overall, pharmacokinetics, safety, tolerability, and efficacy in patients aged 2-11 years were consistent with prior results in adults and adolescents.”
The study was funded by Arcutis Biotherapeutics. Dr. Hebert reported that she is an investigator for Arcutis. About half the coauthors are employees of Arcutis, and the other half disclosed grants, research funding and/or honoraria from the company. Research grants from the company for this study were paid to the McGovern Medical School at the University of Texas.
In patients aged 2-11 years, roflumilast cream was well tolerated and improved signs and symptoms of psoriasis over 4 weeks, according to results from a pair of phase two studies.
“Limited topical treatments are approved for children younger than 12 years old with psoriasis,” researchers led by Adelaide A. Hebert, MD, wrote in their abstract. The results were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.
Roflumilast cream 0.3% (Zoryve) is a once-daily, topical nonsteroidal treatment from Arcutis Biotherapeutics. A phosphodiesterase-4 inhibitor, it was approved by the Food and Drug Administration in 2022 for mild, moderate and severe psoriasis in individuals aged 12 and older, including intertriginous psoriasis.
For the analysis, Dr. Hebert, chief of pediatric dermatology at the University of Texas, Houston, and colleagues conducted two 4-week, phase 2, open-label safety studies of roflumilast cream 0.3%.
One, study 216, enrolled 10 children aged 2-5, and all but one were Black. The other, study 215, enrolled 20 children aged 6-11, and half were Black and nearly half were White. At baseline, patients had 2% or greater body surface area (BSA) involvement and an Investigator Global Assessment (IGA) score of at least mild.
Caregivers applied roflumilast cream to all affected areas once daily for 28 days. The researchers collected pharmacokinetic samples at week 2 and week 4. The primary endpoints were pharmacokinetic, safety, and tolerability.
Efficacy was evaluated as exploratory endpoints: An IGA of clear or almost clear plus a 2-grade or more improvement from baseline, a 50% or greater improvement and a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI-50 and PASI-75), a 4-point or greater reduction in the Worst Itch–Numeric Rating Scale (WI-NRS) in patients with a baseline score of 4 or greater, a mean change from baseline in BSA, and improvement in the Children’s Dermatology Life Quality Index (CDLQI).
At baseline, the mean BSA was similar for patients enrolled in studies 216 and 215 (9.6% and 8.8%, respectively), and 80% of all patients had baseline IGA of moderate. By week 2, the mean roflumilast and N-oxide predose plasma concentrations among patients in the younger group were 2.15 and 22.4 ng/mL, compared with 3.15 and 28.9 ng/mL among those in the older group. At week 4, the mean roflumilast and N-oxide predose concentrations were 2.04 and 15.8 ng/mL in the younger group (study 216), compared with 1.68 and 15.7 ng/mL in the older group (study 215).
As for efficacy, 90% and 40% of patients in studies 216 and 215 achieved IGA success at week 4, respectively, while 90% and 50% achieved PASI-75, 90% and 40% achieved WI-NRS success, and the mean BSA reductions at week 4 were 79.1% and 44.4%. Meanwhile, one younger patient in study 216 reported a treatment-emergent adverse event (TEAE) of headache, which was considered mild, while four older patients in study 215 reported 8 TEAEs, which were considered mild and ranged from back pain to nasal congestion.
“The rapid onset of action was surprising but exceedingly rewarding for the subjects enrolled in the study,” Dr. Hebert told this news organization after the meeting. “The PASI scores and itch scores were markedly improved at the end of the 4-week clinical trial. Patient and parents alike were pleased to use a steroid-free option with once-daily application and rapid onset of action to help control plaque psoriasis.”
In the poster abstract, she and her coauthors concluded that “under maximal use conditions in children aged 2-11 years, roflumilast cream 0.3% was well tolerated and improved signs and symptoms of psoriasis with measured improvements in IGA score, PASI score, BSA involvement, CDLQI, and WI-NRS. Overall, pharmacokinetics, safety, tolerability, and efficacy in patients aged 2-11 years were consistent with prior results in adults and adolescents.”
The study was funded by Arcutis Biotherapeutics. Dr. Hebert reported that she is an investigator for Arcutis. About half the coauthors are employees of Arcutis, and the other half disclosed grants, research funding and/or honoraria from the company. Research grants from the company for this study were paid to the McGovern Medical School at the University of Texas.
In patients aged 2-11 years, roflumilast cream was well tolerated and improved signs and symptoms of psoriasis over 4 weeks, according to results from a pair of phase two studies.
“Limited topical treatments are approved for children younger than 12 years old with psoriasis,” researchers led by Adelaide A. Hebert, MD, wrote in their abstract. The results were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.
Roflumilast cream 0.3% (Zoryve) is a once-daily, topical nonsteroidal treatment from Arcutis Biotherapeutics. A phosphodiesterase-4 inhibitor, it was approved by the Food and Drug Administration in 2022 for mild, moderate and severe psoriasis in individuals aged 12 and older, including intertriginous psoriasis.
For the analysis, Dr. Hebert, chief of pediatric dermatology at the University of Texas, Houston, and colleagues conducted two 4-week, phase 2, open-label safety studies of roflumilast cream 0.3%.
One, study 216, enrolled 10 children aged 2-5, and all but one were Black. The other, study 215, enrolled 20 children aged 6-11, and half were Black and nearly half were White. At baseline, patients had 2% or greater body surface area (BSA) involvement and an Investigator Global Assessment (IGA) score of at least mild.
Caregivers applied roflumilast cream to all affected areas once daily for 28 days. The researchers collected pharmacokinetic samples at week 2 and week 4. The primary endpoints were pharmacokinetic, safety, and tolerability.
Efficacy was evaluated as exploratory endpoints: An IGA of clear or almost clear plus a 2-grade or more improvement from baseline, a 50% or greater improvement and a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI-50 and PASI-75), a 4-point or greater reduction in the Worst Itch–Numeric Rating Scale (WI-NRS) in patients with a baseline score of 4 or greater, a mean change from baseline in BSA, and improvement in the Children’s Dermatology Life Quality Index (CDLQI).
At baseline, the mean BSA was similar for patients enrolled in studies 216 and 215 (9.6% and 8.8%, respectively), and 80% of all patients had baseline IGA of moderate. By week 2, the mean roflumilast and N-oxide predose plasma concentrations among patients in the younger group were 2.15 and 22.4 ng/mL, compared with 3.15 and 28.9 ng/mL among those in the older group. At week 4, the mean roflumilast and N-oxide predose concentrations were 2.04 and 15.8 ng/mL in the younger group (study 216), compared with 1.68 and 15.7 ng/mL in the older group (study 215).
As for efficacy, 90% and 40% of patients in studies 216 and 215 achieved IGA success at week 4, respectively, while 90% and 50% achieved PASI-75, 90% and 40% achieved WI-NRS success, and the mean BSA reductions at week 4 were 79.1% and 44.4%. Meanwhile, one younger patient in study 216 reported a treatment-emergent adverse event (TEAE) of headache, which was considered mild, while four older patients in study 215 reported 8 TEAEs, which were considered mild and ranged from back pain to nasal congestion.
“The rapid onset of action was surprising but exceedingly rewarding for the subjects enrolled in the study,” Dr. Hebert told this news organization after the meeting. “The PASI scores and itch scores were markedly improved at the end of the 4-week clinical trial. Patient and parents alike were pleased to use a steroid-free option with once-daily application and rapid onset of action to help control plaque psoriasis.”
In the poster abstract, she and her coauthors concluded that “under maximal use conditions in children aged 2-11 years, roflumilast cream 0.3% was well tolerated and improved signs and symptoms of psoriasis with measured improvements in IGA score, PASI score, BSA involvement, CDLQI, and WI-NRS. Overall, pharmacokinetics, safety, tolerability, and efficacy in patients aged 2-11 years were consistent with prior results in adults and adolescents.”
The study was funded by Arcutis Biotherapeutics. Dr. Hebert reported that she is an investigator for Arcutis. About half the coauthors are employees of Arcutis, and the other half disclosed grants, research funding and/or honoraria from the company. Research grants from the company for this study were paid to the McGovern Medical School at the University of Texas.
FROM SPD 2023
Free teledermatology clinic helps underserved patients initiate AD care
A in other underserved areas in the United States.
Washington, D.C., has “staggering health disparities that are among the largest in the country,” and Ward 8 and surrounding areas in the southeastern part of the city are “dermatology deserts,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who started the program in 2021 with a pilot project. Dr. Friedman spoke about the project, which has since been expanded to include alopecia areata, at the Revolutionizing Atopic Dermatitis conference in April and in an interview after the meeting.
Patients who attend the clinics – held at the Temple of Praise Church in a residential area of Ward 8, a predominantly Black community with a 30% poverty rate – are entered into the GW Medical Faculty Associates medical records system and educated on telemedicine best practices (such as not having light behind them during a session) and how to use telemedicine with their own device.
Those with AD who participate learn about the condition through an image-rich poster showing how it appears in various skin tones, handouts, National Eczema Association films, and discussion with medical students who staff the clinics under Dr. Friedman’s on-site supervision. Participants with alopecia areata similarly can view a poster and converse about the condition.
Patients then have a free 20-minute telehealth visit with a GWU dermatology resident in a private room, and a medical student volunteer nearby to assist with the technology if needed. They leave with a treatment plan, which often includes prescriptions, and a follow-up telemedicine appointment.
The program “is meant to be a stepping point for initiating care ... to set someone up for success for recurrent telehealth visits in the future” and for treatment before symptoms become too severe, Dr. Friedman said in an interview. “We want to demystify telemedicine and educate on the disease state and dispel myths ... so the patient understands why it’s happening” and how it can be treated.
The pilot project, funded with a grant from Pfizer, involved five 2-hour clinics held on Mondays from 4 p.m. to 6 p.m., that together served almost 50 adult and pediatric patients. Grants from Pfizer and Eli Lilly enabled additional clinics in the spring of 2023 and into the summer. And in June, GWU and Pfizer announced a $1 million national grant program focused on broad implementation of what they’ve coined the “Teledermatology Help Desk Clinic” model.
Practices or organizations that secure grants will utilize GWU’s experience and meet with an advisory council of experts in dermatology telemedicine and community advocacy. Having a “long-term plan” and commitment to sustainability is an important element of the model, said Dr. Friedman, who is chairing the grant program.
Patients deem clinic ‘extremely’ helpful
As one of the most prevalent skin disorders – and one with a documented history of elevated risk for specific populations – AD was a good starting point for the teledermatology clinic program. Patients who identify as Black have a higher incidence and prevalence of AD than those who identify as White and Hispanic, and they tend to have more severe disease. Yet they account for fewer visits to dermatologists for AD.
One cross-sectional study of about 3,500 adults in the United States with AD documented that racial/ethnic and socioeconomic disparities reduce outpatient utilization of AD care and increase urgent care and hospital utilization. And in a longitudinal cohort study of children in the United States with AD, Black children with poorly controlled AD were significantly less likely than White children to see a dermatologist.
Like other programs, the GWU department of dermatology had pivoted to telehealth in 2020, and a published survey of patients who attended telehealth appointments during the early part of the pandemic showed that it was generally well liked – and not only for social distancing, but for time efficiency and because transportation was not needed. Only 10% of the 168 patients who completed the survey (out of 894 asked) reported they were unlikely to undertake another telehealth visit. For 10%, eczema was the reason for the visit.
However, only 1% of the survey respondents were from Ward 8, which “begged the question, did those who really need access know this was an option?” Dr. Friedman said at the RAD meeting. He wondered whether there was not only a dermatology desert in Ward 8, but a “technology desert” as well.
Findings from a patient satisfaction survey taken at the end of the pilot program are encouraging, Dr. Friedman said. While data on follow-up visits has not been collected yet, “what I do now have a sense of” is that “the entry point [afforded by the clinics] changed the course in terms of patients’ understanding of the disease and how they feel about its management.”
About 94% of survey respondents indicated the clinic was “extremely” helpful and the remainder said it was “very” helpful; 90% said telehealth significantly changed how they will manage their condition; and 97% said it is “extremely” important to continue the clinics. The majority of patients – 70% – indicated they did not have a dermatologist.
Education about AD at the clinics covers moisturizers/emollients, bathing habits, soaps and detergents, trigger avoidance, and the role of stress and environmental factors in disease exacerbation. Trade samples of moisturizers, mild cleansers, and other products have increasingly been available.
For prescriptions of topical steroids and other commonly prescribed medications, Dr. Friedman and associates combed GoodRx for coupons and surveyed local pharmacies for self-pay pricing to identify least expensive options. Patients with AD who were deemed likely candidates for more advanced therapies in the future were educated about these possibilities.
Alopecia areata
The addition of alopecia areata drew patients with other forms of hair loss as well, but “we weren’t going to turn anyone away who did not have that specific autoimmune form of hair loss,” Dr. Friedman said. Depending on the diagnosis, prescriptions were written for minoxidil and 5-alpha reductase inhibitors.
Important for follow-up is GWU’s acceptance of Medicaid and the availability of both a sliding scale for self-pay and services that assist patients in registering for Medicaid and, if eligible, other insurance plans.
Building partnerships, earning trust
Establishment of the teledermatology clinic program took legwork and relationship building. “You can’t just show up. That’s not enough,” said Dr. Friedman, who also directs the dermatology residency program at GWU. “You have to show through action and through investment of time and energy that you are legitimate, that you’re really there for the long haul.”
Dr. Friedman had assistance from the Rodham Institute, which was established at GWU (and until recently was housed there) and has a history of engagement with local stakeholders such as community centers, church leadership, politicians, and others in the Washington area. He was put in touch with Bishop Deborah Webb at the Temple of Praise Church, a community pillar in Ward 8, and from there “it was a courtship,” he said, with trust to be built and logistics to be worked out. (Budgets for the clinics, he noted, have included compensation to the church and gift cards for church volunteers who are present at the clinics.)
In the meantime, medical student volunteers from GWU, Howard University, and Georgetown University were trained in telemedicine and attended a “boot camp” on AD “so they’d be able to talk with anyone about it,” Dr. Friedman said.
Advertising “was a learning experience,” he said, and was ultimately multipronged, involving church service announcements, flyers, and, most importantly, Facebook and Instagram advertisements. (People were asked to call a dedicated phone line to schedule an appointment and were invited to register in the GW Medical Faculty Associates records system, though walk-ins to the clinics were still welcomed.)
In a comment, Misty Eleryan, MD, MS, a Mohs micrographic surgeon and dermatologist in Santa Monica, Calif., said dermatology deserts are often found in rural areas and/or areas “with a higher population of marginalized communities, such as Black, Brown, or poorer individuals” – communities that tend to rely on care from urgent care or ED physicians who are unaware of how skin conditions present on darker skin tones.
Programs that educate patients about various presentations of skin conditions are helpful not only for the patients themselves, but could also enable them to help friends, family members, and colleagues, said Dr. Eleryan, who did her residency training at GWU.
“Access,” she noted, is more than just physical access to a person, place, or thing. Referring to a “five A’s” framework described several decades ago, Dr. Eleryan said access to care is characterized by affordability, availability (extent to which the physician has the requisite resources, such as personnel and technology, to meet the patient’s needs), accessibility (geographic), accommodation (extent to which the physician can meet the patient’s constraints and preferences – such as hours of operation, how communications are handled, ability to receive care without prior appointments), and acceptability (extent to which the patient is comfortable with the “more immutable characteristics” of the physician and vice versa).
The GWU program, she said, “is a great start.”
Dr. Friedman said he’s fully invested. There has long been a perception, “rightfully so, that underserved communities are overlooked especially by large institutions. One attendee told me she never expected in her lifetime to see something like this clinic and someone who looked like me caring about her community. ... It certainly says a great deal about the work we need to put in to repair longstanding injury.”
Dr. Friedman disclosed that, in addition to being a recipient of grants from Pfizer and Lilly, he is a speaker for Lilly. Dr. Eleryan said she has no relevant disclosures.
A in other underserved areas in the United States.
Washington, D.C., has “staggering health disparities that are among the largest in the country,” and Ward 8 and surrounding areas in the southeastern part of the city are “dermatology deserts,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who started the program in 2021 with a pilot project. Dr. Friedman spoke about the project, which has since been expanded to include alopecia areata, at the Revolutionizing Atopic Dermatitis conference in April and in an interview after the meeting.
Patients who attend the clinics – held at the Temple of Praise Church in a residential area of Ward 8, a predominantly Black community with a 30% poverty rate – are entered into the GW Medical Faculty Associates medical records system and educated on telemedicine best practices (such as not having light behind them during a session) and how to use telemedicine with their own device.
Those with AD who participate learn about the condition through an image-rich poster showing how it appears in various skin tones, handouts, National Eczema Association films, and discussion with medical students who staff the clinics under Dr. Friedman’s on-site supervision. Participants with alopecia areata similarly can view a poster and converse about the condition.
Patients then have a free 20-minute telehealth visit with a GWU dermatology resident in a private room, and a medical student volunteer nearby to assist with the technology if needed. They leave with a treatment plan, which often includes prescriptions, and a follow-up telemedicine appointment.
The program “is meant to be a stepping point for initiating care ... to set someone up for success for recurrent telehealth visits in the future” and for treatment before symptoms become too severe, Dr. Friedman said in an interview. “We want to demystify telemedicine and educate on the disease state and dispel myths ... so the patient understands why it’s happening” and how it can be treated.
The pilot project, funded with a grant from Pfizer, involved five 2-hour clinics held on Mondays from 4 p.m. to 6 p.m., that together served almost 50 adult and pediatric patients. Grants from Pfizer and Eli Lilly enabled additional clinics in the spring of 2023 and into the summer. And in June, GWU and Pfizer announced a $1 million national grant program focused on broad implementation of what they’ve coined the “Teledermatology Help Desk Clinic” model.
Practices or organizations that secure grants will utilize GWU’s experience and meet with an advisory council of experts in dermatology telemedicine and community advocacy. Having a “long-term plan” and commitment to sustainability is an important element of the model, said Dr. Friedman, who is chairing the grant program.
Patients deem clinic ‘extremely’ helpful
As one of the most prevalent skin disorders – and one with a documented history of elevated risk for specific populations – AD was a good starting point for the teledermatology clinic program. Patients who identify as Black have a higher incidence and prevalence of AD than those who identify as White and Hispanic, and they tend to have more severe disease. Yet they account for fewer visits to dermatologists for AD.
One cross-sectional study of about 3,500 adults in the United States with AD documented that racial/ethnic and socioeconomic disparities reduce outpatient utilization of AD care and increase urgent care and hospital utilization. And in a longitudinal cohort study of children in the United States with AD, Black children with poorly controlled AD were significantly less likely than White children to see a dermatologist.
Like other programs, the GWU department of dermatology had pivoted to telehealth in 2020, and a published survey of patients who attended telehealth appointments during the early part of the pandemic showed that it was generally well liked – and not only for social distancing, but for time efficiency and because transportation was not needed. Only 10% of the 168 patients who completed the survey (out of 894 asked) reported they were unlikely to undertake another telehealth visit. For 10%, eczema was the reason for the visit.
However, only 1% of the survey respondents were from Ward 8, which “begged the question, did those who really need access know this was an option?” Dr. Friedman said at the RAD meeting. He wondered whether there was not only a dermatology desert in Ward 8, but a “technology desert” as well.
Findings from a patient satisfaction survey taken at the end of the pilot program are encouraging, Dr. Friedman said. While data on follow-up visits has not been collected yet, “what I do now have a sense of” is that “the entry point [afforded by the clinics] changed the course in terms of patients’ understanding of the disease and how they feel about its management.”
About 94% of survey respondents indicated the clinic was “extremely” helpful and the remainder said it was “very” helpful; 90% said telehealth significantly changed how they will manage their condition; and 97% said it is “extremely” important to continue the clinics. The majority of patients – 70% – indicated they did not have a dermatologist.
Education about AD at the clinics covers moisturizers/emollients, bathing habits, soaps and detergents, trigger avoidance, and the role of stress and environmental factors in disease exacerbation. Trade samples of moisturizers, mild cleansers, and other products have increasingly been available.
For prescriptions of topical steroids and other commonly prescribed medications, Dr. Friedman and associates combed GoodRx for coupons and surveyed local pharmacies for self-pay pricing to identify least expensive options. Patients with AD who were deemed likely candidates for more advanced therapies in the future were educated about these possibilities.
Alopecia areata
The addition of alopecia areata drew patients with other forms of hair loss as well, but “we weren’t going to turn anyone away who did not have that specific autoimmune form of hair loss,” Dr. Friedman said. Depending on the diagnosis, prescriptions were written for minoxidil and 5-alpha reductase inhibitors.
Important for follow-up is GWU’s acceptance of Medicaid and the availability of both a sliding scale for self-pay and services that assist patients in registering for Medicaid and, if eligible, other insurance plans.
Building partnerships, earning trust
Establishment of the teledermatology clinic program took legwork and relationship building. “You can’t just show up. That’s not enough,” said Dr. Friedman, who also directs the dermatology residency program at GWU. “You have to show through action and through investment of time and energy that you are legitimate, that you’re really there for the long haul.”
Dr. Friedman had assistance from the Rodham Institute, which was established at GWU (and until recently was housed there) and has a history of engagement with local stakeholders such as community centers, church leadership, politicians, and others in the Washington area. He was put in touch with Bishop Deborah Webb at the Temple of Praise Church, a community pillar in Ward 8, and from there “it was a courtship,” he said, with trust to be built and logistics to be worked out. (Budgets for the clinics, he noted, have included compensation to the church and gift cards for church volunteers who are present at the clinics.)
In the meantime, medical student volunteers from GWU, Howard University, and Georgetown University were trained in telemedicine and attended a “boot camp” on AD “so they’d be able to talk with anyone about it,” Dr. Friedman said.
Advertising “was a learning experience,” he said, and was ultimately multipronged, involving church service announcements, flyers, and, most importantly, Facebook and Instagram advertisements. (People were asked to call a dedicated phone line to schedule an appointment and were invited to register in the GW Medical Faculty Associates records system, though walk-ins to the clinics were still welcomed.)
In a comment, Misty Eleryan, MD, MS, a Mohs micrographic surgeon and dermatologist in Santa Monica, Calif., said dermatology deserts are often found in rural areas and/or areas “with a higher population of marginalized communities, such as Black, Brown, or poorer individuals” – communities that tend to rely on care from urgent care or ED physicians who are unaware of how skin conditions present on darker skin tones.
Programs that educate patients about various presentations of skin conditions are helpful not only for the patients themselves, but could also enable them to help friends, family members, and colleagues, said Dr. Eleryan, who did her residency training at GWU.
“Access,” she noted, is more than just physical access to a person, place, or thing. Referring to a “five A’s” framework described several decades ago, Dr. Eleryan said access to care is characterized by affordability, availability (extent to which the physician has the requisite resources, such as personnel and technology, to meet the patient’s needs), accessibility (geographic), accommodation (extent to which the physician can meet the patient’s constraints and preferences – such as hours of operation, how communications are handled, ability to receive care without prior appointments), and acceptability (extent to which the patient is comfortable with the “more immutable characteristics” of the physician and vice versa).
The GWU program, she said, “is a great start.”
Dr. Friedman said he’s fully invested. There has long been a perception, “rightfully so, that underserved communities are overlooked especially by large institutions. One attendee told me she never expected in her lifetime to see something like this clinic and someone who looked like me caring about her community. ... It certainly says a great deal about the work we need to put in to repair longstanding injury.”
Dr. Friedman disclosed that, in addition to being a recipient of grants from Pfizer and Lilly, he is a speaker for Lilly. Dr. Eleryan said she has no relevant disclosures.
A in other underserved areas in the United States.
Washington, D.C., has “staggering health disparities that are among the largest in the country,” and Ward 8 and surrounding areas in the southeastern part of the city are “dermatology deserts,” said Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, who started the program in 2021 with a pilot project. Dr. Friedman spoke about the project, which has since been expanded to include alopecia areata, at the Revolutionizing Atopic Dermatitis conference in April and in an interview after the meeting.
Patients who attend the clinics – held at the Temple of Praise Church in a residential area of Ward 8, a predominantly Black community with a 30% poverty rate – are entered into the GW Medical Faculty Associates medical records system and educated on telemedicine best practices (such as not having light behind them during a session) and how to use telemedicine with their own device.
Those with AD who participate learn about the condition through an image-rich poster showing how it appears in various skin tones, handouts, National Eczema Association films, and discussion with medical students who staff the clinics under Dr. Friedman’s on-site supervision. Participants with alopecia areata similarly can view a poster and converse about the condition.
Patients then have a free 20-minute telehealth visit with a GWU dermatology resident in a private room, and a medical student volunteer nearby to assist with the technology if needed. They leave with a treatment plan, which often includes prescriptions, and a follow-up telemedicine appointment.
The program “is meant to be a stepping point for initiating care ... to set someone up for success for recurrent telehealth visits in the future” and for treatment before symptoms become too severe, Dr. Friedman said in an interview. “We want to demystify telemedicine and educate on the disease state and dispel myths ... so the patient understands why it’s happening” and how it can be treated.
The pilot project, funded with a grant from Pfizer, involved five 2-hour clinics held on Mondays from 4 p.m. to 6 p.m., that together served almost 50 adult and pediatric patients. Grants from Pfizer and Eli Lilly enabled additional clinics in the spring of 2023 and into the summer. And in June, GWU and Pfizer announced a $1 million national grant program focused on broad implementation of what they’ve coined the “Teledermatology Help Desk Clinic” model.
Practices or organizations that secure grants will utilize GWU’s experience and meet with an advisory council of experts in dermatology telemedicine and community advocacy. Having a “long-term plan” and commitment to sustainability is an important element of the model, said Dr. Friedman, who is chairing the grant program.
Patients deem clinic ‘extremely’ helpful
As one of the most prevalent skin disorders – and one with a documented history of elevated risk for specific populations – AD was a good starting point for the teledermatology clinic program. Patients who identify as Black have a higher incidence and prevalence of AD than those who identify as White and Hispanic, and they tend to have more severe disease. Yet they account for fewer visits to dermatologists for AD.
One cross-sectional study of about 3,500 adults in the United States with AD documented that racial/ethnic and socioeconomic disparities reduce outpatient utilization of AD care and increase urgent care and hospital utilization. And in a longitudinal cohort study of children in the United States with AD, Black children with poorly controlled AD were significantly less likely than White children to see a dermatologist.
Like other programs, the GWU department of dermatology had pivoted to telehealth in 2020, and a published survey of patients who attended telehealth appointments during the early part of the pandemic showed that it was generally well liked – and not only for social distancing, but for time efficiency and because transportation was not needed. Only 10% of the 168 patients who completed the survey (out of 894 asked) reported they were unlikely to undertake another telehealth visit. For 10%, eczema was the reason for the visit.
However, only 1% of the survey respondents were from Ward 8, which “begged the question, did those who really need access know this was an option?” Dr. Friedman said at the RAD meeting. He wondered whether there was not only a dermatology desert in Ward 8, but a “technology desert” as well.
Findings from a patient satisfaction survey taken at the end of the pilot program are encouraging, Dr. Friedman said. While data on follow-up visits has not been collected yet, “what I do now have a sense of” is that “the entry point [afforded by the clinics] changed the course in terms of patients’ understanding of the disease and how they feel about its management.”
About 94% of survey respondents indicated the clinic was “extremely” helpful and the remainder said it was “very” helpful; 90% said telehealth significantly changed how they will manage their condition; and 97% said it is “extremely” important to continue the clinics. The majority of patients – 70% – indicated they did not have a dermatologist.
Education about AD at the clinics covers moisturizers/emollients, bathing habits, soaps and detergents, trigger avoidance, and the role of stress and environmental factors in disease exacerbation. Trade samples of moisturizers, mild cleansers, and other products have increasingly been available.
For prescriptions of topical steroids and other commonly prescribed medications, Dr. Friedman and associates combed GoodRx for coupons and surveyed local pharmacies for self-pay pricing to identify least expensive options. Patients with AD who were deemed likely candidates for more advanced therapies in the future were educated about these possibilities.
Alopecia areata
The addition of alopecia areata drew patients with other forms of hair loss as well, but “we weren’t going to turn anyone away who did not have that specific autoimmune form of hair loss,” Dr. Friedman said. Depending on the diagnosis, prescriptions were written for minoxidil and 5-alpha reductase inhibitors.
Important for follow-up is GWU’s acceptance of Medicaid and the availability of both a sliding scale for self-pay and services that assist patients in registering for Medicaid and, if eligible, other insurance plans.
Building partnerships, earning trust
Establishment of the teledermatology clinic program took legwork and relationship building. “You can’t just show up. That’s not enough,” said Dr. Friedman, who also directs the dermatology residency program at GWU. “You have to show through action and through investment of time and energy that you are legitimate, that you’re really there for the long haul.”
Dr. Friedman had assistance from the Rodham Institute, which was established at GWU (and until recently was housed there) and has a history of engagement with local stakeholders such as community centers, church leadership, politicians, and others in the Washington area. He was put in touch with Bishop Deborah Webb at the Temple of Praise Church, a community pillar in Ward 8, and from there “it was a courtship,” he said, with trust to be built and logistics to be worked out. (Budgets for the clinics, he noted, have included compensation to the church and gift cards for church volunteers who are present at the clinics.)
In the meantime, medical student volunteers from GWU, Howard University, and Georgetown University were trained in telemedicine and attended a “boot camp” on AD “so they’d be able to talk with anyone about it,” Dr. Friedman said.
Advertising “was a learning experience,” he said, and was ultimately multipronged, involving church service announcements, flyers, and, most importantly, Facebook and Instagram advertisements. (People were asked to call a dedicated phone line to schedule an appointment and were invited to register in the GW Medical Faculty Associates records system, though walk-ins to the clinics were still welcomed.)
In a comment, Misty Eleryan, MD, MS, a Mohs micrographic surgeon and dermatologist in Santa Monica, Calif., said dermatology deserts are often found in rural areas and/or areas “with a higher population of marginalized communities, such as Black, Brown, or poorer individuals” – communities that tend to rely on care from urgent care or ED physicians who are unaware of how skin conditions present on darker skin tones.
Programs that educate patients about various presentations of skin conditions are helpful not only for the patients themselves, but could also enable them to help friends, family members, and colleagues, said Dr. Eleryan, who did her residency training at GWU.
“Access,” she noted, is more than just physical access to a person, place, or thing. Referring to a “five A’s” framework described several decades ago, Dr. Eleryan said access to care is characterized by affordability, availability (extent to which the physician has the requisite resources, such as personnel and technology, to meet the patient’s needs), accessibility (geographic), accommodation (extent to which the physician can meet the patient’s constraints and preferences – such as hours of operation, how communications are handled, ability to receive care without prior appointments), and acceptability (extent to which the patient is comfortable with the “more immutable characteristics” of the physician and vice versa).
The GWU program, she said, “is a great start.”
Dr. Friedman said he’s fully invested. There has long been a perception, “rightfully so, that underserved communities are overlooked especially by large institutions. One attendee told me she never expected in her lifetime to see something like this clinic and someone who looked like me caring about her community. ... It certainly says a great deal about the work we need to put in to repair longstanding injury.”
Dr. Friedman disclosed that, in addition to being a recipient of grants from Pfizer and Lilly, he is a speaker for Lilly. Dr. Eleryan said she has no relevant disclosures.
Injecting long-acting antiretrovirals into clinic care
At the Whitman-Walker Health Center, Washington, community health workers see about 3,200 antiretroviral users a year. With long-acting injections now available, the clinic opted to integrate the new medications into its peer staff program.
“Our peer workers are very competent,” said Rupa Patel, MD, MPH, medical liason of the pre-exposure prophylaxis for HIV prevention program at Washington University at St. Louis.* “They do phlebotomy, they give you your meds. They’re your main doctor until you really need to see the doctor.”
In the peer staff program, workers are trained in a 4-month medical residency–style program that shows them how to test for HIV, inject long-acting formulations of new drugs, and conduct follow-up visits.
Presenting the new approach at the International AIDS Society Conference on HIV Science, Dr. Patel reported that 139 people have received long-acting injections at the clinic since the program launched with a total of 314 injections administered.
The training program includes lectures, mock injection, and client care sessions, observation and supervised administration, a written exam, and case review sessions.
Retention for the second injection was 95%, with 91% of injections given within the 14-day window. For the third injection, retention was 91%, with 63% given within the window.
The program reports a high level of client satisfaction with the peer-administered injections, which are also given in a room decorated with a beach theme and music to help calm people who might be nervous of receiving shots.
“Our retention is going to be the highest compared to other clinics because your peer, your friend, is reminding you and comforting you and telling you: ‘Don’t worry, I’m on the injection too,’ ” Dr. Patel said.
Andrew Grulich, MD, PhD, head of the HIV epidemiology and prevention program at the Kirby Institute, Sydney, pointed out there is tension between wanting to use long-acting injectables for people who are struggling with taking oral therapies daily and the need to ensure that they come back for their injections on time.
“I think it’s a potential way forward – we’re learning as we’re going with these new forms of therapy,” he said in an interview. “It is absolutely critical that people turn up on time for those injections, and if they don’t, resistance can be an issue.”
Presenting new data from another project at the HIV Clinic at San Francisco General Hospital, Monica Gandhi, MD, MPH, told the conference: “There are multiple reasons why it’s hard to take oral antiretrovirals every day.”
At the HIV Clinic in San Francisco General, people without homes, those with mental illness, and those using stimulants receive care.
The clinical trials for long-acting injectable antiretrovirals included only people who were virologically suppressed, which is also the Food and Drug Administration criteria for use. However, this clinic offered long-acting injections to patients with viremia because it was too difficult for them to take a daily pill.
In a comment, Dr. Gandhi, director of the University of California, San Francisco’s Center for AIDS Research, said: “We don’t call people hard to reach, we call them hardly reached because it’s not their fault.” There are just all of these issues that have made it harder for them to take medication consistently.
Dr. Gandhi reported that, of the 133 people being treated with long-acting injectable cabotegravir and rilpivirine at the clinic through this program, 57 had viremia at baseline.
However, only two of these patients experienced virologic failure while on the injectable antiretroviral program. The overall virologic failure rate was 1.5%, which was equivalent to that seen in clinical trials in virologically suppressed individuals.
The results presented at the conference and were also published in Annals of Internal Medicine.
The clinic found that 73% of people attended their injection appointments on time, and those who did not were followed up with telephone calls to ensure they received their injection within the 14-day window.
Dr. Gandhi said people were highly motivated to turn up for their injection appointments. “They are virologically suppressed, so it feels so amazing. They’re self-motivated for the first time to want to get an injection.”
A version of this article first appeared on Medscape.com.
*Correction, 8/4/23: An earlier version of this article misstated Dr. Patel's university affiliation.
At the Whitman-Walker Health Center, Washington, community health workers see about 3,200 antiretroviral users a year. With long-acting injections now available, the clinic opted to integrate the new medications into its peer staff program.
“Our peer workers are very competent,” said Rupa Patel, MD, MPH, medical liason of the pre-exposure prophylaxis for HIV prevention program at Washington University at St. Louis.* “They do phlebotomy, they give you your meds. They’re your main doctor until you really need to see the doctor.”
In the peer staff program, workers are trained in a 4-month medical residency–style program that shows them how to test for HIV, inject long-acting formulations of new drugs, and conduct follow-up visits.
Presenting the new approach at the International AIDS Society Conference on HIV Science, Dr. Patel reported that 139 people have received long-acting injections at the clinic since the program launched with a total of 314 injections administered.
The training program includes lectures, mock injection, and client care sessions, observation and supervised administration, a written exam, and case review sessions.
Retention for the second injection was 95%, with 91% of injections given within the 14-day window. For the third injection, retention was 91%, with 63% given within the window.
The program reports a high level of client satisfaction with the peer-administered injections, which are also given in a room decorated with a beach theme and music to help calm people who might be nervous of receiving shots.
“Our retention is going to be the highest compared to other clinics because your peer, your friend, is reminding you and comforting you and telling you: ‘Don’t worry, I’m on the injection too,’ ” Dr. Patel said.
Andrew Grulich, MD, PhD, head of the HIV epidemiology and prevention program at the Kirby Institute, Sydney, pointed out there is tension between wanting to use long-acting injectables for people who are struggling with taking oral therapies daily and the need to ensure that they come back for their injections on time.
“I think it’s a potential way forward – we’re learning as we’re going with these new forms of therapy,” he said in an interview. “It is absolutely critical that people turn up on time for those injections, and if they don’t, resistance can be an issue.”
Presenting new data from another project at the HIV Clinic at San Francisco General Hospital, Monica Gandhi, MD, MPH, told the conference: “There are multiple reasons why it’s hard to take oral antiretrovirals every day.”
At the HIV Clinic in San Francisco General, people without homes, those with mental illness, and those using stimulants receive care.
The clinical trials for long-acting injectable antiretrovirals included only people who were virologically suppressed, which is also the Food and Drug Administration criteria for use. However, this clinic offered long-acting injections to patients with viremia because it was too difficult for them to take a daily pill.
In a comment, Dr. Gandhi, director of the University of California, San Francisco’s Center for AIDS Research, said: “We don’t call people hard to reach, we call them hardly reached because it’s not their fault.” There are just all of these issues that have made it harder for them to take medication consistently.
Dr. Gandhi reported that, of the 133 people being treated with long-acting injectable cabotegravir and rilpivirine at the clinic through this program, 57 had viremia at baseline.
However, only two of these patients experienced virologic failure while on the injectable antiretroviral program. The overall virologic failure rate was 1.5%, which was equivalent to that seen in clinical trials in virologically suppressed individuals.
The results presented at the conference and were also published in Annals of Internal Medicine.
The clinic found that 73% of people attended their injection appointments on time, and those who did not were followed up with telephone calls to ensure they received their injection within the 14-day window.
Dr. Gandhi said people were highly motivated to turn up for their injection appointments. “They are virologically suppressed, so it feels so amazing. They’re self-motivated for the first time to want to get an injection.”
A version of this article first appeared on Medscape.com.
*Correction, 8/4/23: An earlier version of this article misstated Dr. Patel's university affiliation.
At the Whitman-Walker Health Center, Washington, community health workers see about 3,200 antiretroviral users a year. With long-acting injections now available, the clinic opted to integrate the new medications into its peer staff program.
“Our peer workers are very competent,” said Rupa Patel, MD, MPH, medical liason of the pre-exposure prophylaxis for HIV prevention program at Washington University at St. Louis.* “They do phlebotomy, they give you your meds. They’re your main doctor until you really need to see the doctor.”
In the peer staff program, workers are trained in a 4-month medical residency–style program that shows them how to test for HIV, inject long-acting formulations of new drugs, and conduct follow-up visits.
Presenting the new approach at the International AIDS Society Conference on HIV Science, Dr. Patel reported that 139 people have received long-acting injections at the clinic since the program launched with a total of 314 injections administered.
The training program includes lectures, mock injection, and client care sessions, observation and supervised administration, a written exam, and case review sessions.
Retention for the second injection was 95%, with 91% of injections given within the 14-day window. For the third injection, retention was 91%, with 63% given within the window.
The program reports a high level of client satisfaction with the peer-administered injections, which are also given in a room decorated with a beach theme and music to help calm people who might be nervous of receiving shots.
“Our retention is going to be the highest compared to other clinics because your peer, your friend, is reminding you and comforting you and telling you: ‘Don’t worry, I’m on the injection too,’ ” Dr. Patel said.
Andrew Grulich, MD, PhD, head of the HIV epidemiology and prevention program at the Kirby Institute, Sydney, pointed out there is tension between wanting to use long-acting injectables for people who are struggling with taking oral therapies daily and the need to ensure that they come back for their injections on time.
“I think it’s a potential way forward – we’re learning as we’re going with these new forms of therapy,” he said in an interview. “It is absolutely critical that people turn up on time for those injections, and if they don’t, resistance can be an issue.”
Presenting new data from another project at the HIV Clinic at San Francisco General Hospital, Monica Gandhi, MD, MPH, told the conference: “There are multiple reasons why it’s hard to take oral antiretrovirals every day.”
At the HIV Clinic in San Francisco General, people without homes, those with mental illness, and those using stimulants receive care.
The clinical trials for long-acting injectable antiretrovirals included only people who were virologically suppressed, which is also the Food and Drug Administration criteria for use. However, this clinic offered long-acting injections to patients with viremia because it was too difficult for them to take a daily pill.
In a comment, Dr. Gandhi, director of the University of California, San Francisco’s Center for AIDS Research, said: “We don’t call people hard to reach, we call them hardly reached because it’s not their fault.” There are just all of these issues that have made it harder for them to take medication consistently.
Dr. Gandhi reported that, of the 133 people being treated with long-acting injectable cabotegravir and rilpivirine at the clinic through this program, 57 had viremia at baseline.
However, only two of these patients experienced virologic failure while on the injectable antiretroviral program. The overall virologic failure rate was 1.5%, which was equivalent to that seen in clinical trials in virologically suppressed individuals.
The results presented at the conference and were also published in Annals of Internal Medicine.
The clinic found that 73% of people attended their injection appointments on time, and those who did not were followed up with telephone calls to ensure they received their injection within the 14-day window.
Dr. Gandhi said people were highly motivated to turn up for their injection appointments. “They are virologically suppressed, so it feels so amazing. They’re self-motivated for the first time to want to get an injection.”
A version of this article first appeared on Medscape.com.
*Correction, 8/4/23: An earlier version of this article misstated Dr. Patel's university affiliation.
FROM IAS 2023
UNAIDS targets: Progress reported, but ‘HIV is far from over’
BRISBANE, AUSTRALIA – The year was 1987 and the Grim Reaper (a personification of death), holding a large scythe, rolled a 10-pin bowling ball through a dark, foggy place. In the advertisement on television, the cloaked skeleton aimed the bowling ball at the other end of a lane where a group of people stood in place of pins.
Who would fall next?
In the 1980s, cases of HIV were rising in the community and people in Australia and elsewhere were dying of AIDS. The Australian government opted to use mainstream media to deliver a blunt message through advertising to raise awareness about the health risk and how to manage HIV in the community.
But the campaign also contributed to stigma for those living with the disease and especially those in the gay community who felt ostracized by rising public concern.
In the inner city of Sydney, a few thousand people died of AIDS, Andrew Grulich, MD, PhD, from the Kirby Institute at the University of New South Wales, Sydney, and involved in tracking cases, said in an interview. “Sydney was devastated by AIDS, it was truly devastated.”
HIV and AIDS quickly became an even more severe problem for several countries around Australia in Thailand, Papua New Guinea, and beyond. After HIV was first reported in Thailand in 1984, the region had the highest prevalence of HIV in Southeast Asia. Through the 1990s in Papua New Guinea, HIV prevalence rose steeply as well.
By 2010, the Joint United Nations Programme on HIV/AIDS (UNAIDS) set a target of a 90% reduction in HIV incidence, a 90% reduction in AIDS deaths by 2030, and 95% of people living with HIV and AIDS being aware of their status, on treatment, and having an undetectable viral load.
Since then, significant progress has been made globally with 86% of people knowing their HIV status. However, new infections persist at a rate that has not dropped as fast as possible.
New infections
According to the latest UNAIDS report, regions of North America and western and central Europe showed a 23% decline in new infections from 2010 to 2022, below the target 90% reduction.
Some regions of the United States have seen significant declines in new HIV infections. San Francisco has a 67% drop in new diagnoses. And now, along with the District of Columbia, the four states with the highest HIV rates are New York, Maryland, Georgia, and Florida.
Several countries in eastern and southern Africa are close to achieving their target HIV reduction of 90%.
Mitchell Warren, executive director of AVAC for global health advocacy, access, and equity, said that many of the low- and middle-income countries that are on track to achieve targets are able to do so because of support from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
“That foreign development assistance is transforming the AIDS response in a number of African countries, and yet at home, in various states and municipalities, not only are we not reaching that effort, we don’t even use those targets,” Mr. Warren pointed out.
“We might see municipalities that are performing well, but at a national level it’s frankly a disgrace by comparison, because we know what’s possible,” Mr. Warren said.
Lowering cases
Today, in the inner city of Sydney, new HIV diagnoses have plummeted by 88%, which puts the area on track to achieve the 90% UNAIDS target ahead of schedule.
Dr. Grulich and his team at the Kirby Institute are tracking new diagnoses by postal code and reported their encouraging findings here this week at the International AIDS Society Conference on HIV Science.
“This 88% decline is happening in an area where, in the ’80s and ’90s, a few thousand people died of AIDS,” Dr. Grulich told this news organization. “It feels close to miraculous.”
Dr. Grulich attributes some of the success to long-term government leadership that for the most part has been apolitical. HIV has been perceived by the public as an important health issue to be addressed. “We’ve never had a political contest over it,” he added. “We have politicians who are committed to evidence-based policy.”
In inner city Sydney, HIV prevention campaigns are a visible part of community life, Dr. Grulich explained. At public events, it is discussed; at bus stops, posters are on display; and passing trains have messages plastered to the side of them.
That community effort has consistently received government funding for years – albeit linked to key performance indicators – but it has enabled a high level of communication among government, community, clinicians, and researchers.
Another advantage is Australia’s universal health coverage, said Sharon Lewin, PhD, president of the International AIDS Society and director of the Peter Doherty Institute for Infection and Immunity at the University of Melbourne. “One very clear difference for Australia is a health system that provides free medication and free prevention,” she said. “You can’t underestimate the impact that has on public health.”
Globally, significant progress has been made toward the UN’s 95-95-95 targets, with 86% of people with HIV now knowing their status, 88% of those being on treatment, and 93% of those having an undetectable viral load, “for a total of 75% of all people living with HIV worldwide with undetectable viral load,” Dr. Grulich pointed out.
But Dr. Lewin cautioned that now is not the time to take our eye off the ball, especially with respect to the 39 million or so people living with HIV globally, all of whom need lifelong treatment and care to manage their disease. “We also need to be aware that if we relax the investment, and people stop their treatment, transmission occurs again,” Dr. Lewin warned. “Despite the great news of potentially getting close to eliminating HIV transmission in Australia, HIV is far from over.”
A version of this article first appeared on Medscape.com.
BRISBANE, AUSTRALIA – The year was 1987 and the Grim Reaper (a personification of death), holding a large scythe, rolled a 10-pin bowling ball through a dark, foggy place. In the advertisement on television, the cloaked skeleton aimed the bowling ball at the other end of a lane where a group of people stood in place of pins.
Who would fall next?
In the 1980s, cases of HIV were rising in the community and people in Australia and elsewhere were dying of AIDS. The Australian government opted to use mainstream media to deliver a blunt message through advertising to raise awareness about the health risk and how to manage HIV in the community.
But the campaign also contributed to stigma for those living with the disease and especially those in the gay community who felt ostracized by rising public concern.
In the inner city of Sydney, a few thousand people died of AIDS, Andrew Grulich, MD, PhD, from the Kirby Institute at the University of New South Wales, Sydney, and involved in tracking cases, said in an interview. “Sydney was devastated by AIDS, it was truly devastated.”
HIV and AIDS quickly became an even more severe problem for several countries around Australia in Thailand, Papua New Guinea, and beyond. After HIV was first reported in Thailand in 1984, the region had the highest prevalence of HIV in Southeast Asia. Through the 1990s in Papua New Guinea, HIV prevalence rose steeply as well.
By 2010, the Joint United Nations Programme on HIV/AIDS (UNAIDS) set a target of a 90% reduction in HIV incidence, a 90% reduction in AIDS deaths by 2030, and 95% of people living with HIV and AIDS being aware of their status, on treatment, and having an undetectable viral load.
Since then, significant progress has been made globally with 86% of people knowing their HIV status. However, new infections persist at a rate that has not dropped as fast as possible.
New infections
According to the latest UNAIDS report, regions of North America and western and central Europe showed a 23% decline in new infections from 2010 to 2022, below the target 90% reduction.
Some regions of the United States have seen significant declines in new HIV infections. San Francisco has a 67% drop in new diagnoses. And now, along with the District of Columbia, the four states with the highest HIV rates are New York, Maryland, Georgia, and Florida.
Several countries in eastern and southern Africa are close to achieving their target HIV reduction of 90%.
Mitchell Warren, executive director of AVAC for global health advocacy, access, and equity, said that many of the low- and middle-income countries that are on track to achieve targets are able to do so because of support from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
“That foreign development assistance is transforming the AIDS response in a number of African countries, and yet at home, in various states and municipalities, not only are we not reaching that effort, we don’t even use those targets,” Mr. Warren pointed out.
“We might see municipalities that are performing well, but at a national level it’s frankly a disgrace by comparison, because we know what’s possible,” Mr. Warren said.
Lowering cases
Today, in the inner city of Sydney, new HIV diagnoses have plummeted by 88%, which puts the area on track to achieve the 90% UNAIDS target ahead of schedule.
Dr. Grulich and his team at the Kirby Institute are tracking new diagnoses by postal code and reported their encouraging findings here this week at the International AIDS Society Conference on HIV Science.
“This 88% decline is happening in an area where, in the ’80s and ’90s, a few thousand people died of AIDS,” Dr. Grulich told this news organization. “It feels close to miraculous.”
Dr. Grulich attributes some of the success to long-term government leadership that for the most part has been apolitical. HIV has been perceived by the public as an important health issue to be addressed. “We’ve never had a political contest over it,” he added. “We have politicians who are committed to evidence-based policy.”
In inner city Sydney, HIV prevention campaigns are a visible part of community life, Dr. Grulich explained. At public events, it is discussed; at bus stops, posters are on display; and passing trains have messages plastered to the side of them.
That community effort has consistently received government funding for years – albeit linked to key performance indicators – but it has enabled a high level of communication among government, community, clinicians, and researchers.
Another advantage is Australia’s universal health coverage, said Sharon Lewin, PhD, president of the International AIDS Society and director of the Peter Doherty Institute for Infection and Immunity at the University of Melbourne. “One very clear difference for Australia is a health system that provides free medication and free prevention,” she said. “You can’t underestimate the impact that has on public health.”
Globally, significant progress has been made toward the UN’s 95-95-95 targets, with 86% of people with HIV now knowing their status, 88% of those being on treatment, and 93% of those having an undetectable viral load, “for a total of 75% of all people living with HIV worldwide with undetectable viral load,” Dr. Grulich pointed out.
But Dr. Lewin cautioned that now is not the time to take our eye off the ball, especially with respect to the 39 million or so people living with HIV globally, all of whom need lifelong treatment and care to manage their disease. “We also need to be aware that if we relax the investment, and people stop their treatment, transmission occurs again,” Dr. Lewin warned. “Despite the great news of potentially getting close to eliminating HIV transmission in Australia, HIV is far from over.”
A version of this article first appeared on Medscape.com.
BRISBANE, AUSTRALIA – The year was 1987 and the Grim Reaper (a personification of death), holding a large scythe, rolled a 10-pin bowling ball through a dark, foggy place. In the advertisement on television, the cloaked skeleton aimed the bowling ball at the other end of a lane where a group of people stood in place of pins.
Who would fall next?
In the 1980s, cases of HIV were rising in the community and people in Australia and elsewhere were dying of AIDS. The Australian government opted to use mainstream media to deliver a blunt message through advertising to raise awareness about the health risk and how to manage HIV in the community.
But the campaign also contributed to stigma for those living with the disease and especially those in the gay community who felt ostracized by rising public concern.
In the inner city of Sydney, a few thousand people died of AIDS, Andrew Grulich, MD, PhD, from the Kirby Institute at the University of New South Wales, Sydney, and involved in tracking cases, said in an interview. “Sydney was devastated by AIDS, it was truly devastated.”
HIV and AIDS quickly became an even more severe problem for several countries around Australia in Thailand, Papua New Guinea, and beyond. After HIV was first reported in Thailand in 1984, the region had the highest prevalence of HIV in Southeast Asia. Through the 1990s in Papua New Guinea, HIV prevalence rose steeply as well.
By 2010, the Joint United Nations Programme on HIV/AIDS (UNAIDS) set a target of a 90% reduction in HIV incidence, a 90% reduction in AIDS deaths by 2030, and 95% of people living with HIV and AIDS being aware of their status, on treatment, and having an undetectable viral load.
Since then, significant progress has been made globally with 86% of people knowing their HIV status. However, new infections persist at a rate that has not dropped as fast as possible.
New infections
According to the latest UNAIDS report, regions of North America and western and central Europe showed a 23% decline in new infections from 2010 to 2022, below the target 90% reduction.
Some regions of the United States have seen significant declines in new HIV infections. San Francisco has a 67% drop in new diagnoses. And now, along with the District of Columbia, the four states with the highest HIV rates are New York, Maryland, Georgia, and Florida.
Several countries in eastern and southern Africa are close to achieving their target HIV reduction of 90%.
Mitchell Warren, executive director of AVAC for global health advocacy, access, and equity, said that many of the low- and middle-income countries that are on track to achieve targets are able to do so because of support from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
“That foreign development assistance is transforming the AIDS response in a number of African countries, and yet at home, in various states and municipalities, not only are we not reaching that effort, we don’t even use those targets,” Mr. Warren pointed out.
“We might see municipalities that are performing well, but at a national level it’s frankly a disgrace by comparison, because we know what’s possible,” Mr. Warren said.
Lowering cases
Today, in the inner city of Sydney, new HIV diagnoses have plummeted by 88%, which puts the area on track to achieve the 90% UNAIDS target ahead of schedule.
Dr. Grulich and his team at the Kirby Institute are tracking new diagnoses by postal code and reported their encouraging findings here this week at the International AIDS Society Conference on HIV Science.
“This 88% decline is happening in an area where, in the ’80s and ’90s, a few thousand people died of AIDS,” Dr. Grulich told this news organization. “It feels close to miraculous.”
Dr. Grulich attributes some of the success to long-term government leadership that for the most part has been apolitical. HIV has been perceived by the public as an important health issue to be addressed. “We’ve never had a political contest over it,” he added. “We have politicians who are committed to evidence-based policy.”
In inner city Sydney, HIV prevention campaigns are a visible part of community life, Dr. Grulich explained. At public events, it is discussed; at bus stops, posters are on display; and passing trains have messages plastered to the side of them.
That community effort has consistently received government funding for years – albeit linked to key performance indicators – but it has enabled a high level of communication among government, community, clinicians, and researchers.
Another advantage is Australia’s universal health coverage, said Sharon Lewin, PhD, president of the International AIDS Society and director of the Peter Doherty Institute for Infection and Immunity at the University of Melbourne. “One very clear difference for Australia is a health system that provides free medication and free prevention,” she said. “You can’t underestimate the impact that has on public health.”
Globally, significant progress has been made toward the UN’s 95-95-95 targets, with 86% of people with HIV now knowing their status, 88% of those being on treatment, and 93% of those having an undetectable viral load, “for a total of 75% of all people living with HIV worldwide with undetectable viral load,” Dr. Grulich pointed out.
But Dr. Lewin cautioned that now is not the time to take our eye off the ball, especially with respect to the 39 million or so people living with HIV globally, all of whom need lifelong treatment and care to manage their disease. “We also need to be aware that if we relax the investment, and people stop their treatment, transmission occurs again,” Dr. Lewin warned. “Despite the great news of potentially getting close to eliminating HIV transmission in Australia, HIV is far from over.”
A version of this article first appeared on Medscape.com.