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FDA approves first over-the-counter birth control pill
The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.
The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.
Likely to drive debate
Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.
“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.
“It’s a huge win for patients who need better access to contraception,” said Dr. Gray, who is also a spokesperson for the American College of Obstetricians and Gynecologists.
Women who want hormonal birth control but live in areas without convenient access to a doctor, women who cannot easily take time off of work to see a doctor and get a prescription filled, and women without insurance are examples of people who will benefit, she said.
The Catholic Medical Association, in contrast, expressed “deep concern and disappointment” after an FDA advisory committee’s unanimous vote on May 11 recommending the drug be available over the counter. In a statement after the vote, the group cited “extensive medical studies demonstrating the risks and adverse effects of hormonal contraceptives,” adding that “the social impact of [full approval] would be dramatic.”
But doctors largely disagreed.
“It is definitely a huge win for reproductive autonomy. I’m glad that the FDA is prioritizing patient safety and well-being over politics,” said Catherine Cansino, MD, MPH, an ob.gyn. and clinical professor in the University of California Davis department of obstetrics and gynecology. She said the FDA approved the over-the-counter version because the medication is safe.
While opponents like the Catholic Medical Association cite safety concerns and believe doctors should screen all women before prescribing hormonal contraception, Dr. Gray disagreed. “There’s a lot of evidence that patients can figure out if a progestin-only pill is right for them and safe for them. Medical professionals don’t have to be the gatekeepers for contraception,” she said.
Pricing unknown
Whether insurance companies will pay for Opill now that it will be available without a prescription remains unknown. For some medications, paying a copay through insurance can be less expensive than buying at a retail price.
“Although pricing issues will be relevant, the FDA’s decision will enhance women’s access to hormonal birth control,” said Andrew M. Kaunitz, MD, a professor and associate chairman in the department of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville.
The drugmaker, Perrigo, based in Ireland, has not yet announced how much the pill will cost. The price tag could affect how widely available this form of birth control is. The drug has been shown to be as much as 93% effective for pregnancy prevention. Perrigo says it plans to make the pill available at low or no cost to some women.
Caveats to consider
There are some women for whom hormonal contraceptives have always carried greater risks. For example, women who have breast cancer or a history of breast cancer should not use hormonal contraceptives, the FDA said in a news release announcing the approval. Women with other types of cancer should check with their doctors first, the agency noted.
Women who smoke, who take some medications to lower blood pressure, or who have migraines should also take caution, Dr. Cansino said. “People with migraines may not be suitable for over-the-counter oral contraceptives. But a simple screening through a provider can identify whether you are truly eligible or not.”
Irregular bleeding, headaches, dizziness, nausea, increased appetite, belly pain, cramps, or bloating are the most common side effects of Opill, the FDA said.
The Opill is a progestin-only birth control pill. Similar pills have been available in the United Kingdiom for about 2 years, often referred to as “mini pills” because they contain a single hormone. In contrast, prescription birth control pills in the United States and elsewhere contain more than one hormone, estrogen and progestin, to prevent pregnancy.
Prescription pill packs for combination contraception often feature a week of placebo pills without an active ingredient. While skipping a placebo pill might not make a difference in pregnancy prevention, Opill is different. Every pill in the packet will contain medication, Gray said. “So it’s important to take the pill the same time every day for it to be most effective.”
Even though this may mean one less visit to your doctor, Dr. Kaunitz hopes women will stay up to date on their other medical checkups. “One of our challenges as providers of care to women will be to encourage them to continue to receive important services, including cancer screening and vaccinations, even while they can initiate and continue hormonal contraception without contact with a provider.”
Just the beginning?
The American Medical Association hopes this approval signals more to come.
“While we applaud this move, the AMA continues to urge the FDA and HHS to consider a variety of oral contraceptive options for over-the-counter use,” the association, which has more than 250,000 doctor members, said in a statement. “It is important patients have options when choosing which type of birth control works best for them,”
The American College of Obstetricians and Gynecologists said the FDA’s decision will help many women. “We are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” Verda J. Hicks, MD, the group’s president, and Christopher M. Zahn, MD, interim chief executive officer, said in a statement.
“Allowing individuals to access birth control at their local pharmacy or drug store will eliminate some barriers,” they said.
A version of this article first appeared on WebMD.com.
This article was updated 7/13/23.
The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.
The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.
Likely to drive debate
Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.
“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.
“It’s a huge win for patients who need better access to contraception,” said Dr. Gray, who is also a spokesperson for the American College of Obstetricians and Gynecologists.
Women who want hormonal birth control but live in areas without convenient access to a doctor, women who cannot easily take time off of work to see a doctor and get a prescription filled, and women without insurance are examples of people who will benefit, she said.
The Catholic Medical Association, in contrast, expressed “deep concern and disappointment” after an FDA advisory committee’s unanimous vote on May 11 recommending the drug be available over the counter. In a statement after the vote, the group cited “extensive medical studies demonstrating the risks and adverse effects of hormonal contraceptives,” adding that “the social impact of [full approval] would be dramatic.”
But doctors largely disagreed.
“It is definitely a huge win for reproductive autonomy. I’m glad that the FDA is prioritizing patient safety and well-being over politics,” said Catherine Cansino, MD, MPH, an ob.gyn. and clinical professor in the University of California Davis department of obstetrics and gynecology. She said the FDA approved the over-the-counter version because the medication is safe.
While opponents like the Catholic Medical Association cite safety concerns and believe doctors should screen all women before prescribing hormonal contraception, Dr. Gray disagreed. “There’s a lot of evidence that patients can figure out if a progestin-only pill is right for them and safe for them. Medical professionals don’t have to be the gatekeepers for contraception,” she said.
Pricing unknown
Whether insurance companies will pay for Opill now that it will be available without a prescription remains unknown. For some medications, paying a copay through insurance can be less expensive than buying at a retail price.
“Although pricing issues will be relevant, the FDA’s decision will enhance women’s access to hormonal birth control,” said Andrew M. Kaunitz, MD, a professor and associate chairman in the department of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville.
The drugmaker, Perrigo, based in Ireland, has not yet announced how much the pill will cost. The price tag could affect how widely available this form of birth control is. The drug has been shown to be as much as 93% effective for pregnancy prevention. Perrigo says it plans to make the pill available at low or no cost to some women.
Caveats to consider
There are some women for whom hormonal contraceptives have always carried greater risks. For example, women who have breast cancer or a history of breast cancer should not use hormonal contraceptives, the FDA said in a news release announcing the approval. Women with other types of cancer should check with their doctors first, the agency noted.
Women who smoke, who take some medications to lower blood pressure, or who have migraines should also take caution, Dr. Cansino said. “People with migraines may not be suitable for over-the-counter oral contraceptives. But a simple screening through a provider can identify whether you are truly eligible or not.”
Irregular bleeding, headaches, dizziness, nausea, increased appetite, belly pain, cramps, or bloating are the most common side effects of Opill, the FDA said.
The Opill is a progestin-only birth control pill. Similar pills have been available in the United Kingdiom for about 2 years, often referred to as “mini pills” because they contain a single hormone. In contrast, prescription birth control pills in the United States and elsewhere contain more than one hormone, estrogen and progestin, to prevent pregnancy.
Prescription pill packs for combination contraception often feature a week of placebo pills without an active ingredient. While skipping a placebo pill might not make a difference in pregnancy prevention, Opill is different. Every pill in the packet will contain medication, Gray said. “So it’s important to take the pill the same time every day for it to be most effective.”
Even though this may mean one less visit to your doctor, Dr. Kaunitz hopes women will stay up to date on their other medical checkups. “One of our challenges as providers of care to women will be to encourage them to continue to receive important services, including cancer screening and vaccinations, even while they can initiate and continue hormonal contraception without contact with a provider.”
Just the beginning?
The American Medical Association hopes this approval signals more to come.
“While we applaud this move, the AMA continues to urge the FDA and HHS to consider a variety of oral contraceptive options for over-the-counter use,” the association, which has more than 250,000 doctor members, said in a statement. “It is important patients have options when choosing which type of birth control works best for them,”
The American College of Obstetricians and Gynecologists said the FDA’s decision will help many women. “We are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” Verda J. Hicks, MD, the group’s president, and Christopher M. Zahn, MD, interim chief executive officer, said in a statement.
“Allowing individuals to access birth control at their local pharmacy or drug store will eliminate some barriers,” they said.
A version of this article first appeared on WebMD.com.
This article was updated 7/13/23.
The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.
The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.
Likely to drive debate
Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.
“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.
“It’s a huge win for patients who need better access to contraception,” said Dr. Gray, who is also a spokesperson for the American College of Obstetricians and Gynecologists.
Women who want hormonal birth control but live in areas without convenient access to a doctor, women who cannot easily take time off of work to see a doctor and get a prescription filled, and women without insurance are examples of people who will benefit, she said.
The Catholic Medical Association, in contrast, expressed “deep concern and disappointment” after an FDA advisory committee’s unanimous vote on May 11 recommending the drug be available over the counter. In a statement after the vote, the group cited “extensive medical studies demonstrating the risks and adverse effects of hormonal contraceptives,” adding that “the social impact of [full approval] would be dramatic.”
But doctors largely disagreed.
“It is definitely a huge win for reproductive autonomy. I’m glad that the FDA is prioritizing patient safety and well-being over politics,” said Catherine Cansino, MD, MPH, an ob.gyn. and clinical professor in the University of California Davis department of obstetrics and gynecology. She said the FDA approved the over-the-counter version because the medication is safe.
While opponents like the Catholic Medical Association cite safety concerns and believe doctors should screen all women before prescribing hormonal contraception, Dr. Gray disagreed. “There’s a lot of evidence that patients can figure out if a progestin-only pill is right for them and safe for them. Medical professionals don’t have to be the gatekeepers for contraception,” she said.
Pricing unknown
Whether insurance companies will pay for Opill now that it will be available without a prescription remains unknown. For some medications, paying a copay through insurance can be less expensive than buying at a retail price.
“Although pricing issues will be relevant, the FDA’s decision will enhance women’s access to hormonal birth control,” said Andrew M. Kaunitz, MD, a professor and associate chairman in the department of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville.
The drugmaker, Perrigo, based in Ireland, has not yet announced how much the pill will cost. The price tag could affect how widely available this form of birth control is. The drug has been shown to be as much as 93% effective for pregnancy prevention. Perrigo says it plans to make the pill available at low or no cost to some women.
Caveats to consider
There are some women for whom hormonal contraceptives have always carried greater risks. For example, women who have breast cancer or a history of breast cancer should not use hormonal contraceptives, the FDA said in a news release announcing the approval. Women with other types of cancer should check with their doctors first, the agency noted.
Women who smoke, who take some medications to lower blood pressure, or who have migraines should also take caution, Dr. Cansino said. “People with migraines may not be suitable for over-the-counter oral contraceptives. But a simple screening through a provider can identify whether you are truly eligible or not.”
Irregular bleeding, headaches, dizziness, nausea, increased appetite, belly pain, cramps, or bloating are the most common side effects of Opill, the FDA said.
The Opill is a progestin-only birth control pill. Similar pills have been available in the United Kingdiom for about 2 years, often referred to as “mini pills” because they contain a single hormone. In contrast, prescription birth control pills in the United States and elsewhere contain more than one hormone, estrogen and progestin, to prevent pregnancy.
Prescription pill packs for combination contraception often feature a week of placebo pills without an active ingredient. While skipping a placebo pill might not make a difference in pregnancy prevention, Opill is different. Every pill in the packet will contain medication, Gray said. “So it’s important to take the pill the same time every day for it to be most effective.”
Even though this may mean one less visit to your doctor, Dr. Kaunitz hopes women will stay up to date on their other medical checkups. “One of our challenges as providers of care to women will be to encourage them to continue to receive important services, including cancer screening and vaccinations, even while they can initiate and continue hormonal contraception without contact with a provider.”
Just the beginning?
The American Medical Association hopes this approval signals more to come.
“While we applaud this move, the AMA continues to urge the FDA and HHS to consider a variety of oral contraceptive options for over-the-counter use,” the association, which has more than 250,000 doctor members, said in a statement. “It is important patients have options when choosing which type of birth control works best for them,”
The American College of Obstetricians and Gynecologists said the FDA’s decision will help many women. “We are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” Verda J. Hicks, MD, the group’s president, and Christopher M. Zahn, MD, interim chief executive officer, said in a statement.
“Allowing individuals to access birth control at their local pharmacy or drug store will eliminate some barriers,” they said.
A version of this article first appeared on WebMD.com.
This article was updated 7/13/23.
FDA approves new device for enlarged prostate treatment
Designed and marketed by Urotronic (Plymouth, Minn.), the Optilume BPH Catheter System employs mechanical dilation to relieve obstruction of the prostate and then delivers paclitaxel to aid in prostate healing. The device is used in an outpatient setting and is less invasive than other procedures.
“There’s nothing else like Optilume BPH that’s currently available, it’s the only treatment option that requires no cutting, burning, steaming, or implants,” said Urotronic President and CEO David Perry in a press release.
Two randomized trials, EVEREST-1 and PINNACLE, both showed that the Optilume BPH system improved urinary flow rate and decreased the amount of urine stored in the bladder following urination. Men who used the OPTILUME device were able to ejaculate normally and reported no sexual difficulties.
“Optilume BPH is the next generation of minimally invasive technology, creating a new drug device space among BPH therapies,” Steven A. Kaplan, MD, professor of urology at the Icahn School of Medicine at Mount Sinai, New York, said in the press release. Dr. Kaplan led the EVEREST-1 and PINNACLE studies, which Urotronic funded.
More than 80% of men older than age 70 have an enlarged prostate, based on autopsy analyses.
A version of this article first appeared on Medscape.com.
Designed and marketed by Urotronic (Plymouth, Minn.), the Optilume BPH Catheter System employs mechanical dilation to relieve obstruction of the prostate and then delivers paclitaxel to aid in prostate healing. The device is used in an outpatient setting and is less invasive than other procedures.
“There’s nothing else like Optilume BPH that’s currently available, it’s the only treatment option that requires no cutting, burning, steaming, or implants,” said Urotronic President and CEO David Perry in a press release.
Two randomized trials, EVEREST-1 and PINNACLE, both showed that the Optilume BPH system improved urinary flow rate and decreased the amount of urine stored in the bladder following urination. Men who used the OPTILUME device were able to ejaculate normally and reported no sexual difficulties.
“Optilume BPH is the next generation of minimally invasive technology, creating a new drug device space among BPH therapies,” Steven A. Kaplan, MD, professor of urology at the Icahn School of Medicine at Mount Sinai, New York, said in the press release. Dr. Kaplan led the EVEREST-1 and PINNACLE studies, which Urotronic funded.
More than 80% of men older than age 70 have an enlarged prostate, based on autopsy analyses.
A version of this article first appeared on Medscape.com.
Designed and marketed by Urotronic (Plymouth, Minn.), the Optilume BPH Catheter System employs mechanical dilation to relieve obstruction of the prostate and then delivers paclitaxel to aid in prostate healing. The device is used in an outpatient setting and is less invasive than other procedures.
“There’s nothing else like Optilume BPH that’s currently available, it’s the only treatment option that requires no cutting, burning, steaming, or implants,” said Urotronic President and CEO David Perry in a press release.
Two randomized trials, EVEREST-1 and PINNACLE, both showed that the Optilume BPH system improved urinary flow rate and decreased the amount of urine stored in the bladder following urination. Men who used the OPTILUME device were able to ejaculate normally and reported no sexual difficulties.
“Optilume BPH is the next generation of minimally invasive technology, creating a new drug device space among BPH therapies,” Steven A. Kaplan, MD, professor of urology at the Icahn School of Medicine at Mount Sinai, New York, said in the press release. Dr. Kaplan led the EVEREST-1 and PINNACLE studies, which Urotronic funded.
More than 80% of men older than age 70 have an enlarged prostate, based on autopsy analyses.
A version of this article first appeared on Medscape.com.
A decade after first DAA, only one in three are HCV free
In the decade since safe, curative oral treatments were approved for treating hepatitis C virus (HCV) infections, only one in three U.S. patients diagnosed with the disease have been cleared of it, according to new data from the Centers for Disease Control and Prevention.
The findings indicate that current progress falls far short of the goal of the Viral Hepatitis National Strategic Plan for the United States, which calls for eliminating HCV for at least 80% of patients with the virus by 2030.
Lead author Carolyn Wester, MD, with the CDC’s Division of Viral Hepatitis, called the low numbers “stunning” and said that the researchers found that patients face barriers to being cured at every step of the way, from being diagnosed to accessing breakthrough direct-acting antiviral (DAA) agents.
The article was published online in the CDC’s Morbidity and Mortality Weekly Report.
Outcomes vary by age and insurance
Using longitudinal data from Quest Diagnostics laboratories, the researchers identified 1.7 million people who had a history of HCV infection from Jan. 1, 2013, to Dec. 31, 2022.
Of those patients, 1.5 million (88%) were categorized as having undergone viral testing.
Among those who underwent such testing, 1 million (69%) were categorized as having an initial infection. Just 356,807 patients with initial infection (34%) were cured or cleared of HCV. Of those found to be cured or cleared, 23,518 (7%) were found to have persistent infection or reinfection.
Viral clearance varied greatly by insurance. While 45% of the people covered under Medicare experienced viral clearance, only 23% of the uninsured and 31% of those on Medicaid did so.
Age also played a role in viral clearance. It was highest (42%) among those aged 60 and older. Clearance was lowest (24%) among patients in the 20-39 age group, the group most likely to be newly infected in light of the surge in HCV cases because of the opioid epidemic, Dr. Wester said. Persistent infection or reinfection was also highest in the 20-39 age group.
With respect to age and insurance type combined, the highest HCV clearance rate (49%) was for patients aged 60 and older who had commercial insurance; the lowest (16%) was for uninsured patients in the 20-39 age group.
The investigators evaluated people who had been diagnosed with HCV, Dr. Wester said. “It’s estimated about 40% of people in the U.S. are unaware of their infection.” Because of this, the numbers reported in the study may vastly underestimate the true picture, she told this news organization.
Barriers to treatment ‘insurmountable’ without major transformation
Increased access to diagnosis, treatment, and prevention services for persons with or at risk for acquiring hepatitis C needs to be addressed to prevent progression of disease and ongoing transmission and to achieve national hepatitis C elimination goals, the authors wrote.
The biggest barriers to improving HCV clearance are the high cost of treatment, widely varying insurance coverage, insurer restrictions, and challenges in diagnosing the disease, Dr. Wester added.
Overcoming these barriers requires implementation of universal HCV screening recommendations, including HCV RNA testing for all persons with reactive HCV antibody results, provision of treatment for all persons regardless of payer, and prevention services for persons at risk for acquiring new HCV infection, the authors concluded.
“The current barriers are insurmountable without a major transformation in our nation’s response,” Dr. Wester noted.
She expressed her support of the National Hepatitis C Elimination Program, offered as part of the Biden Administration’s 2024 budget proposal. She said that the initiative “is what we need to prevent the needless suffering from hepatitis C and to potentially save not only tens of thousands of lives but tens of billions of health care dollars.”
The three-part proposal includes a national subscription model to purchase DAA agents for those most underserved: Medicaid beneficiaries, incarcerated people, the uninsured, and American Indian and Alaska Native individuals treated through the Indian Health Service.
Under this model, the federal government would negotiate with manufacturers to buy as much treatment as needed for all individuals in the underserved groups.
What can physicians do?
Physicians can help improve HCV treatment and outcomes by being aware of the current testing guidelines, Dr. Wester said.
Guidelines now call for hepatitis C screening at least once in a lifetime for all adults, except in settings where the prevalence of HCV infection is less than 0.1%. They also call for screening during each pregnancy, with the same regional-prevalence exception.
Recommendations include curative treatment “for nearly everybody who is living with hepatitis C,” Dr. Wester added.
These CDC guidelines came out in April 2020, a time when the medical focus shifted to COVID-19, and that may have hurt awareness, she noted.
Physicians can also help by fighting back against non–evidence-based reasons insurance companies give for restricting coverage, Dr. Wester said.
Those restrictions include requiring specialists to prescribe DAA agents instead of allowing primary care physicians to do so, as well as requiring patients to have advanced liver disease or requiring patients to demonstrate sobriety or prove they are receiving counseling prior to their being eligible for treatment, Dr. Wester said.
Prior authorization a problem
Stacey B. Trooskin MD, PhD, MPH, assistant professor of medicine at the University of Pennsylvania in Philadelphia, told this news organization that prior authorization has been a major barrier for obtaining medications. Prior authorization requirements differ by state.
The paperwork must be submitted by already-stretched physician offices, and appeals are common. In that time, the window for keeping patients with HCV in the health care system may be lost, said Dr. Trooskin, chief medical adviser to the National Viral Hepatitis Roundtable.
“We know that about half of all Medicaid programs have removed prior authorization for most patients entirely,” she said, “but there are still half that require prior authorization.”
Action at the federal level is also needed, Dr. Trooskin said.
The countries that are successfully eliminating HCV and have successfully deployed the lifesaving medications provide governmental support for meeting patients where they are, she added.
Support can include inpatient and outpatient substance use disorder treatment programs or support in mental health settings, she noted.
“It’s not enough to want patients to come into their primary care provider and for that primary care provider to screen them,” Dr. Trooskin said. “This is about creating health care infrastructure so that we are finding patients at greatest risk for hepatitis C and integrating hepatitis C treatment into the services they are already accessing.”
Coauthor Harvey W. Kaufman, MD, is an employee of and owns stock in Quest Diagnostics. Coauthor William A. Meyer III, PhD, is a consultant to Quest Diagnostics. No other potential conflicts of interest were disclosed. Dr. Trooskin oversees C-Change, a hepatitis C elimination program, which receives funding from Gilead Sciences.
A version of this article first appeared on Medscape.com.
In the decade since safe, curative oral treatments were approved for treating hepatitis C virus (HCV) infections, only one in three U.S. patients diagnosed with the disease have been cleared of it, according to new data from the Centers for Disease Control and Prevention.
The findings indicate that current progress falls far short of the goal of the Viral Hepatitis National Strategic Plan for the United States, which calls for eliminating HCV for at least 80% of patients with the virus by 2030.
Lead author Carolyn Wester, MD, with the CDC’s Division of Viral Hepatitis, called the low numbers “stunning” and said that the researchers found that patients face barriers to being cured at every step of the way, from being diagnosed to accessing breakthrough direct-acting antiviral (DAA) agents.
The article was published online in the CDC’s Morbidity and Mortality Weekly Report.
Outcomes vary by age and insurance
Using longitudinal data from Quest Diagnostics laboratories, the researchers identified 1.7 million people who had a history of HCV infection from Jan. 1, 2013, to Dec. 31, 2022.
Of those patients, 1.5 million (88%) were categorized as having undergone viral testing.
Among those who underwent such testing, 1 million (69%) were categorized as having an initial infection. Just 356,807 patients with initial infection (34%) were cured or cleared of HCV. Of those found to be cured or cleared, 23,518 (7%) were found to have persistent infection or reinfection.
Viral clearance varied greatly by insurance. While 45% of the people covered under Medicare experienced viral clearance, only 23% of the uninsured and 31% of those on Medicaid did so.
Age also played a role in viral clearance. It was highest (42%) among those aged 60 and older. Clearance was lowest (24%) among patients in the 20-39 age group, the group most likely to be newly infected in light of the surge in HCV cases because of the opioid epidemic, Dr. Wester said. Persistent infection or reinfection was also highest in the 20-39 age group.
With respect to age and insurance type combined, the highest HCV clearance rate (49%) was for patients aged 60 and older who had commercial insurance; the lowest (16%) was for uninsured patients in the 20-39 age group.
The investigators evaluated people who had been diagnosed with HCV, Dr. Wester said. “It’s estimated about 40% of people in the U.S. are unaware of their infection.” Because of this, the numbers reported in the study may vastly underestimate the true picture, she told this news organization.
Barriers to treatment ‘insurmountable’ without major transformation
Increased access to diagnosis, treatment, and prevention services for persons with or at risk for acquiring hepatitis C needs to be addressed to prevent progression of disease and ongoing transmission and to achieve national hepatitis C elimination goals, the authors wrote.
The biggest barriers to improving HCV clearance are the high cost of treatment, widely varying insurance coverage, insurer restrictions, and challenges in diagnosing the disease, Dr. Wester added.
Overcoming these barriers requires implementation of universal HCV screening recommendations, including HCV RNA testing for all persons with reactive HCV antibody results, provision of treatment for all persons regardless of payer, and prevention services for persons at risk for acquiring new HCV infection, the authors concluded.
“The current barriers are insurmountable without a major transformation in our nation’s response,” Dr. Wester noted.
She expressed her support of the National Hepatitis C Elimination Program, offered as part of the Biden Administration’s 2024 budget proposal. She said that the initiative “is what we need to prevent the needless suffering from hepatitis C and to potentially save not only tens of thousands of lives but tens of billions of health care dollars.”
The three-part proposal includes a national subscription model to purchase DAA agents for those most underserved: Medicaid beneficiaries, incarcerated people, the uninsured, and American Indian and Alaska Native individuals treated through the Indian Health Service.
Under this model, the federal government would negotiate with manufacturers to buy as much treatment as needed for all individuals in the underserved groups.
What can physicians do?
Physicians can help improve HCV treatment and outcomes by being aware of the current testing guidelines, Dr. Wester said.
Guidelines now call for hepatitis C screening at least once in a lifetime for all adults, except in settings where the prevalence of HCV infection is less than 0.1%. They also call for screening during each pregnancy, with the same regional-prevalence exception.
Recommendations include curative treatment “for nearly everybody who is living with hepatitis C,” Dr. Wester added.
These CDC guidelines came out in April 2020, a time when the medical focus shifted to COVID-19, and that may have hurt awareness, she noted.
Physicians can also help by fighting back against non–evidence-based reasons insurance companies give for restricting coverage, Dr. Wester said.
Those restrictions include requiring specialists to prescribe DAA agents instead of allowing primary care physicians to do so, as well as requiring patients to have advanced liver disease or requiring patients to demonstrate sobriety or prove they are receiving counseling prior to their being eligible for treatment, Dr. Wester said.
Prior authorization a problem
Stacey B. Trooskin MD, PhD, MPH, assistant professor of medicine at the University of Pennsylvania in Philadelphia, told this news organization that prior authorization has been a major barrier for obtaining medications. Prior authorization requirements differ by state.
The paperwork must be submitted by already-stretched physician offices, and appeals are common. In that time, the window for keeping patients with HCV in the health care system may be lost, said Dr. Trooskin, chief medical adviser to the National Viral Hepatitis Roundtable.
“We know that about half of all Medicaid programs have removed prior authorization for most patients entirely,” she said, “but there are still half that require prior authorization.”
Action at the federal level is also needed, Dr. Trooskin said.
The countries that are successfully eliminating HCV and have successfully deployed the lifesaving medications provide governmental support for meeting patients where they are, she added.
Support can include inpatient and outpatient substance use disorder treatment programs or support in mental health settings, she noted.
“It’s not enough to want patients to come into their primary care provider and for that primary care provider to screen them,” Dr. Trooskin said. “This is about creating health care infrastructure so that we are finding patients at greatest risk for hepatitis C and integrating hepatitis C treatment into the services they are already accessing.”
Coauthor Harvey W. Kaufman, MD, is an employee of and owns stock in Quest Diagnostics. Coauthor William A. Meyer III, PhD, is a consultant to Quest Diagnostics. No other potential conflicts of interest were disclosed. Dr. Trooskin oversees C-Change, a hepatitis C elimination program, which receives funding from Gilead Sciences.
A version of this article first appeared on Medscape.com.
In the decade since safe, curative oral treatments were approved for treating hepatitis C virus (HCV) infections, only one in three U.S. patients diagnosed with the disease have been cleared of it, according to new data from the Centers for Disease Control and Prevention.
The findings indicate that current progress falls far short of the goal of the Viral Hepatitis National Strategic Plan for the United States, which calls for eliminating HCV for at least 80% of patients with the virus by 2030.
Lead author Carolyn Wester, MD, with the CDC’s Division of Viral Hepatitis, called the low numbers “stunning” and said that the researchers found that patients face barriers to being cured at every step of the way, from being diagnosed to accessing breakthrough direct-acting antiviral (DAA) agents.
The article was published online in the CDC’s Morbidity and Mortality Weekly Report.
Outcomes vary by age and insurance
Using longitudinal data from Quest Diagnostics laboratories, the researchers identified 1.7 million people who had a history of HCV infection from Jan. 1, 2013, to Dec. 31, 2022.
Of those patients, 1.5 million (88%) were categorized as having undergone viral testing.
Among those who underwent such testing, 1 million (69%) were categorized as having an initial infection. Just 356,807 patients with initial infection (34%) were cured or cleared of HCV. Of those found to be cured or cleared, 23,518 (7%) were found to have persistent infection or reinfection.
Viral clearance varied greatly by insurance. While 45% of the people covered under Medicare experienced viral clearance, only 23% of the uninsured and 31% of those on Medicaid did so.
Age also played a role in viral clearance. It was highest (42%) among those aged 60 and older. Clearance was lowest (24%) among patients in the 20-39 age group, the group most likely to be newly infected in light of the surge in HCV cases because of the opioid epidemic, Dr. Wester said. Persistent infection or reinfection was also highest in the 20-39 age group.
With respect to age and insurance type combined, the highest HCV clearance rate (49%) was for patients aged 60 and older who had commercial insurance; the lowest (16%) was for uninsured patients in the 20-39 age group.
The investigators evaluated people who had been diagnosed with HCV, Dr. Wester said. “It’s estimated about 40% of people in the U.S. are unaware of their infection.” Because of this, the numbers reported in the study may vastly underestimate the true picture, she told this news organization.
Barriers to treatment ‘insurmountable’ without major transformation
Increased access to diagnosis, treatment, and prevention services for persons with or at risk for acquiring hepatitis C needs to be addressed to prevent progression of disease and ongoing transmission and to achieve national hepatitis C elimination goals, the authors wrote.
The biggest barriers to improving HCV clearance are the high cost of treatment, widely varying insurance coverage, insurer restrictions, and challenges in diagnosing the disease, Dr. Wester added.
Overcoming these barriers requires implementation of universal HCV screening recommendations, including HCV RNA testing for all persons with reactive HCV antibody results, provision of treatment for all persons regardless of payer, and prevention services for persons at risk for acquiring new HCV infection, the authors concluded.
“The current barriers are insurmountable without a major transformation in our nation’s response,” Dr. Wester noted.
She expressed her support of the National Hepatitis C Elimination Program, offered as part of the Biden Administration’s 2024 budget proposal. She said that the initiative “is what we need to prevent the needless suffering from hepatitis C and to potentially save not only tens of thousands of lives but tens of billions of health care dollars.”
The three-part proposal includes a national subscription model to purchase DAA agents for those most underserved: Medicaid beneficiaries, incarcerated people, the uninsured, and American Indian and Alaska Native individuals treated through the Indian Health Service.
Under this model, the federal government would negotiate with manufacturers to buy as much treatment as needed for all individuals in the underserved groups.
What can physicians do?
Physicians can help improve HCV treatment and outcomes by being aware of the current testing guidelines, Dr. Wester said.
Guidelines now call for hepatitis C screening at least once in a lifetime for all adults, except in settings where the prevalence of HCV infection is less than 0.1%. They also call for screening during each pregnancy, with the same regional-prevalence exception.
Recommendations include curative treatment “for nearly everybody who is living with hepatitis C,” Dr. Wester added.
These CDC guidelines came out in April 2020, a time when the medical focus shifted to COVID-19, and that may have hurt awareness, she noted.
Physicians can also help by fighting back against non–evidence-based reasons insurance companies give for restricting coverage, Dr. Wester said.
Those restrictions include requiring specialists to prescribe DAA agents instead of allowing primary care physicians to do so, as well as requiring patients to have advanced liver disease or requiring patients to demonstrate sobriety or prove they are receiving counseling prior to their being eligible for treatment, Dr. Wester said.
Prior authorization a problem
Stacey B. Trooskin MD, PhD, MPH, assistant professor of medicine at the University of Pennsylvania in Philadelphia, told this news organization that prior authorization has been a major barrier for obtaining medications. Prior authorization requirements differ by state.
The paperwork must be submitted by already-stretched physician offices, and appeals are common. In that time, the window for keeping patients with HCV in the health care system may be lost, said Dr. Trooskin, chief medical adviser to the National Viral Hepatitis Roundtable.
“We know that about half of all Medicaid programs have removed prior authorization for most patients entirely,” she said, “but there are still half that require prior authorization.”
Action at the federal level is also needed, Dr. Trooskin said.
The countries that are successfully eliminating HCV and have successfully deployed the lifesaving medications provide governmental support for meeting patients where they are, she added.
Support can include inpatient and outpatient substance use disorder treatment programs or support in mental health settings, she noted.
“It’s not enough to want patients to come into their primary care provider and for that primary care provider to screen them,” Dr. Trooskin said. “This is about creating health care infrastructure so that we are finding patients at greatest risk for hepatitis C and integrating hepatitis C treatment into the services they are already accessing.”
Coauthor Harvey W. Kaufman, MD, is an employee of and owns stock in Quest Diagnostics. Coauthor William A. Meyer III, PhD, is a consultant to Quest Diagnostics. No other potential conflicts of interest were disclosed. Dr. Trooskin oversees C-Change, a hepatitis C elimination program, which receives funding from Gilead Sciences.
A version of this article first appeared on Medscape.com.
FDA clears the Tandem Mobi insulin pump
The product is half the size of the company’s t:slim X2 and is now the smallest of the commercially available durable tubed pumps. It is fully controllable from a mobile app through a user’s compatible iPhone.
Features of the Mobi include a 200-unit insulin cartridge and an on-pump button that can be used instead of the phone for bolusing insulin. The device can be clipped to clothing or worn on-body with an adhesive sleeve that is sold separately.
The Mobi is compatible with all existing Tandem-branded infusion sets manufactured by the Convatec Group, and there is a new 5-inch tubing option made just for the Tandem Mobi.
The Mobi is part of a hybrid-closed loop automated delivery system, along with the current Control-IQ technology and a compatible continuous glucose monitor (CGM). The CGM sensor predicts glucose values 30 minutes ahead and adjusts insulin delivery every 5 minutes to prevent highs and lows. Users must still manually bolus for meals. The system can deliver automatic correction boluses for up to 1 hour to prevent hyperglycemia.
Limited release of the Tandem Mobi is expected in late 2023, followed by full commercial availability in early 2024.
A version of this article originally appeared on Medscape.com.
The product is half the size of the company’s t:slim X2 and is now the smallest of the commercially available durable tubed pumps. It is fully controllable from a mobile app through a user’s compatible iPhone.
Features of the Mobi include a 200-unit insulin cartridge and an on-pump button that can be used instead of the phone for bolusing insulin. The device can be clipped to clothing or worn on-body with an adhesive sleeve that is sold separately.
The Mobi is compatible with all existing Tandem-branded infusion sets manufactured by the Convatec Group, and there is a new 5-inch tubing option made just for the Tandem Mobi.
The Mobi is part of a hybrid-closed loop automated delivery system, along with the current Control-IQ technology and a compatible continuous glucose monitor (CGM). The CGM sensor predicts glucose values 30 minutes ahead and adjusts insulin delivery every 5 minutes to prevent highs and lows. Users must still manually bolus for meals. The system can deliver automatic correction boluses for up to 1 hour to prevent hyperglycemia.
Limited release of the Tandem Mobi is expected in late 2023, followed by full commercial availability in early 2024.
A version of this article originally appeared on Medscape.com.
The product is half the size of the company’s t:slim X2 and is now the smallest of the commercially available durable tubed pumps. It is fully controllable from a mobile app through a user’s compatible iPhone.
Features of the Mobi include a 200-unit insulin cartridge and an on-pump button that can be used instead of the phone for bolusing insulin. The device can be clipped to clothing or worn on-body with an adhesive sleeve that is sold separately.
The Mobi is compatible with all existing Tandem-branded infusion sets manufactured by the Convatec Group, and there is a new 5-inch tubing option made just for the Tandem Mobi.
The Mobi is part of a hybrid-closed loop automated delivery system, along with the current Control-IQ technology and a compatible continuous glucose monitor (CGM). The CGM sensor predicts glucose values 30 minutes ahead and adjusts insulin delivery every 5 minutes to prevent highs and lows. Users must still manually bolus for meals. The system can deliver automatic correction boluses for up to 1 hour to prevent hyperglycemia.
Limited release of the Tandem Mobi is expected in late 2023, followed by full commercial availability in early 2024.
A version of this article originally appeared on Medscape.com.
FDA: No excess mortality risk from paclitaxel stents, balloons for peripheral intervention
, the agency July 11 in a statement to health care providers.
The FDA announcement comes about 4 years after it warned physicians of a “potentially concerning” signal of excess mortality linked to paclitaxel-coated balloons and paclitaxel-eluting stents in published analysis.
The agency’s concerns had been based on a December 2018 meta-analysis in the Journal of the American Heart Association that saw a 68% jump in mortality risk at 2 years and a 93% excess risk at 5 years associated with the paclitaxel devices in the periphery.
The findings, which led an FDA advisory committee to recommend device labeling changes and otherwise upended the practice of peripheral interventions, were followed by an FDA recommendation to limit the use of paclitaxel devices in the periphery to higher-risk cases.
In its July 11 update to providers, the FDA said it was satisfied the devices do not pose an excess mortality risk. It based its conclusion on extensive further evidence review and recently available “additional data” from the randomized controlled trials (RCTs) contributing to the meta-analysis that had ignited the controversy.
“FDA clinicians and statisticians reviewed the study data,” the agency said, “and concluded that the updated RCT meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk.”
A version of this article originally appeared on Medscape.com.
, the agency July 11 in a statement to health care providers.
The FDA announcement comes about 4 years after it warned physicians of a “potentially concerning” signal of excess mortality linked to paclitaxel-coated balloons and paclitaxel-eluting stents in published analysis.
The agency’s concerns had been based on a December 2018 meta-analysis in the Journal of the American Heart Association that saw a 68% jump in mortality risk at 2 years and a 93% excess risk at 5 years associated with the paclitaxel devices in the periphery.
The findings, which led an FDA advisory committee to recommend device labeling changes and otherwise upended the practice of peripheral interventions, were followed by an FDA recommendation to limit the use of paclitaxel devices in the periphery to higher-risk cases.
In its July 11 update to providers, the FDA said it was satisfied the devices do not pose an excess mortality risk. It based its conclusion on extensive further evidence review and recently available “additional data” from the randomized controlled trials (RCTs) contributing to the meta-analysis that had ignited the controversy.
“FDA clinicians and statisticians reviewed the study data,” the agency said, “and concluded that the updated RCT meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk.”
A version of this article originally appeared on Medscape.com.
, the agency July 11 in a statement to health care providers.
The FDA announcement comes about 4 years after it warned physicians of a “potentially concerning” signal of excess mortality linked to paclitaxel-coated balloons and paclitaxel-eluting stents in published analysis.
The agency’s concerns had been based on a December 2018 meta-analysis in the Journal of the American Heart Association that saw a 68% jump in mortality risk at 2 years and a 93% excess risk at 5 years associated with the paclitaxel devices in the periphery.
The findings, which led an FDA advisory committee to recommend device labeling changes and otherwise upended the practice of peripheral interventions, were followed by an FDA recommendation to limit the use of paclitaxel devices in the periphery to higher-risk cases.
In its July 11 update to providers, the FDA said it was satisfied the devices do not pose an excess mortality risk. It based its conclusion on extensive further evidence review and recently available “additional data” from the randomized controlled trials (RCTs) contributing to the meta-analysis that had ignited the controversy.
“FDA clinicians and statisticians reviewed the study data,” the agency said, “and concluded that the updated RCT meta-analysis does not indicate that the use of paclitaxel-coated devices is associated with a late mortality risk.”
A version of this article originally appeared on Medscape.com.
FDA approves first leadless dual-chamber pacing system
, one based in part on an already-approved leadless single-chamber device, Abbott has announced.
The company’s AVEIR DR leadless pacing system consists of two percutaneously implanted devices, the single-chamber AVEIR VR leadless pacemaker, implanted within the right ventricle, and the novel AVEIR AR single-chamber pacemaker for implantation in the right atrium.
The AVEIR DR system relies on proprietary wireless technology to provide bidirectional, beat-to-beat communication between its two components to achieve dual-chamber synchronization, the company stated in a press release on the approval.
The system also provides real-time pacing analysis, Abbott said, allowing clinicians to assess proper device placement during the procedure and before implantation. The system is designed to be easily removed if the patient’s pacing needs evolve or its battery needs replacing.
Experienced operators achieved a 98% implantation success rate using the AVIER DR system in a 300-patient study conducted at 55 sites in Canada, Europe, and the United States. In that study, 63% of the patients had sinus-node dysfunction and 33% had AV block as their primary dual-chamber pacing indication.
The system exceeded its predefined safety and performance goals, providing AV-synchronous pacing in 97% of patients for at least 3 months, it was reported in May at the annual scientific sessions of the Heart Rhythm Society and in a simultaneous publication in The New England Journal of Medicine.
“Modern medicine has been filled with technological achievements that fundamentally changed how doctors approach patient care, and now we can officially add dual-chamber leadless pacing to that list of achievements,” coauthor Vivek Reddy, MD, director of cardiac arrhythmia services for Mount Sinai Hospital and the Mount Sinai Health System, New York, said in the press release.
A version of this article first appeared on Medscape.com.
, one based in part on an already-approved leadless single-chamber device, Abbott has announced.
The company’s AVEIR DR leadless pacing system consists of two percutaneously implanted devices, the single-chamber AVEIR VR leadless pacemaker, implanted within the right ventricle, and the novel AVEIR AR single-chamber pacemaker for implantation in the right atrium.
The AVEIR DR system relies on proprietary wireless technology to provide bidirectional, beat-to-beat communication between its two components to achieve dual-chamber synchronization, the company stated in a press release on the approval.
The system also provides real-time pacing analysis, Abbott said, allowing clinicians to assess proper device placement during the procedure and before implantation. The system is designed to be easily removed if the patient’s pacing needs evolve or its battery needs replacing.
Experienced operators achieved a 98% implantation success rate using the AVIER DR system in a 300-patient study conducted at 55 sites in Canada, Europe, and the United States. In that study, 63% of the patients had sinus-node dysfunction and 33% had AV block as their primary dual-chamber pacing indication.
The system exceeded its predefined safety and performance goals, providing AV-synchronous pacing in 97% of patients for at least 3 months, it was reported in May at the annual scientific sessions of the Heart Rhythm Society and in a simultaneous publication in The New England Journal of Medicine.
“Modern medicine has been filled with technological achievements that fundamentally changed how doctors approach patient care, and now we can officially add dual-chamber leadless pacing to that list of achievements,” coauthor Vivek Reddy, MD, director of cardiac arrhythmia services for Mount Sinai Hospital and the Mount Sinai Health System, New York, said in the press release.
A version of this article first appeared on Medscape.com.
, one based in part on an already-approved leadless single-chamber device, Abbott has announced.
The company’s AVEIR DR leadless pacing system consists of two percutaneously implanted devices, the single-chamber AVEIR VR leadless pacemaker, implanted within the right ventricle, and the novel AVEIR AR single-chamber pacemaker for implantation in the right atrium.
The AVEIR DR system relies on proprietary wireless technology to provide bidirectional, beat-to-beat communication between its two components to achieve dual-chamber synchronization, the company stated in a press release on the approval.
The system also provides real-time pacing analysis, Abbott said, allowing clinicians to assess proper device placement during the procedure and before implantation. The system is designed to be easily removed if the patient’s pacing needs evolve or its battery needs replacing.
Experienced operators achieved a 98% implantation success rate using the AVIER DR system in a 300-patient study conducted at 55 sites in Canada, Europe, and the United States. In that study, 63% of the patients had sinus-node dysfunction and 33% had AV block as their primary dual-chamber pacing indication.
The system exceeded its predefined safety and performance goals, providing AV-synchronous pacing in 97% of patients for at least 3 months, it was reported in May at the annual scientific sessions of the Heart Rhythm Society and in a simultaneous publication in The New England Journal of Medicine.
“Modern medicine has been filled with technological achievements that fundamentally changed how doctors approach patient care, and now we can officially add dual-chamber leadless pacing to that list of achievements,” coauthor Vivek Reddy, MD, director of cardiac arrhythmia services for Mount Sinai Hospital and the Mount Sinai Health System, New York, said in the press release.
A version of this article first appeared on Medscape.com.
Malaria is spreading in the U.S. for the first time in 20 years
, the Centers for Disease Control and Prevention says.
The federal health agency recently issued a nationwide warning to health providers and officials to be on the lookout for symptoms of the potentially fatal illness. Usually, people in the U.S. who get malaria get the disease during international travel.
All five people – four in Florida and one in Texas – have received treatment and are improving, according to the CDC. The case in Texas is not related to the Florida cases, and all occurred in the past 2 months.
Malaria cannot be transmitted from person to person. It is spread by the bite of an infected female mosquito. The last cases of people being infected while in the U.S. occurred 20 years ago, when there were eight cases in Palm Beach County, Fla. The Texas Department of State Health Services said the last time malaria was locally acquired in the state was 1994.
The Florida Department of Health said it was spraying for mosquitoes in the two counties surrounding Sarasota, Fla., where the four cases occurred.
The CDC said the risk of getting malaria while in the United States “remains extremely low.” The agency advised people to protect themselves by taking precautions to prevent mosquito bites, such as wearing insect repellent and wearing long-sleeved shirts and pants. People should also do things to ensure that mosquitoes aren’t around their home, such as getting rid of standing water, which is an environment for mosquitoes to lay eggs.
More than 240 million malaria cases occur annually worldwide, the CDC said, with 95% in Africa. There are 2,000 cases diagnosed annually in the U.S. that are related to international travel. Malaria symptoms are similar to those of other illnesses and include fever, chills, a headache, and muscle aches. If not treated, malaria can be fatal.
A version of this article first appeared on WebMD.com.
, the Centers for Disease Control and Prevention says.
The federal health agency recently issued a nationwide warning to health providers and officials to be on the lookout for symptoms of the potentially fatal illness. Usually, people in the U.S. who get malaria get the disease during international travel.
All five people – four in Florida and one in Texas – have received treatment and are improving, according to the CDC. The case in Texas is not related to the Florida cases, and all occurred in the past 2 months.
Malaria cannot be transmitted from person to person. It is spread by the bite of an infected female mosquito. The last cases of people being infected while in the U.S. occurred 20 years ago, when there were eight cases in Palm Beach County, Fla. The Texas Department of State Health Services said the last time malaria was locally acquired in the state was 1994.
The Florida Department of Health said it was spraying for mosquitoes in the two counties surrounding Sarasota, Fla., where the four cases occurred.
The CDC said the risk of getting malaria while in the United States “remains extremely low.” The agency advised people to protect themselves by taking precautions to prevent mosquito bites, such as wearing insect repellent and wearing long-sleeved shirts and pants. People should also do things to ensure that mosquitoes aren’t around their home, such as getting rid of standing water, which is an environment for mosquitoes to lay eggs.
More than 240 million malaria cases occur annually worldwide, the CDC said, with 95% in Africa. There are 2,000 cases diagnosed annually in the U.S. that are related to international travel. Malaria symptoms are similar to those of other illnesses and include fever, chills, a headache, and muscle aches. If not treated, malaria can be fatal.
A version of this article first appeared on WebMD.com.
, the Centers for Disease Control and Prevention says.
The federal health agency recently issued a nationwide warning to health providers and officials to be on the lookout for symptoms of the potentially fatal illness. Usually, people in the U.S. who get malaria get the disease during international travel.
All five people – four in Florida and one in Texas – have received treatment and are improving, according to the CDC. The case in Texas is not related to the Florida cases, and all occurred in the past 2 months.
Malaria cannot be transmitted from person to person. It is spread by the bite of an infected female mosquito. The last cases of people being infected while in the U.S. occurred 20 years ago, when there were eight cases in Palm Beach County, Fla. The Texas Department of State Health Services said the last time malaria was locally acquired in the state was 1994.
The Florida Department of Health said it was spraying for mosquitoes in the two counties surrounding Sarasota, Fla., where the four cases occurred.
The CDC said the risk of getting malaria while in the United States “remains extremely low.” The agency advised people to protect themselves by taking precautions to prevent mosquito bites, such as wearing insect repellent and wearing long-sleeved shirts and pants. People should also do things to ensure that mosquitoes aren’t around their home, such as getting rid of standing water, which is an environment for mosquitoes to lay eggs.
More than 240 million malaria cases occur annually worldwide, the CDC said, with 95% in Africa. There are 2,000 cases diagnosed annually in the U.S. that are related to international travel. Malaria symptoms are similar to those of other illnesses and include fever, chills, a headache, and muscle aches. If not treated, malaria can be fatal.
A version of this article first appeared on WebMD.com.
FDA clears new biomarker assays for early Alzheimer’s detection
The Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys total-tau CSF assays (tTau) (used as a tTau/Abeta42 ratio) are for use in adults ages 55 and older being evaluated for AD.
They join the Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys phospho-tau (181P) CSF (pTau181) assays (used as a pTau181/Abeta42 ratio) that received FDA 510(k) clearance in 2022.
“An early and accurate diagnosis can help patients, caregivers and physicians determine a path forward, and the Elecsys CSF assays support diagnosis at early disease stages, when treatment is most effective,” Brad Moore, president and CEO of Roche Diagnostics North America, said in a statement.
Appropriate use recommendations for new and emerging AD drugs call for confirmation of amyloid pathology. Currently, the only FDA-cleared methods to confirm amyloid pathology are CSF tests and PET scans.
“The Elecsys AD CSF assays are concordant with amyloid PET scan imaging and have the potential to provide a more affordable and accessible routine option to confirm the presence of amyloid pathology in the brain,” Roche said.
“They also offer detection of both amyloid and tau biomarkers from one draw, with no radiation and potential to detect Alzheimer’s pathology in early stages of disease,” the company added.
The previously approved Elecsys pTau181/Abeta42 ratio is currently available and the newly approved Elecsys tTau/Abeta42 ratio will be available in the fourth quarter of 2023.
A version of this article first appeared on Medscape.com.
The Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys total-tau CSF assays (tTau) (used as a tTau/Abeta42 ratio) are for use in adults ages 55 and older being evaluated for AD.
They join the Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys phospho-tau (181P) CSF (pTau181) assays (used as a pTau181/Abeta42 ratio) that received FDA 510(k) clearance in 2022.
“An early and accurate diagnosis can help patients, caregivers and physicians determine a path forward, and the Elecsys CSF assays support diagnosis at early disease stages, when treatment is most effective,” Brad Moore, president and CEO of Roche Diagnostics North America, said in a statement.
Appropriate use recommendations for new and emerging AD drugs call for confirmation of amyloid pathology. Currently, the only FDA-cleared methods to confirm amyloid pathology are CSF tests and PET scans.
“The Elecsys AD CSF assays are concordant with amyloid PET scan imaging and have the potential to provide a more affordable and accessible routine option to confirm the presence of amyloid pathology in the brain,” Roche said.
“They also offer detection of both amyloid and tau biomarkers from one draw, with no radiation and potential to detect Alzheimer’s pathology in early stages of disease,” the company added.
The previously approved Elecsys pTau181/Abeta42 ratio is currently available and the newly approved Elecsys tTau/Abeta42 ratio will be available in the fourth quarter of 2023.
A version of this article first appeared on Medscape.com.
The Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys total-tau CSF assays (tTau) (used as a tTau/Abeta42 ratio) are for use in adults ages 55 and older being evaluated for AD.
They join the Elecsys beta-amyloid (1-42) CSF II (Abeta42) and Elecsys phospho-tau (181P) CSF (pTau181) assays (used as a pTau181/Abeta42 ratio) that received FDA 510(k) clearance in 2022.
“An early and accurate diagnosis can help patients, caregivers and physicians determine a path forward, and the Elecsys CSF assays support diagnosis at early disease stages, when treatment is most effective,” Brad Moore, president and CEO of Roche Diagnostics North America, said in a statement.
Appropriate use recommendations for new and emerging AD drugs call for confirmation of amyloid pathology. Currently, the only FDA-cleared methods to confirm amyloid pathology are CSF tests and PET scans.
“The Elecsys AD CSF assays are concordant with amyloid PET scan imaging and have the potential to provide a more affordable and accessible routine option to confirm the presence of amyloid pathology in the brain,” Roche said.
“They also offer detection of both amyloid and tau biomarkers from one draw, with no radiation and potential to detect Alzheimer’s pathology in early stages of disease,” the company added.
The previously approved Elecsys pTau181/Abeta42 ratio is currently available and the newly approved Elecsys tTau/Abeta42 ratio will be available in the fourth quarter of 2023.
A version of this article first appeared on Medscape.com.
FDA approves ritlecitinib for ages 12 and up for alopecia areata
Taken as a once-daily pill, ritlecitinib is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3 (JAK3). The recommended dose of ritlecitinib, which will be marketed as Litfulo, is 50 mg once a day, according to the statement announcing the approval from Pfizer.
It is the second JAK inhibitor approved for treating alopecia areata, following approval of baricitinib (Olumiant) in June 2022 for AA in adults. Ritlecitinib is the first JAK inhibitor approved for children ages 12 and older with AA.
The European Medicines Agency has also accepted the Marketing Authorization Application for ritlecitinib in the same population and a decision is expected in the fourth quarter of this year.
Approval based on ALLEGRO trials
Approval was based on previously announced results from trials, including the phase 2b/3 ALLEGRO study of ritlecitinib in 718 patients aged 12 years and older with alopecia areata, with 50% of more scalp hair loss, as measured by the Severity of Alopecia Tool (SALT), including patients with alopecia totalis (complete scalp hair loss) and alopecia universalis (complete scalp, face, and body hair loss).
Patients in the trial were experiencing a current episode of alopecia areata that had lasted between 6 months and 10 years. They were randomized to receive once-daily ritlecitinib at doses of 30 mg or 50 mg (with or without 1 month of initial treatment with once-daily ritlecitinib 200 mg), ritlecitinib 10 mg, or placebo.
Statistically significantly higher proportions of patients treated with ritlecitinib 30 mg and 50 mg (with or without the loading dose) had 80% or more scalp hair coverage, as measured by a SALT score of 20 or less after 6 months of treatment versus placebo. After 6 months of treatment, among those on the 50-mg dose, 23% had achieved a SALT score of 20 or less, compared with 2% of those on placebo. The results were published in The Lancet.
According to the company release, efficacy and safety of ritlecitinib was consistent between those ages 12-17 and adults, and the most common adverse events reported in the study, in at least 4% of patients treated with ritlecitinib, were headache (10.8%), diarrhea (10%), acne (6.2%), rash (5.4%), and urticaria (4.6%).
Ritlecitinib labeling includes the boxed warning about the risk for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis, which is included in the labels for other JAK inhibitors.
Ritlecitinib evaluated for other diseases
In addition to alopecia areata, ritlecitinib has shown efficacy and acceptable safety in treating ulcerative colitis and is being evaluated for treating vitiligo, Crohn’s disease, and rheumatoid arthritis.
In the statement, the company says that ritlecitinib will be available “in the coming weeks.” The manufacturer says it also has completed regulatory submissions for ritlecitinib in the United Kingdom, China, and Japan, and expects decisions this year.
Alopecia areata affects about 6.8 million people in the United States and 147 million globally.
In a statement, Nicole Friedland, president and CEO of the National Alopecia Areata Foundation, said that NAAF “is thrilled to have a second FDA-approved treatment for alopecia areata, which is the first approved for adolescents.”
A version of this article first appeared on Medscape.com.
Taken as a once-daily pill, ritlecitinib is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3 (JAK3). The recommended dose of ritlecitinib, which will be marketed as Litfulo, is 50 mg once a day, according to the statement announcing the approval from Pfizer.
It is the second JAK inhibitor approved for treating alopecia areata, following approval of baricitinib (Olumiant) in June 2022 for AA in adults. Ritlecitinib is the first JAK inhibitor approved for children ages 12 and older with AA.
The European Medicines Agency has also accepted the Marketing Authorization Application for ritlecitinib in the same population and a decision is expected in the fourth quarter of this year.
Approval based on ALLEGRO trials
Approval was based on previously announced results from trials, including the phase 2b/3 ALLEGRO study of ritlecitinib in 718 patients aged 12 years and older with alopecia areata, with 50% of more scalp hair loss, as measured by the Severity of Alopecia Tool (SALT), including patients with alopecia totalis (complete scalp hair loss) and alopecia universalis (complete scalp, face, and body hair loss).
Patients in the trial were experiencing a current episode of alopecia areata that had lasted between 6 months and 10 years. They were randomized to receive once-daily ritlecitinib at doses of 30 mg or 50 mg (with or without 1 month of initial treatment with once-daily ritlecitinib 200 mg), ritlecitinib 10 mg, or placebo.
Statistically significantly higher proportions of patients treated with ritlecitinib 30 mg and 50 mg (with or without the loading dose) had 80% or more scalp hair coverage, as measured by a SALT score of 20 or less after 6 months of treatment versus placebo. After 6 months of treatment, among those on the 50-mg dose, 23% had achieved a SALT score of 20 or less, compared with 2% of those on placebo. The results were published in The Lancet.
According to the company release, efficacy and safety of ritlecitinib was consistent between those ages 12-17 and adults, and the most common adverse events reported in the study, in at least 4% of patients treated with ritlecitinib, were headache (10.8%), diarrhea (10%), acne (6.2%), rash (5.4%), and urticaria (4.6%).
Ritlecitinib labeling includes the boxed warning about the risk for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis, which is included in the labels for other JAK inhibitors.
Ritlecitinib evaluated for other diseases
In addition to alopecia areata, ritlecitinib has shown efficacy and acceptable safety in treating ulcerative colitis and is being evaluated for treating vitiligo, Crohn’s disease, and rheumatoid arthritis.
In the statement, the company says that ritlecitinib will be available “in the coming weeks.” The manufacturer says it also has completed regulatory submissions for ritlecitinib in the United Kingdom, China, and Japan, and expects decisions this year.
Alopecia areata affects about 6.8 million people in the United States and 147 million globally.
In a statement, Nicole Friedland, president and CEO of the National Alopecia Areata Foundation, said that NAAF “is thrilled to have a second FDA-approved treatment for alopecia areata, which is the first approved for adolescents.”
A version of this article first appeared on Medscape.com.
Taken as a once-daily pill, ritlecitinib is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3 (JAK3). The recommended dose of ritlecitinib, which will be marketed as Litfulo, is 50 mg once a day, according to the statement announcing the approval from Pfizer.
It is the second JAK inhibitor approved for treating alopecia areata, following approval of baricitinib (Olumiant) in June 2022 for AA in adults. Ritlecitinib is the first JAK inhibitor approved for children ages 12 and older with AA.
The European Medicines Agency has also accepted the Marketing Authorization Application for ritlecitinib in the same population and a decision is expected in the fourth quarter of this year.
Approval based on ALLEGRO trials
Approval was based on previously announced results from trials, including the phase 2b/3 ALLEGRO study of ritlecitinib in 718 patients aged 12 years and older with alopecia areata, with 50% of more scalp hair loss, as measured by the Severity of Alopecia Tool (SALT), including patients with alopecia totalis (complete scalp hair loss) and alopecia universalis (complete scalp, face, and body hair loss).
Patients in the trial were experiencing a current episode of alopecia areata that had lasted between 6 months and 10 years. They were randomized to receive once-daily ritlecitinib at doses of 30 mg or 50 mg (with or without 1 month of initial treatment with once-daily ritlecitinib 200 mg), ritlecitinib 10 mg, or placebo.
Statistically significantly higher proportions of patients treated with ritlecitinib 30 mg and 50 mg (with or without the loading dose) had 80% or more scalp hair coverage, as measured by a SALT score of 20 or less after 6 months of treatment versus placebo. After 6 months of treatment, among those on the 50-mg dose, 23% had achieved a SALT score of 20 or less, compared with 2% of those on placebo. The results were published in The Lancet.
According to the company release, efficacy and safety of ritlecitinib was consistent between those ages 12-17 and adults, and the most common adverse events reported in the study, in at least 4% of patients treated with ritlecitinib, were headache (10.8%), diarrhea (10%), acne (6.2%), rash (5.4%), and urticaria (4.6%).
Ritlecitinib labeling includes the boxed warning about the risk for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis, which is included in the labels for other JAK inhibitors.
Ritlecitinib evaluated for other diseases
In addition to alopecia areata, ritlecitinib has shown efficacy and acceptable safety in treating ulcerative colitis and is being evaluated for treating vitiligo, Crohn’s disease, and rheumatoid arthritis.
In the statement, the company says that ritlecitinib will be available “in the coming weeks.” The manufacturer says it also has completed regulatory submissions for ritlecitinib in the United Kingdom, China, and Japan, and expects decisions this year.
Alopecia areata affects about 6.8 million people in the United States and 147 million globally.
In a statement, Nicole Friedland, president and CEO of the National Alopecia Areata Foundation, said that NAAF “is thrilled to have a second FDA-approved treatment for alopecia areata, which is the first approved for adolescents.”
A version of this article first appeared on Medscape.com.
FDA approves talazoparib for metastatic prostate cancer
Talazoparib is already approved for adults with deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer. The new approval, granted following priority review, is based on findings from the randomized, placebo-controlled, phase 3 TALAPRO-2 trial, published in The Lancet.
The 399 patients in the study were randomly assigned in a 1:1 ratio to receive either enzalutamide 160 mg daily plus either talazoparib 0.5 mg or placebo daily. Median radiographic progression-free survival (PFS) was not reached in the treatment group; it was 13.8 months in the placebo group (hazard ratio, 0.45). In an exploratory analysis by BRCA mutation status, patients with BRCA-mutated disease who received talazoparib exhibited an even stronger median radiographic PFS (HR, 0.20; not reached vs. 11 months) in comparison with those without BRCA-mutated disease (HR, 0.72; 24.7 vs. 16.7 months).
Serious adverse reactions occurred in 30% of patients who received talazoparib plus enzalutamide. The most common serious adverse reactions, reported in more than 2% of patients, included anemia (9%) and fracture (3%). Discontinuation of talazoparib occurred in 10% of patients, according to a Pfizer statement.
Pfizer also noted that a marketing authorization application for the drug combination has been accepted for review by the European Medicines Agency.
“Despite treatment advancement in metastatic castration-resistant prostate cancer, the disease can progress quickly, and many patients may only receive one line of therapy,” lead investigator Neeraj Agarwal, MD, of the Huntsman Cancer Institute, University of Utah, Salt Lake City, said in a statement. Patients with metastatic castration-resistant prostate cancer harboring HRR genetic alterations have even worse outcomes, and thus the FDA’s approval of the talazoparib and enzalutamide combination “represents a treatment option deserving of excitement and attention.”
A version of this article originally appeared on Medscape.com.
Talazoparib is already approved for adults with deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer. The new approval, granted following priority review, is based on findings from the randomized, placebo-controlled, phase 3 TALAPRO-2 trial, published in The Lancet.
The 399 patients in the study were randomly assigned in a 1:1 ratio to receive either enzalutamide 160 mg daily plus either talazoparib 0.5 mg or placebo daily. Median radiographic progression-free survival (PFS) was not reached in the treatment group; it was 13.8 months in the placebo group (hazard ratio, 0.45). In an exploratory analysis by BRCA mutation status, patients with BRCA-mutated disease who received talazoparib exhibited an even stronger median radiographic PFS (HR, 0.20; not reached vs. 11 months) in comparison with those without BRCA-mutated disease (HR, 0.72; 24.7 vs. 16.7 months).
Serious adverse reactions occurred in 30% of patients who received talazoparib plus enzalutamide. The most common serious adverse reactions, reported in more than 2% of patients, included anemia (9%) and fracture (3%). Discontinuation of talazoparib occurred in 10% of patients, according to a Pfizer statement.
Pfizer also noted that a marketing authorization application for the drug combination has been accepted for review by the European Medicines Agency.
“Despite treatment advancement in metastatic castration-resistant prostate cancer, the disease can progress quickly, and many patients may only receive one line of therapy,” lead investigator Neeraj Agarwal, MD, of the Huntsman Cancer Institute, University of Utah, Salt Lake City, said in a statement. Patients with metastatic castration-resistant prostate cancer harboring HRR genetic alterations have even worse outcomes, and thus the FDA’s approval of the talazoparib and enzalutamide combination “represents a treatment option deserving of excitement and attention.”
A version of this article originally appeared on Medscape.com.
Talazoparib is already approved for adults with deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer. The new approval, granted following priority review, is based on findings from the randomized, placebo-controlled, phase 3 TALAPRO-2 trial, published in The Lancet.
The 399 patients in the study were randomly assigned in a 1:1 ratio to receive either enzalutamide 160 mg daily plus either talazoparib 0.5 mg or placebo daily. Median radiographic progression-free survival (PFS) was not reached in the treatment group; it was 13.8 months in the placebo group (hazard ratio, 0.45). In an exploratory analysis by BRCA mutation status, patients with BRCA-mutated disease who received talazoparib exhibited an even stronger median radiographic PFS (HR, 0.20; not reached vs. 11 months) in comparison with those without BRCA-mutated disease (HR, 0.72; 24.7 vs. 16.7 months).
Serious adverse reactions occurred in 30% of patients who received talazoparib plus enzalutamide. The most common serious adverse reactions, reported in more than 2% of patients, included anemia (9%) and fracture (3%). Discontinuation of talazoparib occurred in 10% of patients, according to a Pfizer statement.
Pfizer also noted that a marketing authorization application for the drug combination has been accepted for review by the European Medicines Agency.
“Despite treatment advancement in metastatic castration-resistant prostate cancer, the disease can progress quickly, and many patients may only receive one line of therapy,” lead investigator Neeraj Agarwal, MD, of the Huntsman Cancer Institute, University of Utah, Salt Lake City, said in a statement. Patients with metastatic castration-resistant prostate cancer harboring HRR genetic alterations have even worse outcomes, and thus the FDA’s approval of the talazoparib and enzalutamide combination “represents a treatment option deserving of excitement and attention.”
A version of this article originally appeared on Medscape.com.