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What FPs should know about pharmacogenetic testing

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VIDEO: Don’t miss reservoirs when treating recurrent onychomycosis

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– Patients attribute every nail problem to nail fungus, but part of the problem with nails is concomitant tinea pedis, tinea corporis, and other reservoirs of infection, according to Neal Bhatia, MD, director of clinical dermatology at Therapeutics Clinical Research in San Diego.

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– Patients attribute every nail problem to nail fungus, but part of the problem with nails is concomitant tinea pedis, tinea corporis, and other reservoirs of infection, according to Neal Bhatia, MD, director of clinical dermatology at Therapeutics Clinical Research in San Diego.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– Patients attribute every nail problem to nail fungus, but part of the problem with nails is concomitant tinea pedis, tinea corporis, and other reservoirs of infection, according to Neal Bhatia, MD, director of clinical dermatology at Therapeutics Clinical Research in San Diego.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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VIDEO: Consider PPIs as a cause of cutaneous reactions

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– Any proton pump inhibitor (PPI) has the potential to cause skin reactions, so it is important to ask patients about their use, according to J. Mark Jackson, MD, of the University of Louisville (Ky.).

If patients are going to react to a PPI, they usually will do so within 3 or 4 months of starting treatment, rather than in the first week or so of treatment, Dr. Jackson said in a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

Skin reactions to PPIs are often maculopapular, with a flat and a raised component that can be nonspecific, Dr. Jackson noted.

Interestingly, he added, many times patients can switch to a different PPI and not get a skin reaction. However, there are some patients who develop a lupuslike reaction on the skin, and in these cases, there tends to be cross reactivity, “so they couldn’t switch to a different PPI and be risk-free” of the same reaction, he noted.

Dr. Jackson disclosed financial relationships with companies including AbbVie, Amgen, Celgene, Dermira, Galderma, Genentech, Janssen, Lilly, Medimetriks, Merck, Novartis, Pfizer, Promius, and Top MD.

SDEF and this news organization are owned by the same parent company.

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– Any proton pump inhibitor (PPI) has the potential to cause skin reactions, so it is important to ask patients about their use, according to J. Mark Jackson, MD, of the University of Louisville (Ky.).

If patients are going to react to a PPI, they usually will do so within 3 or 4 months of starting treatment, rather than in the first week or so of treatment, Dr. Jackson said in a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

Skin reactions to PPIs are often maculopapular, with a flat and a raised component that can be nonspecific, Dr. Jackson noted.

Interestingly, he added, many times patients can switch to a different PPI and not get a skin reaction. However, there are some patients who develop a lupuslike reaction on the skin, and in these cases, there tends to be cross reactivity, “so they couldn’t switch to a different PPI and be risk-free” of the same reaction, he noted.

Dr. Jackson disclosed financial relationships with companies including AbbVie, Amgen, Celgene, Dermira, Galderma, Genentech, Janssen, Lilly, Medimetriks, Merck, Novartis, Pfizer, Promius, and Top MD.

SDEF and this news organization are owned by the same parent company.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
 

 

– Any proton pump inhibitor (PPI) has the potential to cause skin reactions, so it is important to ask patients about their use, according to J. Mark Jackson, MD, of the University of Louisville (Ky.).

If patients are going to react to a PPI, they usually will do so within 3 or 4 months of starting treatment, rather than in the first week or so of treatment, Dr. Jackson said in a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

Skin reactions to PPIs are often maculopapular, with a flat and a raised component that can be nonspecific, Dr. Jackson noted.

Interestingly, he added, many times patients can switch to a different PPI and not get a skin reaction. However, there are some patients who develop a lupuslike reaction on the skin, and in these cases, there tends to be cross reactivity, “so they couldn’t switch to a different PPI and be risk-free” of the same reaction, he noted.

Dr. Jackson disclosed financial relationships with companies including AbbVie, Amgen, Celgene, Dermira, Galderma, Genentech, Janssen, Lilly, Medimetriks, Merck, Novartis, Pfizer, Promius, and Top MD.

SDEF and this news organization are owned by the same parent company.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
 
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VIDEO: Dermatologists often miss adult onset atopic dermatitis

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– Evidence from several recent studies suggests that the prevalence of adult onset atopic dermatitis in the United States may be as high as 7%-10%, said Jonathan I. Silverberg, MD, of the department of dermatology, preventive medicine, and medical social sciences, Northwestern University, Chicago.

Many features are similar to atopic dermatitis (AD) seen in childhood, but in adults the eczema is more likely to affect the hands and the eyelids. “We often have a hard time telling that apart from contact dermatitis,” Dr. Silverberg said in a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

Some adults may have forgotten they had AD as children and don’t recognize it if it reappears in adulthood, but sometimes AD appears with no childhood history, he noted. “There’s a skepticism that if it is adult onset, it must not be atopic dermatitis,” but he has found that is not always the case.

A take-home message for clinicians: “Don’t be surprised when a patient walks in the door as an adult meeting all criteria for atopic dermatitis. It can be, and you can diagnose them comfortably,” said Dr. Silverberg, who is also director of the Northwestern Medicine Multidisciplinary Eczema Center, Northwestern Memorial Hospital, Chicago.

Most of the treatments for adult AD “cover many different arms of the immune system,” and include topical steroids and immunosuppressants, he added.

Dr. Silverberg disclosed relationships with companies including AbbVie, Anacor, Celgene, Chugai, GlaxoSmithKline, Lilly, MedImmune-AstraZeneca, Pfizer, Procter & Gamble, Puricore, and Regeneron-Sanofi. SDEF and this news organization are owned by the same parent company.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
 
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– Evidence from several recent studies suggests that the prevalence of adult onset atopic dermatitis in the United States may be as high as 7%-10%, said Jonathan I. Silverberg, MD, of the department of dermatology, preventive medicine, and medical social sciences, Northwestern University, Chicago.

Many features are similar to atopic dermatitis (AD) seen in childhood, but in adults the eczema is more likely to affect the hands and the eyelids. “We often have a hard time telling that apart from contact dermatitis,” Dr. Silverberg said in a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

Some adults may have forgotten they had AD as children and don’t recognize it if it reappears in adulthood, but sometimes AD appears with no childhood history, he noted. “There’s a skepticism that if it is adult onset, it must not be atopic dermatitis,” but he has found that is not always the case.

A take-home message for clinicians: “Don’t be surprised when a patient walks in the door as an adult meeting all criteria for atopic dermatitis. It can be, and you can diagnose them comfortably,” said Dr. Silverberg, who is also director of the Northwestern Medicine Multidisciplinary Eczema Center, Northwestern Memorial Hospital, Chicago.

Most of the treatments for adult AD “cover many different arms of the immune system,” and include topical steroids and immunosuppressants, he added.

Dr. Silverberg disclosed relationships with companies including AbbVie, Anacor, Celgene, Chugai, GlaxoSmithKline, Lilly, MedImmune-AstraZeneca, Pfizer, Procter & Gamble, Puricore, and Regeneron-Sanofi. SDEF and this news organization are owned by the same parent company.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
 

 

– Evidence from several recent studies suggests that the prevalence of adult onset atopic dermatitis in the United States may be as high as 7%-10%, said Jonathan I. Silverberg, MD, of the department of dermatology, preventive medicine, and medical social sciences, Northwestern University, Chicago.

Many features are similar to atopic dermatitis (AD) seen in childhood, but in adults the eczema is more likely to affect the hands and the eyelids. “We often have a hard time telling that apart from contact dermatitis,” Dr. Silverberg said in a video interview at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.

Some adults may have forgotten they had AD as children and don’t recognize it if it reappears in adulthood, but sometimes AD appears with no childhood history, he noted. “There’s a skepticism that if it is adult onset, it must not be atopic dermatitis,” but he has found that is not always the case.

A take-home message for clinicians: “Don’t be surprised when a patient walks in the door as an adult meeting all criteria for atopic dermatitis. It can be, and you can diagnose them comfortably,” said Dr. Silverberg, who is also director of the Northwestern Medicine Multidisciplinary Eczema Center, Northwestern Memorial Hospital, Chicago.

Most of the treatments for adult AD “cover many different arms of the immune system,” and include topical steroids and immunosuppressants, he added.

Dr. Silverberg disclosed relationships with companies including AbbVie, Anacor, Celgene, Chugai, GlaxoSmithKline, Lilly, MedImmune-AstraZeneca, Pfizer, Procter & Gamble, Puricore, and Regeneron-Sanofi. SDEF and this news organization are owned by the same parent company.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
 
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VIDEO: Sofosbuvir with velpatasvir beat other HCV GT3 regimens

Study offers insight into HCV GT3 treatment difficulty
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Regimens containing sofosbuvir and velpatasvir were most effective for treating both cirrhotic and noncirrhotic genotype 3 hepatitis C virus infection (HCV GT3), according to a meta-analysis reported in the March issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.10.03).

“Our analyses indicated that ribavirin significantly increases SVR [sustained viral response] rates and should be considered, if tolerated,” added Floor A.C. Berden, MD, of Radboud University Medical Center, Nijmegen, the Netherlands, and her associates.

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Direct-acting antiviral regimens successfully treat chronic HCV infection, but tend to perform suboptimally in HCV GT3, especially when patients are treatment experienced and have cirrhosis. Options for HCV GT3 infection include sofosbuvir combined with ribavirin, daclatasvir, or velpatasvir. But head-to-head trials of these regimens are lacking, and are unlikely to occur, in part because the Food and Drug Administration permits single-arm trials with historical controls as the comparator, the investigators said.

Therefore, they searched PubMed, Embase, and the Web of Science database through March 15, 2016, for randomized trials and real-world studies of at least one direct-acting antiviral agent in adults with chronic HCV GT3 infection. They also manually searched abstracts presented at the 2015 conferences of the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases. This work yielded 27 studies: 16 randomized controlled trials, 6 single-arm studies, and 5 observational cohort studies. The researchers used a Bayesian analysis based on Markov chain Monte Carlo methods.
 

 

For patients without cirrhosis, sofosbuvir and velpatasvir with ribavirin yielded the highest estimated likelihood of SVR (99%; 95% confidence interval, 98%-100%), followed by sofosbuvir and velpatasvir without ribavirin (97%; 95% CI, 95%-99%), sofosbuvir and daclatasvir with ribavirin (96%; 95% CI, 92%-98%), and sofosbuvir and peginterferon with ribavirin (95%; 95% CI, 91%-98%), all for 12 weeks, the investigators reported.

For patients with cirrhosis, the most effective regimen was sofosbuvir with velpatasvir for 24 weeks (estimated SVR, 96%; 95% CI, 92%-99%), followed by sofosbuvir and daclatasvir with ribavirin for 24 weeks (94%; 95% CI, 87%-98%), sofosbuvir and velpatasvir and ribavirin for 12 weeks (94%; 95% CI, 86%-98%). The estimated efficacy of sofosbuvir and velpatasvir held up in sensitivity analyses that honed in on studies with a low risk of bias, approved regimens, or those under regulatory evaluation, patients without decompensated cirrhosis, and patients without HIV coinfection.

Adding ribavirin to a direct-acting antiviral regimen improved the odds of SVR about 2.6-fold (95% CI, 1.3-4.7) among noncirrhotic patients and by about 4.5 times in cirrhotic patients (95% CI, 2.5-7.7), the investigators reported. “In clinical practice, choice of treatment may depend on several factors, such as availability and price of direct-acting antivirals, tolerance of ribavirin, risk of adverse events or drug-drug interactions, and the presence of resistance-associated substitutions,” they added. Nonetheless, these findings can help prioritize therapies for HCV GT3 infection in both clinical guidelines and practice, they emphasized.

Dr. Berden and four coinvestigators had no relevant financial disclosures. Senior author Joost Drenth, MD, PhD, disclosed serving on advisory boards and receiving research grants from several pharmaceutical companies.

Body

The rapid development of direct-acting antiviral agents (DAAs) to treat hepatitis C has yielded many surprises and left some gaps in our knowledge.

One of the surprises was that genotype 3, previously considered “easier to treat,” proved quite resistant to the first generation of DAAs. One of the gaps in knowledge was a lack of randomized and head-to-head trials for current medications. One could argue that randomized trials have limited utility in a disease with essentially no spontaneous cures, and that head-to-head trials are pointless in a rapidly evolving field where regimens may be obsolete by the time the study is completed.

On the bright side, a hard endpoint like sustained virologic response (SVR) makes comparison between trials possible. The paper by Bergen et al. offers some guidance in closing the knowledge gap. Their meta-analysis using Bayesian Markov Chain Monte Carlo methods examined the effectiveness of currently available antiviral agents in 27 studies that focused entirely on genotype 3. All studies used antiviral agents that are currently available in the United States, and effectiveness was tested in both noncirrhotic and cirrhotic patients.  

Dr. Norman Sussman
The results were uniformly excellent – 94%-99% SVR, substantially higher than reported in clinical trials. The analysis also showed that sofosbuvir plus velpatasvir was superior to sofosbuvir plus daclatasvir or sofosbuvir plus interferon plus ribavirin. This result conforms to in vitro data that show good inhibitory activity of velpatasvir against the NS5A replication complex inhibitor in genotype 3 replicons. The study also showed that the addition of ribavirin improved SVR in all groups, all durations of treatment, and with all drug combinations – not bad for a weak antiviral agent with an unknown mode of action.

The evolution of antiviral therapy has been amazing. After decades of incremental gains, we entered an era of dizzying progress.  Genotype 3 went from great news to bad news, and genotype 1 went from a scourge to a piece of cake.

Norman L. Sussman, MD, is associate professor of surgery, Baylor College of Medicine, Houston; director, Project ECHO. He has received speaking and consulting fees for AbbVie, BMS, Gilead, and Merck.

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The rapid development of direct-acting antiviral agents (DAAs) to treat hepatitis C has yielded many surprises and left some gaps in our knowledge.

One of the surprises was that genotype 3, previously considered “easier to treat,” proved quite resistant to the first generation of DAAs. One of the gaps in knowledge was a lack of randomized and head-to-head trials for current medications. One could argue that randomized trials have limited utility in a disease with essentially no spontaneous cures, and that head-to-head trials are pointless in a rapidly evolving field where regimens may be obsolete by the time the study is completed.

On the bright side, a hard endpoint like sustained virologic response (SVR) makes comparison between trials possible. The paper by Bergen et al. offers some guidance in closing the knowledge gap. Their meta-analysis using Bayesian Markov Chain Monte Carlo methods examined the effectiveness of currently available antiviral agents in 27 studies that focused entirely on genotype 3. All studies used antiviral agents that are currently available in the United States, and effectiveness was tested in both noncirrhotic and cirrhotic patients.  

Dr. Norman Sussman
The results were uniformly excellent – 94%-99% SVR, substantially higher than reported in clinical trials. The analysis also showed that sofosbuvir plus velpatasvir was superior to sofosbuvir plus daclatasvir or sofosbuvir plus interferon plus ribavirin. This result conforms to in vitro data that show good inhibitory activity of velpatasvir against the NS5A replication complex inhibitor in genotype 3 replicons. The study also showed that the addition of ribavirin improved SVR in all groups, all durations of treatment, and with all drug combinations – not bad for a weak antiviral agent with an unknown mode of action.

The evolution of antiviral therapy has been amazing. After decades of incremental gains, we entered an era of dizzying progress.  Genotype 3 went from great news to bad news, and genotype 1 went from a scourge to a piece of cake.

Norman L. Sussman, MD, is associate professor of surgery, Baylor College of Medicine, Houston; director, Project ECHO. He has received speaking and consulting fees for AbbVie, BMS, Gilead, and Merck.

Body

The rapid development of direct-acting antiviral agents (DAAs) to treat hepatitis C has yielded many surprises and left some gaps in our knowledge.

One of the surprises was that genotype 3, previously considered “easier to treat,” proved quite resistant to the first generation of DAAs. One of the gaps in knowledge was a lack of randomized and head-to-head trials for current medications. One could argue that randomized trials have limited utility in a disease with essentially no spontaneous cures, and that head-to-head trials are pointless in a rapidly evolving field where regimens may be obsolete by the time the study is completed.

On the bright side, a hard endpoint like sustained virologic response (SVR) makes comparison between trials possible. The paper by Bergen et al. offers some guidance in closing the knowledge gap. Their meta-analysis using Bayesian Markov Chain Monte Carlo methods examined the effectiveness of currently available antiviral agents in 27 studies that focused entirely on genotype 3. All studies used antiviral agents that are currently available in the United States, and effectiveness was tested in both noncirrhotic and cirrhotic patients.  

Dr. Norman Sussman
The results were uniformly excellent – 94%-99% SVR, substantially higher than reported in clinical trials. The analysis also showed that sofosbuvir plus velpatasvir was superior to sofosbuvir plus daclatasvir or sofosbuvir plus interferon plus ribavirin. This result conforms to in vitro data that show good inhibitory activity of velpatasvir against the NS5A replication complex inhibitor in genotype 3 replicons. The study also showed that the addition of ribavirin improved SVR in all groups, all durations of treatment, and with all drug combinations – not bad for a weak antiviral agent with an unknown mode of action.

The evolution of antiviral therapy has been amazing. After decades of incremental gains, we entered an era of dizzying progress.  Genotype 3 went from great news to bad news, and genotype 1 went from a scourge to a piece of cake.

Norman L. Sussman, MD, is associate professor of surgery, Baylor College of Medicine, Houston; director, Project ECHO. He has received speaking and consulting fees for AbbVie, BMS, Gilead, and Merck.

Title
Study offers insight into HCV GT3 treatment difficulty
Study offers insight into HCV GT3 treatment difficulty

 

Regimens containing sofosbuvir and velpatasvir were most effective for treating both cirrhotic and noncirrhotic genotype 3 hepatitis C virus infection (HCV GT3), according to a meta-analysis reported in the March issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.10.03).

“Our analyses indicated that ribavirin significantly increases SVR [sustained viral response] rates and should be considered, if tolerated,” added Floor A.C. Berden, MD, of Radboud University Medical Center, Nijmegen, the Netherlands, and her associates.

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Direct-acting antiviral regimens successfully treat chronic HCV infection, but tend to perform suboptimally in HCV GT3, especially when patients are treatment experienced and have cirrhosis. Options for HCV GT3 infection include sofosbuvir combined with ribavirin, daclatasvir, or velpatasvir. But head-to-head trials of these regimens are lacking, and are unlikely to occur, in part because the Food and Drug Administration permits single-arm trials with historical controls as the comparator, the investigators said.

Therefore, they searched PubMed, Embase, and the Web of Science database through March 15, 2016, for randomized trials and real-world studies of at least one direct-acting antiviral agent in adults with chronic HCV GT3 infection. They also manually searched abstracts presented at the 2015 conferences of the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases. This work yielded 27 studies: 16 randomized controlled trials, 6 single-arm studies, and 5 observational cohort studies. The researchers used a Bayesian analysis based on Markov chain Monte Carlo methods.
 

 

For patients without cirrhosis, sofosbuvir and velpatasvir with ribavirin yielded the highest estimated likelihood of SVR (99%; 95% confidence interval, 98%-100%), followed by sofosbuvir and velpatasvir without ribavirin (97%; 95% CI, 95%-99%), sofosbuvir and daclatasvir with ribavirin (96%; 95% CI, 92%-98%), and sofosbuvir and peginterferon with ribavirin (95%; 95% CI, 91%-98%), all for 12 weeks, the investigators reported.

For patients with cirrhosis, the most effective regimen was sofosbuvir with velpatasvir for 24 weeks (estimated SVR, 96%; 95% CI, 92%-99%), followed by sofosbuvir and daclatasvir with ribavirin for 24 weeks (94%; 95% CI, 87%-98%), sofosbuvir and velpatasvir and ribavirin for 12 weeks (94%; 95% CI, 86%-98%). The estimated efficacy of sofosbuvir and velpatasvir held up in sensitivity analyses that honed in on studies with a low risk of bias, approved regimens, or those under regulatory evaluation, patients without decompensated cirrhosis, and patients without HIV coinfection.

Adding ribavirin to a direct-acting antiviral regimen improved the odds of SVR about 2.6-fold (95% CI, 1.3-4.7) among noncirrhotic patients and by about 4.5 times in cirrhotic patients (95% CI, 2.5-7.7), the investigators reported. “In clinical practice, choice of treatment may depend on several factors, such as availability and price of direct-acting antivirals, tolerance of ribavirin, risk of adverse events or drug-drug interactions, and the presence of resistance-associated substitutions,” they added. Nonetheless, these findings can help prioritize therapies for HCV GT3 infection in both clinical guidelines and practice, they emphasized.

Dr. Berden and four coinvestigators had no relevant financial disclosures. Senior author Joost Drenth, MD, PhD, disclosed serving on advisory boards and receiving research grants from several pharmaceutical companies.

 

Regimens containing sofosbuvir and velpatasvir were most effective for treating both cirrhotic and noncirrhotic genotype 3 hepatitis C virus infection (HCV GT3), according to a meta-analysis reported in the March issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.10.03).

“Our analyses indicated that ribavirin significantly increases SVR [sustained viral response] rates and should be considered, if tolerated,” added Floor A.C. Berden, MD, of Radboud University Medical Center, Nijmegen, the Netherlands, and her associates.

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Direct-acting antiviral regimens successfully treat chronic HCV infection, but tend to perform suboptimally in HCV GT3, especially when patients are treatment experienced and have cirrhosis. Options for HCV GT3 infection include sofosbuvir combined with ribavirin, daclatasvir, or velpatasvir. But head-to-head trials of these regimens are lacking, and are unlikely to occur, in part because the Food and Drug Administration permits single-arm trials with historical controls as the comparator, the investigators said.

Therefore, they searched PubMed, Embase, and the Web of Science database through March 15, 2016, for randomized trials and real-world studies of at least one direct-acting antiviral agent in adults with chronic HCV GT3 infection. They also manually searched abstracts presented at the 2015 conferences of the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases. This work yielded 27 studies: 16 randomized controlled trials, 6 single-arm studies, and 5 observational cohort studies. The researchers used a Bayesian analysis based on Markov chain Monte Carlo methods.
 

 

For patients without cirrhosis, sofosbuvir and velpatasvir with ribavirin yielded the highest estimated likelihood of SVR (99%; 95% confidence interval, 98%-100%), followed by sofosbuvir and velpatasvir without ribavirin (97%; 95% CI, 95%-99%), sofosbuvir and daclatasvir with ribavirin (96%; 95% CI, 92%-98%), and sofosbuvir and peginterferon with ribavirin (95%; 95% CI, 91%-98%), all for 12 weeks, the investigators reported.

For patients with cirrhosis, the most effective regimen was sofosbuvir with velpatasvir for 24 weeks (estimated SVR, 96%; 95% CI, 92%-99%), followed by sofosbuvir and daclatasvir with ribavirin for 24 weeks (94%; 95% CI, 87%-98%), sofosbuvir and velpatasvir and ribavirin for 12 weeks (94%; 95% CI, 86%-98%). The estimated efficacy of sofosbuvir and velpatasvir held up in sensitivity analyses that honed in on studies with a low risk of bias, approved regimens, or those under regulatory evaluation, patients without decompensated cirrhosis, and patients without HIV coinfection.

Adding ribavirin to a direct-acting antiviral regimen improved the odds of SVR about 2.6-fold (95% CI, 1.3-4.7) among noncirrhotic patients and by about 4.5 times in cirrhotic patients (95% CI, 2.5-7.7), the investigators reported. “In clinical practice, choice of treatment may depend on several factors, such as availability and price of direct-acting antivirals, tolerance of ribavirin, risk of adverse events or drug-drug interactions, and the presence of resistance-associated substitutions,” they added. Nonetheless, these findings can help prioritize therapies for HCV GT3 infection in both clinical guidelines and practice, they emphasized.

Dr. Berden and four coinvestigators had no relevant financial disclosures. Senior author Joost Drenth, MD, PhD, disclosed serving on advisory boards and receiving research grants from several pharmaceutical companies.

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Key clinical point. Regimens containing sofosbuvir and velpatasvir were more effective than were other direct-acting antiviral combinations for treating genotype 3 hepatitis C virus infection, regardless of cirrhosis status.

Major finding: For patients without cirrhosis, sofosbuvir and velpatasvir with ribavirin for 12 weeks yielded the highest estimated likelihood of sustained viral response (99%). For patients with cirrhosis, the most effective regimen was sofosbuvir with velpatasvir for 24 weeks (estimated SVR, 96%).

Data source: A systematic review and meta-analysis of 27 studies: 16 randomized controlled trials, 6 single-arm studies, and 5 observational cohort studies.

Disclosures: Dr. Berden and four coinvestigators had no relevant financial disclosures. Senior author Joost Drenth, MD, PhD, disclosed serving on advisory boards and receiving research grants from several pharmaceutical companies.

Strategies for prophylactic oophoropexy

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Dr. Casey is Fellow, Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, Tennessee.

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Dr. Casey is Fellow, Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, Tennessee.

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Dr. Casey is Fellow, Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, Tennessee.

Dr. Yunker is Assistant Professor, Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, Tennessee.

Dr. Casey reports no financial relationships relevant to this article. Dr. Yunker reports that she is a consultant to and speaker for Olympus.

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VIDEO: Health law changes under new administration

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Thu, 03/28/2019 - 14:57

 

WASHINGTON – A new president is taking office along with new staffers to lead the country’s top health care agencies.

In this video, Joyce Hall, chair of the American Bar Association Health Law Section, discusses what changes she foresees in health law issues under the new administration and what to expect from the leadership transition. Ms. Hall also speaks on potential alterations to the Medicare Access and CHIP Reauthorization Act of 2015 and whether the potential appointment of Rep. Tom Price (R-Ga.) as U.S. Department of Health and Human Services Secretary will be positive or negative for health care providers.

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WASHINGTON – A new president is taking office along with new staffers to lead the country’s top health care agencies.

In this video, Joyce Hall, chair of the American Bar Association Health Law Section, discusses what changes she foresees in health law issues under the new administration and what to expect from the leadership transition. Ms. Hall also speaks on potential alterations to the Medicare Access and CHIP Reauthorization Act of 2015 and whether the potential appointment of Rep. Tom Price (R-Ga.) as U.S. Department of Health and Human Services Secretary will be positive or negative for health care providers.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

WASHINGTON – A new president is taking office along with new staffers to lead the country’s top health care agencies.

In this video, Joyce Hall, chair of the American Bar Association Health Law Section, discusses what changes she foresees in health law issues under the new administration and what to expect from the leadership transition. Ms. Hall also speaks on potential alterations to the Medicare Access and CHIP Reauthorization Act of 2015 and whether the potential appointment of Rep. Tom Price (R-Ga.) as U.S. Department of Health and Human Services Secretary will be positive or negative for health care providers.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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VIDEO: First multicenter trial of CAR T cells shows response in DLBCL

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– Aggressive, refractory non-Hodgkin lymphomas responded to anti-CD19 chimeric antigen receptor T cells in ZUMA-1, the first multicenter trial of the cellular immunotherapy, based on early data reported at the annual meeting of the American Society of Hematology.

In an interim analysis of 51 patients with diffuse large B-cell lymphomas, 47% had complete remissions and 29% had partial remissions. But the remission rate declined to 33% complete remissions and 6% partial remissions after 3 months.

There have really been no new treatments in the last 20 years for patients with non-Hodgkin lymphoma that does not respond to chemotherapy or recurs after autologous stem cell transplant. With median overall survival of 6 months, and about 8% complete remissions with existing therapies, CAR T cells might be a solution for these patients, said ZUMA-1 investigator Sattva S. Neelapu, MD, of the University of Texas MD Anderson Cancer Center in Houston.

In our video interview at the meeting, Dr. Neelapu discussed initial results in the real-world setting of 22 participating centers, most of which had no previous experience with CAR T-cell therapy. With an efficient production and logistics plan, 91% of 110 patients were able to receive the investigational product, known as KTE-C19.

ZUMA-1 is funded by Kite, which makes KTE-C19, and the Leukemia & Lymphoma Society Therapy Acceleration Program. Dr. Neelapu receives research support from and is an advisor to Kite.

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– Aggressive, refractory non-Hodgkin lymphomas responded to anti-CD19 chimeric antigen receptor T cells in ZUMA-1, the first multicenter trial of the cellular immunotherapy, based on early data reported at the annual meeting of the American Society of Hematology.

In an interim analysis of 51 patients with diffuse large B-cell lymphomas, 47% had complete remissions and 29% had partial remissions. But the remission rate declined to 33% complete remissions and 6% partial remissions after 3 months.

There have really been no new treatments in the last 20 years for patients with non-Hodgkin lymphoma that does not respond to chemotherapy or recurs after autologous stem cell transplant. With median overall survival of 6 months, and about 8% complete remissions with existing therapies, CAR T cells might be a solution for these patients, said ZUMA-1 investigator Sattva S. Neelapu, MD, of the University of Texas MD Anderson Cancer Center in Houston.

In our video interview at the meeting, Dr. Neelapu discussed initial results in the real-world setting of 22 participating centers, most of which had no previous experience with CAR T-cell therapy. With an efficient production and logistics plan, 91% of 110 patients were able to receive the investigational product, known as KTE-C19.

ZUMA-1 is funded by Kite, which makes KTE-C19, and the Leukemia & Lymphoma Society Therapy Acceleration Program. Dr. Neelapu receives research support from and is an advisor to Kite.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– Aggressive, refractory non-Hodgkin lymphomas responded to anti-CD19 chimeric antigen receptor T cells in ZUMA-1, the first multicenter trial of the cellular immunotherapy, based on early data reported at the annual meeting of the American Society of Hematology.

In an interim analysis of 51 patients with diffuse large B-cell lymphomas, 47% had complete remissions and 29% had partial remissions. But the remission rate declined to 33% complete remissions and 6% partial remissions after 3 months.

There have really been no new treatments in the last 20 years for patients with non-Hodgkin lymphoma that does not respond to chemotherapy or recurs after autologous stem cell transplant. With median overall survival of 6 months, and about 8% complete remissions with existing therapies, CAR T cells might be a solution for these patients, said ZUMA-1 investigator Sattva S. Neelapu, MD, of the University of Texas MD Anderson Cancer Center in Houston.

In our video interview at the meeting, Dr. Neelapu discussed initial results in the real-world setting of 22 participating centers, most of which had no previous experience with CAR T-cell therapy. With an efficient production and logistics plan, 91% of 110 patients were able to receive the investigational product, known as KTE-C19.

ZUMA-1 is funded by Kite, which makes KTE-C19, and the Leukemia & Lymphoma Society Therapy Acceleration Program. Dr. Neelapu receives research support from and is an advisor to Kite.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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VIDEO: Despite toxicities, ibrutinib is beneficial for treatment-resistant graft-vs.-host disease

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– An oral regimen of 420 mg ibrutinib achieved complete response in one-third of allogeneic stem cell recipients with chronic graft-vs.-host disease, David Miklos, MD, reported during a late-breaker session at the annual meeting of the American Society of Hematology.

Fully 79% of patients in this open-label phase II study were considered responders when first assessed, 71% of responses lasted at least 5 months, and patients whose disease involved multiple organs generally showed responses in at least two organs, said Dr. Miklos of Stanford (Calif.) University.

Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor. Cardiotoxicities have been a concern with ibrutinib, but were not observed in this cohort of 42 patients whose graft-vs.-host disease had not benefited from frontline therapy, Dr. Miklos said during a video interview. However, 52% of patients in this study developed other serious adverse events that are typical with ibrutinib, including pneumonia, septic shock, and fever, he said.

Chronic graft-vs.-host disease is the most common morbidity after allogeneic transplant. This is an “orphan disease” – there are no approved therapies for patients for whom corticosteroids are ineffective, Dr. Miklos noted. Based on these results, investigators are planning a randomized, placebo-controlled, phase III study, he added.

Ibrutinib is jointly commercialized and developed by Janssen Biotech and by Pharmacyclics LLC, an Abbvie company. Dr. Miklos disclosed a consulting relationship, travel and expenses reimbursements, and research funding from Pharmacyclics.

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– An oral regimen of 420 mg ibrutinib achieved complete response in one-third of allogeneic stem cell recipients with chronic graft-vs.-host disease, David Miklos, MD, reported during a late-breaker session at the annual meeting of the American Society of Hematology.

Fully 79% of patients in this open-label phase II study were considered responders when first assessed, 71% of responses lasted at least 5 months, and patients whose disease involved multiple organs generally showed responses in at least two organs, said Dr. Miklos of Stanford (Calif.) University.

Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor. Cardiotoxicities have been a concern with ibrutinib, but were not observed in this cohort of 42 patients whose graft-vs.-host disease had not benefited from frontline therapy, Dr. Miklos said during a video interview. However, 52% of patients in this study developed other serious adverse events that are typical with ibrutinib, including pneumonia, septic shock, and fever, he said.

Chronic graft-vs.-host disease is the most common morbidity after allogeneic transplant. This is an “orphan disease” – there are no approved therapies for patients for whom corticosteroids are ineffective, Dr. Miklos noted. Based on these results, investigators are planning a randomized, placebo-controlled, phase III study, he added.

Ibrutinib is jointly commercialized and developed by Janssen Biotech and by Pharmacyclics LLC, an Abbvie company. Dr. Miklos disclosed a consulting relationship, travel and expenses reimbursements, and research funding from Pharmacyclics.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– An oral regimen of 420 mg ibrutinib achieved complete response in one-third of allogeneic stem cell recipients with chronic graft-vs.-host disease, David Miklos, MD, reported during a late-breaker session at the annual meeting of the American Society of Hematology.

Fully 79% of patients in this open-label phase II study were considered responders when first assessed, 71% of responses lasted at least 5 months, and patients whose disease involved multiple organs generally showed responses in at least two organs, said Dr. Miklos of Stanford (Calif.) University.

Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor. Cardiotoxicities have been a concern with ibrutinib, but were not observed in this cohort of 42 patients whose graft-vs.-host disease had not benefited from frontline therapy, Dr. Miklos said during a video interview. However, 52% of patients in this study developed other serious adverse events that are typical with ibrutinib, including pneumonia, septic shock, and fever, he said.

Chronic graft-vs.-host disease is the most common morbidity after allogeneic transplant. This is an “orphan disease” – there are no approved therapies for patients for whom corticosteroids are ineffective, Dr. Miklos noted. Based on these results, investigators are planning a randomized, placebo-controlled, phase III study, he added.

Ibrutinib is jointly commercialized and developed by Janssen Biotech and by Pharmacyclics LLC, an Abbvie company. Dr. Miklos disclosed a consulting relationship, travel and expenses reimbursements, and research funding from Pharmacyclics.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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Key clinical point: Ibrutinib (420 mg) led to complete responses in one-third of patients with chronic, treatment-resistant graft-vs-host disease.

Major finding: No cardiotoxicities were observed, but 52% of patients had other serious adverse effects, such as sepsis, pyrexia, and pneumonia.

Data source: An open-label phase II study of 42 patients who developed chronic, treatment-resistant graft-vs.-host disease after undergoing allogeneic stem cell transplantation.

Disclosures: Ibrutinib is jointly commercialized and developed by Janssen Biotech and by Pharmacyclics LLC, an Abbvie company. Dr. Miklos disclosed a consulting relationship, reimbursement for travel and expenses, and research funding from Pharmacyclics.