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Gilead Requests Approval of Sofosbuvir/Velpatasvir Coformulation for All Hepatitis C Genotypes

Gilead Sciences last week requested U.S. Food and Drug Administration (FDA) approval for a single-tablet regimen containing the hepatitis C virus (HCV) polymerase inhibitor sofosbuvir and the next-generation pangenotypic NS5A inhibitor velpatasvir, formerly known as GS-5816. Unlike the widely used sofosbuvir/ledipasvir (Harvoni), the new combination shows potent activity against HCV genotypes 1 through 6.

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EACS 2015: Sofosbuvir/ Ledipasvir for 8 Weeks Cures Most Hard-to-Treat Hepatitis C in Real Life

Most hepatitis C patients in the GECCO German hepatitis C cohort who were treated with sofosbuvir/ledipasvir (Harvoni) for 8 weeks in a real-world clinical setting achieved sustained virological response, even those who are advised to stay on treatment for 12 weeks due to factors such as liver cirrhosis, prior treatment experience, and high HCV viral load, according to a presentation last week at the 15th European AIDS Conference in Barcelona.

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IDWeek 2015 Features HIV and Hepatitis C Prevention, Treatment, and Cure Research

Immediate antiretroviral therapy is the big HIV news of the year and interferon-free therapy has transformed the treatment of hepatitis C despite its high cost, experts said during an overview of "What's Hot" in the field, presented at the IDWeek 2015 conference taking place this week in San Diego. Participants also heard a keynote talk by Ian Crozier, a doctor who survived Ebola virus disease.

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FDA Warns Viekira Pak and Technivie for Hepatitis C Can Cause Serious Liver Injury

The U.S. Food and Drug Administration (FDA) issued a warning this week that recently approved interferon-free therapy for hepatitis C virus (HCV) infection can produce serious liver damage, mainly in people who already have advanced liver disease. The warning applies to AbbVie's paritaprevir/ritonavir/ombitasvir coformulation, which is sold alone as Technivie for the treatment of HCV genotype 4, and as part of the Viekira Pak regimen for HCV genotype 1; in Europe the latter regimen is sold as separate components, Viekirax and Exviera.

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Coverage of IDWeek 2015

HIVandHepatitis.com coverage of IDWeek 2015, October 7-11 in San Diego.

Conference highlights include new HIV therapies and treatment strategies, HIV and hepatitis C continuums of care, and comorbidities among people with HIV and HIV/HCV coinfection, as well as news about antibiotic stewardship and other infectious diseases including Ebola virus.

Full listing of coverage by topic

IDWeek website

10/9/15

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