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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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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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Achillion's Odalasvir with Sofosbuvir Cured Hepatitis C in 6-8 Weeks in Phase 2 Study

Achillion Pharmaceuticals' experimental NS5A inhibitor odalasvir (ACH-3102) plus Gilead Science's sofosbuvir (Sovaldi), taken without ribavirin, produced sustained virological response at 12 weeks post-treatment in all previously untreated genotype 1 hepatitis C patients treated for 6 or 8 weeks in a small Phase 2 study, according to a recent company announcement. Treatment was safe and well-tolerated.

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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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Gilead's Sofosbuvir + Velpatasvir Combo Shows Good Results in Phase 3 Trials

A dual combination of Gilead Sciences' sofosbuvir (Sovaldi) and new pangenotypic HCV NS5A inhibitor velpatasvir (GS-5816) taken for 12 weeks produced cure rates of 95% to 100% for people with hepatitis C genotypes 1 through 6, including patients with compensated liver cirrhosis, in the ASTRAL trials, the company announced this week. People with decompensated cirrhosis, however, did better when they added ribavirin.

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