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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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Coverage of the 15th European AIDS Conference

HIVandHepatitis.com coverage of the 15th European AIDS Conference, sponsored by the European AIDS Clinical Society (EACS), October 21-14, 2015, in Barcelona.

Conference highlights include antiretroviral therapy and treatment strategies, new European HIV treatment guidelines, HIV pre-exposure prophylaxis (PrEP), and treatment for hepatitis C.

Full listing by topic

15th European AIDS Conference website

10/28/15

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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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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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ICAAC 2015: New Hepatitis C NS5A Inhibitor Looks Promising in Early Studies

A new hepatitis C virus (HCV) NS5A inhibitor being developed by Enanta -- EDP-239 -- was well-tolerated and demonstrated promising antiviral activity against genotype 1 HCV in a single-dose monotherapy study presented at the 55th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) last week in San Diego.

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