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FDA Advisory Committee Gives Positive Opinions on HCV Drugs Simeprevir and Sofosbuvir

The Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) this week gave unanimous recommendations for approval of 2 next-generation direct-acting antivirals for hepatitis C, Janssen's simeprevir (formerly TMC435) and Gilead Science's sofosbuvir (formerly GS-7977 and PSI-7977).

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EACS 2013: Faldaprevir Demonstrates Good Early Response in Genotype 1 HIV/HCV Coinfection

The HCV protease inhibitor faldaprevir added to pegylated interferon and ribavirin increased the likelihood that HIV/HCV co-infected people would achieve a sustained response at 4 weeks after completing treatment, according to a report at the 4th European AIDS Conference last week in Brussels.

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EACS 2013: Simeprevir with Interferon Effective for Genotype 1 HIV/HCV Coinfected People

Adding the direct-acting hepatitis C drug simeprevir to pegylated interferon and ribavirin produced high response rates for HIV positive people coinfected with HCV genotype 1, researchers reported at the 14th European AIDS Conference this week in Brussels. Particularly impressive was a 57% sustained response rate for prior null responders. Another study showed simeprevir to be active against HCV genotype 4 in monoinfected patients.

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Coverage of the 14th European AIDS Conference

HIVandHepatitis.com coverage of the 14th European AIDS Conference, sponsored by the European AIDS Clinical Society (EACS), October 16-19, 2013, in Brussels.

Conference highlights include antiretroviral therapy strategies and new HIV drugs, new treatment for hepatitis C, biomedical HIV prevention, HIV cure research, and the epidemic in Eastern Europe.

Full listing by topic

10/20/13

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EACS 2013: New Drugs Will Bring Revolution in Hepatitis C Treatment

The advent of direct-acting antiviral agents can rightly be described as a revolution in treatment for chronic hepatitis C, but potential challenges remain including drug interactions and cost, Heinrich Wedemeyer told participants during a plenary session at the 14thEuropean AIDS Conference (EACS 2013) this week in Brussels.

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