An international study to assess the safety and efficacy of a combination of new investigational drugs in hepatitis C virus infected patients with advanced liver disease or require treatment after liver transplantation

Woman and Man

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Extract

The primary objectives of this study are: • To explore the antiviral efficacy of combination therapy with SOF/LDV FDC + RBV for 12 or 24 weeks in subjects with advanced liver disease (either pre-liver transplant or not currently wait-listed) and post-liver transplant HCV subjects with cirrhosis as measured by SVR 12 weeks after discontinuation of therapy (SVR12 defined as HCV RNA < Lower Limit of Quantification [LLOQ] 12 weeks post-treatment) • To evaluate the safety and tolerability of SOF/LDV FDC + RBV administered for 12 or 24 weeks in each patient population

Inclusion criteria

Chronic Genotype 1 and Genotype 4 Hepatitis C Virus Infection

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An international study to assess the safety and efficacy of a combination of new investigational drugs in hepatitis C virus infected patients with advanced liver disease or require treatment after liv...