Woman and Man
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Extract
The primary objectives of this study are: * To evaluate the safety of sofosbuvir (SOF) 200mg or 400mg + ribavirin (RBV) for 24 weeks as assessed by review of the accumulated safety data in each treatment arm * To evaluate the efficacy of sofosbuvir (SOF) 200mg or 400mg + ribavirin (RBV) for 24 weeks measured by the proportion of subjects with renal insufficiency who have achieved a sustained viral response 12 weeks after treatment discontinuation (SVR12) in each treatment arm * To evaluate the steady state pharmacokinetics of SOF and its metabolites upon dosing SOF 200mg or 400mg in subjects with renal insufficiency
Inclusion criteria
- Chronic hepatitis C virus infection