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Treatment duration was fixed in each study and was not guided by patients’ HCV RNA levels (no response guided algorithm). Sustained virologic response (SVR) was the primary endpoint to determine the HCV cure rate for all studies which was defined as HCV RNA less than LLOQ at 12 weeks after the end of treatment (SVR12). A single subject with genotype 5 and all 6 patients with genotype 6 HCV infection in this study achieved SVR12. Patients with genotype 2 or 3 HCV were enrolled in an approximately 1:3 ratio. Patients were randomised in 3:1 ratio and stratified by cirrhosis (presence versus absence). Patients were randomised in a 1:1 ratio and stratified by cirrhosis (presence versus absence) and HCV genotype (2 versus 3). The study was designed as a direct comparison of sofosbuvir and ribavirin versus placebo for 12 weeks.

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  • As an alternative for nonresponders, combine peginterferon alfa with sofosbuvir and ribavirin for 12 weeks.
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