Sofosbuvir plus ribavirin with or without peginterferon for the treatment of HCV: Results from a Phase 3b study in China.

Background and AimSofosbuvir is a nucleotide analog inhibitor of the hepatitis C virus (HCV) NS5B RNA polymerase with pangenotypic potency. This phase 3b study evaluated the safety and efficacy of sofosbuvir+ribavirinpeginterferon in Chinese patients infected with HCV genotype 1, 2, 3, or 6. MethodsPatients with genotype 1 or 6 received sofosbuvir+peginterferon/ribavirin for 12weeks or sofosbuvir+ribavirin for 24weeks, depending on prior treatment and interferon eligibility. Patients with genotype 2 or 3 received sofosbuvir+ribavirin for 12 or 24weeks, respectively. The primary endpoint was sustained virologic response at 12weeks after the end of treatment (SVR12). ResultsOf 389 patients, 42% had genotype 1, 16% genotype 2, 32% genotype 3, and 9% genotype 6. Half were male, 58% were treatment-naive, and 15% had cirrhosis. SVR12 rates for patients receiving 12 weeks of sofosbuvir+peginterferon/ribavirin were 94% (95% confidence interval [CI], 87-98%) for HCV genotype 1 and 97% (95% CI, 84-100%) for genotype 6. SVR12 rates for those receiving sofosbuvir+ribavirin for 24weeks were 95% (95% CI, 87-99%) for genotype 1, 100% (95% CI, 40-100%) for genotype 6, and 95% (95% CI, 90-98%) for genotype 3. For genotype 2 patients receiving sofosbuvir+ribavirin for 12weeks, the SVR12 rate was 92% (95% CI, 83-97%). Twenty patients (5%) relapsed. Ten (3%) experienced serious adverse events. Three (<1%) discontinued treatment because of adverse events, of whom one died because of treatment-unrelated adverse events. ConclusionsSofosbuvir-based regimens were highly effective and safe in Chinese patients with HCV genotype 1, 2, 3, or 6, suggesting sofosbuvir could serve as the backbone for HCV treatment in China irrespective of genotype.