Objective To investigate the clinical efficacy and safety of sofosbuvir combined with ribavirin in the treatment of treatment-naive patients with genotype 2 chronic hepatitis C virus(HCV) infection. Methods Treatment-naive patients with genotype 2 HCV infection were screened in sixteen research centers of China. All patients received sofosbuvir(400 mg/tablet,1 tablet/d) combined with ribavirin(1000 mg/d for patients with a body weight of < 75 kg and 1200 mg/d for those with a body weight of ≥75 kg) for 12 weeks and were followed up for 12 weeks after drug withdrawal. The primary outcome measure was sustained virologic response at week 12 of follow-up,and the secondary outcome measures included the proportion of patients with HCV RNA below the lower limit of quantitation at weeks 2,4,8,and 12 of treatment and after 4 weeks of drug withdrawal,virological rebound rate at weeks 4,8,and 12 of treatment,and recurrence rate at weeks 4 and 12 of follow-up. Adverse events were observed during treatment to evaluate drug safety. Results A total of 136 subjects were enrolled,among whom 121 had no liver cirrhosis and 15 had compensated liver cirrhosis. The sustained virologic response(SVR) ratewas 92. 6%(95% confidence interval: 88. 3%-97. 0%) after 12 weeks of drug withdrawal. At week 8 of treatment,1 patient experienced virological rebound; after 4 weeks of drug withdrawal,8 patients experienced virological rebound; after 12 weeks of drug withdrawal,10 patients experienced virological rebound. Among the 136 subjects,128(94. 1%) reported 549 cases of treatment-emergent adverse events,among which 243 cases were associated with sofosbuvir and/or ribavirin and were reported in 99 subjects(72. 8%). No adverse events leading to the adjustment or discontinuation of sofosbuvir were observed. A total of 7 serious adverse events were reported in 6 patients(4. 4%),among which only one(a low echo area in the liver with unknown nature) was considered possibly associated with sofosbuvir and/or ribavirin. No adverse events leading to study discontinuation or death were observed. Conclusion Sofosbuvir combined with ribavirin can achieve a high SVR rate in treatment-na6 ve patients with genotype 2 chronic HCV infection,with mild adverse reactions and acceptable safety profile.
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