RAPID COMMUNICATION Sofosbuvir With Peginterferon-Ribavirin for 12 Weeks in Previously Treated Patients With Hepatitis C

Sofosbuvir (SOF) in combination with ribavirin (RBV) for 12 or 24 weeks is the current standard of care for patients infected with hepatitis C virus (HCV) genotypes 2 and 3, respectively. However, in clinical trials treatment-experienced patients, particularly those with cirrhosis, had suboptimal sustained virological response (SVR) rates. We assessed the efficacy and safety of sofosbuvir plus peginterferon and ribavirin (SOF1Peg-IFN1RBV) administered for 12 weeks to treatment-experienced patients with HCV genotypes 2 and 3, with and without cirrhosis. We enrolled 47 patients in this open-label, nonrandomized, uncontrolled phase 2 study. The primary endpoint was the proportion of patients with SVR at 12 weeks after cessation of study treatment (SVR12). The overall rate of SVR12 was 89 % (95 % confidence interval [CI]: 77-97). Rates of SVR12 were higher in patients with genotype 2 than in those with genotype 3, 96 % (95 % CI: 78-100) and 83 % (95% CI: 62-95), respectively. Rates of SVR12 were similar in patients with and without cirrho-sis: for genotype 2, 93 % of patients with cirrhosis and 100 % of patients without cirrhosis achieved SVR12, and for genotype 3, the SVR12 rate was 83 % in patients both with and without cirrhosis. One patient discontinued study treatment because of an adverse even