Abstract

Recently, Sofosbuvir was launched in India at affordable cost. We conducted a real-life study to determine the efficacy and safety of Sofosbuvir plus Ribavirin, with and without peginterferon-alfa 2a, in patients with chronic hepatitis C (CHC) genotype 3, the commonest genotype in South Asia. This study included data of CHC patients from 11 sites in northern India between March 2015 and December 2015 (n=1203). Patients with CHC genotype 3 (n=931), who were treated with either Sofosbuvir 400mg plus weight-based Ribavirin, daily×24weeks (n=432) (dual therapy), or Peginterferon-α2a 180 mcg weekly, Sofosbuvir 400mg plus weight-based Ribavirin, daily×12weeks (n=499) (triple therapy) were included for analysis. Primary outcome was the proportion of patients achieving sustained viral response at 12weeks post-therapy. The overall SVR rates were 91 and 92% in the dual and triple therapy arms, respectively. The SVR rates in treatment experienced were 67 and 74% versus 93 and 96% in naïve patients, on the dual and triple therapy arms, respectively. The SVR rates of cirrhotics were 73 and 75% on the dual and triple treatment arms, respectively. The SVR rates were low in the experienced cirrhotic patients: 44% (dual therapy) and 58% (triple therapy). Common adverse events were fatigue, headache, and myalgia. Both dual and triple therapy regimes resulted in SVR rates of>95% in CHC genotype 3 who were naive non-cirrhotics. However, the SVR rates were low in treatment-experienced cirrhotics.

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