A Randomized study of sofosbuvir plus ribavirin with and without PEG interferon alpha 2b in treatment of hepatitis C genotype 3 infection: Real life data from a Tertiary Care Center

Abstract

Background and Aim- Sofosbuvir, a polymerase inhibitor is pangenotypic directly acting antiviral for hepatitis C. In this study we evaluate two sofosbuvir containing regimens with or without pegylated interferon (PEGIFN) in patients with chronic hepatitis or compensated cirrhosis caused by hepatitis C genotype 3 infections.Methods- It was a prospective, single centre, randomized open label study. Thirty nine patients were randomized into two groups: sofosbuvir plus ribavirin with (A) and without (B) PEGIFN alpha 2b for 12 and 24 weeks respectively. Patients with contraindications and treatment experience were excluded. Primary end points were end of treatment response (ETR) and sustained virological response at 12 weeks (SVR12). Rates of adverse effects were secondary end point.Results- Baseline characteristics in both groups were comparable. Two patients in group B did not complete therapy and excluded from analysis. ETR and SVR12 rate in group A were 100 % and in group B were 89.4 % showing 100% concordance between ETR and SVR12 in either group. Non-specific adverse effects were more frequent in group A than group B (94.4 versus 79%). Rates of hemoglobin decrease, neutropenia and thrombocytopenia were 100, 17 and 44.4% in group A and 94, 0 and 15.8% in group B respectively.Conclusion- Addition of PEGIFN to sofosbuvir and ribavirin achieves higher ETR and SVR12 and reduces duration of therapy. PEG-IFN based treatment leads to higher hematological as well as non hematological side effects but these are mild and easily manageable during 12 weeks treatment.