Results of Sofosbuvir Based Combination Therapy for Chronic Hepatitis C Cohort of Indian Patients in Real-Life Clinical Practice

Abstract

Introduction: The introduction of Sofosbuvir(SOF), a direct acting antiviral (DAA), has revolutionized the treatment of chronic hepatitis C virus (HCV). Phase 3 clinical trials have demonstrated the efficacy and tolerability of Sofosbuvir-based regimens. This study was planned to observe whether excellent clinical trial results translate into real life clinical practice. Methods: This is a prospective, non-randomized observational study conducted in the Department of Gastroenterology at a tertiary care center in India, between April 2015 and December 2015. All consecutive treatment naive patients diagnosed with chronic hepatitis C (genotype 1-5) were included. Sofosbuvir was the only DAA available in India during this period and was used either as a part of triple drug regime (Pegylated interferon, Ribavirin, Sofosbuvir) or dual drug regime (Sofosbuvir and Ribavirin). Response to therapy was assessed at week 4 (Rapid Virological Response, RVR), week 12 or 24 (End of Treatment Response, ETR) and 12 weeks after cessation of therapy (Sustained Virological Response, SVR). Results: A total 947 patients were diagnosed with chronic HCV infection in our unit during the study period, of which 736 patients (77.1%) opted and completed anti viral treatment. Mean age of the patients was 45.1 years and the Male: Female ratio was 1.7:1. Genotype 3 (589/736, 80%) was the commonest followed by genotype 1 and 4 (106/736, 14.4%% and 36/736, 4.89 % respectively). Viral load was high (>600,000 IU/l) in 397/736 (53.9%); 335 patients (45.5%) had cirrhosis (of which 105 (31.4%) were decompensated) and 6 patients (0.8%) had hepatocellular carcinoma at presentation. Most of the patients with genotype 1,4,5 (n=135) were treated with triple drug regime for 12 weeks (10 patients with advanced liver disease were treated with sofosbuvir and ribavirin for 36 weeks). Patients with genotype 3 (n=589, 80%) were treated either with dual therapy for 24 weeks (n=405) or triple therapy for 12 weeks (n=184). SVR was achieved in 452/470 (96.2%) and there was no statistically significant difference in the SVR rates in different genotypes. Conclusion: SOF- based treatment regimens achieve high SVR rates in real life cohort of Indian patients with chronic hepatitis C infection. Patients with decompensated cirrhosis who were earlier ineligible to receive interferon-based protocols can also be considered for anti viral therapy.