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INTRODUCTION: There is scarcity of data in literature regarding the treatment response with Sofosbuvir (SOF) based therapy in Indian patients with chronic Hepatitis-C Virus (HCV) infection. AIM: This study was designed to observe initial treatment response to SOF based therapy in a "real-life" cohort of Indian patients with HCV infection. MATERIALS AND METHODS: This is a prospective, observational and single center study. A total of 107 patients who were diagnosed with chronic HCV infection and received SOF based treatment between March 2015 and December 2015 were included. The patients were treated with either triple drug regimen [SOF, Ribavirin (RBV) and Pegylated Interferon-α (Peg IFN-α)] or dual drug regimen (SOF and RBV) for either 12 or 24 weeks. The virological responses were obtained at baseline and thereafter weekly (up to four weeks) till viral load became undetected during treatment. RESULTS: A total of 107 patients who received SOF based therapy for chronic HCV infection were included in the study. Mean age of the patients was 48.7±10.7 years. Among included patients, 24 (22.4%) patients were treatment-experienced. Majority of the patients (n=69; 64.5%) were infected with HCV genotype-3. Except one patient, all the included patients achieved virological response up to week-4 of the treatment. There was statistically insignificant association between virological response (up to four week of the treatment) and severity of the disease (cirrhosis and non-cirrhosis) or treatment status (treatment-naïve and treatment-experienced), or HCV genotype (genotype-1 and 3). CONCLUSION: The results of this observational study demonstrated rapid initial virological response of SOF based therapy in "real-life" cohort of Indian patients with chronic HCV infection. However, long-term follow-up data are needed to ensure the sustained antiviral efficacy of SOF based therapy.
RESUMO
BACKGROUND: The safety and efficacy of sofosbuvir-based treatment (sofosbuvir and ribavirin with or without pegylated interferon-α) for hepatitis C virus (HCV) infection has been established in clinical trials. However, there is limited data regarding safety and efficacy of sofosbuvir-based treatment for HCV infection in a "real-life" cohort. We describe our experience with sofosbuvir-based treatment for HCV infection in a real-life cohort. METHODS: This was a prospective, nonrandomized and observational study at a tertiary care centre in Surat, India. The primary end-point was proportion of the study patients who achieved a sustained virological response 12 weeks after cessation of treatment (SVR 12). Secondary end-points of the study include SVR 4, virological relapse and appearance of adverse events. RESULTS: A total of 107 patients with chronic HCV who received sofosbuvir-based treatment were included in the study. During study period, two patients died due to severity of liver complications. Hence, overall rate of SVR 4 and SVR 12 was 98.1 % (n = 103/105) and 94.3 % (n = 99/105), respectively. Among 67 patients with HCV genotype-3 infection, the SVR 12 rate was 92.5 % (n = 62/67), and among 38 patients with HCV genotype-1 infection, the rate of SVR 12 was 97.4 % (n=37/38). A total of 32 (29.9 %) patients reported adverse events during the course of sofosbuvir-based treatment. None of the patient discontinued treatment due to adverse event. CONCLUSIONS: Sofosbuvir-based treatment is safe and efficacious in clinical practice in Indian patients with HCV genotype-1 and genotype-3 infection.
