Sofosbuvir plus daclatasvir treatment for patients with chronic hepatitis C genotype 3 infection with or without cirrhosis

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Omesh Goyal, Ajesh Bansal and Rajoo Singh Chhina

D.M.C. and Hospital, Ludhiana, India

: J Liver Disease Transplant

Abstract

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Statement of the Problem: In treatment-naïve patients with chronic hepatitis C(CHC) genotype 3(G-3) infection without cirrhosis, sofosbuvir plus daclatasvir daily for 12 weeks is the recommended therapy. In patients of CHC-G3 with cirrhosis, it is recommended to add daily ribavirin for 24 weeks along with the above combination, as data regarding the optimal duration of therapy in this subgroup is scarce. We aimed to study the SVR rates in CHC G3 patients with or without cirrhosis treated with sofosbuvir and daclatasvir. Methodology & Theoretical Orientation: Total 192 treatment naïve CHC-G3 patients treated with sofosbuvir and daclatasvir were enrolled. Of these, 112 did not have cirrhosis (group I), 42 had compensated cirrhosis (Child-Pugh A) (group II) and 32 patients had decompensated cirrhosis (Child Pugh B/C) (group III). Group I was treated with daily sofosbuvir(400 mg) and daily daclatasvir(60 mg) for 12 weeks, group II with daily sofosbuvir, daclatasvir and ribavirin(1000 or 1200 mg; weight based) for 12 weeks, and group III with sofosbuvir, daclatasvir and ribavirin for 24 weeks. HCV RNA was repeated at 12 weeks post-therapy for sustained virological response (SVR). Findings: Baseline characteristics in the three groups were similar (median age 48 years, 78% males). SVR rates in three groups are shown in figure. The SVR rate of group II was similar to group I (p< 0.0001). The SVR rate of group III was also similar to that of group II (p< 0.0001). No major adverse events were reported. On multivariate analysis, presence of decompensated cirrhosis was the only factor associated with relapse. Conclusion & Significance: This is the first study to show that patients of CHC G3 infection with compensated cirrhosis can achieve excellent SVR rate when treated with sofosbuvir, daclatasvir and ribavirin for 12 weeks. Patients with decompensated cirrhosis require triple therapy for 24 weeks.

Biography

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Omesh Goyal is working as an Associate Professor in Gastroenterology and Hepatology in a tertiary care institute in northern India. He has done lot of research work on chronic hepatitis C and complications of cirrhosis. His other major interest includes functional bowel disorders and ano-rectal manometry. He is a part of the Indian working group on Chronic Constipation which will formulate guidelines for constipation in India under the leadership of Dr Uday Ghoshal. His research work in has been acclaimed at international level. He won the National Scholar Award at UEG in Sweden and Best paper award in APICON in Hyderabad, India. He is working as an editor of the Journal of Gastrointestinal Infections and is an active member of various academic bodies