Reduced duration of eight versus twelve weeks of Sofosbuvir-daclatasvir in treatment naive non-cirrhotic patients with chronic hepatitis C virus infection: An open-label, randomized pilot trial

Background: HCV is a hepatotropic virus and all those with HCV viremia need treatment. In absence of cirrhosis, HCV is treated with pan-genotypic drug, sofosbuvir/daclatasvir, for 12 weeks and the treatment is successful if HCV RNA is remained undetectable at 12 weeks (SVR12) after stopping the drugs. Recent data and our own experience have shown that the treatment duration can be reduced from 12 to 8 weeks for without compromising the response. Large, good quality data are required on effectiveness of 8 weeks of sofosbuvir/daclatasvir combination.

Research question:  Can anti-HCV treatment duration be reduced from 12 weeks to 8 weeks without compromising the virological response?

Primary objective: Compare the sustained virological response (SVR12) in non-cirrhotic HCV infected patients treated with 8 weeks versus 12 weeks of sofosbuvir/daclatasvir combination

Methodology: This open label, randomized pilot study will include 180 treatments naïve, viraemic, non-cirrhotic HCV patients. Participants will be randomized to receive either 8- or 12-week treatment followed by HCV RNA testing at 12 weeks after treatment completion for SVR12 to define treatment success or failure. A blood specimen will also be collected at baseline (for HCV genotype determination), at 4 weeks of treatment (for early virological response).

Proposed outcome:  The study will provide data on efficacy of 8 weeks of treatment as compared to standard of care (12 weeks) in non-cirrhotic patients with active HCV infection.

Future plan: If the results of our study will support, we will plan a double-blind, multicentric, RCT to provide a reliable evidence and reach the final conclusion.