8 weeks versus 12 weeks of sofosbuvir-velpatasvir for treatment-naive, non-cirrhotic, chronic hepatitis C (RESOLVE): a multicentre, open-label, non-inferiority, randomised controlled trial in India

Chronic hepatitis C virus (HCV) infection without cirrhosis can be treated with 12 weeks of sofosbuvir-velpatasvir combination therapy. We aimed to assess whether a shorter 8-week treatment regimen of this combination was non-inferior to the standard 12-week regimen in successfully clearing HCV infection in HCV-infected patients without evidence of cirrhosis.

RESOLVE was a multicentre, open-label, non-inferiority, randomised controlled trial, conducted in five publicly funded hospitals in India. We randomly assigned (1:1) treatment-naive adults (aged ≥18 years) with non-cirrhotic HCV mono-infection to receive sofosbuvir 400 mg and velpatasvir 100 mg (orally, daily) for either 8 weeks or 12 weeks. The primary outcome was the proportion of participants with sustained virological response-ie, absence of quantifiable HCV RNA at 12 weeks after treatment completion (SVR12), with 95% assumed proportion with 12-week treatment, 5% non-inferiority margin, 2·5% one-sided alpha error, and 90% study power in the per-protocol population. The trial was registered with the Clinical Trial Registry of India, CTRI/2022/03/041368, and is complete.