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.
Amit Goel, Sumit Rungta, Vinod Kumar et al.
✦ AI-curated · Sources linked
In 30 seconds
The RESOLVE multicentre, open-label, randomised non-inferiority trial compared 8 versus 12 weeks of daily sofosbuvir-velpatasvir in treatment-naive adults with chronic hepatitis C without cirrhosis at five publicly funded hospitals in India. Among 880 participants assigned to treatment, per-protocol sustained virological response 12 weeks after treatment was 98·8% (410/415) with 8 weeks and 99·0% (397/401) with 12 weeks; the shorter regimen met the prespecified non-inferiority criterion. No drug-related serious adverse events or adverse-event-related discontinuations were reported.
Key findings
- Per-protocol SVR12 was 98·8% (410/415) with 8 weeks versus 99·0% (397/401) with 12 weeks; risk difference 0·2% (-1·5 to 1·9).
- In intention-to-treat analysis, SVR12 was 93·5% (414/443) with 8 weeks versus 91·8% (401/437) with 12 weeks; risk difference -1·7% (-5·2 to 1·9).
- No participant had a drug-related serious adverse event or discontinued treatment because of an adverse event.
Why it matters
A shorter course achieved virological response rates similar to the standard course in this trial population. Reducing treatment duration may lessen the time patients need to take therapy, while the randomised comparison provides evidence beyond an observational association. The findings are relevant to treatment-naive adults with non-cirrhotic HCV mono-infection, the population studied.
What to keep in mind
The trial was open-label and conducted in five publicly funded hospitals in India; applicability to populations outside the studied setting is uncertain.