- Design
- Multicentre, open-label, randomised non-inferiority trial, 5 Indian public hospitals
- Population
- 880 treatment-naive adults with chronic hepatitis C without cirrhosis, median age 35
- Primary outcome
- SVR12 (per protocol)
- Effect
- 98.8% (8 weeks) vs 99.0% (12 weeks); difference 0.2% (95% CI −1.5 to 1.9)
RESOLVE, funded by the Indian Council of Medical Research, randomised 880 treatment-naive adults with hepatitis C and no cirrhosis at five public hospitals in India to sofosbuvir 400 mg plus velpatasvir 100 mg daily for 8 or 12 weeks. Median age was 35. The primary outcome was cure, measured as no detectable virus 12 weeks after treatment (SVR12).
Per protocol, 98.8% were cured with 8 weeks and 99.0% with 12, a difference of 0.2 percentage points (95% CI −1.5 to 1.9), well within the 5-point non-inferiority margin. By intention to treat, figures were 93.5% and 91.8%, again non-inferior. Nobody had a drug-related serious adverse event or stopped because of one.
A third shorter course means less cost, fewer visits and fewer people lost before finishing, all of which matter in a national elimination programme. The result applies to treatment-naive patients without cirrhosis and without HIV or hepatitis B co-infection, and genotype mix in India differs from elsewhere. It has not yet changed the labelled 12-week duration or international guidelines, so the decision to shorten sits with the treating clinician and programme policy.
- Confirm absence of cirrhosis before considering a shorter course; the trial excluded it.
- The evidence covers treatment-naive adults with hepatitis C alone, not HIV or hepatitis B co-infection.
- Consider discussing 8 weeks with programme or hepatology leads for eligible patients, noting the label is still 12 weeks.
- Check SVR12 at 12 weeks after the end of treatment whatever the course length.
- Plan the SVR12 recall at the start; the gap between per-protocol and intention-to-treat cure here was largely people not tested.
Why it matters
A shorter course could cut cost and drop-out across India's hepatitis C elimination programme.
Don't overread it
Guidelines and the drug label still specify 12 weeks; one trial has not changed them.
The statistics, in plain English
Non-inferiority asks whether the shorter course is no more than a set amount worse — here, 5 percentage points. The 95% interval for the difference ran from −1.5 to 1.9, so even the least favourable plausible result is far inside that margin. The intention-to-treat figures are lower because they count everyone randomised, including those who did not come back for testing.
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