- Design
- Multicentre, open-label, randomised non-inferiority trial
- Population
- 880 treatment-naive adults with non-cirrhotic hepatitis C in India
- Primary outcome
- Sustained virological response at 12 weeks
- Effect
- 98.8% vs 99.0%; difference 0.2% (95% CI −1.5 to 1.9)
RESOLVE randomised 880 treatment-naive adults with chronic hepatitis C mono-infection and no cirrhosis, median age 35, at five publicly funded Indian hospitals to daily sofosbuvir 400 mg and velpatasvir 100 mg for 8 or 12 weeks. The Indian Council of Medical Research funded it.
Per protocol, sustained virological response at 12 weeks was 98.8% with 8 weeks and 99.0% with 12 weeks (difference 0.2%, 95% CI −1.5 to 1.9), well within the 5% non-inferiority margin. By intention to treat, the rates were 93.5% and 91.8%. There were no drug-related serious adverse events or discontinuations.
For hepatology clinics and public programmes in India, where this combination is widely used, a shorter course means lower drug cost and less chance of patients dropping out before completion. Current guidelines still recommend 12 weeks for this combination, and the trial did not include cirrhosis, prior treatment or HIV or hepatitis B co-infection.
- For treatment-naive, non-cirrhotic hepatitis C, an 8-week sofosbuvir-velpatasvir course is now supported by randomised evidence.
- Keep 12 weeks for cirrhosis, prior treatment or co-infection.
- Confirm cure with HCV RNA 12 weeks after treatment ends.
- Follow programme or guideline rules on duration until they are updated.
Why it matters
Cutting treatment by a third could widen access and completion in Indian programmes.
Don't overread it
Guidelines still specify 12 weeks for this combination; this is a single trial.
The statistics, in plain English
Non-inferiority was tested against a 5-point margin; the worst plausible difference was under 2 points. Open-label design matters little here because cure is a laboratory measurement.
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