- Design
- Multicentre, open-label, randomised non-inferiority trial
- Population
- 880 treatment-naive adults with non-cirrhotic chronic hepatitis C in India
- Primary outcome
- Sustained virological response 12 weeks after treatment
- Effect
- 98.8% (8 weeks) vs 99.0% (12 weeks); difference 0.2% (95% CI −1.5 to 1.9)
RESOLVE was a non-inferiority trial in five publicly funded Indian hospitals, funded by the Indian Council of Medical Research. It randomised 880 treatment-naive adults with chronic hepatitis C and no cirrhosis, median age 35, to daily sofosbuvir 400 mg plus velpatasvir 100 mg for 8 or 12 weeks.
Per protocol, 98.8% were cured (sustained virological response at 12 weeks) after 8 weeks and 99.0% after 12 weeks, a difference of 0.2% (95% CI −1.5 to 1.9), well inside the 5% margin. By intention to treat, cure rates were 93.5% and 91.8%. No one had a drug-related serious adverse event or stopped for side effects.
The standard course for this combination is 12 weeks. A shorter course reduces drug cost by a third and gives fewer chances to drop out, which matters in public programmes such as India's National Viral Hepatitis Control Programme. Guidelines have not yet changed, and the trial did not include people with cirrhosis, prior treatment or HIV co-infection.
- For treatment-naive, non-cirrhotic hepatitis C, an 8-week course of sofosbuvir-velpatasvir is supported by this trial.
- Do not shorten treatment in cirrhosis, prior treatment failure or co-infection; they were not studied.
- Check what your national or programme guideline currently allows before changing practice.
- Use the shorter course to discuss adherence with patients who may struggle to complete 12 weeks.
Why it matters
One-third less treatment could reach more people in programmes where cost and follow-up are the limits.
Don't overread it
Current guidelines still specify 12 weeks for this combination; this is one trial.
The statistics, in plain English
Non-inferiority means showing the short course is not worse by more than an agreed margin, here 5 percentage points. The worst plausible difference was under 2 points, so the short course clearly passed. The open-label design matters little because cure was measured by a blood test.
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