- Design
- Multicentre, open-label, non-inferiority randomised trial (RESOLVE)
- Population
- 880 treatment-naive adults with non-cirrhotic HCV, five Indian public hospitals
- 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 was an open-label non-inferiority trial at five publicly funded hospitals in India, funded by the Indian Council of Medical Research. It randomised 880 treatment-naive adults with non-cirrhotic hepatitis C monoinfection to sofosbuvir-velpatasvir for 8 or 12 weeks. The median age was 35.
Per-protocol SVR12 was 98.8% with 8 weeks against 99.0% with 12 weeks (difference 0.2%, 95% CI −1.5 to 1.9), well inside the 5% margin. On intention-to-treat, 93.5% against 91.8%. No drug-related serious adverse events or discontinuations occurred.
The usual sofosbuvir-velpatasvir course is 12 weeks. A shorter course reduces cost, pill burden and the chance of drop-out — the main reason for treatment failure in programme settings. This is directly relevant to India's National Viral Hepatitis Control Programme. The findings apply only to treatment-naive, non-cirrhotic patients without HIV or hepatitis B coinfection, and confirming the absence of cirrhosis is essential before shortening.
- Consider 8 weeks of sofosbuvir-velpatasvir for treatment-naive, non-cirrhotic hepatitis C.
- Confirm absence of cirrhosis with elastography or a validated score before shortening treatment.
- Keep 12 weeks or longer for cirrhosis, prior treatment or coinfection, outside this evidence.
- Check SVR12 at 12 weeks after the end of treatment, as usual.
- Note that guidelines may not yet reflect this trial; follow local programme protocols.
Why it matters
Shorter treatment in public programmes means lower cost and fewer patients lost before cure.
Don't overread it
The result does not extend to cirrhosis, prior treatment or HIV or hepatitis B coinfection.
The statistics, in plain English
The confidence interval of −1.5 to 1.9 percentage points sits well within the 5-point non-inferiority margin, so 8 weeks is very unlikely to be meaningfully worse. Intention-to-treat rates are lower because they count patients lost to follow-up as failures.
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