Design: Multicentre, open-label, non-inferiority randomised trial
Population: 880 treatment-naive adults with non-cirrhotic chronic hepatitis C in India
Primary outcome: Sustained virological response 12 weeks after treatment (SVR12)
Effect: 98.8% vs 99.0% per protocol; risk difference 0.2% (−1.5 to 1.9)

RESOLVE randomised 880 treatment-naive adults with hepatitis C and no cirrhosis, at five public hospitals in India, to sofosbuvir 400 mg with velpatasvir 100 mg daily for 8 or 12 weeks. The median age was 35 and about half were women. It was open-label, publicly funded by the ICMR, and designed to show non-inferiority within a 5% margin.

Cure, defined as undetectable virus 12 weeks after treatment, was 98.8% with 8 weeks and 99.0% with 12 weeks among those who completed treatment and testing (risk difference 0.2%, −1.5 to 1.9). Counting everyone randomised, it was 93.5% versus 91.8%. No participant stopped because of an adverse event.

A third fewer weeks means a third less drug, fewer pharmacy visits and less chance of dropping out — all of which matter in public programmes where loss to follow-up is a larger threat than drug failure. The trial population was Indian, which makes this directly applicable to Indian public-sector practice.

The result applies only to people without cirrhosis who have not been treated before. Current guidance for this combination still specifies 12 weeks, and the guideline has not changed on the basis of one trial.

Confirm absence of cirrhosis before considering a shorter course; the trial excluded it.
The result applies to treatment-naive patients only, not to those who have failed earlier therapy.
Current guidance still lists 12 weeks for this combination; discuss a shorter course within your programme's protocol.
Check HCV RNA 12 weeks after the course ends to confirm cure, whichever duration is used.
Shorter courses may help patients who struggle to return for refills.

Why it matters

It challenges the assumption that 12 weeks is needed for everyone, in the population Indian clinicians actually treat.

The statistics, in plain English

The cure rates differed by 0.2 percentage points, and the 95% confidence interval (−1.5 to 1.9) lies well inside the 5-point margin the trial set, so 8 weeks is very unlikely to be meaningfully worse. Intention-to-treat rates are lower in both arms because they count people who did not complete testing as failures.