8 weeks versus 12 weeks of sofosbuvir-velpatasvir for treatment-naive, non-cirrhotic, chronic hepatitis C (RESOLVE): a multicentre, open-label, non-inferiority, randomised controlled trial in India
In brief
Eight-week hepatitis C treatment matched 12 weeks, clearing 99% in trial
In this Indian randomized trial, 98.8% of participants who completed 8 weeks of sofosbuvir-velpatasvir cleared the virus, compared with 99.0% after 12 weeks; the shorter course also met non-inferiority criteria in the full randomized groups. The result supports shorter treatment for treatment-naive adults without cirrhosis, but does not establish effectiveness in other patient groups.
- Journal
- Lancet (London, England) (Q1)
- Published
- 30 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Amit Goel, Sumit Rungta, Vinod Kumar, Shalimar, Ajay Kumar, Harshita Katiyar, et al.
- PMID
- 42815507
- DOI
- 10.1016/S0140-6736(26)01380-2
Why clinicians should know about it
- Picked for Microbiology (medical) (top studies of the week, 4 October 2026): High-quality evidence in a top journal
Abstract
BACKGROUND: Chronic hepatitis C virus (HCV) infection without cirrhosis can be treated with 12 weeks of sofosbuvir-velpatasvir combination therapy. We aimed to assess whether a shorter 8-week treatment regimen of this combination was non-inferior to the standard 12-week regimen in successfully clearing HCV infection in HCV-infected patients without evidence of cirrhosis. METHODS: RESOLVE was a multicentre, open-label, non-inferiority, randomised controlled trial, conducted in five publicly funded hospitals in India. We randomly assigned (1:1) treatment-naive adults (aged ≥18 years) with non-cirrhotic HCV mono-infection to receive sofosbuvir 400 mg and velpatasvir 100 mg (orally, daily) for either 8 weeks or 12 weeks. The primary outcome was the proportion of participants with sustained virological response-ie, absence of quantifiable HCV RNA at 12 weeks after treatment completion (SVR12), with 95% assumed proportion with 12-week treatment, 5% non-inferiority margin, 2·5% one-sided alpha error, and 90% study power in the per-protocol population. The trial was registered with the Clinical Trial Registry of India, CTRI/2022/03/041368, and is complete. FINDINGS: Between May 15, 2022, and Sept 10, 2024, we screened 1620 participants, of whom 880 (54·3%) were enrolled in the study and randomly assigned to the 12-week (n=437 [50%]) or 8-week (n=443 [50%]) groups. 455 (52%) participants were women, 425 (48%) were men, and the median age was 35 years (IQR 28 to 47). 816 (93%) participants completed the intended 12-week (401 [92%] of 437) or 8-week (415 [94%] of 443) treatment and SVR12 testing. On per-protocol analysis, the proportion reaching SVR12 with 8-week treatment (410/415; 98·8% [95% CI 97·2 to 99·6]) was non-inferior to 12-week treatment (397/401; 99·0% [97·5 to 99·7]), with a risk difference of 0·2% (-1·5 to 1·9). Further, on intention-to-treat analysis, the proportion of participants reaching SVR12 with 8-week treatment (414/443; 93·5% [90·9 to 95·5]) was non-inferior to 12-week treatment (401/437; 91·8% [88·8 to 94·2]) with a risk difference of -1·7% (-5·2 to 1·9). No participant had any drug-related serious adverse event or drug discontinuation due to an adverse event. INTERPRETATION: An 8-week regimen of sofosbuvir-velpatasvir was similar in efficacy to the standard 12-week treatment in individuals with chronic HCV infection without cirrhosis. This finding supports shortening the duration of treatment in such patients. FUNDING: Indian Council of Medical Research, Department of Health Research, Government of India.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.