Home›Gastroenterology› Eight-Week Sofosbuvir-Velpatasvir Matches Twelve-Week Course in Non-Cirrhotic Hepatitis C
Eight-Week Sofosbuvir-Velpatasvir Matches Twelve-Week Course in Non-Cirrhotic Hepatitis CTrial shows 8-week treatment works for Hepatitis C
Lancet (London, England)Published October 17, 2026Study authors: Goel Amit, Rungta Sumit, Kumar Vinod, Shalimar, Kumar Ajay, Katiyar Harshita, Singh Surender, Deep A…PubMed ↗DOI ↗Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease
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Key Takeaway
Eight weeks of sofosbuvir-velpatasvir was non-inferior to 12 weeks in non-cirrhotic, treatment-naive hepatitis C.
This multicentre randomized controlled trial enrolled 880 treatment-naive adults aged 18 years or older with non-cirrhotic hepatitis C virus mono-infection across five publicly funded hospitals in India. Participants received oral sofosbuvir 400 mg plus velpatasvir 100 mg daily, randomized to either 8 weeks or the standard 12 weeks of therapy.
The primary outcome was sustained virological response at 12 weeks after treatment completion, defined as absence of quantifiable HCV RNA. In the per-protocol analysis, SVR12 was 98.8% with the 8-week regimen (410/415) versus 99.0% with 12 weeks (397/401), a risk difference of 0.2% with a 95% confidence interval of -1.5 to 1.9, meeting the non-inferiority criterion.
Intention-to-treat results were 93.5% (414/443) for 8 weeks and 91.8% (401/437) for 12 weeks, a risk difference of -1.7% (95% CI -5.2 to 1.9), again indicating non-inferiority. No participant experienced a drug-related serious adverse event, and no one discontinued treatment because of an adverse event.
The trial was open-label, which is a limitation for interpreting subjective safety endpoints. Funding came from the Indian Council of Medical Research and the Department of Health Research, Government of India. For clinicians, these findings suggest that shortening sofosbuvir-velpatasvir to 8 weeks may offer comparable efficacy in non-cirrhotic, treatment-naive patients, though confirmation in broader populations remains prudent.
How this fits prior evidence
How this fits prior evidence: This finding addresses a gap in clinical management for patients with viral hepatitis infections, which are known to pose a significantly higher risk for liver cancer than smoking-related lung cancer. While previous coverage noted that major HCV genotypes G1, G2, and G3 account for 98.02% of infections in FSU regions, this trial provides specific data on treatment duration for non-cirrhotic patients.
A clinical trial in India looked at how long patients with certain types of Hepatitis C needed to take medication. The study included 880 adults who had not previously received treatment for the virus and did not have liver scarring. Researchers compared an 8-week daily dose of sofosbuvir and velpatasvir against the standard 12-week treatment.
The results showed that the 8-week treatment was highly effective. In one analysis, 98.8% of people on the shorter course achieved a sustained response, which is nearly identical to the 99.0% success rate seen in the 12-week group. A second analysis showed 93.5% success for the 8-week group compared to 91.8% for the 12-week group.
No participants experienced serious side effects related to the medication, and no one had to stop treatment early due to safety concerns. While the results are promising for shortening treatment times, patients should talk to their doctors to see if a shorter course is appropriate for their specific health needs.
What this means for you:
An 8-week course of sofosbuvir and velpatasvir showed similar success to a 12-week course for some patients.
Common questions
Is the 8-week treatment as effective as the 12-week treatment?
Yes, the study found the 8-week regimen was non-inferior to the 12-week treatment. In one analysis, 98.8% of patients on the 8-week course achieved a sustained response, while 99.0% of those on the 12-week course did the same.
Were there any serious side effects from the shorter treatment?
The study reported that no participant experienced any drug-related serious adverse events. Additionally, no participants had to stop their treatment early because of any adverse events during the trial.
Who was included in this study?
The study included 880 adults who had not been treated before for Hepatitis C. Specifically, the participants had a mono-infection and did not have cirrhosis, which is a type of liver scarring.
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.
