A randomized Indian trial found that eight weeks of sofosbuvir/velpatasvir was non-inferior to twelve weeks for treatment-naive adults with chronic hepatitis C who did not have cirrhosis. In the final per-protocol analysis, 98.8% of the eight-week group and 99.0% of the twelve-week group achieved SVR12. The result applies to the population studied; it does not establish an eight-week course as suitable for every person with hepatitis C.
What the trial compared
The RESOLVE trial compared two treatment durations using the same antiviral combination, sofosbuvir/velpatasvir: eight weeks versus twelve weeks. It was a multicentre, open-label, randomized non-inferiority trial conducted at five tertiary-care hospitals in India. The protocol describes the planned study and its population; the trial registry identifier is CTRI/2022/03/041368 (published protocol). The final indexed study summary reports 880 randomized participants: 443 assigned to eight weeks and 437 to twelve weeks (final study summary).
What the cure-rate figures mean
The primary reported outcome was SVR12: sustained virological response measured twelve weeks after treatment ends. It is commonly described as a cure, but the timing matters: the trial’s rates refer to the assessment twelve weeks after the course was completed.
| Treatment duration | Participants with SVR12 in per-protocol analysis | 95% confidence interval |
|---|---|---|
| Eight weeks | 410 of 415 (98.8%) | 97.2%–99.6% |
| Twelve weeks | 397 of 401 (99.0%) | 97.5%–99.7% |
The reported difference was 0.2 percentage points, with a 95% confidence interval from −1.5 to 1.9 percentage points. The authors concluded that eight weeks met the trial’s prespecified non-inferiority criterion. That is a statistical finding about the defined trial population and outcome, not proof that the two durations are interchangeable for every patient.
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Who the result applies to
Participants were adults with chronic HCV who had not previously received treatment and did not have cirrhosis. The trial therefore does not establish that an eight-week course is appropriate for people with cirrhosis, previous HCV treatment, or other groups not represented under the protocol’s eligibility criteria. Individual treatment duration should be determined with a qualified clinician using the patient’s circumstances and current guidance.
What the study does not answer
- It does not compare different drug combinations. Both groups received sofosbuvir/velpatasvir; only duration differed.
- It does not settle every safety or subgroup question. The reported final summary supports the primary efficacy result, but detailed adverse-event and subgroup findings are not established by the figures presented here.
- It does not justify combining interim and final results. An earlier conference abstract reported interim data for the first 727 participants. Those figures are distinct from the final 880-participant report and should not be added to it.
Potential cost implications
Hindustan Times reported that investigators estimated a saving of about ₹3,000 per patient from reducing treatment by four weeks. That is an attributed estimate; the report does not provide a full costing method, so it should not be treated as a guaranteed saving for an individual or a treatment programme. The same report says the study received ₹1.65 crore in funding from the ICMR Department of Health Research and involved SGPGIMS and KGMU in Lucknow, BHU-IMS in Varanasi, and AIIMS and GB Pant Hospital in New Delhi, with statistical expertise from CSIR-Central Drug Research Institute (Hindustan Times report).
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