In patients with recently diagnosed hepatitis C virus (HCV) infection, a 6-week course of therapy with sofosbuvir-velpatasvir appeared to be less effective compared with standard 12-week therapy, according to results of a study published in the Journal of Hepatology.
In this phase 4 non-inferiority trial (ClinicalTrials.gov: NCT02625909), patients with HCV who were diagnosed within the past 12 months were randomly assigned to receive either short course (6-week) or standard course (12-week) therapy with sofosbuvir-velpatasvir. Sustained virologic response 12 weeks after treatment end was the primary endpoint.
A total of 188 patients were enrolled in the trial: 93 received short course therapy and 95 received standard course therapy. Of patients included in the study, 97% were men and 69% had HIV infection. Among patients in the intention-to-treat population, sustained virologic response at 12 weeks was 81.7% (95% CI, 72.4-89.0) among those in the short course group and 90.5% (95% CI, 82.8-95.6) among those in the standard course group. The difference between groups was –8.81 (95% CI, –18.6 to 1.0). Although non-inferiority was not achieved, the difference in sustained virologic response between both treatment groups was not statistically significant (P =.08).
In a modified analysis that excluded patients who died, had non-virologic failure, or were re-infected the sustained virologic response among patients in the short and standard groups was 89.4% (95% CI, 80.8-95.0) and 97.7% (95% CI, 92.3-99.7), respectively, with a difference of –8.3 (P =.025).
The study was limited by the high proportion of men with HIV infection who were not intravenous drug users, the heterogeneity of the study population, including those with symptomatic and asymptomatic infections, and the use of only 1 treatment.
According to the researchers, “engagement of individuals early in [HCV] infection is crucial for [HCV] elimination efforts.” In addition, this trial “…provides important data on [HCV] therapeutic intervention outcomes for recent infection among a high-risk population, with implications for individual care and [HCV] elimination strategies,” the researchers concluded.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Matthews GV, Bhagani S, Van der Valk M, et al. Sofosbuvir/velpatasvir for 12 vs. 6 weeks for the treatment of recently acquired hepatitis C infection. J Hepatol. Published online May 21, 2021. doi: 10.1016/j.jhep.2021.04.056