A Multicenter, open-label, randomized, non-inferiority trial of 8 versus 12 weeks of sofosbuvir/ravidasvir treatment in non-cirrhotic patients with chronic hepatitis C virus infection (EASE trial).

OBJECTIVE

To determine whether an 8-week regimen of sofosbuvir/ravidasvir is non-inferior to the standard 12-week regimen in non-cirrhotic chronic hepatitis C virus (HCV) infection.

DESIGN OR

METHODS

We conducted a multicenter open-label, randomized, non-inferiority clinical trial across nine hospitals and 17 primary healthcare centers in Malaysia. Adults aged 18-69 years with chronic HCV infection without cirrhosis were randomized (1:1) to receive 8 or 12 weeks of sofosbuvir/ravidasvir. The primary endpoint was sustained virologic response 12 weeks post-treatment (SVR12). The non-inferiority margin was 5%. The primary analysis was performed in the modified intention-to-treat population, excluding participants with missing primary endpoint data.

RESULTS

Between March 2021, and March 2023, 322 participants were randomized (161 per arm). Among those with available SVR12 results, 142/152 (93.4%) in the 8-week group and 143/153 (93.5%) in the 12-week group (difference: -0.04%; 90% CI: -4.94% to 4.85%; P = 0.047), demonstrating non-inferiority. Efficacy was consistent across genotype, baseline viral load, and HIV co-infection subgroups. Treatment-emergent adverse events were comparable and predominantly mild; no treatment-related serious adverse events occurred.

CONCLUSION

An 8-week sofosbuvir/ravidasvir regimen achieved SVR12 comparable to 12 weeks in non-cirrhotic adults with chronic HCV infection and was well tolerated. Further pragmatic and cost-effectiveness studies are needed to inform large-scale implementation.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04885855 [09/05/2021].