Time to viral load suppression with 8-week versus 12-week ravidasvir/sofosbuvir regimens among chronic hepatitis C patients in Malaysia: a non-inferiority, randomized clinical trial

Hepatitis C virus (HCV) infection remains a major global health burden, contributing to chronic liver disease and significant mortality. Malaysia has implemented direct-acting antiviral (DAA) therapy to support the World Health Organization’s goal of eliminating HCV by 2030. Ravidasvir/sofosbuvir (RDV/SOF) is a potent, pan-genotypic DAA regimen with high efficacy. Yet evidence comparing time to viral load suppression between shorter and standard treatment durations remains limited. This study aimed to determine the time to HCV RNA viral load suppression for the 8-week and 12-week RDV/SOF regimens among chronic HCV patients in Malaysia and to identify factors associated with the time to suppression. This secondary analysis utilized data from a randomized, open-label, multicenter, non-inferiority clinical trial (2016–2020) involving 321 adult patients with chronic HCV infection. Kaplan–Meier survival analysis and Cox proportional hazards regression were used to evaluate time to viral suppression (HCV RNA < 15 IU/mL) and associated predictors. The final model was stratified by baseline HCV RNA load, concomitant medications, and imprisonment risk to satisfy the proportional hazards assumption. The median time to viral load suppression was 28 days for both treatment groups, with no significant difference in Kaplan–Meier analysis ( p = 0.076). In multivariable Cox regression, patients receiving the 8-week regimen were more likely to achieve viral suppression earlier than those on the 12-week regimen (adjusted hazard ratio [aHR] = 1.29, 95% CI: 1.01–1.63, p = 0.038). Higher baseline HCV RNA load was significantly associated with delayed suppression ( p < 0.001). Other demographic and clinical factors were not significant. Both 8-week and 12-week RDV/SOF regimens achieved rapid viral suppression, with comparable median times to viral suppression. The 8-week regimen was associated with a higher likelihood of earlier suppression; however, given the modest statistical power, this finding should be interpreted with caution. The results suggest potential as an effective alternative in Genotype 1 patients. However, given the significant treatment-by-genotype interaction, the magnitude of benefit with the shorter regimen in the predominant Genotype 3 population warrants further investigation before broad programmatic recommendations can be made. ClinicalTrials.gov Identifier: NCT04885855 [09/05/2021].