Trial reportBMC infectious diseases2026
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.
Trial report in BMC infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04885855 (Efficacy and Safety of 8- Versus 12-week Sofosbuvir-ravidasvir Treatment of Non-cirrhotic Chronic Hepatitis C Patients), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Efficacy and Safety of 8- Versus 12-week Sofosbuvir-ravidasvir Treatment of Non-cirrhotic Chronic Hepatitis C Patients: An Open-label, Randomized, Multicenter Study in Malaysia
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Authors and funding
9 authors.
Funding
Abstract
backgroundHepatitis 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.
methodsThis 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.
resultsThe 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.
conclusionBoth 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.
trial registrationClinicalTrials.gov Identifier: NCT04885855 [09/05/2021].
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