Virological response among patients with available outcome testing after sofosbuvir plus ravidasvir in Malaysia’s decentralised hepatitis C programme: A national registry-based observational cohort study

Abstract

Objective: To evaluate the real-world effectiveness of sofosbuvir plus ravidasvir (SOF/RDV) for chronic hepatitis C in Malaysia.

Methods: This is a national registry-based observational cohort study using programme data from public hospitals and primary care clinics. Adults with confirmed active hepatitis C virus infection who received SOF/RDV from 2018 to 2024 were included. Patients without cirrhosis received 12 weeks of therapy and those with compensated cirrhosis received 24 weeks. Sustained virological response at 12 weeks was assessed using hepatitis C virus RNA or core antigen testing. Variables were summarised using frequencies, percentages, and medians with interquartile ranges. Assessed variables included demographic characteristics, injection-drug-use history, HIV co-infection, cirrhosis, treatment duration, treatment setting, treatment status, and sustained virological response 12 weeks after treatment (SVR12). Group comparisons used Chi-square, Fisher's exact, or Mann-Whitney U tests. Multivariable logistic regression assessed factors associated with failure to achieve SVR12.

Results: A total of 1 143 patients were included. Their median age was 48 years (IQR 41.0–56.5), 1 055 (92.3%) were male, 815 (71.3%) were people who inject drugs, and 49 (4.3%) had HIV co-infection. SVR12 testing was available for 504 patients (44.1%); 469/504 achieved SVR12 (93.1%). SVR12 was achieved by 336/358 people who inject drugs (PWID) (93.9%, 95% CI 90.9%-95.9%) and 133/146 non-PWID (91.1%, 95% CI 85.4%-94.7%). The exploratory multivariable model did not identify statistically significant predictors, but precision was limited by the small number of failures.

Conclusions: Among the 44.1% of treated patients with available post-treatment virological testing, SOF/RDV was associated with a high SVR12 rate. Substantial incomplete outcome ascertainment prevents a definitive estimate of programme-wide effectiveness and limits generalisability to the full treated population. Strengthening treatment-cascade documentation and post-treatment testing is necessary for reliable monitoring of cure and elimination progress.

Keywords

Hepatitis C / Antiviral agents / Sofosbuvir / Ravidasvir / Sustained virological response / Primary health care / Malaysia

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