A Two-Year Outcome Evaluation of Government-Led Initiative to Upscale Hospital-based Hepatitis C Treatment Using a Standard Two-Drug Regimen in Malaysia

Abstract

Background: Malaysia has been fully committed to the global endeavor to eliminate hepatitis C virus (HCV) infection by 2030. In early 2018, the Ministry of Health (MOH) embarked on a “one-size-fits-all strategy” by introducing generic versions of sofosbuvir and daclatasvir as the standard treatment for HCV infection in public hospitals nationwide. Objectives: To evaluate the outcomes of such an initiative in multiple aspects, including the number and characteristics of patients treated, the extent of evidence-based drug use, the treatment completion status, individual responses to treatment, common side effects of treatment, and its economic implications. Methods: The findings were generated from the data compiled by the MOH, capturing the information regarding the treatment provided to adult HCV-infected patients in 16 selected hospitals between April 2018 and March 2020, along with the drug costs incurred. Results: A total of 1,797 patients were treated, nearly four times more than the patients receiving interferon-based treatment across the country in the preceding two years. Approximately one-third of them had liver cirrhosis, and the main HCV genotypes were 3 (46.9%) and 1a (20.0%). Dosing, treatment duration and the addition of ribavirin to the treatment generally agreed with the recommendations of the MOH. More than 90% of the patients completed the treatment course, and a sustained virologic response (SVR) rate of 95.4% (95% CI: 94.2, 96.7%) was recorded in those with a known treatment outcome (n = 1,163). The SVR achievement did not vary across HCV genotypes and cirrhosis status, but those ≥ 50 years of age (adjusted OR: 2.13; 95% CI: 1.16, 3.92) were more likely to fail the treatment. Side effects were rare. Anemia and fatigue caused treatment discontinuation in only 0.3% of the patients. The total drug expenditure reached US$678,258.20, and the mean cost of a 12-week treatment course of sofosbuvir and daclatasvir (US$235.16) was lower than the cost expected by the MOH (US$300). Conclusions: The findings demonstrate a high degree of real-world effectiveness, safety, and affordability of the standard treatment, suggesting that such a government-led initiative was reasonable and timely and could be extended to include more public health institutions.

Assessing the impact of simplified HCV care on linkage to care amongst high-risk patients at primary healthcare clinics in Malaysia: a prospective observational study

“…Initiatives by the MOH after the study started have led to a tremendous expansion in screening and treatment for HCV. [31][32][33][34] The evidence from this study has catalysed plans for MOH to roll-out decentralised HCV care from the 25 sites to all PHCs nationwide, in a stepwise manner from quarter 1 of 2020. 34 The model for scale-up builds on key aspects that were integral to this study design, including the use of RDTs for point of care results, optimal turnaround times and the use of DAA therapies at PHCs for non-cirrhotic and uncomplicated cases of HCV, where there is capacity present on-site.…”

Assessing feasibility of a modified same-day test-and-treat model for hepatitis C among rural people who inject drugs

“…Family physicians in Malaysia were found to be capable of managing PWID with HCV effectively, including cases complicated by cirrhosis and HIV infection, and initiating DAA-based treatment when necessary, similar to the experience in Cambodia [ 30 ]. Furthermore, the participants achieved an SVR rate that was almost as high as that reported by hospitals when sofosbuvir-based treatment was first made available in Malaysia [ 16 ]. These positive findings throughout the care cascade increase in the confidence of the Ministry of Health in extending HCV care to more hard-to-reach populations in the country.…”

“…To determine the feasibility of the model, the study team assessed whether its outcomes were comparable to those achieved in standard HCV care in Malaysia. Based on a review of relevant studies [ 16 , 19 ] and local data obtained from the Ministry of Health, the team considered the model feasible if it met the following criteria: (i) at least 70% of PWID who tested positive for anti-HCV received HCV RNA testing; (ii) only a small fraction (< 5%) of PWID repeated HCV RNA testing due to an initial invalid result; (iii) at least 70% of PWID who underwent HCV RNA testing had a detectable level of HCV RNA; (iv) at least 60% of eligible PWID received treatment; (v) at least 60% of PWID who were treated started treatment on the same day; (vi) at least 70% of PWID who started treatment completed it; (vii) at least 60% of PWID who completed treatment underwent SVR testing; (viii) at least 80% of PWID achieved SVR after completing treatment; and (ix) at least 30% of the PWID who received treatment under the model were referred from sources other than the study sites.…”

“…To overcome the limitations of accessing patented DAAs, Malaysia took the pioneering step of issuing a compulsory license to authorize the import and use of generic sofosbuvir in 2017 [ 14 , 15 ]. Sofosbuvir/daclatasvir was subsequently selected to be the standard treatment regimen for HCV in public hospitals, resulting in an SVR rate of 95.4% [ 16 ]. By implementing compulsory licensing on sofosbuvir, Malaysia successfully made free HCV treatment available through the public health system without incurring a substantial budgetary strain [ 17 , 18 ].…”

Ravidasvir: equitable access through an alternative drug development pathway

“…The Ministry of Health also expanded hepatitis C testing and treatment services in the Malaysian public healthcare system, while using compulsory licensing to secure affordable supplies of sofosbuvir from Pharco, despite the intense global political pressure against it. 6,7 Similarly, the Thai Ministry of Public Health invested heavily in the STORM-C trials, despite the possible risk of failure.…”