Hepatitis C elimination by 2030 in Malaysia: an achievable goal?

To the Editor: The World Health Organization (WHO) aims to achieve global hepatitis C elimination by 2030, defined as diagnosis of 90% of infected individuals and treatment initiation of 80% of eligible individuals. Most lower- and middle-income countries face multifaceted challenges within their respective healthcare systems to achieve these targets, ranging from underequipped healthcare infrastructure to funding constraints [1].

In Malaysia, a middle-income country in the Southeast Asia region, it is estimated that 90% of 380,000 individuals with chronic hepatitis C virus (HCV) infection are undiagnosed and untreated. Presently, generic direct-acting antiviral (DAA) regimens are available only in specific Ministry of Health facilities, where the 23,000 individuals diagnosed with HCV will be treated in stages with sofosbuvir and daclatasvir (SOF + DAC) for 12 weeks for individuals without cirrhosis and 24 weeks for cirrhotic individuals, with the addition of ribavirin for individuals with genotype 3 compensated cirrhosis and all individuals with decompensated cirrhosis [2]. This regimen was obtained by Malaysia through a government-use compulsory licence for sofosbuvir, which then resulted in the originator company Gilead extending its voluntary licence scheme to Malaysia, making widespread access to other generic regimens, including sofosbuvir and velpatasvir (SOF + VEL), possible upon approval [3].

With the availability of these two DAA regimens, a cost-efficient stratified treatment strategy is now possible, where SOF + DAC can be used to treat non-cirrhotic individuals with HCV for 12 weeks and SOF + VEL can be used to treat cirrhotic individuals with HCV for 12 weeks [4]. Presently, the acquisition cost for generic SOF + DAC is lower than the estimated cost of generic SOF + VEL in Malaysia. The projected cost savings from using a stratified strategy [5], mainly due to the omission of ribavirin for genotype 3 compensated cirrhosis and the shorter treatment duration with SOF + VEL for cirrhotic individuals, would reduce the financial impact of HCV treatment on the national healthcare budget.

It is projected that in order to meet the WHO elimination targets by 2030, Malaysia will need a steep scale-up in the annual number of treatments initiated [6]. It has been proposed that the annual number of individuals initiated on DAA treatment would need to increase from 5000 individuals in 2018 to 15,000 individuals annually by 2022, then rapidly scaled up further to reach 30,000 treatments initiated annually by 2025 [6]. When most eligible individuals have been treated, treatment initiation can reduce to 25,000 per year by 2029 and 2030, thereby achieving the WHO targets, which will subsequently lead to reductions in downstream financial and clinical consequences of HCV infection nationally [6]. A scaled-up treatment strategy of this magnitude is only feasible alongside a large-scale national screening programme to prevent saturation of the individual pool, since many individuals living with HCV in Malaysia are undiagnosed.

Currently, it is very challenging for Malaysia to meet the WHO elimination targets by 2030 due to constraints within the healthcare infrastructure, as well as the huge financial and resource investments required to implement the necessary scaled-up treatment and screening programmes [6,7]. These challenges potentially highlight the need for realistic expectations and strategies with regard to the country's goal and timeline to achieving HCV elimination, which may include adopting simplified service delivery using public health approaches and task shifting to decentralise HCV testing and treatment to primary care facilities and community-based harm reduction sites. Community engagement and collaborative efforts with local advocacy groups, including Positive Malaysian Treatment Access and Advocacy Group and Hepatitis Free Malaysia, remain crucial towards achieving national HCV elimination targets.