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 patients. Most lower and middle-income countries face multifaceted challenges within their respective healthcare systems to achieve these targets, ranging from under-equipped healthcare infrastructure to funding constraints 1.

In Malaysia, a middle income country in the South-east 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 antivirals (DAAs) regimens are only available in specific Ministry of Health facilities, where the 23,000 diagnosed HCV patients will be treated in stages with sofosbuvir and daclatasvir (SOF+DAC) for 12 weeks for patients without cirrhosis and 24 weeks for cirrhotic patients, with the addition of ribavirin for Genotype 3 compensated cirrhosis patients and all patients with decompensated cirrhosis 2. This regimen was obtained by Malaysia through a government-use compulsory license for sofosbuvir, which then resulted in the originator company Gilead extending their voluntary license 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 direct acting antiviral regimens, a cost-efficient stratified treatment strategy is now possible, where SOF+DAC can be used to treat non-cirrhotic HCV patients for 12 weeks and SOF+VEL to treat cirrhotic HCV patients 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 patients 4 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 treatment initiated6. It has been proposed that the annual number of patients initiated on DAA treatment needs to increase from 5000 patients in 2018 to 15,000 patients annually by 2022, then rapidly scaled up further to reach 30,000 treatment initiated annually by 20256. When most eligible patients 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 nationally6. A scaled-up treatment strategy of this magnitude is only feasible alongside a large-scale national screening program to prevent saturation of the patient pool, since many HCV infected individuals 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 programs 6,7. These challenges potentially highlight the need for realistic expectations and strategies with regards 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.