Malaysia takes the lead on a public health approach to hepatitis C with new initiative to enhance diagnosis & treatment

14 Aug 2018

New agreement between Clinical Research Malaysia & FIND on R&D for hepatitis C diagnostic tests continues an existing Malaysian partnership with DNDi for hepatitis C treatment

The Foundation for Innovative New Diagnostics (FIND) and Clinical Research Malaysia (CRM), both DNDi partners, recently signed a memorandum of understanding (MoU) to collaborate in the research and development of an innovative hepatitis C diagnostic testing strategy.

CRM is a non-profit company owned by the Ministry of Health in Malaysia and supporting the Government’s pioneering efforts to tackle hepatitis C. The new initiative continues the Malaysian government’s project to advance access to effective hepatitis C diagnosis and treatment. FIND will demonstrate the feasibility of using rapid diagnostic tests in decentralized primary healthcare facilities and provide technical assistance to the Ministry of Health in Malaysia to support the project.

“The partnership between FIND and DNDi is a collaboration with the Malaysian Ministry of Health as well as its non-profit company, Clinical Research Malaysia, to overcome barriers to diagnosis and treatment of hepatitis C through assessing the feasibility of using rapid diagnostic tests in decentralized primary healthcare facilities,” said Dr Dzulkefly Ahmad, Minister of Health, Malaysia, at the signing of the CRM-FIND MoU.

“This project will enable some 50,000 people to be screened [for hepatitis C] and from this, 1200 are expected to require treatment and be assessed for potential recruitment into an ongoing DNDi clinical trial.”

All patients will be screened with WHO pre-qualified diagnostic tests. Those confirmed as having active hepatitis C will be linked to care. Treatment will be provided either as part of the ongoing DNDi clinical trial or by the Malaysian national HCV programme, which, following an ambitious treatment strategy to overcome the prohibitively high cost of HCV treatment in the country, now offers free hepatitis C treatment (sofosbuvir/daclatasvir) in 21 government hospitals.

The clinical trial is co-sponsored by the Malaysian Ministry of Health and designed to assess the efficacy and safety of a new, alternative treatment regimen combining sofosbuvir with the investigational drug ravidasvir. Results from the first stage of the trial published in April 2018 show this drug combination to be safe and effective, with extremely high cure rates for patients, including hard-to-treat cases.