Wednesday, 3 October 2018

Malaysia takes the lead on a public health approach to hepatitis C

The Foundation for Innovative New Diagnostics (FIND) and Clinical Research Malaysia (CRM) today signed a Memorandum of Understanding (MOU) to collaborate in the research and development of an innovative Hep C diagnostic testing strategy.

CRM is a non-profit company owned by the Ministry of Health in Malaysia, and this work underscores the importance of research and development in the government’s pioneering efforts to tackle the disease. The initiative is being conducted in continuation of a partnership with the Drugs for Neglected Diseases initiative (DNDi) and forms part of a larger FIND project known as Hepatitis C Elimination through Access to Diagnostics (HEAD-Start), supported by Unitaid. Malaysia is the only high-middle-income country included in the project.

“It is a great honour to be part of this research and development effort with FIND, that will eventually lead to more cost efficient and earlier detection of the Hepatitis C. In line with our effort to be a globally trusted organization and participate in research that matters to the Malaysian population we will continue to strive our best to deliver together with our partner FIND” said Dr. Akhmal Yusof, Chief Executive Officer of Clinical Research Malaysia.

Although the World Health Organization (WHO) has prequalified different types of HCV tests, screening vulnerable and hard-to-reach populations remains a challenge due to centralized health services, making it difficult to identify those with the disease who need to be linked to care and treatment. FIND will demonstrate the feasibility of using rapid diagnostic tests (RDTs) in decentralized primary healthcare facilities, and provide technical assistance to the Ministry of Health in Malaysia to support the project.

“The introduction of RDTs and simpler diagnostic pathways is a critical step in scaling up hepatitis C care,” said Catharina Boehme, CEO of FIND. “This MOU with CRM allows us to work closely with the Malaysian government and ensure that the evidence generated can be used to inform national policy so that more people can know their status and enter the care cascade.”

All patients screened during the study with World Health Organization pre-qualified diagnostic tests and confirmed as having active HCV (viraemia) will be linked to care. Treatment will be provided:
either as part of an ongoing DNDi clinical trial, which 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;1
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 MoU was signed by Dr. Akhmal Yusof, Chief Executive Officer of CRM and Mr. Zachary Katz, Chief Access Officer of FIND and witnessed by the Minister of Health, YB Dr. Dzulkefly Ahmad, the Director-General of Health, YBhg Datuk Dr. Noor Hisham, the Deputy Director-General of Health (Research & Technical Support), YBhg. Datuk Dr. Shahnaz Murad, the Director of National Clinical Research Centre (CRC), YBhg Dato Dr. Goh Pik Pin and the Head of HCV & HIV Unit, FIND, Dr. Francesco Marinucci.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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