Clinical Research Malaysia and the Drugs for Neglected Diseases initiative sign agreement to launch clinical studies for a public health approach to hepatitis C in Malaysia

[Putrajaya, 13 January 2016]
Joint Media Release: Ministry of Health Malaysia and the Drugs for Neglected Diseases initiative (DNDi)

The Drugs for Neglected Diseases initiative (DNDi) and the Ministry of Health of the Government of Malaysia have agreed to work together to develop a public health approach to Hepatitis C within the framework of the future National Strategic Plan on viral hepatitis. The immediate goal is to conduct clinical studies of promising new treatment regimens for Hepatitis C, to be followed by scale-up of treatment for patients, with the overall objective of ensuring equitable access to affordable and effective treatments for patients suffering from this disease in Malaysia.

The clinical studies will be launched later this year in multiple sites, with DNDi and Clinical Research Malaysia (CRM), a non-profit company owned by the Ministry of Health, as the co-sponsors.

If the clinical studies are successful, the data and information from these studies will provide the Ministry of Health with critical evidence of the feasibility of using recently-approved drugs and clinical-stage compounds for Hepatitis C,” said Datuk Seri Dr. S. Subramaniam, the Minister of Health. “This will enable the Ministry of Health to take informed and appropriate policy and economic decisions on adopting these regimens as a public health tool in Malaysia.

Hepatitis C virus infection in Malaysia is a clinical and social burden to the Government of Malaysia. A scale-up of treatment is necessary in order to have an impact on the number of cases, which are steadily increasing. As of 2009, there were 453,700 people living with Hepatitis C infection in Malaysia, including 2.5 % of the adult population 15-64 years old.[1] By some estimates the disease burden is as high as 3.5%.[2]

The Hepatitis C project in Malaysia is an integral part of DNDi’s global access plan for Hepatitis C, which will include clinical studies in Thailand, to prove the feasibility of making these new combination treatment regimens available to broad patient populations at an affordable price. We are pleased to launch this landmark project with our founding partner, the Ministry of Health of Malaysia,” said Dr Bernard Pécoul, Executive Director of DNDi.

If the new treatment regimens are adopted as part of the National Strategic Plan on viral hepatitis, the Ministry of Health will follow-through with the scale-up of these regimens, meaning testing and treating patients and disease advocacy with the healthcare stakeholders of Malaysia,” said Datuk Seri Dr. S. Subramaniam, the Minister of Health.


Kementerian Kesihatan MalaysiaMinistry of Health MalaysiaDNDi


Drugs for Neglected Diseases initiative (DNDi)
A not-for-profit research and development organization, DNDi works to deliver new treatments for neglected diseases, in particular leishmaniasis, human African trypanosomiasis, Chagas disease, specific filarial infections, paediatric HIV, mycetoma, and hepatitis C. Since its inception in 2003, DNDi has delivered six treatments: two fixed-dose antimalarials (ASAQ and ASMQ), nifurtimox-eflornithine combination therapy (NECT) for late-stage sleeping sickness, sodium stibogluconate and paromomycin (SSG&PM) combination therapy for visceral leishmaniasis in Africa, a set of combination therapies for visceral leishmaniasis in Asia, and a paediatric dosage form of benznidazole for Chagas disease. DNDi has established regional disease-specific platforms, which bring together partners in disease-endemic countries to strengthen existing clinical research capacity, as well as to build new capacity where necessary.

Clinical Research Malaysia (CRM)
M is a non-profit company wholly owned by MOH, established to position Malaysia as a preferred global destination for industry-sponsored research (ISR). CRM support growth in ISR, facilitate the needs and requirements of industry players, grow the pool of capable investigators, support staff and trial sites.

Press Contacts
Mr. Siva Krishnan
Press Secretary
Office of the Health Minister, Ministry of Health

Ilan Moss, +1 646 266 5216 (US),
Manisha Sharma, +91 9711 009 088 (India),
[1] Mc Donald SA et al BMC Infectious Diseases 2014; 14:1-8. Global Burden of Disease Study 2010. Malaysia Global Burden of Disease Study 2010. Results 1990-2010.

[2] Mohd Hanafiah K, Groeger J, Flaxman AD, Wiersma, ST. Global epidemiology of hepatitis C virus infection: New estimates of age-specific antibody to HCV seroprevalence. Hepatology 2013;57:1333-42. doi: 10.1002/hep.26141