CRM and the Drugs for Neglected Diseases initiative Signed Agreement to Launch Clinical Studies for a Public Health Approach to Hepatitis C in Malaysia
[Putrajaya, 13 January 2016] 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.
Health Minister Datuk Seri Dr S. Subramaniam (centre) witnessing the exchanging of a memorandum of understanding between Clinical Research Malaysia chief executive officer Dr Akhmal Yusof (right) and Drugs for Neglected Diseases initiative Head of Paediatrics HIV Programme Dr Marc Lallemont
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,” added said Datuk Seri Dr. S. Subramaniam, the Minsiter of Health.
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. www.dndi.org
Clinical Research Malaysia (CRM)
CRM 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.
[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
Press Conference: Signing Ceremony between CRM & DNDi Cooperat…Press Conference: Signing Ceremony between CRM & DNDi Cooperation on Hepatitis C Virus Clinical Project in Malaysia
Posted by KEMENTERIAN KESIHATAN MALAYSIA on Wednesday, January 13, 2016
From the online news:
- NST Online: Health Ministry to slash spending
- The Sun Daily: Health Ministry conducting clinical studies to seek new treatment for victims of Hepatitis C
- The Malaysian Insider: Health Ministry in joint effort to produce cheaper Hepatitis C drug
- Free Malaysia Today: Cheaper Hepatitis C treatments in Malaysia?
- The Rakyat Post: Malaysia facing severe shortage of cardiothoracic surgeons
Newspapers:
from New Straits Times | 14th January 2016
from The Star | 14th January 2016
