Initiative in Malaysia to enhance country's public health approach to hepatitis C
- Decentralized screening for hepatitis C virus (HCV) using pre-qualified rapid diagnostic tests will be initiated in Malaysia in an effort to expand the reach of screening initiatives
- People who screen positive and are subsequently confirmed to have HCV can be linked to direct-acting antiviral treatment as part of a DNDi clinical trial or in government hospitals
- Work is being conducted in collaboration with the Ministry of Health in Malaysia; evidence from these coordinated interventions will be used to support policy change and scale up of HCV diagnosis and treatment in the country and beyond
Amsterdam/Geneva - 23 July 2018 - The Foundation for Innovative New Diagnostics (FIND) and the Drugs for Neglected Diseases initiative (DNDi) will partner to generate evidence that will support policy change and scale up of hepatitis C (HCV) diagnosis and treatment. This work, announced at the AIDS 2018 conference in Amsterdam and ahead of World Hepatitis Day 2018, is being conducted in collaboration with the Ministry of Health in Malaysia with a view to overcoming barriers to diagnosis and treatment. It forms part of a larger FIND project known as Hepatitis C Elimination through Access to Diagnostics (HEAD-Start), supported by Unitaid.
Although the World Health Organization (WHO) has prequalified different types of HCV tests, screening and confirmatory diagnosis of hepatitis C are not widely available, and remain largely centralized and siloed where they do exist. This means that identifying those with the disease so they can be linked to care is a huge challenge. 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. "It will make screening widely accessible and increase the number of people who know their status and can enter the care cascade."
All patients confirmed during the study as having active HCV (viremia) will be linked to care. Treatment will be provided:
- either as part of an ongoing DNDi clinical trial. The DNDi clinical trial, which is co-sponsored by the Malaysian Ministry of Health, is 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 the combination to be safe and effective, with extremely high cure rates for patients, including hard-to-treat cases; 
- or by the Malaysian national HCV programme, which, following an ambitious treatment strategy to overcome the prohibitively high cost of treatments in the country, now offers free hepatitis C treatment (sofosbuvir/daclatasvir) in government hospitals.
"Our ambition is provide a treatment that is pan-genotypic, simple and affordable in order to facilitate a public health approach to HCV," said Dr Bernard Pécoul, Executive Director of DNDi. "Combined with a simplified diagnostic algorithm, this could make it easier for healthcare providers to scale up treatment to much higher levels than is possible today."
A Memorandum of Understanding is expected to be signed in August 2018 with Clinical Research Malaysia (CRM), a non-profit company owned by the Ministry of Health.
"Our core business in the Ministry of Health is to provide affordable, accessible and equitable healthcare for the citizens of Malaysia," said Dr Hisham Abdullah Director-General of Health Malaysia. "The evidence generated by both the FIND and DNDi projects will be used to update national guidelines that will cover HCV screening, diagnosis, treatment and monitoring, for an effective HCV public health approach in Malaysia."
About Hepatitis C
HCV is one of the world's most common infectious diseases, usually contracted through unsafe healthcare and injection drug use. Globally, more than 71 million people are chronically infected, over 80% of whom live in low- and middle-income countries (LMICs) - but only one in five people know they have the disease.  Around 400,000 people die every year, and the mortality rate is increasing, making it a global health priority: the World Health Organization (WHO) has set an ambitious target of viral hepatitis elimination by 2030.  In Malaysia, HCV disease burden is high and predicted to rise steeply over the coming decades, leading to a projected 63,900 HCV-related deaths by 2039. 
FIND was established in 2003 as a global non-profit dedicated to accelerating the development, evaluation and delivery of high-quality, affordable diagnostic tests for poverty-related diseases, now including malaria, tuberculosis, HIV/AIDS, sleeping sickness, hepatitis C, leishmaniasis, Chagas disease, Buruli ulcer, non-malarial fever and diseases with outbreak potential, such as Ebola. FIND has partnered in the delivery of 20 new diagnostic tools and created an enabling environment for numerous others through the provision of specimen banks, reagent development and better market visibility. FIND also supports better access to new diagnostics through implementation, quality assurance and lab strengthening work. FIND has nearly 200 partners globally, including research institutes and laboratories, health ministries and national disease control programmes, commercial partners, bilateral and multilateral organizations, especially WHO, and clinical trial sites. For further information, please visit http://www.finddx.org
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit R&D organization working to deliver new treatments for neglected patients, in particular for sleeping sickness, Chagas disease, leishmaniasis, filaria, mycetoma, paediatric HIV/AIDS, and hepatitis C virus (HCV). DNDi's ambition is to enable access to HCV treatment, through the development and registration of affordable, safe and efficacious pan-genotypic direct-acting antivirals (DAAs), and by supporting policy change and political will to remove barriers to access to DAAs globally. http://www.dndi.org
FIND: Sarah-Jane Loveday, Head of Communications
T: +41 (0) 22 710 27 88
M: +41 (0) 79 431 62 44
At the AIDS 2018 conference: +41 79 432 62 97
In Malaysia: + 60 12 546 8362
 DNDi press release, 12 April 2018. https://www.dndi.org/2018/media-centre/press-releases/new-affordable-hepatitis-c-combination-treatment-shows-97-cure-rate/ (accessed 18 July 2018)
 World Health Organization. Global hepatitis report 2017. http://www.who.int/hepatitis/publications/global-hepatitis-report2017/en/ (accessed 27 June 2018)
 World Health Organization. Disease burden and mortality estimates, 2000-2015. http://www.who.int/healthinfo/global_burden_disease/estimates/en/index1.html (accessed 27 June 2018)
 World Health Organization. Combating hepatitis B and C to reach elimination by 2030, May 2016. http://apps.who.int/iris/bitstream/handle/10665/206453/WHO_HIV_2016.04_eng.pdf;jsessionid=0B0881916BBDF9EB2B47D4B004DB7969?sequence=1 (accessed 5 July 2018)
 Raihan R, et al. Euroasian J Hepato-Gastroenterol 2017;7(1):65-67