KUALA LUMPUR: In another step up for Malaysia on access to Hepatitis C diagnosis and treatment, 50,000 rapid diagnostic test kits will be made available to high-risk patients in selected clinics.
Global health non-profit body Foundation for Innovative New Diagnostics (FIND) – in collaboration with Drugs for Neglected Diseases initiative – will help the Health Ministry to kick-start the screening process in a big way.
Access to Hepatitis C screening and treatment was limited due to high treatment costs coupled with the lack of awareness, symptoms and screening facilities.
Former health minister Datuk Seri Dr S. Subramaniam announced in March that around 2,000 patients would be treated in public hospitals after the Government gained access to a generic version of the medication sofosbuvir through compulsory licencing (CL).
However, it is estimated that while 400,000 Malaysians are infected with Hepatitis C, only 23,000 have been diagnosed.
FIND HCV country project manager Sem XiaoHui said it would provide technical assistance to the ministry and demonstrate the easy-to-use rapid diagnostic test (RDT).
The 50,000 RDT kits would be distributed to 25 selected health clinics within 12 months from mid-September, she said.
“It requires only a finger prick. The RDT is fast and can produce highly accurate results in five to 20 minutes,” she said.
Currently, confirmation tests are available only in state and referral hospitals and patients may need to wait up to a month for the results because these are only tested in laboratories and are labour-intensive, she said.
Sem said the ministry’s first edition HCV guidelines introduced on Oct 17 had put RDTs as a recommended diagnostic test.
The RDT selected was based on the World Health Organisation’s (WHO) recommendation, she said.
On July 23, Drugs for Neglected Diseases initiative (DNDi) said in a statement that it would partner with FIND to generate evidence that would support policy change and the scale up of HCV diagnosis and treatment.
The work will be carried out with the ministry.
It is part of a larger FIND project, known as Hepatitis C Elimination through Access to Diagnostics (HEAD-Start), and is supported by Unitaid, a global health initiative working with partners to end the world’s epidemics.
It said patients confirmed having active HCV (viremia) would be treated as part of an ongoing DNDi clinical trial – co-sponsored by the ministry – using a new, alternative treatment regimen combining sofosbuvir with the investigational drug ravidasvir.
Patients could also be treated at selected government hospitals through the national HCV programme using generic versions of sofosbuvir/daclatasvir.
Sem said the efforts – decentralising testing and services and making these accessible at the clinic level – were aimed at achieving WHO’s viral hepatitis elimination goals, which was to get 90% of the population screened and diagnosed and 80% treated by 2030.
Sem said less than 20% of the general global population were aware of their Hepatitis C status.
DNDi South-East Asia clinical project manager S. Sasikala said of the 50,000 people screened, 1,200 were expected to require treatment and be absorbed by DNDI and the ministry’s clinical trials in five district/state hospitals.
She said high-risk populations such as those injecting drugs, care providers, those in homosexual relationships, HIV patients, sex workers, those had received blood transfusion before 1992 and family members of infected patients should get tested for HCV.
“The Institute for Medical Research has evaluated the kit and it has very good sensitivity and specificity,” said Health director-general Datuk Dr Noor Hisham Abdullah.
Asked if Malaysia could eliminate Hepatitis C through its public health approach after the CL, he said it was on track on achieving this by 2030.
Although the ministry said it would provide a limited 2,000 treatments this year, Dr Noor Hisham said this capacity would be increased in stages.
Patients had to register with 21 hospitals which provide the treatment, he added.