New Malaysia-made hepatitis drug gets conditional approval

A new affordable drug for treating hepatitis C, which Malaysia helped to develop, has been given conditional approval by the Drug Control Authority.

The drug, Ravidasvir hydrochloride, is a result of a collaborative effort between Malaysia and the Drugs for Neglected Diseases Initiative (DNDI).

It comes in the form of a 200mg Ravida tablet and is used in a combination with Sofosbuvir for a 12-week treatment course.

Malaysia became the first country to approve its use recently.

Malaysia is the first country to approve the use of a new drug for hepatitis C. (stanford.edu pic)

Health director-general Dr Noor Hisham Abdullah said clinical trials showed a 97% efficacy in curing a non-cirrhotic liver and 96% for cirrhotic liver among 600 hepatitis C patients in Malaysia and Thailand.

Moreover, the hepatitis C patients with HIV co-infection or other comorbidities also responded well to the 12-week treatment, unlike the 24 weeks needed with the Daclatasvir-Sofosbuvir combination currently being used, he said.

“This Ravidasvir-Sofosbuvir is the best combination so far and it costs only US$100 (RM410) for a 12-week treatment,” he told FMT.

Noor Hisham said the efficacy was even better than the Daclatasvir-Sofosbuvir combination, which was 86%.

“With early diagnosis and treatment for hepatitis C patients, we can prevent liver cirrhosis, liver failure and liver cancers in the future. It will bring us closer to achieving the World Health Organization’s viral hepatitis elimination goals by 2030,” said Noor Hisham.

Noor Hisham said that currently, the ministry will use both combination therapies (Ravidasvir-Sofosbuvir and Daclatasvir-Sofosbuvir) in public hospitals.

The health ministry had estimated that there were about 400,000 hepatitis C patients in Malaysia and 75% of them were asymptomatic, and this posed a public health threat.

Noor Hisham said a collaborative trial between DNDi, Clinical Research Malaysia and the Institute for Clinical Research led to the discovery of a compound, where combined with sofosbuvir, gives better results and outcome.

He said the health ministry carried out a major nationwide decentralisation of hepatitis C screening and treatment using Daclatasvir-Sofosbuvir since 2018 by training healthcare workers in its community clinics to carry out the work, which previously was done only in hospitals.

The Ravidasvir-Sofosbuvir combination therapy uses oral tablets and this meant that patients could also be treated at the clinics in urban and rural areas, said Noor Hisham.

The ministry also teamed up with the Foundation for Innovative New Diagnostics to come up with an affordable diagnostic rapid test kit at point of care.

The Ravidasvir-Sofosbuvir success story showed that partnerships could “make the impossible, possible”, as Noor Hisham put it.

By : Loh Foon Fong – FMT

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