KUALA LUMPUR: Malaysia has become the first country in the world to grant conditional registration for the Ravida (Ravidasvir Hydrochloride 200mg) tablet to treat Hepatitis C patients.
Ravidasvir is the first Hepatitis C virus (HCV) drug to be developed through South-South collaboration between Malaysia and Egypt, in partnership with non-profit organisations, Drugs for Neglected Diseases Initiative (DNDi) and Médecins Sans Frontières (Doctors Without Borders).
Health director-general Tan Sri Dr Noor Hisham Abdullah said Hepatitis C is a leading silent epidemic that is largely asymptomatic, as three out of four patients are unaware that they are infected.
The viral infection that primarily attacks the liver (leading to liver cancer, liver cirrhosis and liver failure) has infected 400,000 people in Malaysia to date.
"Although hepatitis can be cured, there is a vicious circle that stands in the way of providing treatment to all in need: the disease is mostly a 'silent killer', the diagnostic process is complex, so patients go undetected, and direct-acting antivirals (DAAs) are often too expensive.
"In 2016, Malaysia signed a Memorandum of Understanding (MoU) with DNDi to explore a new compound - ravidasvir - to treat HCV patients.
"In August 2017, we managed to convince the government to issue the compulsory license and subsequently, in October 2017, we also obtained the voluntary license for the private sector.
"Today's announcement is a milestone on Malaysia's long journey to achieve the World Health Organisation's goal of eliminating hepatitis C by 2030," he said, during a press conference via Zoom, today.
The compulsory license, that was issued by the Domestic Trade and Consumer Affairs Ministry (KPDNHEP), allowed Malaysian pharmaceutical company Pharmaniaga Berhad, to source generic sofosbuvir from Pharco Pharmaceuticals in Egypt.
A clinical trial called STORM-C-1, sponsored by the Health Ministries of Malaysia and Thailand with DNDi, reported 97 per cent cure rates among chronic HCV patients after being treated with a combination of ravidasvir and sofosbuvir for 12 weeks.
The trial results, which was published in The Lancet Gastroenterology and Hepatology in April 2021, involved 300 patients, from Malaysia and Thailand.
Dr Noor Hisham said, the ravidasvir treatment is currently priced at USD300 per 12-week course but he expected competitive market pricing to further lower the cost.
"We hope to bring down the price to USD100 and we are also exploring on the possibility for an 8-week course treatment for patients," he said, adding that the Cabinet has also extended the product's compulsory license period.
The next strategy, he said, is to make rapid diagnostic testing for HCV available in clinics, followed by the ravidasvir combination therapy.
"Data will be collected over the next 10 years to further innovate the HCV treatment method and make it more cost-effective.
"From the administrative point of view, this is a massive public health measure. If we can eliminate Hepatitis C in the next 10 years, then we can indirectly eradicate liver cancer, liver failure and liver cirrhosis," he said.
Meanwhile, Datuk Dr Muhammad Radzi Abu Hassan, who heads the Health ministry's Gastroenterology and Hepatology Division, said decentralisation will be a key strategy in rolling out HCV testing and treatment to patients.
The HCV treatment, he said, will be extended to prisons and rehabilitation centres while engaging with private hospitals and selected general practitioners.
Pharmaniaga Berhad's Regulatory Affairs Director, Sharifah Fauziyah Syed Mohthar commended the conditional registration of ravidasvir as the first step towards Malaysia achieving "regulatory maturity".
"We engaged with the National Pharmaceutical Regulatory Agency (NPRA) as early as March 2018 when we introduced ravidasvir as a new compound and presented the preliminary clinical trial data to them.
"The regulatory advice provided by NPRA during our first pre-submission meeting (PSM) on Jan 16, 2020, were also incorporated in the registration dossier.
"The product is currently in the final stages of manufacturing and process validation," she said.
Southeast Asia Director for DNDi, Jean-Michel Piedagnel said, Ravidasvir is the ninth medical treatment that the organisation has developed in the last 16 years.
He also congratulated Malaysia for translating medical innovation into access for HCV patients in the country.