Health director-general Dr Noor Hisham Abdullah said the affordable drug Ravidasvir, which has a near 100% efficacy when used in combination with Sofosbuvir, is expected to be made available by the end of this year or early next year.
“It will take a few months for us to procure Ravidasvir now that it has been given conditional approval.” Malaysia is the first country to have approved its use.
Noor Hisham said the continued decentralisation of Hepatitis C treatment, which has been ongoing since 2018, will be able to prevent future cases of liver cancer, liver failure and liver cirrhosis, saving lives and cost.
He was speaking during a press conference on the drug’s approval, organised by the Drugs for Neglected Diseases Initiative (DNDi).
Other panellists included: National head of gastroenterology and hepatology at the health ministry Dr Muhammad Radzi Abu Hassan, chief executive of Pharco Corporation Dr. Sherine Helmy, regulatory affairs director at Pharmaniaga Sharifah Fauziyah Syed Mohthar, director of DNDi‘s Southeast Asia regional office Jean-Michel Piedagnel, and director of the Third World Network Chee Yoke Ling.
Noor Hisham said the focus of decentralisation and the ramping up of screening to find ‘missing’ patients by rolling out simpler diagnostic tests, will ensure that the country will be able to meet the World Health Organization’s (WHO) goal to eliminate the virus by 2030.
Panellists emphasised that this is the first time an affordable drug treatment that can fully cure and eliminate Hepatitis C in patients has been developed.
The drug was also developed through a South-South initiative, between Egyptian drug manufacturer Pharco Pharmaceuticals, and Malaysia through the health ministry and Pharmaniaga, with support from NGOs such as DNDi and Médecins Sans Frontières (MSF).
Panellists agreed that the previous first-line treatment, Daclatasvir used in combination with Sofosbuvir, was more expensive and less effective (86% efficacy).
Therefore, according to them, this new development will be able to address the lack of affordable treatment for the disease and shift away from the usual monopoly by Big Pharma and western countries on drug research and development.
The drug comes in the form of a 200mg Ravida tablet and is used in a combination with Sofosbuvir for a three-month course or more, depending on the severity of the patient. The combo-therapy costs RM410 for a three-month course.
Clinical trials sponsored by the ministries of health of Malaysia and Thailand among Hepatitis C patients in both countries showed a 97% efficacy in curing a non-cirrhotic liver and 96% for cirrhotic liver among 600 patients.
The virus can lead to chronic liver disease, cirrhosis, cancer, and death, affecting about 58 million people worldwide, with only about 13% having received treatment to date.
The disease causes around 300,000 deaths a year.