PETALING JAYA: Affordable Hepatitis C treatment will soon be available for patients once trials on generic drugs are completed.
The non-profit Drugs for Neglected Diseases initiative (DNDi), of which the Malaysian Health Ministry is a founding member, and Egyptian drug manufacturer Pharco Pharmaceuticals on Wednesday signed agreements covering clinical testing and scale-up of a Hepatitis C treatment regimen at a price of just under US$300 (RM1,166) at the International Liver Congress 2016 in Barcelona, Spain.
This is a fraction of the current US$40,000 treatment (RM155,442) using the original drug brand, according to a Health Ministry official.
Health Minister Datuk Seri Dr S. Subramaniam said that it had been almost impossible for governments to provide access to Hepatitis C treatment at the necessary scale because of the high prices of new medicines.
“We are pleased to support this project and hope data from these studies will support our efforts to introduce this combination as soon as possible and scale up to reach all patients in need,” he said in a press release by DNDi.
In a Phase III trial in Egypt carried out by Pharco, ravidasvir had shown cure rates of up to 100% in patients with genotype 4 Hepatitis C when used in combination with sofosbuvir.
In a separate press statement, Health director-general Datuk Dr Noor Hisham Abdullah said that clinical trials in Malaysia would begin in July at selected centres.
He said that DNDi and Clinical Research Malaysia had agreed on Jan 13 to carry out clinical trials for Hepatitis C treatment together with the Ministry.
"The collaboration between DNDi and the Ministry will cover Phase II and III clinical trials on combination therapy ravidasvir and sofosbuvir for Hepatitis C patients in Malaysia," he said.
Ravidasvir is inhibitor NS5A, one of the new generation direct-acting antivirals for Hepatitis C treatment.
Dr Hisham said the trials would register around 400 participants and would assess the efficacy, safety and pharmacokinetics of the sofosbuvir plus ravidasvir oral combination in patients with various levels of liver fibrosis, various genotypes, and with or without HIV co-infection.
"The early part of the trials is to assess the new Hepatitis C treatment regimen," he said.
He added that effective treatment was necessary in view of the growing number of Hepatitis C cases.
Hepatitis C infection in Malaysia is a clinical and social burden for the Government, he said.
Dr Hisham said in 2009, there were 453,700 cases of people living with Hepatitis C in Malaysia, with estimated disease burden as high as 2.5% to 2.3%.
The clinical trials will also be carried out in Thailand with the support of the government there.
