KUALA LUMPUR: In another milestone for Malaysia, a new affordable Hepatitis C combination treatment of which clinical trials have been held in the country, has shown not only a high 97% cure rate but also better efficacy of treating the most severe form of Hepatitis.
The treatment, which uses the new drug candidate ravidasvir (in combination with a generic version of sofosbuvir) has been shown to be safe and effective, with extremely high cure rates for patients, according to interim results from the Phase II/III STORM-C-1 trial.
The results were presented by the non-profit research and development organisation Drugs for Neglected Diseases initiative (DNDi) at the five-day International Liver Conference currently on in Paris.
“As Hepatitis C has become a major public health concern in Malaysia, it is crucial to increase access to treatment for the benefit of the nation,” said Health director-general Datuk Dr Noor Hisham Abdullah in a press release issued by the DNDi yesterday.
Last September, The Star reported that the Government had notably issued a “government-use” licence on sofosbuvir patents to allow 400,000 people living with Hepatitis C in Malaysia to access generic Hepatitis C regimens in public hospitals.
While the Government has gone on to buy the sofosbuvir-daclatasvir generic drug combination, the new combination announced by DNDi will be able to treat Genotype 3 Hepatitis C. This means that the new combination could be another option for patients or replace the sofosbuvir-daclatasvir combination.
When contacted, Dr Noor Hisham said while the sofosbuvir+ravidasvir generic combination could treat all six genotypes, it also provides better outcomes for Genotype 3, compared with sofosbuvir+daclatasvir generic combination.
“The results indicate that the sofosbuvir/ravidasvir combination is comparable to the very best Hepatitis C therapies available today but it is priced affordably and could allow an alternative option in countries excluded from pharmaceutical company access programmes,” said DNDi executive director Dr Bernard Pecoul.
The trial using medicines produced by Egyptian drug manufacturer Pharco Pharmaceuticals was run by DNDi and co-sponsored by the Malaysian Health Ministry. The clinical trials were conducted in Malaysia and Thailand.
For the trials, 301 chronically infected adults were treated with the ravidasvir/sofosbuvir combination for 12 weeks for patients without cirrhosis of the liver, and for 24 weeks for those with compensated cirrhosis.
When the 12 weeks was up, 97% of those enrolled were cured. Cure rates were very high even for the hardest-to-treat patient.
Dr Noor Hisham said the drug combination is expected to be made available to public hospitals by year end.
Over 71 million people worldwide live with Hepatitis C, a disease which causes 400,000 deaths a year. Despite the availability of highly effective treatments, fewer than three million people are on treatment.
The World Health Organisation targets 80% of people diagnosed with the Hepatitis C virus to be put on treatment by 2030.