Over 71 million people suffer from hepatitis worldwide which is responsible for causing 400,000 deaths in a year. World Health Organization aims to put 80% of the people infected with hepatitis, on treatment by 2030.A group of researchers conducted a Phase II/III STORM-C-1 to evaluate the relevance of sofosbuvir/ravidasvir drug combination for treatment of Hepatitis and concluded that a combination is an affordable option for treatment of Hepatitis with success rate of 97 percent. This trial was presented by an organization Drugs for Neglected Diseases initiative (DNDi) at the International Liver Conference 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 Datuk Dr Noor Hisham Abdullah Director General of Health, Ministry of Health, Malaysia. In September 2017, the government of Malaysia issued a “government-use” license on sofosbuvir patents to allow 400,000 people living with hepatitis C in Malaysia to access generic HCV regimens in public hospitals.
DNDi conducted the STORM-C-1 open-label trial to assess the efficacy, safety, tolerance, and pharmacokinetics of the drug candidate ravidasvir combined with sofosbuvir. 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. In accordance with international standards defining cure for HCV treatments, 12 weeks after treatment completion, 97% of those enrolled were cured (95% CI: 94.4-98.6). Cure rates were very high even for the hardest-to-treat patients: people with liver cirrhosis (96% cured), people living with HIV using their usual treatment (97%), people infected with genotype 3 (97%) including those with cirrhosis (96%), and people who had been exposed to previous HCV treatments (96%). Importantly, patients combining several of these risk factors were cured, and no unexpected safety signals were detected.
“From a treatment provider perspective, this is very exciting as we have been waiting for a simple, affordable, robust treatment tolerated by all patients groups, including those whose treatment outcomes are currently poorer, like patients under antiretroviral therapy,” said Pierre Mendiharat, Deputy Operations Director for Médecins Sans Frontières / Doctors Without Borders (MSF). “This will be crucial to expanding treatment to the most vulnerable categories of patients in developing countries.”MSF and DNDi are working together to increase access to care and treatment for HCV patients in key low- and middle-income countries, through the STORM-C project financed by MSF’s Transformational Investment Capacity (TIC) initiative.
Ravidasvir is an oral NS5A inhibitor licensed to DNDi by Presidio Pharmaceuticals. Most people enrolled in the DNDi trial in Malaysia and Thailand had genotype 1 (42% of participants) or genotype 3 (53%), thereby confirming the combination’s effectiveness for those two additional genotypes. Further trials are planned to document the efficacy and safety of the combination in patients infected with the other HCV genotypes and in particularly vulnerable groups, to enable a public health approach to the treatment of hepatitis C.
“Pharco is proud to enable a public health approach to hepatitis C treatment by providing affordable treatments. We look forward to future collaboration in additional clinical trials to confirm the safety and efficacy of ravidasvir,” said Dr. Sherine Helmy, CEO, Pharco.