New affordable hepatitis C combination treatment shows 97 percent cure rate

The sofosbuvir/ravidasvir combination treatment for hepatitis C has been shown to be safe and effective, with extremely high cure rates, according to interim results from the Phase II/III STORM-C-1 trial."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 programs," said Bernard Pécoul Executive Director, DNDi.

                                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.

                        Over 71 million people live with hepatitis C worldwide, a disease which causes 400,000 deaths a year. Although highly effective treatments have existed for a number of years, less than three million people are on treatment, with more people infected every year than are put on treatment. The World Health Organization aims for 80% of people diagnosed with HCV to be put on treatment by 2030.

                   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