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An affordable hepatitis C combination treatment including the new drug candidate ravidasvir has been shown to be safe and effective, with extremely high cure rates for patients, including hard-to-treat cases, according to interim results from the Phase II/III STORM-C-1 trial presented by Drugs for Neglected Diseases initiative (DND i ) at the International Liver Conference in Paris.
Sofosbuvir/ravidasvir combination is comparable to hepatitis C therapies available today. The trial using medicines produced by Egyptian drug manufacturer Pharco Pharmaceuticals was run by DNDi and co-sponsored by the Malaysian Ministry of Health, in ten sites in Malaysia and Thailand. 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.
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 in 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.
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