Studies of new generic $300 HepC combination of ravidasvir and sofosbuvir for low-income countries

Drugs for Neglected Diseases initiative (DNDi) issued a press statement at EASL 2016 about a new HCV combination that is entering studies for pan-genotypic HCV in Malaysia and Thailand.

DNDi and the Egyptian manufacturer Pharco Pharmaceuticals, are launching studies to compare sofosbuvir with ravidasvir compared to sofosbuvir plus daclatasvir. If effective, the new combination will be available at less than $300 for a standard course.

Ravidasvir is an NS5A inhibitor, one of a new generation of direct-acting antivirals (DAAs) that are revolutionizing the treatment of hepatitis C. In a Phase III clinical trial in Egypt, conducted by Pharco, ravidasvir showed cure rates of up to 100% in patients with genotype 4 when used in combination with sofosbuvir, which also is a DAA.

These studies will enrol approximately 1,000 participants and will evaluate the efficacy, safety, and pharmacokinetics of the sofosbuvir plus ravidasvir combination in patients with various levels of liver fibrosis, various genotypes, and with/without HIV co-infection.

Malaysia and Thailand are among the many middle-income countries that are excluded from the voluntary licensing agreements that Gilead and Bristol-Myers Squibb, the intellectual property holders of the hepatitis C drugs sofosbuvir and daclatasvir, respectively, have concluded with generic companies. Of the up to 150 million people infected with chronic hepatitis C globally, approximately 75% live in middle-income countries.

DNDi has licensed rights for ravidasvir in low- and middle-income countries from Presidio Pharmaceuticals.

DNDi press release. Drugs for Neglected Diseases initiative and Pharco Pharmaceuticals to test affordable hepatitis C regimen with support of Malaysian and Thai governments. (13 April 2016)