pharmafileApril 13, 2018
Tag: hepatitis C
A partnership of the not-for-profit organisation Drugs for Neglected Diseases initiative (DNDi) and Egyptian drug firm Pharco Pharmaceuticals is working to bring a new, effective and affordable combination therapy to patients with hepatitis C (HCV).
The combo is comprised of Gilead’s Sovaldi (sofosbuvir) and a new oral NS5A inhibitor, ravidasvir. As revealed in results from a Malaysian Ministry of Health-sponsored Phase 2/3 trial of the combination, it is very effective in the treatment of even traditionally resistant cases of the disease. In the trial, 301 participants with chronic hepatitis C infection were divided into two groups: those with liver cirrhosis and those with compensated cirrhosis, treating them with the combo for 12 weeks in the former and 24 weeks in the latter. 42% of participants had HCV genotype 1, while 53% had genotype 3. According to internationally-defined standards for HCV treatments, by 12 weeks following the completion of treatment, around 96-97% across both groups were cured, including patients infected with genotype 3 and those who had been exposed to previous HCV treatments.
In Egypt, where the virus is more common than anywhere in the world, affecting 7% of citizens between 15 and 59, the combo was trialled in 300 participants and because of different genetic characteristics, it proved 100% effective.
"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," remarked Bernard Pécoul Executive Director of the DNDi.
While current treatments on the market can cost as much as $84,000 in the case of Sovaldi, Pharco and the DNDi’s combination, however, has a target price of just $300 for 12 weeks of treatment in Malaysia, where the trial was conducted as well as in Thailand.
Trials are ongoing in South Africa and Ukraine in the hopes of tackling all six of the virus’ genotypes. The combination is forecast to be made available in Malaysia within two years, whilst deals have also been signed in Latin America to sell it at an initial price of $500, to be brought down to $300 over time.
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