R&D Portfolio Update March 2018: DNDi Hepatitis C programme

 

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DNDi aims to deliver:

  • A safe, effective, and easy-to-use direct-acting antiviral regimen, to be used as an affordable combination paving the way for a public health approach to HCV.

 

DNDi’s current HCV portfolio includes:

Male hep C patient discussing with medical staff

 

Development

Development

One project in the development phase:

 

  • Ravidasvir/sofosbuvir:In 2016, DNDi launched a Phase II/III study in Malaysia and Thailand to assess the efficacy, safety, tolerability, pharmacokinetics, and acceptability of 12- and 24-week regimens containing sofosbuvir in combination with the drug candidate ravidasvir in participants infected with HCV. A total of 301 patients were included: 220 in Malaysia and 81 in Thailand. Patients were included regardless of HIV co-infection status, as were patients with compensated liver disease with or without cirrhosis (for the latter group, treatment duration was 24 weeks).

    The trial assessed the regimen’s efficacy against genotypes 1, 2, 3, and 6, with data for genotype 4 already available from an earlier Egyptian study. Results will be published in April 2018. To further establish the pan-genotypic profile of ravidasvir, further data will be collected in Malaysia and Thailand, and other trials are envisioned in South Africa (for genotype 5) and Ukraine (for vulnerable patient groups, including injecting drug users). Registration of ravidasvir will be pursued in Malaysia and other middle-income countries, including in Latin America.

    The widespread use of affordable, safe and effective direct-acting antivirals would enable a public health approach to the epidemic: if people are diagnosed and treated early enough to avoid infecting others, the disease could be eliminated. Yet relatively few patients have access to diagnosis and treatment, notably due to expensive treatment prices. An affordable pan-genotypic combination would benefit many patients, particularly in countries that are excluded from licensing agreements that enable access to generic HCV treatments, and in which generic competition is not sufficiently robust to bring prices down.

    DNDi‘s HCV programme includes work with Médecins Sans Frontières (Doctors Without Borders) to develop and implement simpler models of care in specific target populations as well as in large-scale treatment cohorts in Cambodia and Ukraine. The objective is to demonstrate that the challenges posed by HCV can be addressed through a public health approach.

 

 

 

 

 

Photo credit: Suriyan Tanasri – DNDi