R&D Portfolio Update February 2019: DNDi Hepatitis C programme

 

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.
  • Increased access to affordable treatments by supporting policy change and encouraging political will to treat HCV.
  • Innovative programmes to improve access to HCV diagnosis and treatment in a variety of countries.

 

HCV patient standing in the streetDNDi’s current HCV portfolio includes:

 

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 the drug candidate ravidasvir combination with sofosbuvir in patients 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).

    Initial results published in April 2018 showed that after 12 weeks of treatment, 97% of the 301 patients enrolled were cured (95% CI: 94.4- 98.6). Cure rates were very high even for the hardest-to-treat patients. Importantly, patients combining several risk factors were cured, and no unexpected safety signals were detected.

    To further establish the pan-genotypic profile of ravidasvir, the second stage of the trial was launched in late 2018 in Malaysia, and will soon start in Thailand, with other trials envisioned in other parts of the world (for genotypes 2 and 5) and Ukraine (for vulnerable patient groups, including people who use drugs). Registration of ravidasvir will be pursued in Malaysia and other middle-income countries, including in Latin America.

    In July 2018, DNDi and FIND announced a partnership, in collaboration with the Ministry of Health in Malaysia, to generate evidence to support policy change and scale up HCV diagnosis and treatment. As a part of the project, decentralized screening for HCV will be initiated in Malaysia, and people who screen positive and are subsequently confirmed to have HCV are linked to DAA treatment in government hospitals or, on a voluntary basis/if they consent, as part of a DNDi clinical trial.

    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.

    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 actually be eliminated globally, as planned by WHO. 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.

 

 

 

Photo credit: Bobby Tan-DNDi