DNDi plans to enable the use of DAAs as a public health tool to treat HCV. A public health approach for resource-limited settings will be taken, including simplified models of care that allow for decentralization to the primary healthcare level, task shifting of clinical and non-clinical services, and reduced dependence on genotyping and other sophisticated lab monitoring.

DNDi is proposing a two-step project with a focus on:

  1. Regional research & development (R&D): In the medium term, DNDi and partners will conduct Phase III clinical trials in Malaysia, Thailand, and other countries to test the efficacy of a combination of sofosbuvir (SOF, already registered for HCV) + ravidasvir (RDV, a promising drug candidate) as a pan-genotypic treatment and public health for tackling the HCV epidemic.
  2. Support affordable access: An actively engaged Advisory Group has been created to advise the project on the rapidly-changing HCV treatment access There are many avenues for access, including but not limited to: developing alternative treatments with favourable licensing/access terms, patent oppositions, compulsory licensing, and voluntary licensing. Multi-stakeholder projects will be piloted in key countries.

 

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.

 

 

Hepatitis C R&D StrategyAn alternative Research and Development Strategy to Deliver Affordable Treatments for Hepatitis C Patients

The Drugs for Neglected Diseases initiative’s hepatitis C drug development strategy based on patient needs, not profits

 

[1] Esmat, G., El Raziky, M, Gomaa, A., Tamer, E, Abouelkhair, MM, Sabry, A, El Deen, HG, Ashour, MK, Abdel-Hamid, M, Nada, O, Helmy, S, Abdel-Maguid, H, Colonno, R, Brown, N, Ruby, E, Vig, P, Imam Waked, I. High Virologic Response Rate in Egyptian HCV-Geno- type 4 Patients Treated with Ravidasvir (PPI-668) and Sofosbuvir: Results of a Large Multicenter Phase 3 Registrational Trial. AASLD Liver Meeting. San Francisco, November 13-17, 2015. Abstract LB-4.