Hepatitis CDevelopment

 

  • Target disease: Hepatitis C
  • Main partners (since project start): Associated Medical Sciences/PHPT International Research Unit, Thailand; Clinical Research Malaysia, Ministry of Health, Malaysia; Doppel Pharma, Italy; Fundación Mundo Sano, Argentina; Hospital Kuala Lumpur, Malaysia; Hospitals of Geneva, Switzerland; Insud Pharma, Argentina; Laboratorio ELEA PHOENIX, Argentina; Médecins Sans Frontières, Ukraine; Ministry of Health and Ministry of Industry, Science and Technology, Thailand; Pharco Pharmaceuticals, Inc, Egypt; Pharmaniaga, Malaysia; Presidio Pharmaceuticals, Inc, USA.
  • Project start: 2016
  • Funding (since project start): Bill & Melinda Gates Foundation; Department for International Development (DFID), UK; Médecins Sans Frontières/Doctors without Borders, International; MSF Transformational Investment Capacity (MSF-TIC); The Starr International Foundation, Switzerland.

 

Overall Objective:

  • Advocate for better access to HCV treatments globally, through the development and registration of ravidasvir, an affordable, safe and efficacious pan-genotypic direct-acting antiviral (DAA), in selected countries.

 

 

Hepatitis C is one of a very few diseases which could be eliminated globally with the tools that exist today, provided there is a political will to do so. WHO has a goal to eliminate viral hepatitis as a major public health threat by 2030, yet, today, more people get infected by HCV than get treated every year.

Although new safe and highly efficacious direct-acting antivirals (DAAs) have been available for several years, access to affordable HCV treatment remains extremely limited in many developing countries. Securing wider access to DAAs will be necessary to develop a public health approach to the disease and put this growing epidemic into reverse.

DNDi’s Phase II/III study in Malaysia and Thailand aims to develop an affordable alternative to existing treatments. The study seeks to establish the efficacy, safety, tolerability, pharmacokinetics, and acceptability of a regimen containing the drug candidate ravidasvir, supplied by Egyptian manufacturer Pharco, in combination with sofosbuvir.  The trial results will be used for regulatory submission in selected countries.

 

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 injecting drug users). 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.

All 301 patients in DNDi’s Phase II/III trial combining ravidasvir and sofosbuvir in Malaysia and Thailand have completed treatment. Top-line results are being analysed and will be published in April 2018.

At the end of 2016, six study sites in Malaysia had recruited 164 patients (out of a target of 300) and four sites in Thailand had been initiated, with the full cooperation of the Ministries of Health in these countries. Sites in additional countries including Vietnam should be initiated in the coming months.


Last update: February 2019