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:

  • Conduct Phase II/III clinical trials to evaluate the efficacy of a ravidasvir + sofosbuvir combination

 

 

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 hepatitis C than get treated every year.

Although new safe and highly efficacious direct-acting antivirals (DAAs) have been available for several years, access to affordable hepatitis C 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.

Ravidasvir was developed by the US biopharmaceutical company Presidio and identified by DNDi. In 2016, Presidio, DNDi, and the Egyptian generic manufacturer Pharco signed a licence agreement to secure supplies of ravidasvir and of 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, in combination with sofosbuvir, for people living with hepatitis C.

 

Interim results published in April 2018 showed that 12 weeks after the end 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 December 2018 in Malaysia and in Thailand in May 2019. Other trials are envisioned in other parts of the world, for vulnerable patient groups, such as people who use drugs.

Registration of ravidasvir will be pursued in Malaysia and other middle-income countries, including in in Argentina, with DNDi’s pharmaceutical partners Pharmaniaga and Elea Phoenix, respectively.

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 hepatitis C diagnosis and treatment. As a part of the project, decentralized screening for hepatitis C will be initiated in Malaysia, and people who screen positive and are subsequently confirmed to have hepatitis C 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.

DNDi signed a technology transfer agreement with Pharco (Egypt) and Pharmaniaga in late 2017.

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: August 2019