Conduct Phase II/III clinical trials to evaluate the efficacy of a ravidasvir + sofosbuvir combination
current phase of drug development
updated 27 Jul 2023
An affordable cure to leave no one behind
First hepatitis C drug to be developed through South-South collaboration
Hepatitis C is one of very few diseases that could be eliminated globally with tools that exist today, provided there is political will to do so. The World Health Organization (WHO) has set a goal to eliminate viral hepatitis as a major public health threat by 2030, but only about one in five people living with hepatitis C today are aware that they are infected, and only 13% have had access to treatment. Roughly as many people are newly infected each year as receive treatment.
Although new safe and highly efficacious direct-acting antivirals (DAAs) have been available since 2013, access to affordable hepatitis C treatment remains extremely limited in many low- and middle-income countries. Securing widespread access to affordable combinations of DAAs that are optimised for public health is a critical step towards reversing this epidemic.
In 2016, DNDi signed agreements with US biopharmaceutical company Presidio Pharmaceuticals, developer of the DAA drug candidate ravidasvir, and its licensing partner, the Egyptian generic manufacturer Pharco Pharmaceuticals, to enable testing of a new combination treatment using ravidasvir and sofosbuvir.
That same year, 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 ravidasvir + sofosbuvir regimens. The trial was co-sponsored by the Malaysian and Thai Ministries of Health and co-financed by the Médecins Sans Frontières (Doctors Without Borders, or MSF) Transformational Investment Capacity (TIC) initiative.
Final results of the first stage of the study published in The Lancet Gastroenterology & Hepatology in April 2021 showed that 12 weeks after the end of treatment, 97% of participants were cured. 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.
In June 2021, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia granted a conditional registration for ravidasvir. In 2022, ravidasvir was officially launched in Malaysia, with the first patient treated with the combination of ravidasvir + sofosbuvir. Ravidasvir was included in the National Essential Medicines List (NEML), Ministry of Health Medicines Formulary (MOHMF), and WHO’s Essential Medicines List in 2023, and was recommended as one of the alternative treatments for HIV/HCV co-infected patients in the Malaysian Consensus Guidelines on Antiretroviral Therapy 2022.
DNDi and FIND have also partnered on a project in collaboration with the Ministry of Health in Malaysia to generate evidence to support policy change and scale-up of hepatitis C diagnosis and treatment. During the period 2021-2022, DNDi contributed as a supporting partner for a study on HCV self-testing, one of the first studies in the world to assess the impact of home-based HCV self-testing on the uptake of HCV antibody testing.
- Granted conditional registration by the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia in June 2021
- Added to the National Essential Medicines List (NEML), Ministry of Health Medicines Formulary (MOHMF), and WHO’s Essential Medicines List in 2023
- Submission in Brazil is underway
‘I had to wait and wait for years, but was eventually offered the ravidasvir + sofosbuvir combination treatment. I took the treatment for 3 months and my illness is no longer there.’
Huang Siang Ping, Farmer
‘The development of this new drug is the result of a partnership between public and private actors sharing the same public health objective from the very start: the development of an affordable medicine.’
Dr Bernard Pécoul, Founder, DNDi
News & resources
- 5 August 2023 - WHO lists Malaysian-developed hepatitis C drug as essential medicine, Free Malaysia Today
- 20 July 2023 - Fiocruz signs agreement to register hepatitis C medication with Brazilian health regulatory agency
- 19 July 2023 - Fiocruz assina acordo para registro de medicamento para hepatite C, O Globo
- 20 October 2021 - Ravidasvir: equitable access through an alternative drug development pathway, The Lancet Global Health
- 23 June 2021 - A new milestone in hepatitis C treatment, BFM
- 17 June 2021 - The story of a ‘political drug’ against hepatitis C, Geneva Solutions
- 16 June 2021 - The story of a ‘political drug’ against hepatitis C, Geneva Solutions
- 15 June 2021 - L’histoire d’un «médicament politique» contre l’hépatite C, Heidi News
- 14 June 2021 - Le Ravidasvir, nouveau médicament contre l’hépatite C, approuvé en Malaisie, RFI
- 14 June 2021 - Public-private partnerships can accelerate the end of hepatitis C
- 14 June 2021 - Desarrollan un nuevo fármaco “seguro, eficaz y asequible” para la hepatitis C, Europa Press
- 14 June 2021 - First hepatitis C treatment developed through South-South cooperation registered in Malaysia
- 14 June 2021 - Waiting for the Cure
- 14 June 2021 - The STORM-C-1 trial
- 15 April 2021 - Efficacy and safety of ravidasvir plus sofosbuvir in patients with chronic hepatitis C infection without cirrhosis or with compensated cirrhosis (STORM-C-1): interim analysis of a two-stage, open-label, multicentre, single arm, phase 2/3 trial, The Lancet Gastroenterology and Hepatology
- 25 June 2020 - Hépatite C : le prix des médicaments compromet l’élimination mondiale de la maladie, VIH Hépatites virales Santé sexuelle AFRAVIH
- 25 November 2019 - Efforts to register new hepatitis C treatment in Malaysia receive support from Pharmaniaga
- 9 January 2019 - Accelerating the elimination of viral hepatitis: a Lancet Gastroenterology & Hepatology Commission, The Lancet Gastroenterology & Hepatology
- 23 July 2018 - FIND and DNDi team up to support Malaysian MOH efforts to simplify and decentralize hepatitis C screening & treatment
- 16 April 2018 - Treatment advocate tactics to expand access to antiviral therapy for HIV and viral hepatitis C in low- to high-income settings: making sure no one is left behind, Journal of the International Aids Society
- 12 April 2018 - New affordable hepatitis C combination treatment shows 97% cure rate
- 5 March 2018 - Pharmaceutical companies and non-profits team up to provide affordable hepatitis C treatment in Latin America
- 13 April 2016 - Drugs for Neglected Diseases initiative and Pharco Pharmaceuticals to test affordable hepatitis C regimen with support of Malaysian and Thai governments
- Final results presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2022
- September 2021 – Systems thinking analyses for health policy and systems development: A Malaysian case study
- Find the Missing Millions: Malaysia’s experience with nationwide hepatitis C screening campaign in the general population. Journal of Viral Hepatitis, January 2020.
- Comment on: “Projections of the Healthcare Costs and Disease Burden due to Hepatitis C Infection Under Different Treatment Policies in Malaysia, 2018–2040”. Applied Health Economics and Health Policy, December 2019.
- Initial results presented at the International Liver Congress 2018
Get our latest news, personal stories, research articles, and job opportunities.