Thailand’s Food and Drug Administration (FDA) has approved ravidasvir as a safe and effective treatment against hepatitis C following clinical trials conducted in Thailand and Malaysia. Ravidasvir is approved for use in combination with another antiviral called sofosbuvir. The oral combination treatment is taken once daily for 12 weeks.
The combination of ravidasvir and sofosbuvir—two direct-acting antivirals—was shown in clinical studies to be safe and effective, including in hard-to-treat cases and among people living with both hepatitis C and HIV. With this approval, Thailand becomes the third country—after Malaysia and Egypt in 2021—to register ravidasvir.
‘This approval is a significant step that will help expand treatment options for people living with hepatitis C in Thailand and strengthen the country’s path toward eliminating this deadly viral disease,’ said Dr Graciela Diap, HCV Project Leader at DNDi. ‘This registration opens the door to better access to life-saving treatments for the tens of thousands of Thais living with the disease, more supply security, and also better prevention of treatment resistance.’
In Thailand, an estimated 350,000 people are living with chronic hepatitis C infection. About 50 million people worldwide are living with the virus, according to the World Health Organization. Around 1 million new infections and more than 240,000 deaths, mostly due to cirrhosis and liver cancer, occur each year.
In June 2025, DNDi, Egypt’s Pharco Pharmaceuticals, and Thailand’s Government Pharmaceutical Organization (GPO) signed a memorandum of understanding to support the introduction of ravidasvir into the Thai market.
‘Ravidasvir’s registration is positive news for Thailand’s progress toward hepatitis C elimination; it will ultimately help to save lives and reduce healthcare costs,’ said Assoc. Prof. Surakit Nathisuwan, Dean of the Faculty of Pharmacy at Mahidol University, Thailand.
‘I commend GPO for its leadership and commitment to expanding access to ravidasvir in Thailand. I also thank the Thai FDA’s Medicines Regulation Division and all reviewers for their support in securing regulatory approval. My sincere appreciation goes to the investigators, regulators, and patients involved in the clinical trials, whose contributions made this registration possible,’ he added.
Ravidasvir is the outcome of a unique model of South-South collaboration. Its development brought together research institutions and industrial partners from low- and middle-income countries, united to address a shared public health need and develop an alternative, safe, effective, and affordable hepatitis C treatment regimen for their populations.
This effort started in 2016, when the high cost of the first direct-acting antiviral treatments placed a significant burden on the national health budgets of Thailand and many low- and middle-income countries.
Ravidasvir’s development was driven by Pharco Pharmaceuticals, the Ministry of Health Malaysia, the Ministry of Public Health Thailand, and DNDi. The clinical trial in Thailand was conducted in collaboration with the Faculty of Medicine of Chulalongkorn University, Chiang Mai University, and the Ministry of Public Health.
‘Ravidasvir represents an important addition to the global effort to eliminate hepatitis C,’ said Dr Sherine Helmy, CEO of Pharco Pharmaceuticals. ‘If you don’t look, you won’t see. We are grateful to everyone who made this possible, working to leave no patient behind. Together with our partners, we hope it will help bring effective treatment to more patients and move us closer to a hepatitis C-free world.’
Treatment with direct-acting antivirals can cure hepatitis C and help stop transmission. However, because the infection often remains symptomless for years, proactive national efforts are needed to expand screening, identify everyone living with the disease, and ensure access to treatment. Increasing access to treatment is therefore critical to advancing hepatitis C elimination.
Data from Thailand’s Ministry of Public Health show that the country has already screened 1.83 million people for hepatitis C, with continued nationwide screening planned to reach a target of 42 million people by 2030.
‘GPO is pleased that this new drug is now successfully registered in Thailand—an important step in expanding treatment options for people living with hepatitis C. This will help strengthen the treatment landscape and support Thailand’s progress toward elimination, while we continue to improve nationwide access to affordable care,’ said Dr Mingkwan Suphannaphong, Managing Director of GPO.
DNDi and its partners are also planning to register ravidasvir in additional Latin American countries.
The development of ravidasvir was supported by funding from Médecins Sans Frontières International; Médecins sans Frontières International-Transformational Investment Capacity (MSF-TIC); UK International Development, UK; Ministry of Health, Malaysia; FIND, the global alliance for diagnostics (financed by Unitaid); National Science and Technology Development Agency (NSTDA), Ministry of Science and Technology, Thailand; Starr International Foundation, Switzerland; Fondation ARPE, Switzerland; Pharmaniaga Berhad, Malaysia; Swiss Agency for Development and Cooperation (SDC), Switzerland; and other anonymous individuals and organizations.
About The Government Pharmaceutical Organization (GPO)
The Government Pharmaceutical Organization (GPO) is a Thai state enterprise under the Ministry of Public Health, dedicated to strengthening medicine security and public health. GPO manufactures and distributes a wide range of essential medicines—including antiretrovirals and preventive treatments. Committed to affordability and quality, GPO also exports to countries such as Cambodia, Laos, Myanmar, Malaysia, Singapore, Bangladesh, Nigeria, and Hong Kong.
About Pharco Pharmaceuticals (Egypt)
Founded in 1984 and based in Alexandria, Egypt, Pharco Pharmaceuticals is a leading private company developing, producing, and marketing over 450 pharmaceutical products, including generics and licensed drugs. With exports to over 50 countries and scientific offices across the Middle East, North Africa, and Europe, Pharco specializes in antibiotics, soft gelatin capsules, and Penicillin production. The company is committed to improving global access to safe, effective, and affordable healthcare solutions.
About DNDi
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit medical research organization that discovers, develops, and delivers safe, effective, and affordable treatments for neglected people. DNDi is developing medicines for sleeping sickness, leishmaniasis, Chagas disease, parasitic worm diseases, mycetoma, dengue, paediatric HIV, advanced HIV disease, cryptococcal meningitis, and hepatitis C. Its research priorities include children’s health, gender equity and gender-responsive R&D, and diseases impacted by climate change. Since its creation in 2003, DNDi has joined with public and private partners across the globe to deliver 14 new treatments, saving millions of lives. dndi.org
Media contact
Baralee Meesukh (Bangkok, Thailand)
+66 81 921 6462
bmeesukh@dndi.org
Kanyakumari Damodaran (Kuala Lumpur, Malaysia)
+60 16 749 8047
kdamodaran@dndi.org
Frédéric Ojardias (Geneva, Switzerland)
+41 79 431 62 16
fojardias@dndi.org
Photo credit: Suriyan Tanasri-DNDi
