- New treatment combination for hepatitis C virus (HCV) is an additional affordable option for millions still waiting for access to lifesaving treatments in middle-income countries
- Combination is safe and effective, including for hard-to-treat cases and people with HCV and HIV
- New drug ravidasvir is the first HCV drug to be developed through South-South collaboration and with support from non-profit organizations
The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has granted a conditional registration for a safe, effective hepatitis C treatment developed by a public-private partnership bringing together the Malaysian Ministry of Health, not-for-profit research and development organization Drugs for Neglected Diseases initiative (DNDi), Egyptian pharmaceutical company Pharco, Malaysian pharmaceutical company Pharmaniaga Berhad, and non-governmental-organization Médecins Sans Frontières/Doctors Without Borders (MSF).
This is the very first drug for HCV to be developed through South-South collaboration and with funding and clinical support from non-profit organizations.
This partnership was formed to address one of the more intractable public health challenges of the past decade: the lack of access to affordable direct-acting antivirals (DAAs), a newer generation of powerful HCV treatments that can cure patients in three to six months. HCV, which can lead to chronic liver disease, cirrhosis, cancer, and death, affects about 58 million people worldwide, but only about 13% have received treatment to date. The disease causes around 300,000 deaths a year.
‘Although hepatitis can be cured, there is a vicious circle that stands in the way of providing treatment to all in need: the disease is mostly a ‘silent killer’, the diagnostic process is complex, so people go unfound, and DAAs are often too expensive,‘ said Tan Sri Dato’ Seri Dr Noor Hisham Abdullah, Director General of Health, Ministry of Health, Malaysia. ‘Malaysia decided to act to break this vicious circle. We are actively screening to find ‘missing’ patients, rolling out simpler diagnostic tests, and ensuring we have access to the best prices for treatments, including by conducting clinical research to identify additional affordable treatment options. Today’s announcement is a milestone on Malaysia’s long journey to achieve the World Health Organization goal of eliminating hepatitis C by 2030.’
The approval on 4 June concerns a new drug, ravidasvir, for the treatment of chronic HCV infection in adults in combination with other medicinal products. Ravidasvir was developed by the partnership for use with sofosbuvir, an existing DAA, as an affordable, simple, and efficacious public health tool.
DNDi and partners conducted STORM-C-1, an open-label clinical trial to assess the efficacy, safety, and pharmacokinetics of ravidasvir combined with sofosbuvir in Malaysia and Thailand. The study was sponsored by the Ministries of Health of Malaysia and Thailand, and DNDi. In results published in April 2021 in The Lancet Gastroenterology & Hepatology, the combination showed cure rates of 97% and was well tolerated in a diverse adult population with chronic HCV infection. This included people infected with genotype 3 of the virus, which is particularly hard to treat. No clinically significant drug-drug interactions with the antiretrovirals commonly used to treat HIV were found, which will make this new combination particularly useful to clinicians.
‘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. It is a concrete example of how research and development can deliver innovation driven by public health needs, rather than market imperatives,’ said Dr Bernard Pécoul, Executive Director of DNDi.
Ravidasvir is an oral NS5A inhibitor discovered and owned by Presidio Pharmaceuticals. It was licensed to Egyptian drug manufacturer Pharco Pharmaceuticals and DNDi for clinical development and commercialization. In an earlier Phase III clinical trial in Egypt conducted by Pharco, ravidasvir + sofosbuvir showed cure rates of up to 100% in patients with genotype 4. Pharco and DNDi partnered with Malaysian drug manufacturer Pharmaniaga for the registration and supply of ravidasvir in Malaysia and South-East Asia.
‘This new treatment will be a powerful tool in our arsenal to make the vision of a hepatitis C-free world a reality,‘ said Dr Sherine Helmy, CEO of Pharco Pharmaceuticals. ‘This is why this new combination will be sold at an affordable price between USD 300-500 for a 12-week treatment course.‘
‘NPRA approval is a huge milestone for all parties who have been working tirelessly to make a safe, effective, accessible and, most importantly, affordable treatment for hepatitis C in Malaysia,‘ said Datuk Zulkarnain Mohamed Eusope, Pharmaniaga Group Managing Director. ‘This is a first for us at Pharmaniaga, a generics company, being involved in the development of a new chemical entity. We thank the NPRA for their continuous support, and for prioritizing the approval, obtained within 15 months, compared to standard timelines of two years or more. We hope this latest development will increase options and facilitate access for the public to obtain a more affordable treatment for HCV.‘
The STORM-C project was financed by MSF’s Transformational Investment Capacity initiative, with the objective of increasing access to treatment for HCV patients in low- and middle-income countries.
‘Hundreds of thousands of people die each year from the consequences of hepatitis C and expanding the access to cure is a medical humanitarian imperative,‘ said Pierre Mendiharat, Deputy Operations Director for MSF. ‘HCV affects vulnerable and often marginalized populations including people who use drugs and people co-infected with HIV. To eliminate HCV, we need easy-to-use, simple, and affordable treatments that work, like the ravidasvir + sofosbuvir combination.‘
Plans to register the new ravidasvir + sofosbuvir combination are advancing in other countries, including in Latin America.
‘Our goal is now to help foster the political will and financing needed for wide-scale roll-out of lifesaving testing and treatment for hepatitis C globally,‘ said Dr Bernard Pécoul. ‘The Malaysian example is a showcase of what can be done with the right will, the right partners, and the right tools.‘
A not-for-profit research and development organization, DNDi works to deliver new treatments for neglected patients, those living with Chagas disease, sleeping sickness (human African trypanosomiasis), leishmaniasis, filarial infections, mycetoma, paediatric HIV, and hepatitis C. DNDi is also coordinating the ANTICOV clinical trial to find treatments for mild-to-moderate COVID-19 in Africa. Since its inception in 2003, DNDi has delivered eight new treatments to date, including new drug combinations for kala-azar, two fixed-dose antimalarials, and DNDi’s first successfully developed new chemical entity, fexinidazole, approved in 2018 for the treatment of both stages of sleeping sickness. dndi.org
About Pharmaniaga Berhad
Pharmaniaga is the leading pharmaceutical company of Boustead Holdings Berhad Group of Companies, which together with the Armed Forces Fund Board, are the major shareholders of the Company. Listed on the Main Board of Bursa Malaysia, Pharmaniaga’s core businesses are generic pharmaceuticals manufacturing; research and development; marketing and sales; warehousing and distribution of pharmaceutical and medical products; supply, trading and installation of medical and hospital equipment as well as community pharmacy. With a vision to be the premier Malaysian pharmaceutical company, Pharmaniaga is guided by its philosophy of ‘Do It Right Always’ and is empowered by its motto of Passion for Patients. Strengthened by nine manufacturing plants, nationwide logistics and distribution in Malaysia and Indonesia as well as products registered in 15 countries, Pharmaniaga Group is positioned to be a regional player in the international pharmaceutical arena. www.pharmaniaga.com
Pharco Pharmaceuticals, Inc. is the largest manufacturer of pharmaceuticals in Egypt, focused on research, formulation, manufacturing and commercialization of pharmaceutical products in the MENA region. Today, Pharco employs over 8,000 employees, and has over 650M product sales units—ranking as the leader in the Egyptian pharmaceutical market. Pharco also exports to 47 countries around the world. Pharco works towards one goal: to provide highly effective and safe pharmaceutical products to patients at an affordable price. Pharco licensed ravidasvir hydrochloride, formerly known as (PPI-668), from Presidio Pharmaceuticals, a San Francisco-based clinical stage, specialty pharmaceutical company. www.pharco.org
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Photo credit: Abang Amirrul Hadi – DNDi