The Drug Technology Institute (Farmanguinhos) with Oswaldo Cruz Foundation (Fiocruz) signed a technical and scientific cooperation agreement with the Drugs for Neglected Diseases initiative (DNDi) and Pharco Pharmaceuticals in Egypt to request the registration of ravidasvir, a hepatitis C treatment, with the Brazilian Health Regulatory Agency (Anvisa). This announcement is part of the national awareness campaign known as “Yellow July” (Law 14.613/23), which organizes several initiatives to fight viral hepatitis and focuses on awareness, prevention, assistance, protection, and promoting human rights.
The agreement was signed at Castelo Mourisco, Fiocruz headquarters in Manguinhos, State of Rio de Janeiro, by Vice President Marco Aurelio Krieger, who is currently acting as Fiocruz President; Farmanguinhos Director Jorge Mendonça; DNDi Latin America Director Dr Sergio Sosa-Estani; and Pharco Pharmaceuticals Corporate Business Development & Global HCV Access Director Yasser Fayed.
‘The case of hepatitis is exemplary from the point of view of how innovation can directly impact on improving people’s lives. In less than a decade, we managed to evolve to treatments without side effects and with a high degree of effectiveness. Today, we have taken an important step towards being able to offer, in the future, an innovative treatment at an even more affordable cost for the Unified Health System,’ explains the Vice President of Production and Innovation in Health, Marco Krieger.
This partnership is aimed at making this medication available and affordable in Brazil and have the Unified Health System (SUS) distribute it to patients who have the hepatitis C virus, or HCV. Ravidasvir would then be used in combination with sofosbuvir and become part of the therapeutic options that make up the simplified treatment strategy for hepatitis C patients in Brazil. Farmanguinhos has already registered sofosbuvir and, more recently, added daclatasvir, an antiviral, to its drug development portfolio. With different antiviral options, the Institute is emphasizing its support for the Industrial Economic Complex of Health (CEIS) and promoting the nationalization of hepatitis C treatments.
According to Farmanguinhos Director Jorge Mendonça, hepatitis C was long considered a neglected disease with very few treatment options that were seen as efficient. However, there are currently potential cures. ‘By making a safe, efficient, and low-cost alternative available, we will strengthen the Industrial Economic Complex of Health and the Unified Health System. Most importantly, yet another option will be made available to patients. Additionally, it drives South-South cooperation relations, since information and technologies will be exchanged between countries in the hemisphere, which will certainly strengthen regional policies for other diseases. It is important to highlight the role of DNDi in inducing and supporting the realization of this project. In 2023, Yellow July will make an important impact on the care of hepatitis C patients.’
Signing the agreement was the first step to submitting the request and obtaining the registration of ravidasvir with Anvisa. If the request is approved, Farmanguinhos will count on the technical support of DNDi and Pharco to later submit a request to the National Commission for the Incorporation of Technologies (CONITEC), thus initiating the administrative process to make ravidasvir available through SUS. It is only after the completion of all these steps, that the Ministry of Health (MS) will be able to demand its distribution to the population.
‘The objective of this partnership is to develop an effective, easy-to-administer, and low-cost drug for hepatitis C that will increase access to treatment and reduce the financial burden on patients and the health system,’ explains Dr Sergio Sosa-Estani, DNDi Latin America Director.
‘Having an affordable option in ravidasvir, we will be able to treat more patients in Brazil. We expect our strategic collaboration with Farmanguinhos and DNDi to be an excellent roadmap for the entire region,’ says Yasser Fayed, Corporate Business Development & Global HCV Access Director at Pharco Pharmaceutical.
This innovative drug treats hepatitis C, an inflammation of the liver caused by the HCV virus. The chronic stage of the disease may cause cirrhosis, liver failure, and cancer. The drug was developed for use in combination with sofosbuvir. In 2016, DNDi and Pharco conducted a clinical trial in Malaysia and Thailand to test the combined treatment of ravidasvir and sofosbuvir, which demonstrated cure rates of 97%, even for difficult-to-treat patients. The sofosbuvir + ravidasvir combination is comparable to the best hepatitis C therapies available today and it is also affordable, making it an alternative to treatments available in the country today.
Hepatitis C in Brazil
According to the Epidemiological Bulletin of Viral Hepatitis, released by the Ministry of Health in June 2022, 718,651 confirmed cases of viral hepatitis were reported in Brazil in the Notifiable Diseases Information System (Sinan) between 2000 to 2021. Of this total, 168,175 (23.4%) are hepatitis A cases, 264,640 (36.8%) are hepatitis B cases, 279,872 (38.9%) are hepatitis C cases, and 4,259 (0.6%) are hepatitis D cases.
The 2030 Agenda
In order to eliminate viral hepatitis, WHO proposes the goal of testing 90% of people with viral hepatitis C and treating 80% of people with HCV worldwide by 2030, with a reduction of new infections by 90% and mortality by 65%. The Organization also recommends treatment for all individuals diagnosed with HCV infection, regardless of the stage of the disease, preferably using drugs classified as pangenotypic: sofosbuvir + daclatasvir.
As the official pharmaceutical laboratory linked to the Ministry of Health in Brazil, the Drug Technology Institute (Farmanguinhos) with the Oswaldo Cruz Foundation Fiocruz) was founded in 1976 as a technical-scientific unit that stands out as an advocate to reduce drug costs and allow more people to access public health programs. As far as hepatitis treatments, the Institute currently manufactures the drug ribavirin and has agreements in place to absorb the production technology of sofosbuvir and daclatasvir.
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, river blindness, 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 twelve new treatments, saving millions of lives. dndi.org
About Pharco Pharmaceuticals
Pharco Pharmaceuticals (Pharco), or its affiliate European Egyptian Pharmaceutical Industries (EEPI), is a pharmaceutical company based in Alexandria, Egypt, whose mission is to provide safe and effective pharmaceutical products that are affordable and available to all patients. It has been licensed by Presidio Pharmaceuticals, with the right to manufacture, sell, export, import, and distribute ravidasvir in Egypt, the Middle East, and North African countries, including Gulf Cooperation Council countries and some of the former Soviet Union. The company also has a generic version of sofosbuvir. Pharco has completed a phase-3 study of ravidasvir in combination with sofosbuvir in patients with HCV genotype 4 in Egypt and registered ravidasvir in the country.
Marcela Dobarro – DNDi Latin America
+55 21 981149429