Fiocruz signs agreement for the registration of a drug for hepatitis C at Anvisa

Fiocruz, through the Institute of Drug Technology (Farmanguinhos/Fiocruz), signed this Wednesday (7/19) a technical and scientific partnership agreement with the Drugs for Neglected Diseases Initiative (DNDi) and the Egyptian pharmaceutical company Pharco Pharmaceuticals to request the registration of the drug Ravidasvir, for the treatment of hepatitis C, at the National Health Surveillance Agency (Anvisa). The announcement is part of the national mobilization Yellow July (Law 14.613/23), a set of actions aimed at tackling viral hepatitis, focusing on awareness, prevention, assistance, protection and promotion of human rights. The agreement was signed at the Mourisco Castle, Fiocruz headquarters, by the vice president Marco Aurelio Krieger, in the exercise of the Presidency of Fiocruz; by the director of Farmanguinhos, Jorge Mendonça; by the regional executive director of the DNDi in Latin America, Sergio Sosa-Estani, and by the Corporate Business Development & Global HCV Access Director of Pharco Pharmaceutical, Yasser Fayed.

The signing of the agreement brought together representatives of Fiocruz, DNDi and Pharco Pharmaceutical at the Foundation (photo: Peter Ilicciev)

“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 treatments with no side effects and 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.

The partnership aims to make this drug available in Brazil at an affordable price that can be provided within the Unified Health System (SUS) for patients with the hepatitis C virus (HCV). Thus, Ravidasvir, combined with Sofosbuvir, may be part of the therapeutic options that make up the simplified treatment strategy for patients with hepatitis C in Brazil. Farmanguinhos already holds the registration for Sofosbuvir, and recently added the antiviral Daclatasvir to its development portfolio. With all the different antiviral options, the Institute reinforces its role as a supporter of the Economic-Industrial Health Complex (Ceis) and promoter of national independence in the treatment of hepatitis C.

According to the director of Farmanguinhos, Jorge Mendonça, hepatitis C was, for a long time, considered a neglected disease with few effective treatment options. However, nowadays, there are possibilities for a cure. “Providing a safe, effective and lower-cost treatment alternative strengthens the Economic-Industrial Health Complex and the SUS and, in particular, provides another option for the patient. It also stimulates South-South cooperation relations, as it will be an exchange of information and technologies between countries in these hemispheres, which certainly strengthens regional policies for other diseases. It is important to highlight the role of DNDi, in the induction and support for this project to come true. In 2023, Yellow July will have an important milestone regarding the care of patients with hepatitis C”.

The signed agreement is the first step towards submitting and obtaining registration of Ravidasvir with Anvisa. If approved, Farmanguinhos, with the technical support of the DNDi and Pharco, intends to apply before the National Commission for the Incorporation of Technologies in the Unified Health System (Conitec) to initiate the administrative process for the incorporation of Ravidasvir into the SUS. Only after the completion of all these steps, the Ministry of Health (MOH) will be able to demand its distribution to the population.

For the regional executive director of DNDi in Latin America, Sergio Sosa-Estani, “the partnership aims to develop an effective, easy-to-administer and low-cost drug for hepatitis C that allows increasing the access to treatment and reducing the financial burden on patients and the health system”.

“The affordable price of Ravidasvir will allow treating more patients in Brazil, and we hope that our strategic collaboration with Farmanguinhos and DNDI will be an excellent roadmap for the entire region”, says Yasser Fayed, Corporate Business Development & Global HCV Access Director at Pharco Pharmaceutical.

Ravidasvir is an innovative drug for the treatment of hepatitis C – inflammation of the liver caused by the HCV virus which, when chronic, can lead to cirrhosis, hepatic insufficiency and cancer. The drug was developed for combined use with Sofosbuvir. In 2016, DNDi and Pharco conducted a clinical trial in Malaysia and Thailand to test the combination of Ravidasvir and Sofosbuvir, which had cure rates of 97%, even for difficult-to-treat patients. The Sofosbuvir + Ravidasvir combination, in addition to having an affordable price, compares to the best therapies against hepatitis C available today, being an alternative to the treatments currently available in the country.

According to the Viral Hepatitis Epidemiological Bulletin, released by the Ministry of Health, in June 2022, 718,651 confirmed cases of viral hepatitis in Brazil were reported in the Notifiable Diseases Information System (Sinan) from 2000 to 2021. Of this total, 168,175 (23.4%) refer to cases of hepatitis A, 264,640 (36.8%) to hepatitis B, 279,872 (38.9%) to hepatitis C and 4,259 (0.6%) to hepatitis D.

To eliminate viral hepatitis, WHO proposes 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 infection by the HCV virus, regardless of the stage of the disease, preferably using drugs classified as pangenotypic: Sofosbuvir + Daclatasvir.

Farmanguinhos

Official pharmaceutical laboratory linked to the Ministry of Health, the Institute of Drug Technology (Farmanguinhos/Fiocruz), founded in 1976, is a technical-scientific unit of Fiocruz that distinctively fights for the reduction of drug costs, allowing the expansion of the access to public health programs for a greater number of people. For hepatitis, the Institute currently manufactures the drug Ribavirin and also has agreements in place to absorb the production technology for Sofosbuvir and Daclatasvir.

DNDi

The Drugs for Neglected Diseases (DNDi) initiative was created in 2003 by the Doctors Without Borders (MSF), Fiocruz, the Ministry of Health of Malaysia, the Pasteur Institute of France, among others. The organization is a non-profit Research and Development (R&D) entity that works to create new safe, effective, field-adapted and affordable treatments for neglected patients, in particular for Chagas disease, leishmaniasis, sleeping sickness, hepatitis C and dengue. DNDi's aim is to enable equitable access to HCV treatment through the development and registration of affordable, safe and effective pangenotypic direct-acting antivirals (DAAs) and the policy advocacy needed to remove barriers to access to DDAs globally.

Pharco Pharmaceuticals

Pharco Pharmaceuticals (Pharco), or its affiliate European Egyptian Pharmaceutical Industries (EEPI), is a pharmaceutical company headquartered in Alexandria, Egypt, whose mission is to provide safe and effective pharmaceuticals products that are affordable and available to all patients. It has been licensed by Presidio Pharmaceuticals with the rights 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 countries of the Soviet Union. The company also has a generic version of Sofosbuvir. Pharco has completed a phase 3 study of Ravidasvir in combination with Sofosbovir in patients with HCV genotype 4 in Egypt, with registration of Ravidasvir in the country.