The Oswaldo Cruz Foundation (Fiocruz) has officially concluded the technology transfer process required to manufacture dolutegravir domestically. As the primary antiretroviral medication used in the treatment of HIV in Brazil, dolutegravir is distributed free of charge through the Unified Health System (SUS) to more than 770,000 people. The start of the supply of the domestically produced medication now depends solely on authorization from the National Health Surveillance Agency (Anvisa).
Nationalization of Production
The path to local production began in 2020, when a formal agreement was signed between the Institute of Technology in Drugs (Farmanguinhos/Fiocruz) and ViiV Healthcare, a company specializing in HIV research and treatment belonging to the biopharmaceutical firm GSK. The agreement aimed to gradually nationalize the production of the drug to ensure a steady supply for the public health network. To prepare for this transition, Farmanguinhos undertook extensive structural and operational improvements. These included:
- Adapting the factory floor and industrial plant.
- Acquiring new specialized equipment.
- Training professional staff.
- Structuring the necessary technical, regulatory, and operational processes.
Since 2022, while the technology transfer was underway, Farmanguinhos has been responsible for distributing dolutegravir to the SUS, utilizing supplies manufactured in GSK facilities. During this period, more than 739 million capsules were provided to the public network. By 2025, Farmanguinhos expanded its role to include laboratory quality control analyses for the medication. According to Fiocruz, three initial batches of the drug have already been produced and validated by the institute, awaiting only the final regulatory clearance from Anvisa for distribution.
Clinical Importance and Global Standards
Dolutegravir is recognized globally as a critical component in HIV treatment. It functions by blocking the integrase enzyme, which prevents the virus from replicating within the body’s defense cells. By reducing viral loads to undetectable levels, the medication strengthens the immune system and lowers the risk of progression to AIDS. Since 2019, the World Health Organization (WHO) has recommended dolutegravir as the preferred first- and second-line treatment for all populations living with HIV, including pregnant women and individuals with the potential to become pregnant. The drug is noted for its high efficacy, good tolerability, and low rate of side effects.
Future Expansion: Combination Therapy
The technology transfer agreement between Fiocruz and ViiV Healthcare extends beyond the standalone dolutegravir. The strategic plan includes the domestic production of dolutegravir in combination with lamivudine, another antiretroviral therapy provided by the SUS. Fiocruz has confirmed that it is currently working on the validation of the analytical methodology for the active pharmaceutical ingredient. The expectation is that the production of the combined version will begin in the coming year, further strengthening Brazil’s autonomy in supplying essential HIV medications and reducing reliance on imports.
Impact on the Brazilian Health System
By localizing the manufacturing process, Brazil aims to ensure the long-term sustainability of its HIV treatment program, which remains one of the most robust in the world. In addition to securing the supply chain, the initiative is expected to generate economic savings by reducing dependence on foreign sources and optimizing logistics for distribution across the country. Fiocruz continues to work on the final stages of validation to ensure that the medication produced locally meets the same rigorous international standards of quality and efficacy as those previously imported.
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