Brazil to begin domestic production of key HIV medication
The Oswaldo Cruz Foundation (Fiocruz) has completed the technology transfer required to produce dolutegravir, the main HIV treatment drug in Brazil. The antiretroviral is distributed free of charge through the country’s public health care system, the SUS, and is currently used by more than 770,000 people living with HIV.
The drug was developed by ViiV Health care, a research company specializing in HIV prevention and treatment owned by biopharmaceutical company GSK. In 2020, the two companies signed an agreement with Fiocruz’s Institute of Drug Technology (Farmanguinhos) to gradually localize production and supply the drug to the SUS.
Since then, Farmanguinhos has invested in adapting its manufacturing plant, acquiring new equipment, training staff, and establishing the technical, regulatory, and operational infrastructure required to localize production. The process has now been completed, and supply to the SUS will begin once Brazil’s national drug regulator Anvisa approval is granted.
Since 2022, Farmanguinhos has been distributing medicines produced at GSK plants to the SUS. More than 739 million capsules have already been supplied to the public health system under the arrangement. In 2025, the institute also took over laboratory quality control testing for the medication.
The institute has already manufactured and validated three batches of the medication, which will be ready for distribution through the SUS once Anvisa grants approval. It is also working to validate the analytical methodology for the active pharmaceutical ingredient.
The technology transfer agreement includes another stage: the start of domestic production of dolutegravir combined with lamivudine, another substance. This formulation is also distributed through the SUS. Production is expected to begin at Farmanguinhos next year.
WHO-recommended HIV medication
Dolutegravir is one of the main medications used in HIV treatment worldwide. It works by inhibiting the integrase enzyme, preventing the virus from replicating inside the body’s immune cells. In addition to being highly effective - reducing viral load to undetectable levels - it helps restore immune function and prevent progression to AIDS, with few side effects.
In 2019, the World Health Organization (WHO) recommended the drug as the preferred option for first- and second-line treatment for all populations, including pregnant women and people who may become pregnant.
