Gilead and Fiocruz sign agreement for HIV injection production in Brazil

Pharmaceutical company Gilead Sciences has signed a memorandum of understanding with Farmanguinhos, part of Fiocruz, to assess technology transfer and local production of lenacapavir, a semestral HIV prevention injection. The deal aims to lower costs and improve accessibility in Brazil, though it is not yet a formal commitment. Anvisa approved the drug on January 12, 2026.

Gilead Sciences announced the signing of a memorandum of understanding with Farmanguinhos, the Oswaldo Cruz Foundation's (Fiocruz) pharmaceutical technology institute, to explore cooperation options for producing lenacapavir in Brazil. The document, confirmed by Farmanguinhos, focuses on the potential technology transfer, which could reduce manufacturing costs and make the drug more accessible to the public health system.

Lenacapavir, approved by Anvisa on January 12, 2026, is an injection administered every six months for HIV prevention through PrEP (Pre-Exposure Prophylaxis). However, its high cost poses a barrier: in the United States, annual treatment ranges from US$25,300 (about R$136,000) to US$44,800 (R$241,000). A generic version could cost between US$25 and US$47 per year (R$135 to R$253), per a Lancet study, but Brazil was not authorized by Gilead to produce it, unlike 120 low-income countries.

The pharmaceutical company stresses that the memorandum does not formalize commitments, serving as a basis for discussions. Meanwhile, Gilead is collaborating on clinical studies in the country, donating free doses. The ImPrEP LEN Brazil project, led by Fiocruz, will test the drug in seven cities: São Paulo, Rio de Janeiro, Salvador, Florianópolis, Manaus, Campinas (SP), and Nova Iguaçu (RJ). The target group includes gay and bisexual men, non-binary people identified as male at birth, and transgender individuals aged 16 to 30 seeking PrEP voluntarily.

"Gilead is committed to developing an equitable and sustainable pricing strategy," the company stated. Incorporation into the SUS depends on Conitec and price regulation by CMED, underscoring challenges for universal access.

संबंधित लेख

Fiocruz has completed the technology transfer for dolutegravir, the main antiretroviral used in HIV treatment by Brazil's SUS. Large-scale production now depends on ANVISA registration.

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