Mexico Authorizes Cabotegravir for HIV Prevention

The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has approved the use of cabotegravir, a long-acting injectable pre-exposure prophylaxis (PrEP) to prevent HIV infection. The treatment requires six injections a year, offering an alternative to the standard daily pill regimen.

According to COFEPRIS, the authorization was part of 210 health product approvals granted in July 2025, which included 28 medicines, 164 medical devices, and 18 clinical research protocols. Cabotegravir works by blocking the HIV integrase enzyme, preventing the virus from inserting its genetic material into human cells and establishing infection, reports Medline Plus It can be administered every two months by health professionals, often following an initial oral or monthly injection phase. The injectable is intended for people who test HIV-negative but are at high risk of exposure.

The decision follows evidence from two international trials. The HPTN 083 study, conducted with cisgender men, transgender women, and men who have sex with men, found that cabotegravir reduced HIV risk by about 70% compared with oral PrEP (emtricitabine/tenofovir). The HPTN 084 trial, conducted with cisgender women in sub-Saharan Africa, reported a 90% risk reduction.

Mexico records about 14,000 new HIV infections annually, according to UNAIDS. While oral PrEP is available in some public health institutions, its uptake is limited by barriers such as stigma, availability, and adherence challenges. A bimonthly injection could improve adherence, especially among groups facing difficulties with daily medication.

The approval aligns with global strategies recommended by the World Health Organization (WHO) to expand HIV prevention. In June, Mexico’s Ministry of Health launched the Red de Respuesta al VIH, a digital platform developed with civil society and international organizations to strengthen coordination toward the 2030 targets of eliminating HIV as a public health threat.

Cabotegravir differs from other long-acting injectables, such as lenacapavir, approved in the United States for HIV treatment rather than prevention. By targeting individuals without the virus, cabotegravir aims to reduce transmission rates and expand preventive coverage.

COFEPRIS’ July authorizations also included oncology treatments and clinical trials for diabetes and chronic kidney disease. The agency said these approvals reflect its commitment to ensuring the availability of medical products that meet quality, safety, and efficacy standards.