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[HEALTH] · Mexico, Argentina, Brazil, United States · 20 sources

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Mexico authorizes lenacapavir for semiannual HIV prevention

Mexico's sanitary regulatory agency, Cofepris, has authorized the use of lenacapavir for HIV pre-exposure prophylaxis (PrEP). The medication, developed by Gilead Sciences, is a long-acting antiretroviral administered via subcutaneous injection twice per year.

This authorization follows clinical phase 3 trials, including PURPOSE 1, which reported zero new HIV infections among 2,134 participants, and PURPOSE 2, which recorded two infections. The semiannual dosing schedule offers a significant alternative to daily oral PrEP regimens, potentially improving adherence for individuals facing barriers such as stigma or limited healthcare access.

Additionally, the Pan American Health Organization (PAHO) announced a new access route for lenacapavir in Latin America and the Caribbean through its Regional Revolving Funds. This agreement with Gilead Sciences will allow 14 countries—including Argentina, Brazil, Chile, Colombia, Mexico, and others—to acquire the medication, complementing existing voluntary licensing agreements.

Entities

Cofepris · FDA · Gilead · Gilead Sciences · Mexico · Pan American Health Organization · World Health Organization · lenacapavir

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about 17 hours ago
about 16 hours ago