New route could widen twice-yearly HIV prevention access in 14 Latin American countries

Reuters and Folha de S.Paulo separately reported that the arrangement covers Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay and Venezuela. These countries were outside Gilead's earlier voluntary licences for generic manufacturers.

Lenacapavir is a pre-exposure prophylaxis, or PrEP, given by subcutaneous injection every six months to reduce the risk of acquiring HIV. Less frequent dosing may help people who find daily pills difficult, but it is not a vaccine and does not replace testing, clinical assessment or other prevention measures.

The announcement did not provide a common price, reserved volume or rollout date. Entry into national health systems will depend on whether governments use the PAHO procurement route and complete local regulatory, pricing and budget approvals.

In Brazil, lenacapavir has passed an important regulatory step, but public-system access still requires maximum-price and health-technology assessments. Reporting also stresses that HIV infection must be ruled out before each injection to reduce the risk of drug resistance.