Affordable HIV prevention injection approved, but access gaps remain

The first generic version of a twice-yearly HIV prevention injection has received tentative approval from the US Food and Drug Administration, raising hopes that the treatment could become widely available at a substantially lower price.

Lenacapavir is a long-acting form of pre-exposure prophylaxis, or PrEP, for people at risk of acquiring HIV. Clinical trials found it was almost completely effective at preventing new infections, while its six-monthly dosing could help people who find taking a daily tablet difficult or face stigma around HIV prevention.

The generic injection, developed by Dr Reddy’s Laboratories, is expected to cost approximately $40 per person each year in 120 low- and middle-income countries covered by a voluntary licence from manufacturer Gilead Sciences. Initial supplies could arrive in some countries before the end of 2026, with wider availability anticipated during 2027.

However, Médecins Sans Frontières has warned that 26 low- and middle-income countries remain outside the licensing agreement and therefore may not obtain the generic product at the agreed price. The excluded territories include countries experiencing growing HIV epidemics, particularly in Latin America. The branded medicine has a US list price exceeding $28,000 per year.

A separate arrangement with the Pan American Health Organization has created a procurement route for 14 Latin American and Caribbean countries excluded from the generic licence, including Brazil, Mexico, Colombia and Argentina. Access will still depend on national approvals, purchasing decisions, funding and available supplies.

The approval is therefore a significant regulatory milestone rather than a guarantee of immediate access. Global health organisations are calling for licensing and supply arrangements to be expanded so that where a person lives does not determine whether they can obtain one of the most promising advances in HIV prevention.

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