A ministry can know the name of the drug, the dose, and the trial, and still have nothing to send the warehouse. Twice-yearly lenacapavir for PrEP has been stuck in that gap across much of Latin America: present in the conversation, absent from the purchase order. The open question was not another point of efficacy. It was whether a public buyer could put the injection on a line the treasury would pay.
On 15 September 2026 the Pan American Health Organization announced an agreement with Gilead so that 14 countries can buy twice-yearly lenacapavir for PrEP through PAHO's Regional Revolving Funds. Every order still has to clear that country's own regulatory and programmatic processes. Read the note as a purchasing path. It does not create a voluntary license, and it does not approve the drug anywhere it was not already approved. WHO had already recommended lenacapavir in 2025 as an additional form of PrEP, after trials showing almost 100% efficacy, on a twice-yearly schedule. That recommendation is older than this agreement. What was missing was a way to buy.
Latin America and the Caribbean see about 140,000 new HIV infections a year. An injection given twice a year moves that number only when the doses can be ordered, stored, and offered to people who will come back for the second shot. PAHO Director Dr. Jarbas Barbosa put the condition in one sentence: "Today, the Americas have increasingly effective tools to prevent HIV, but these innovations will have an impact only if they reach the people who need them."
| Region | Countries |
|---|---|
| South America | Argentina, Brazil, Chile, Colombia, Ecuador, Paraguay, Peru, Uruguay, Venezuela |
| Mexico and Central America | Costa Rica, El Salvador, Guatemala, Mexico, Panama |
Those fourteen names are the purchasing list. The release speaks of Latin America and the Caribbean; the countries it names as buyers are the ones in the table. Voluntary licenses already cover 24 countries in the region, inside a global framework of 120. A license says who may manufacture. A revolving fund says who can pay on terms a ministry can actually use. A country can sit inside a license and still have no door through which to place the order. The 15 September agreement is that door, and it complements the licenses rather than replacing them. The prevention line on this site already holds PURPOSE 1, PURPOSE 2, and the 2025 approval of Yeztugo. Those results are not what changed.
Gilead will also advance a technology-transfer process in Brazil, aimed at future local production. No timeline was set. What a purchasing office can do now is buy the product that already exists. Johanna Mercier, at Gilead, said: "The agreement between Gilead and PAHO reflects our shared commitment to help countries move as quickly as possible from scientific innovation to real-world access to HIV prevention and public health impact."
The next day, 16 September 2026, Gilead published a second fact that does not belong in the same sentence. Royalty-free voluntary licenses were expanded to an investigational once-yearly form of lenacapavir, covering 120 countries, while the Phase 3 trial PURPOSE 365 is still running. No regulator has approved once-yearly lenacapavir. It is not the twice-yearly injection the fourteen countries can now try to procure. One item is a purchase national authorities may consider. The other is a candidate that has not left its trial.
None of the fourteen is obliged to order, and the announcement does not show that any order has been placed. Regulators, budgets, and the work of finding people twice a year remain national. The window that opened on 15 September is a way to buy. It is not a shipment, and it is not evidence that new infections in the region have begun to fall.
Sources
PAHO, 15 September 2026: agreement with Gilead so 14 countries can buy twice-yearly lenacapavir for PrEP through the Regional Revolving Funds, subject to national regulatory and programmatic processes. Gilead, 16 September 2026: royalty-free voluntary licenses extended to investigational once-yearly lenacapavir, 120 countries, while Phase 3 PURPOSE 365 continues; that product is not approved. WHO recommendation of lenacapavir as additional PrEP, 2025.