Drugmaker Gilead Sciences and the Pan American Health Organization (PAHO) announced on Tuesday (15) an agreement that creates a new purchasing route for lenacapavir, an injectable medicine given twice a year to prevent HIV, for countries in Latin America and the Caribbean. Brazil is among the 14 countries in the region that could benefit, according to Folha de S.Paulo. Purchases would run through PAHO's Regional Revolving Funds, the organization's pooled procurement mechanism.
The deal creates the possibility of purchase, not immediate delivery. The announcement released on Tuesday did not disclose a price, a volume reserved for Brazil or a supply schedule, and each government must decide whether to join. The route matters mainly for the 14 countries left out of the voluntary licensing agreements Gilead signed with generic drugmakers, among them Argentina, Chile, Colombia, Ecuador, Mexico, Peru, Uruguay and Venezuela, besides Brazil. Without a voluntary license, those governments depend on direct negotiations with the company.
Where Brazil stands
In Brazil, the product, sold as Sunlenca, has already cleared one regulatory hurdle. In January, Anvisa, the national health regulator, approved it as PrEP (pre-exposure prophylaxis, medicine used to prevent HIV infection) for adults and adolescents aged 12 and over who weigh at least 35 kg. Sales still depend on CMED, the government body that sets maximum drug prices. Before it can reach the SUS, the public health system, the medicine must be assessed by Conitec, the commission that reviews new health technologies, and approved by the Health Ministry. In July, the ministry tried to negotiate a direct purchase with Gilead and failed. The company says that despite the PAHO deal it intends to continue negotiations with the Brazilian government.
What lenacapavir offers
Lenacapavir is approved in several countries as PrEP to reduce the risk of sexual HIV transmission in adults and adolescents at risk of acquiring the virus, and also, combined with other antiretrovirals, as part of treatment for multidrug-resistant HIV in adults, according to Gilead itself. The practical advantage is frequency: two injections a year instead of the daily pills of oral PrEP. The company says the drug acts at multiple stages of the virus life cycle, unlike most antivirals, and that a once-a-year version is being studied in clinical trials.
PAHO director Jarbas Barbosa assessed the agreement in a statement carried by the EuropaPress agency. "The Americas now have increasingly effective tools to prevent HIV, but these innovations will only have an impact if they reach the people who need them," he said. "This initiative is an important step to narrow gaps in access to lenacapavir, expand prevention options available to countries and move toward HIV elimination." Johanna Mercier, Gilead's chief commercial and corporate affairs officer, said the deal reflects a shared commitment to help countries move "as quickly as possible from scientific innovation to real access to HIV prevention."
For readers, the practical guidance is simple: the twice-yearly shot is neither on sale nor available through the SUS, and there is no date for that to change. Prevention today remains oral PrEP, daily tablets distributed free of charge by the public system. The agreement changes how purchases could be made; getting the medicine to clinics still depends on pricing, a Conitec review and a decision by the Health Ministry.