RIO DE JANEIRO – News that an antiretroviral drug injected twice a year had prevented almost all HIV infection in trials electrified the HIV sector two years ago – but access to Gilead’s lenacapavir has been slow, particularly for countries in Latin America.

Brazil, which faces significant HIV transmission in certain groups, has been routinely excluded from HIV voluntary licensing deals offered by pharmaceutical companies – particularly for long-acting pre-exposure prophylaxis (PrEP)

Brazilian Health Minister Dr Alexandre Padilha told the International AIDS Conference being hosted in his country that negotiations with Gilead had run aground as the company wanted a price 10 times higher than that being paid by Indonesia and Thailand.

“Innovation without access is injustice,” said Padilha at the conference opening.

Instead of pursuing lenacapavir, his country has opted to use ViiV’s cabotegravir, injected every second month, to bolster its PrEP programme as the company has offered Brazil “an acceptable price”, Padilha added.

ViiV and the Medicines Patent Pool (MPP) signed a voluntary licensing agreement to enable generic manufacturers to make generic versions of long-acting cabotegravir for PrEP for 90 countries – but excluding most Latin American countries.

Long-acting antiretroviral medicine to prevent HIV offers the biggest global opportunity to control the virus that has long evaded a vaccine.

Almost 830,000 Brazilians living with HIV, but Brazil is regarded as an upper-middle-income country and is is routinely excluded from lower prices and affordable generics.

HIV cases continue to increase in some key populations, showing the urgency of their leading role in demanding affordable access to injectable PrEP across South America.

Pressure on Gilead

Last month, Médecins sans Frontières (MSF) launched a campaign to demand that the US-based Gilead “immediately make the highly effective HIV prevention medicine lenacapavir more widely available across the globe”.

The six-monthly injection is particularly important for groups most at risk of HIV, including “men who have sex with men, transgender people, sex workers, people who inject drugs, and incarcerated people, as well as those in conflict and other fragile humanitarian contexts”, said MSF.

While Gilead signed voluntary licensing deals in October 2024 with six pharmaceutical manufacturers to make and sell generic lenacapavir, it sells the medicine for $28,000 a year in the US.

Gilead’s Jared Baeten told a media briefing on Tuesday that the medicine was being rolled out in 10 African countries and that 600,000 people would be using lenacapavir by the end of this year.

However, activists from Brazil, Argentina and Peru have staged several protests against Gilead at the AIDS conference, pointing out that their countries have been part of the clinical trial of lenacapavir and should have access to the product.

Baeten said all trial participants had access to lenacapavir, and this would only stop once they could access it in their countries.

Merck takes a different approach

Merck/ MSD, which is currently testing a monthly pill, alimatravir, as PrEP, has taken an innovative approach to ensure access to its yet-to-be-proven medicine.

Last week, it announced that it had granted voluntary licenses to seven generic companies – three in sub-Saharan Africa and four in India – to produce the medicine for 129 low- and middle-income countries.

“The royalty-free agreements with these companies cover both the public and private sectors and will enable supply of generic alimatravir in 129 LMICs that account for a substantial majority of new HIV diagnoses globally,” the company announced.

Once again, Latin America was excluded – until Tuesday morning, when Merck/ MSD announced that it had signed a memorandum of understanding (MOU) with the Brazilian government’s Oswaldo Cruz Foundation (Fiocruz) to ensure access to alimatravir should the trial be successful.

Fiocruz is the Brazilian government’s biomedical research and medicine production agency. 

Merck/ MSD’s Dr Eliav Barr told a media briefing on Tuesday that the two parties would start to negotiate the terms of access, adding that Fiocruz could produce alimatravir for the Latin American region.

“We are trying to reach agreements now to avoid limited supply at launch,” said Barr, adding that his company was also preparing regulatory submissions if alimatravir proves effective at the conclusion of its phase 3 trial in the second half of 2027.

Image Credits: Márcia Moreira / IAS..