Forgetting to take a pill happens. Twice a week, for your vitamins? Not a big deal. But when it comes to HIV prevention, skipping just one dose can have more serious repercussions. For thirteen years, PrEP – this oral preventive treatment taken every day – has proven its effectiveness and saved millions of lives. But it requires unwavering discipline and remains difficult to access in many low-income countries. Of the tens of millions of people who could benefit from it, only six million take it regularly. Every year, 1.3 million more are infected.
The arrival of lenacapavir could change everything. This new drug, administered by injection twice a year, promises almost total protection against the virus. In clinical trials, it showed 100% effectiveness in women and around 96% in men, trans and non-binary people, a Vox article reveals.
Approved successively by the American FDA, the World Health Organization and the European Union in a few months, the drug benefits from unexpected political support: President Donald Trump. Washington plans to deploy the treatment in a dozen poor countries from 2026 – unprecedented speed for a drug of this type. But science is only half the equation. The other, more dangerous, plays out in the corridors of power.
For decades, HIV treatments targeted the virus’s enzymes – an effective but restrictive strategy. Lenacapavir attacks a completely new link: the conical shell of the virus, the capsid. Long considered “impregnable” by the scientific community, it finally gave in: the discovery opened the way to the first drug capable of blocking several stages of the HIV life cycle.
“It’s extraordinary – it’s the closest thing we have to a vaccine”enthuses Professor Megan Ranney, dean of the Yale School of Public Health. In a trial of young women in South Africa and Uganda, none of the participants who received the treatment contracted the virus. The study was even interrupted prematurely by the health authorities: continuing would have meant depriving some of the volunteers not receiving the treatment of a drug with obvious benefits.
Donald Trump gets involved
The injectable nature of lenacapavir reinforces its potential: in sub-Saharan Africa, injections are already the most common method of contraception. “It is a familiar and very well accepted practice”notes South African researcher Linda-Gail Bekker. But who will actually have access to this breakthrough?
This is where politics comes into play. PEPFAR – the US President’s Emergency Plan for the fight against AIDS, created by George W. Bush in 2003 – has long been praised for its results: it is estimated that it has saved more than 25 million lives. But at the start of the year, the return of Donald Trump to the White House upset this balance. By freezing international aid and paralyzing the United States Agency for International Development (USAID), the president has plunged the program into uncertainty.
Then, in a fundamentally Trumpian move, the American president made an about-face: last month, the White House announced it was relaunching PEPFAR, this time refocused on the distribution of lenacapavir. The stated priority: pregnant and breastfeeding women, in the name of the fight against mother-to-child transmission. A laudable objective on paper – two injections would be enough to protect the mother and the baby – but which arouses criticism from certain associations.
The most fragile left on the sidelines
“It’s an ideological choice, not a scientific one”deplores Asia Russell, of the HealthGAP organization. In the most affected African countries, these women represent only a small fraction of new cases. The main sources of infection are young women, gay men, trans people, sex workers and drug users – all at risk of being, once again, excluded from official programs.
Another change of course: the American government wants to exclude NGOs from distribution, entrusting the task to local health ministries. An attractive idea in Washington, but which demonstrates a total ignorance of the reality on the ground. The history of HIV shows that we do not fight against stigma from the institutions that produce it. In many countries, sexual minorities, marginalized women and drug users are rightly suspicious of these public structures.
“People just don’t come”notes Linda-Gail Bekker. Community centers and LGBTQ+ clinics have proven their effectiveness precisely because they offer a safe and adapted space for these audiences.
Behind this political soap opera, another actor is pulling the strings: Gilead Sciences, the Californian laboratory which developed lenacapavir. In September, the company promised to sell the treatment “at no profit” to PEPFAR and to share the license with six generic manufacturers. A rare – and strategic – gesture. Generic versions could be sold in 120 low- or middle-income countries, potentially from 2027, at around 40 dollars (around 34 euros) per person per year (compared to more than 28,000 dollars in the United States, or 24,000 euros).
But Gilead Sciences retains its exclusive rights for “profitable” markets, such as Brazil or Argentina, where HIV is on the rise again and where public budgets remain limited. “These licenses divide the world into low-value areas, left to generics, and lucrative markets that Gilead keeps under control”explains Tahir Amin, patent lawyer at the I‑MAK organization.
Foundations and international donors – Gates, Unitaid, Clinton Health Access Initiative – support the rapid deployment of generics. If all goes as planned, lenacapavir could cost as little as existing PrEP, while being much simpler to use.
But an innovation only makes sense if it reaches those who need it most, in places where they feel safe. As is often the case in global health, science has already done its part; It is now up to politicians and industrialists to bear a heavy responsibility: the end of HIV… or yet another missed opportunity.