MSF is calling on Gilead to sell lenacapavir directly to MSF and other organisations that are ready and able to purchase it. MSF wants access to additional supply outside the capped amount available through Gilead’s agreement with the Global Fund so that more people, particularly those in humanitarian settings, can benefit from this groundbreaking HIV prevention tool.

Lenacapavir is a twice-yearly injectable HIV prevention tool and one of the most promising advances in the effort to reduce new HIV infections. It has been proven to be highly effective in preventing HIV in cisgender women (100% effective - PURPOSE 1 study) and in gender-diverse people (96% effective - PURPOSE 2 study). Its long-acting formulation makes it especially valuable for people who face barriers to daily or frequent medication, such as those in the humanitarian settings in which MSF operates

MSF works with key populations who have high HIV risk and face major challenges in accessing healthcare services, including sex workers, men who have sex with men, and transgender communities. MSF also works in settings affected by conflict, displacement, and fragile health systems, where access to daily HIV prevention medicines can be extremely difficult. Long-acting HIV prevention tools like lenacapavir, which only need to be administered once every six months, could be life-changing, offering sustained protection from HIV in situations where other prevention options are simply not feasible.

MSF aims to introduce lenacapavir in a range of countries with high HIV burden and clear unmet prevention needs, including Eswatini, Kenya, Zimbabwe, Honduras, Malawi, Mozambique, Democratic Republic of Congo (DRC), Central African Republic (CAR), Haiti and Ethiopia. This includes several humanitarian settings, where prevention options remain particularly limited. We are also exploring opportunities in additional countries in Latin America that are currently excluded from licensing agreements, such as Brazil.

At this stage, only a very limited number of countries have received lenacapavir, with MSF currently implementing it in Eswatini and Kenya.
In several underserved settings—including DRC, CAR and Ethiopia—there are currently no plans for access to lenacapavir. MSF is actively seeking access in these countries, as well as in countries excluded from licensing agreements. In Latin America and the Caribbean (LAC), only Honduras and Haiti are expected to receive small quantities of lenacapavir, while no supplies are currently planned for most countries across the region that are excluded from Gilead’s restrictive license. It is particularly concerning that some of these countries—not only in LAC but across regions—face increasing HIV burden and, in some cases, participated in lenacapavir clinical trials, yet are now left without access, raising serious ethical questions and highlighting significant gaps in equitable access.

Additional doses of this groundbreaking HIV prevention tool are a welcome development. The more lenacapavir available to people at risk, the better.  However, while this figure seems large, it is dwarfed by the demand, and therefore insufficient. It is also unable to reach everyone who needs it, as it is geographically restricted.

By the time this amount of doses is spread over multiple years, split between countries and then divided among facilities, only a handful more doses are likely to reach each clinic or point of distribution. The UNAIDS target for PrEP was set at 21.2 million people by 2025. We have seen how quickly countries are running short of lenacapavir – the Eswatini government has commented on this – and the WHO has also highlighted how the demand is outstripping supply. The need for lenacapavir is so great that the ambition of the response needs to ramp up exponentially.

Beyond that, key countries with rising HIV incidences (Brazil and Mexico are excluded altogether. For those people, this is zero increase on an allocation of nothing.

Unfortunately, the negotiations never reached the stage of defining the number of doses, as Gilead point-blank refused to consider a direct sale to MSF. We explored a range of possible explanations, including those around volume. We asked for a minimum volume for a purchase order, and they would not respond to that. In terms of the scale of purchase MSF represents to Gilead: we are a significant enough purchaser that an order would be worth their while to fulfil, but we are not so large that we would meaningfully take away from Gilead’s global supply planning. The quantities we would request would be negligible relative to Gilead’s overall production volume, but critical for those in need.

We want to be clear: this is not a disagreement about price. During our discussions, Gilead itself acknowledged that generic prices for lenacapavir are expected to fall below the US$40 per person per year announced by generic manufacturers – a striking admission that the cost of production for this drug is low. At the same time, Gilead said it would not be able to offer us the prices that generics announced (US$40) or those reportedly available through the Global Fund (approximately US$100, though the exact terms are secret).

MSF made clear that we understood this. We asked Gilead what price they would be prepared to offer. However, the negotiations never reached that stage: Gilead did not present any price because it was not willing to supply us at all.
It would not be responsible for MSF to speculate on a potential price of lenacapavir in the absence of an offer. That said, past experience shows that outcomes in such negotiations can vary significantly:

• In some cases, MSF has been able to access so-called humanitarian prices (there is no standard definition for what a humanitarian price is, but it varies from a 0% markup to whatever profit margin a company deems “humanitarian”.)
• In other cases, MSF is forced to pay high prices. Take, for example, sofosbuvir, a drug sold by Gilead for hepatitis C treatment. In 2015, MSF began procuring sofosbuvir and daclatasvir from Gilead and BMS through their “access programmes” at prices of US$1,400 to US$1,800 per 12-week treatment course. When quality-assured generics became available, our costs dropped to around US$120 – less than a tenth of the original price. This example helps dispel the notion that MSF is only willing to pay rock-bottom prices; in reality, we have paid very high prices in the past, including to Gilead.
• In the longer term, many countries have told us that, for lenacapavir to be a viable and scalable prevention option, pricing will need to be broadly comparable to that of oral PrEP.

Yes. MSF has negotiated to receive a limited number of doses (70) for its programme in Eswatini through the Ministry of Health. These doses have been procured by the MOH through the Global Fund. At the time of writing, after just 4 weeks of implementation, MSF has already gone through all of its allocated supply. MSF is actively working to negotiate access to doses procured through the Global Fund in a number of other countries, but overall supply is currently limited.

Despite multiple requests over several months, Gilead has refused to sell lenacapavir directly to MSF, even in limited quantities for humanitarian programmes. Gilead has suggested the only route whereby MSF can obtain lenacapavir is through the capped amount allocated to the Global Fund.

The Global Fund supply is:

• 
  Capped: The Global Fund and PEPFAR have negotiated with Gilead to make lenacapavir available to 3 million people, over three years, in a limited number of countries before generics become available.
• Insufficient: 3 million people is well below the estimated global demand for lenacapavir to meet global need. UNAIDS set a target of 21,2 million people on PrEP by 2025 to significantly reduce new HIV infections, making this allocation 14% of the global need
• Not all countries where MSF works are eligible to receive this supply: These initial doses are only available in a subset of countries. MSF would not be able to supply lenacapavir in the Central African Republic, Ethiopia, or Brazil, for example.
• Over-stretched supply: The World Health Organisation has already warned that demand is exceeding supply. This is reflected in MSF’s experiences on the ground and in statements made by the Ministry of Health in Eswatini. 
  Every dose MSF receives from this limited pool is a dose taken away from another programme, which is why MSF is requesting additional supply outside the Global Fund’s cap. MSF is willing to purchase its own supply of lenacapavir from Gilead to avoid further stretching the Global Fund.

Gilead has cited three main arguments:

• Global Fund responsibility: Gilead framed the restricted supply as the Global Fund’s allocation decision, rather than acknowledging that Gilead itself set the supply cap and restrictive terms.
• The expected arrival of generic versions around 2027: Gilead has entered into voluntary licensing agreements with six generic manufacturers to produce generic forms of lenacapavir. These generics are projected to be available by 2027.  Gilead pointed to the voluntary license despite knowing its own licensing agreements prohibit generics in more than two dozen countries with rising HIV infections. This also ignores the fact that the timeline for the availability of generics is not guaranteed, but merely projected. From MSF’s point of view, there is no time to waste and no acceptable reason why additional supply cannot be made available to patients before generics come online.
• Administrative workload: Gilead suggested negotiating additional contracts would be “a lot of work” and take months.
   

Because:

• MSF is a willing buyer, and we are prepared to purchase additional supplies to deliver to people at risk now, as Gilead already does for high-income countries.
• MSF is attempting to secure supplies for some of the most vulnerable and at-risk communities; access cannot wait.
• The current supply cap is a choice made by Gilead, not by the Global Fund.
• Deferring responsibility to future generics leaves many countries with no plan for access in 2026, and others without any plan for access at all.
• Administrative complexity is not a valid justification when people’s health is at stake.

Yes. In November 2025, Gilead’s CEO publicly stated:
“If it needs more and we can implement more, we can produce more.”
MSF is simply asking Gilead to act on this stated capability. 
 

• People in humanitarian and conflict settings at increased risk of HIV
• Communities in low and middle-income countries, particularly those with high HIV incidence
• Key populations, including (but not limited to)
• Men who have sex with men
• Transgender individuals
• Sex workers

These are communities experiencing high HIV risk and significant structural barriers to prevention. They are also communities that have demonstrated high demand for long-acting injectable PrEP options, such as lenacapavir. Disruptions and cuts to international health funding in 2025 hit these communities especially hard. 

 
 

No. MSF expects to purchase lenacapavir at a transparent, fair price. The request is solely for the ability to buy additional supplies outside the capped Global Fund allocation.
 

Because:

• Restricting supply during the critical early years of rollout slows prevention efforts, meaning many more needless HIV infections will take place.
• Many countries cannot access the medicine at all until 2027—and even then, some will be excluded by Gilead’s licensing terms.
• The slow pace and limited scope of rollout fall far short of global need, and many of the people most in need of this ground-breaking innovation are the ones being excluded. 

MSF hopes that Gilead will remove the geographic restrictions from its voluntary licensing agreements with generic companies, increase its supply of lenacapavir to match demand, offer a fair price to everyone and sell lenacapavir to MSF directly.
 

The development of lenacapavir relied on decades of foundational public funding, primarily from the National Institutes of Health (NIH), which mapped the atomic structure of the HIV capsid that the drug targets. Publicly funded researchers at academic institutions conducted the early science and worked directly with Gilead to validate the drug’s mechanism of action using taxpayer-funded equipment and personnel. Gilead significantly lowered its development costs by using the publicly funded HIV Prevention Trials Network (HPTN) to run critical Phase 2 clinical studies in hard-to-reach populations. The U.S. government also provided valuable financial incentives through the Orphan Drug Designation, which offered Gilead millions in tax credits and waived expensive regulatory application fees. Public health donors further de-risked the commercial market by committing to large-scale purchases and funding the technical setup for generic manufacturers. Additionally, the drug’s clinical success was made possible through the essential participation of communities in several middle-income countries during the PURPOSE-2 trials.
 

• It is not acceptable to wait for generics to come online because:
  People need the drug now.  Delaying supply while waiting for additional supply to become available risks people’s health and lives.
• The timeline for generics to become available and the rapidity with which they will be able to produce supply at scale, is not guaranteed. Already, there have been delays in the regulatory approval of the Indian generic manufacturers as they have been asked to produce clinical trial data for local populations.
• Generics will not be available everywhere, and countries excluded from Gilead’s generic voluntary license will face high prices and further delayed access.
• HIV isn’t waiting – why is Gilead?
   

Gilead suggests that the results of its discussions with civil society were that it requested four priorities: “delivering long-acting PrEP with speed, at sufficient volume to meet demand, at prices that enable widespread availability and in coordination with partners on the ground.” They are clearly failing on this front. In terms of the actual amounts that were requested. These were negotiated, behind closed doors, with the Global Fund and seem to have been determined by the amount of funding available and the price Gilead was willing to offer, since they bear no resemblance to the epidemiological need, nor what countries have requested. If these discussions were held in the spirit of wide consultation, there would be no need for the secrecy that has prevailed.