Lenacapavir: Revolution in PrEP or ethical dilemma?

Two doses per year could reshape HIV prevention, but price and licensing issues may limit scalability within the Brazilian public health system (SUS).

The “quasi-vaccine” developed by Gilead Sciences arrives in Brazil with rare clinical evidence and global regulatory endorsement. But the geopolitics of voluntary licenses and the pricing logic in rich markets create a dilemma: how to remunerate innovation without turning prevention into a luxury incompatible with universality?

On January 12, 2026, ANVISA approved a new indication for lenacapavir (Sunlenca - Gilead Sciences) for pre-exposure prophylaxis (PrEP) against HIV, in a six-month schedule. What seems like just a regulatory advance is, in practice, a sign of a step change: two applications per year have the potential to reduce classic adherence frictions, expand coverage, and reorganize the preventive response, especially in populations at higher risk.

The problem is that the technology entered through one door and found another locked. Brazil remains outside the group of 120 countries covered by voluntary royalty-free licenses supported by international coalitions for the production/supply of generic drugs in markets defined as having limited resources and high incidence.

It is within this friction that the ethical dilemma arises, deserving analysis without slogans: what pricing and access architecture is defensible when the product is preventative, has a high population impact, and is directly connected to the global ambition of ending AIDS as a public health threat by 2030?

What makes lenacapavir different: efficacy, adhesion, and friction economy.

Lenacapavir is not just a new drug. It's a redesign of behavior in prevention, and that's the point that often gets lost in debates focused solely on "registration" and "price."

In the landmark clinical trials, the results were exceptional. In PURPOSE 1 (young cisgender women), there were no HIV infections in the lenacapavir arm; in PURPOSE 2 (cisgender gay, bisexual, and transgender and non-binary men, including Latin America), the reported efficacy was also very high, with robust reductions relative to baseline incidences.

But the real disruption lies in the usage design: two doses per year . In prevention, we often don't lose due to a lack of effective technologies; we lose due to friction: routine, stigma, irregular access, perceived risk, abandonment. Reducing friction increases scale. And scale, here, is the name of the game .

Not coincidentally, the WHO recommended injectable lenacapavir every six months as an additional PrEP option in guidelines published in July 2025. UNAIDS , in parallel, has been treating this opportunity as part of a possible inflection point in prevention, provided that the access design does not negate the technological promise.

The number that creates the conflict: when the price is incompatible with the epidemiology.

The controversy doesn't exist because the product is expensive. It exists because the product is expensive for the type of problem it solves.

According to UNAIDS Brazil , the price of lenacapavir in the US (in the context of the North American market) is in the order of tens of thousands of dollars per person/year, while analyses and agreements associated with generics point to annual values in the range of tens of dollars per person (with the potential for further decreases over a larger scale).

This contrast is not a mere accounting detail. It exposes a structural misalignment:

• In gene therapies for rare diseases, stratospheric prices can be justified, not without controversy, because the return model depends on small populations.

  
  

• In HIV prevention, the target is broad, the benefit is systemic, and the social return comes from the network effect: fewer infections today mean less treatment tomorrow, less transmission, less mortality, less stigma, and less accumulated cost.

  
  

In economic terms, lenacapavir is a product with high social value and high impact elasticity at scale. If the price prevents scale, it prevents the very value that justifies innovation .

When price becomes governance: the precedent of insulin in the US and the logic of "architecture," not labeling.

There's a point that often goes unnoticed when looking only at the number: price isn't a label; it's an architecture . And architectures change when the system, regulators, payers, public opinion, and competition redefine what is acceptable.

The insulin precedent shows that the pricing of an essential medicine is not determined solely by cost and R&D , but by social legitimacy and institutional design. In the case of lenacapavir, the question is not whether there is value. It is whether the chosen access model allows that value to be realized at scale.

The precedent set by insulin in the US: when public policy and reputation reprice an "essential medicine"

In 2022, the discussion over insulin pricing in the U.S. reached a regulatory turning point. The Inflation Reduction Act (IRA) established a $35 per month cap on the Medicare beneficiary copayment cost for each covered insulin, effective January 1, 2023, and eliminated the deductible for these products.

The most interesting effect, however, was not just the relief for Medicare beneficiaries. The new political level of acceptability opened up space for a repositioning of the sector: in March 2023, Eli Lilly announced 70% cuts in list prices for widely used insulins and the expansion of programs to limit patient costs to $35/month; subsequently, Sanofi and Novo Nordisk announced substantial list price reductions (on the order of 78% and up to 75% , respectively) for patients in segments beyond Medicare.

The case of insulin is not a "copyable model" for any technology, but it is a practical reminder that, in medicines perceived as essential , price is not just economics: it is governance , legitimacy , and reputational risk . When public policy redefines what is socially acceptable, the industry tends to move not only by rule, but by strategy: it preserves incentives, reorganizes margins, and recalibrates the value proposition.

This precedent helps to frame the central point of lenacapavir : because it is a semi-annual prevention program with population-wide potential, the pricing decision and access design tend to inevitably become a public and institutional matter , and not just a commercial negotiation. It is at this boundary that voluntary licensing enters as an instrument of governance and not just logistics.

Voluntary licenses and the frontier of "selective access"

Voluntary royalty-free licenses for generic drugs in 120 countries are, in themselves, a relevant instrument. They recognize that there is a dimension of public interest that goes beyond the traditional cycle of exclusivity.

But the map matters just as much as the gesture.

UNAIDS Brazil is direct in stating that Brazil remains excluded , along with other middle-income countries in Latin America , despite internal inequality and fiscal pressure. The criticism, more operational than ideological, is that the eligibility criteria create a gray area: countries that are not "poor enough" for generic drugs, but are also not "rich enough" to incorporate them on a large scale without compromising budget and equity.

Here the ethical dilemma becomes more refined: the eligibility criterion is anchored in national average income, but epidemiological risk and the real capacity to finance prevention do not behave like averages. In Brazil, inequality is not a footnote ; it is an explanatory variable.

The Brazilian chessboard: ANVISA, CMED, CONITEC and the risk of innovation becoming underutilized.

With registration, the issue quickly shifts to the terrain where access is truly decided:

1. CMED (pricing): the definition of the ceiling and the price positioning will be crucial — and timing matters, given that Brazil updated its pricing rules, effective in April 2026, altering procedures and categories.

   
   

2. CONITEC (evaluation and incorporation): cost-effectiveness, budgetary impact, and programmatic design.

   
   

3. Implementation in the Brazilian Unified Health System (SUS) : eligibility, logistics, adherence, and integration with combined prevention.

   
   

The risk is clear: if the final price is anchored in "market" references rather than in logic compatible with large-scale prevention , the probability of universal adoption decreases, and lenacapavir becomes an approved but socially underutilized technology.

And there is a global backdrop that makes the delay costly: UNAIDS reports approximately 1.3 million new infections in 2023 and 2024 , more than necessary to meet the target trajectory.

The ethical dilemma of Gilead: value, governance, and social license.

A balanced reading requires recognizing at least two sets of arguments, both plausible, both insufficient when isolated.

The innovation argument

R&D is expensive and uncertain; returns support the pipeline; the price in the US reflects a complex reimbursement architecture; voluntary licenses for 120 countries already represent a significant concession.

The access argument

In prevention, the benefit is collective; the potential market is massive; and when generic drug projections are measured in tens of dollars per year and the reference price is measured in tens of thousands , the discrepancy ceases to be "pricing" and becomes a structural barrier to global goals.

UNAIDS explicitly called for price reductions and expanded licensing, linking access to the goal of ending AIDS as a public health threat.

And there is an often underestimated component: social license to operate . In a technology with the symbolism of a "near-vaccine," the narrative of access is not peripheral; it is part of the value. The company is not just selling a drug. It is vying for a place in contemporary health history.

What Brazil can put on the table: five routes and a strategy.

The Brazilian debate doesn't need to be stuck in the binary of " accept the price " versus " break the system ." There's a range of instruments, with gradations of cooperation and conflict.

1. Negotiation based on price and volume : differentiated pricing with centralized purchasing, coverage targets, and progressive expansion in priority populations and territories.

   
   

2. Real-world evidence-driven input : phased implementation with programmatic effectiveness indicators and adjustment mechanisms.

   
   

3. Regional coalition and reputational pressure : coordination with other excluded Latin American countries, increasing bargaining power and reducing individual costs.

   
   

4. Technology transfer and negotiated local production : convergence between access and industrial policy, with realistic design and robust governance.

   
   

5. Legal flexibilities as a last resort : maintaining the set of sovereign tools available as a safeguard of the public interest.

   
   

The question that can't be avoided.

The lenacapavir scandal has placed Brazil before a sanitary, economic, and moral decision : will we treat HIV prevention as an impactful agenda, or as just another portfolio item negotiated based on global market fluctuations?

Gilead faces a real ethical dilemma : protecting the value of innovation while simultaneously preventing the social value of innovation from being blocked by a pricing and licensing architecture that excludes countries where universality is state policy, but inequality is a daily reality .

The relevant discussion is not "who is right." It's about which institutional design simultaneously incentivizes innovation and provides access at scale , before 2030 becomes just a fancy number in presentations.

by Marcio de Paula

Brazilian Health Innovation Institute - IBIS