Publication date: 15 September 2026
Region: Latin America and the Caribbean
Source: Pan American Health Organization / World Health Organization
A major change in HIV prevention access is taking shape across Latin America. On 15 September 2026, the Pan American Health Organization (PAHO) announced a new procurement pathway that will allow 14 countries to obtain lenacapavir, a long-acting injectable medicine used for HIV pre-exposure prophylaxis (PrEP), through PAHO’s Regional Revolving Funds. [1]
Lenacapavir is administered on a six-monthly schedule, creating an alternative to daily oral PrEP and more frequently administered preventive regimens. WHO recommended injectable lenacapavir in 2025 as an additional HIV prevention option after large clinical trials demonstrated very high protection against HIV acquisition. [2,3]
The development could be especially important in a region where PAHO estimates approximately 140,000 new HIV infections occur each year and where gaps in access to prevention remain. [1]
Which 14 Countries Are Included?
Under the new PAHO agreement, the countries eligible for this procurement pathway are Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, Mexico, Panama, Paraguay, Peru, Uruguay and Venezuela. [1]
The agreement does not mean lenacapavir will immediately become available at every hospital, pharmacy or HIV clinic in these countries.
National regulatory authorization, procurement decisions, clinical protocols, healthcare-worker training, supply planning and programme implementation will still be required before patients can routinely access the medicine. [1]
PAHO is supporting countries with demand forecasting, guideline development, monitoring and health-system preparation as national programmes decide how lenacapavir will be introduced.
What Is Lenacapavir?
Lenacapavir is a long-acting HIV-1 capsid inhibitor. The HIV capsid is the protein shell surrounding important viral genetic material and enzymes. Lenacapavir interferes with several stages of the viral life cycle involving this capsid. [4]
For HIV prevention, lenacapavir is used as pre-exposure prophylaxis, commonly called PrEP.
PrEP is intended for people who do not have HIV but who may benefit from additional protection against acquiring HIV.
Unlike daily oral PrEP, long-acting lenacapavir maintains active drug concentrations for months, allowing continuation injections approximately every 26 weeks. [2,5]
How Effective Is Twice-Yearly Lenacapavir?
The strongest evidence comes from two large Phase 3 clinical trials known as PURPOSE 1 and PURPOSE 2.
PURPOSE 1 Trial
PURPOSE 1 involved adolescent girls and young women in South Africa and Uganda.
Among 2,134 initially HIV-negative participants who received lenacapavir, no HIV infections occurred during the primary analysis period. By comparison, infections occurred among participants receiving daily oral PrEP regimens. [6]
The study therefore recorded an HIV incidence of 0 per 100 person-years in the lenacapavir group.
This was an unusually strong result for an HIV-prevention trial, although it should not be interpreted to mean that infection can never occur in routine clinical use.
PURPOSE 2 Trial
PURPOSE 2 studied a broader population that included cisgender men, transgender women, transgender men and gender-diverse participants.
Among participants included in the efficacy analysis, two HIV infections occurred in the lenacapavir group, compared with nine among participants assigned daily oral emtricitabine/tenofovir disoproxil fumarate. [7]
The CDC subsequently summarized the randomized-trial evidence as showing approximately 100% efficacy among females in PURPOSE 1 and 96% efficacy in the predominantly male PURPOSE 2 population when compared with estimated background HIV incidence. [5]
| Study | Lenacapavir population | Main HIV outcome |
|---|---|---|
| PURPOSE 1 | 2,134 initially HIV-negative participants receiving lenacapavir | 0 HIV infections |
| PURPOSE 2 | 2,183 participants receiving lenacapavir in the study group | 2 HIV infections |
| Dosing | Subcutaneous long-acting PrEP | Approximately every 26 weeks |
These results were a major reason WHO added lenacapavir to its recommended HIV-prevention options in 2025. [2]
Why Twice-Yearly PrEP Could Change HIV Prevention
One of the major difficulties with oral PrEP is not whether the medicine can work, but whether people are able to take it consistently for as long as protection is needed.
Daily tablets can create practical barriers. Some people forget doses, travel frequently, have difficulty storing medicines privately or do not want others to see an HIV-prevention medication.
Stigma can also affect adherence. A person taking HIV prevention tablets may have to explain the medication to partners, family members or colleagues even though they do not have HIV.
A six-monthly preventive regimen substantially reduces the number of medication-taking events required during a year. WHO specifically identified adherence, stigma and difficulties accessing frequent healthcare as reasons why a long-acting option could broaden HIV-prevention choice. [2]
It does not replace oral PrEP or injectable cabotegravir. Instead, it adds another option so prevention can be matched more closely to individual circumstances.
Lenacapavir vs Daily Oral PrEP
| Feature | Lenacapavir PrEP | Daily Oral PrEP |
|---|---|---|
| Frequency | Approximately every 6 months after initiation | Usually daily |
| Administration | Subcutaneous injection by healthcare provider | Oral tablets |
| Daily pill required | No | Yes |
| Clinic attendance | Needed for scheduled injections and testing | Depends on programme and monitoring schedule |
| Injection-site reactions | Possible | Not applicable |
| Missed daily tablets | Avoided | Can reduce protection if adherence becomes inadequate |
| HIV testing | Required | Required |
| Protection against other STIs | No | No |
Neither option eliminates the need for appropriate HIV testing and sexual-health care.
Is Lenacapavir Really Just Two Injections Per Year?
“Twice-yearly injectable PrEP” describes the long-term continuation schedule, but patients should be aware that the complete initiation regimen can involve more than simply receiving one injection every six months.
For example, the U.S. prescribing regimen includes an initial oral loading schedule together with subcutaneous lenacapavir administration. Continuing treatment is then given every 26 weeks. [4]
The continuation dose is administered as two subcutaneous injections at the same visit to provide the total dose.
National protocols adopted in Latin American countries will depend on their regulatory approvals and programme guidelines.
Who May Be Considered for Lenacapavir PrEP?
Lenacapavir PrEP is intended for people without HIV who could benefit from protection against HIV acquisition.
PrEP may be considered when an individual’s sexual or epidemiological circumstances create a meaningful possibility of HIV exposure. Clinical assessment can include sexual history, previous sexually transmitted infections, partners’ HIV status and viral suppression, condom use and other exposure factors. [2,5]
Long-acting PrEP may be particularly relevant for someone who has difficulty maintaining a daily tablet schedule or prefers a discreet, infrequently administered prevention method.
Eligibility and access criteria can differ between countries and national HIV programmes.
HIV Testing Before Lenacapavir Is Essential
Long-acting PrEP should not be started in someone who already has HIV without appropriate HIV treatment.
This is particularly important with lenacapavir because exposure to lenacapavir alone in a person with unrecognized HIV infection can allow drug-resistant HIV variants to emerge. [4]
HIV testing is therefore required before starting long-acting lenacapavir and before subsequent injections.
WHO has also issued specific HIV-testing recommendations to support long-acting injectable PrEP programmes. [2]
Recent potential exposure or symptoms compatible with acute HIV infection may require additional assessment because very early infection can occasionally occur before some tests become positive.
What Are the Main Side Effects?
Clinical-trial and regulatory data indicate that injection-site reactions are the most frequent adverse effects.
In U.S. regulatory data from PURPOSE 1 and PURPOSE 2, injection-site reactions were reported in approximately 69% and 83% of lenacapavir recipients, respectively. Most were mild or moderate. [4]
Common reactions included injection-site nodules, pain, redness, swelling and firmness.
Some subcutaneous nodules can remain noticeable for a prolonged period because lenacapavir forms a drug depot under the skin from which medication is released gradually.
Headache and nausea were also reported among common adverse reactions. [4]
Discontinuation because of injection-site reactions remained uncommon in the major trials.
Does Lenacapavir Prevent Other Sexually Transmitted Infections?
No.
Lenacapavir PrEP is specifically intended to reduce the risk of HIV-1 acquisition. It does not provide protection against infections such as syphilis, gonorrhoea, chlamydia, hepatitis or herpes.
It also does not function as contraception.
Regular STI screening, appropriate vaccination where available and other preventive measures therefore remain important even for someone using highly effective HIV PrEP.
Why the PAHO Procurement Agreement Matters
Access to a newly developed medicine can depend on much more than regulatory approval.
Countries must negotiate prices, forecast demand, establish supply chains and decide how a medicine will be incorporated into public-health programmes.
PAHO’s Regional Revolving Funds use pooled procurement, allowing participating governments to combine demand and procure medicines and other health technologies through a regional mechanism. [8]
For lenacapavir, this could help reduce some of the procurement barriers that might otherwise slow national introduction.
PAHO states that the new route complements voluntary licensing arrangements already covering 24 countries in Latin America and the Caribbean, within a wider access framework covering 120 countries globally. [1]
Brazil May Eventually Produce Lenacapavir Regionally
Another important part of the September 2026 announcement concerns Brazil.
Gilead has committed to work toward a technology-transfer process in Brazil, with the objective of enabling future regional production of lenacapavir. [1]
However, PAHO has made clear that the process is still being developed and that specific production timelines and mechanisms have not yet been established.
Regional manufacturing could eventually strengthen supply security and potentially support more sustainable procurement, but it should not yet be interpreted as confirmation that locally produced lenacapavir will become available on a specific date.
Is Lenacapavir Available in the 14 Countries Now?
Not necessarily.
The September announcement establishes a mechanism through which governments can procure lenacapavir. Actual patient access will develop progressively.
Each country may need to complete regulatory review, determine national eligibility criteria, develop clinical protocols, train healthcare professionals, budget for procurement and establish distribution systems. [1]
Patients interested in long-acting PrEP should therefore check with their national HIV programme or qualified sexual-health provider rather than assuming availability based only on inclusion in the PAHO agreement.
Why This Development Matters for Latin America
The region continues to experience a substantial HIV burden.
PAHO reported in its September announcement that approximately 140,000 new HIV infections occur every year across Latin America and the Caribbean. [1]
At the AIDS 2026 conference, PAHO also emphasized that oral and injectable PrEP, rapid testing, self-testing and prompt antiretroviral treatment are available tools, but access and coverage remain major challenges. [9]
Long-acting prevention cannot solve these problems by itself. Its public-health impact will depend on whether people who could benefit can actually obtain injections on time, receive reliable HIV testing and remain connected to prevention services.
The new procurement pathway represents an important step from successful clinical trials toward real-world implementation.
Frequently Asked Questions About Lenacapavir HIV Prevention
Is lenacapavir 100% effective at preventing HIV?
PURPOSE 1 recorded no HIV infections among 2,134 participants receiving lenacapavir during the primary analysis, while PURPOSE 2 recorded two infections. It is therefore highly effective, but patients should not interpret clinical-trial results as an absolute lifetime guarantee.
How often is lenacapavir given?
Long-term PrEP dosing is approximately every 26 weeks, or twice yearly, after the initiation regimen.
Is lenacapavir a vaccine?
No. Lenacapavir is an antiviral medicine called an HIV capsid inhibitor. It does not train the immune system like a vaccine.
Can someone with HIV use lenacapavir PrEP?
PrEP is intended for people who are HIV-negative. A person diagnosed with HIV requires a complete antiretroviral treatment regimen rather than lenacapavir PrEP alone.
Does lenacapavir protect against herpes or other STIs?
No. It prevents HIV acquisition but does not directly prevent herpes, syphilis, gonorrhoea, chlamydia or other sexually transmitted infections.
Can patients in all 14 countries get it immediately?
No. The PAHO agreement creates a procurement route. Actual availability depends on national regulatory approval, purchasing decisions and implementation by each country’s health programme.
References
- Pan American Health Organization. (2026, September 15). PAHO opens a new pathway to access lenacapavir for HIV prevention in Latin America and the Caribbean. PAHO source
- World Health Organization. (2025, July 14). Guidelines on lenacapavir for HIV prevention and testing strategies for long-acting injectable pre-exposure prophylaxis. WHO guideline
- World Health Organization. (2025, July 14). WHO recommends injectable lenacapavir for HIV prevention. WHO source
- U.S. Food and Drug Administration. (2025). Yeztugo (lenacapavir): Prescribing information. FDA prescribing information
- Patel, R. R., Hoover, K. W., Lale, A., Cabrales, J., Byrd, K. M., & Kourtis, A. P. (2025). Clinical recommendation for the use of injectable lenacapavir as HIV preexposure prophylaxis—United States, 2025. MMWR Morbidity and Mortality Weekly Report, 74(35), 541–549. CDC MMWR article
- Bekker, L.-G., Das, M., Abdool Karim, Q., et al. (2024). Twice-yearly lenacapavir or daily F/TAF for HIV prevention in cisgender women. The New England Journal of Medicine, 391(13), 1179–1192. PubMed record
- Kelley, C. F., Acevedo-Quiñones, M., Agwu, A. L., et al. (2025). Twice-yearly lenacapavir for HIV prevention in men and gender-diverse persons. The New England Journal of Medicine, 392(13), 1261–1276. PubMed record
- Pan American Health Organization. (2026). PAHO Strategic Fund. PAHO Strategic Fund
- Pan American Health Organization. (2026, July 27). AIDS 2026: The Americas have the tools to eliminate HIV, but gaps in access and coverage remain, says PAHO. PAHO AIDS 2026 source
