Mariana Romero Roy
Mexico’s recent regulatory approval of lenacapavir could represent more than another milestone in the fight against HIV. It could also be an early indicator of how Latin America’s healthcare systems will need to adapt as long-acting injectable (LAI) therapies move from clinical innovation into routine care.
On September 24, Mexico’s Federal Commission for the Protection against Sanitary Risks (COFEPRIS) granted sanitary registration to lenacapavir for pre-exposure prophylaxis (PrEP) against HIV. The twice-yearly subcutaneous injection gives people at risk of HIV acquisition an alternative to daily oral PrEP. [1][2]
The timing is significant. Just nine days earlier, the Pan American Health Organization (PAHO) announced an agreement with Gilead Sciences that will enable 14 Latin American and Caribbean countries—including Mexico, Brazil, Colombia, Chile, Peru, and Argentina—to procure lenacapavir through PAHO’s Regional Revolving Funds, subject to national regulatory and programmatic requirements. [3]
In other words, the region is not simply watching the arrival of a new HIV-prevention drug. It is beginning to build the pathways needed to move a new class of long-acting therapies from regulatory approval to real-world delivery.
The Long-Acting Shift
Lenacapavir is notable because of what it changes about the patient experience. Instead of taking a PrEP pill every day, eligible patients receive an injection every six months. The World Health Organization (WHO) recommended twice-yearly injectable lenacapavir as an additional HIV-prevention option in 2025, following clinical trials that demonstrated very high efficacy. [4]
The PURPOSE 1 trial recorded no HIV infections among participants receiving lenacapavir during the primary analysis period, while PURPOSE 2 found a 96% reduction in HIV incidence compared with background incidence among its study population. [5]
That extended dosing interval addresses one of the fundamental challenges of preventive medicine: adherence. Latin America has made substantial progress in expanding access to oral PrEP, but implementation and persistence remain uneven. A 2025 review found that the region has experienced significant growth in PrEP availability while continuing to face barriers involving adherence, healthcare access, cost, and health-system capacity. [6]
Lenacapavir therefore offers an important new model: move some of the burden of medication adherence away from the patient and into the healthcare system. That shift has major implications for hospitals, clinics, pharmacies and healthcare technology providers.
The Infrastructure Behind the Injection
A daily pill can be distributed through conventional pharmacy channels and stored in large quantities. A six-month injectable therapy creates a different operational challenge. The healthcare system must identify eligible patients, confirm HIV-negative status before administration, schedule the next injection, maintain accurate records, and ensure that patients return within the appropriate dosing window. The current U.S. prescribing information, for example, specifies HIV testing before each injection and a continuation dose every 26 weeks, with a limited dosing window around the scheduled date. [7] That creates an immediate opportunity for healthcare IT.
Patient-management platforms will become increasingly important for automated appointment reminders, missed-dose alerts, inventory visibility, and longitudinal tracking. Electronic health records and population-health systems will need to connect clinical information with procurement and scheduling data. For public-health programs managing thousands of patients across geographically dispersed clinics, the ability to see who is due for an injection and where the necessary doses are located could become just as important as the medication itself.
PAHO is already building implementation capacity around long-acting PrEP. In 2026, it launched a training program covering both oral and long-acting PrEP, including lenacapavir, with modules addressing administration, monitoring, testing, and programmatic indicators. [8] The message for MedTech and healthcare IT companies is clear: the product may be pharmaceutical, but the infrastructure required to deliver it is increasingly technological.
Rethinking the Supply Chain
The transition to long-acting therapies also changes how healthcare organizations think about pharmaceutical inventory. There is an important distinction, however. Lenacapavir’s current U.S. PrEP formulation does not require refrigerated storage. The FDA-approved information specifies storage at 20°C to 25°C, with permitted excursions between 15°C and 30°C, while the vials must remain in their original carton to protect them from light. [7] That means the immediate lenacapavir rollout should not be characterized as a conventional cold-chain challenge. But it does highlight a much broader supply-chain issue.
As more high-value injectable therapies enter Latin American markets — including products that do require temperature-controlled storage — health systems will increasingly need reliable visibility into inventory conditions, transportation, and point-of-care availability. IoT-enabled temperature monitoring, connected storage systems, and automated inventory management can become important tools for protecting expensive therapies as they move through increasingly complex distribution networks.
For MedTech companies, this represents an opportunity that extends beyond the syringe. Monitoring equipment, medication-management platforms, connected refrigerators and freezers where required, inventory software, and logistics technologies can all become part of the infrastructure supporting an expanding long-acting treatment ecosystem.
Drug-delivery technology is another potential growth area. Lenacapavir is currently supplied as a dosing kit containing vials, syringes, and injection needles rather than a smart autoinjector. [7] But as pharmaceutical manufacturers develop and deploy additional long-acting therapies, more sophisticated delivery and administration technologies could increasingly become part of the care model.
From Regulatory Approval to Market Opportunity
The biggest mistake for healthcare companies would be to treat COFEPRIS approval as the finish line. It is the beginning of a new procurement cycle. Mexico’s approval does not by itself mean that lenacapavir is already broadly available throughout the country. Access will depend on additional programmatic decisions, procurement, clinical protocols, training, and implementation. PAHO has explicitly noted that introduction across participating countries will occur progressively and depend on national regulatory and health-system processes. [3]
That creates a window for companies to identify where the infrastructure is already in place and where investment will be required. Hospitals and health networks with sophisticated digital patient-management systems may be better positioned to administer a six-month therapy at scale. Others may need new software, staff training, inventory systems, or administration capacity before they can participate effectively.
The same logic applies beyond HIV. If long-acting therapies prove successful in improving adherence and simplifying care, the model could encourage broader adoption of extended-duration injectable approaches across other areas of medicine. The exact technologies and infrastructure requirements will vary by therapy, but the underlying shift is the same: healthcare systems move from managing recurring prescriptions toward managing scheduled clinical interventions.
Key Takeaways for Health Care Companies
For MedTech, pharmaceutical and healthcare IT companies, the opportunity is therefore larger than the market for HIV prevention alone. The COFEPRIS decision is an early signal that regulatory pathways, procurement systems, and public-health programs are beginning to accommodate a new generation of long-acting therapies. PAHO’s regional procurement pathway adds another layer of momentum by creating a mechanism through which 14 countries can potentially access lenacapavir, subject to their national processes. [3]
As regulatory bodies fast-track long-acting therapies, hospital procurement is shifting from bulk pharmacy storage toward more specialized injection, scheduling, monitoring, and inventory infrastructure. That means commercial teams need to understand not just which hospitals purchase pharmaceuticals, but which healthcare networks have the operational capabilities to administer them.
Planning Your LAI Roadmap
Is your commercial team prepared for the long-acting injectable transition? Global Health Intelligence can help identify where the infrastructure exists today — and where future investment is likely to create opportunities.
Using its proprietary HospiScope database, GHI can provide localized intelligence on Latin American public and private health networks, helping companies evaluate hospitals and healthcare systems based on their equipment, infrastructure, and capacity. For companies targeting the next generation of biologics and long-acting therapies, knowing where the technology can actually be deployed is becoming just as important as knowing where the demand exists.
Contact GHI today to learn how HospiScope can help you identify the Latin American health networks best positioned to support the rollout of advanced therapies — and build a more precise commercial strategy around the region’s evolving healthcare infrastructure.
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Sources:
- https://outandaboutpv.com/mexico-approves-twice-yearly-lenacapavir-for-hiv-prevention/
- https://www.gob.mx/cofepris/es/articulos/cofepris-autoriza-lenacapavir-primera-profilaxis-contra-el-vih-de-aplicacion-semestral?idiom=es
- https://www.paho.org/en/news/15-9-2026-paho-opens-new-pathway-access-lenacapavir-hiv-prevention-latin-america-and-caribbean
- https://www.who.int/news/item/14-07-2025-who-recommends-injectable-lenacapavir-for-hiv-prevention
- https://www.nejm.org/doi/full/10.1056/NEJMoa2407001
- https://pmc.ncbi.nlm.nih.gov/articles/PMC11892447/
- https://www.dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1c241af1-ce62-4b0a-9eb7-f6b626174f01
- https://www.paho.org/en/news/25-2-2026-new-paho-course-strengthens-health-workers-capacity-deliver-oral-and-long-acting
- https://www.who.int/tools/prep-implementation-tool
