Long-acting HIV drugs are reshaping care in wealthy countries. Closing the gap for low- and middle-income countries is a different fight, one that starts the moment a drug gets approved.
A new generation of long-acting HIV medications, delivered by injection every one to six months instead of as a daily pill, has changed HIV treatment and prevention in the United States and Europe. For people managing HIV or trying to prevent it, these therapies can mean freedom from a daily reminder of their status, fewer barriers tied to stigma, and better outcomes for people who have struggled with pill-based regimens.
But approval by a regulator like the FDA or the European Medicines Agency doesn't guarantee access. For the roughly two-thirds of people living with HIV who reside in low- and middle-income countries, particularly across sub-Saharan Africa, a drug's arrival in wealthy-country clinics often has little bearing on when, or whether, it reaches them at all. That gap, sometimes stretching years beyond initial approval, is drawing new scrutiny from global health experts who see it as one of the most solvable, and most persistently unsolved, problems in modern medicine.
Dr. Max Lataillade has spent more than two decades on both sides of that divide. A physician and infectious disease specialist who trained at Yale, he spent nearly a decade at Bristol Myers Squibb as Vice President of Specialty Development for Virology before moving to ViiV Healthcare. There, he led global research and development strategy and helped build one of the industry’s largest long-acting HIV portfolios, with work that also included the development of fostemsavir (marketed as Rukobia). Today, as Head of HIV Drug Development at the Gates Foundation, Lataillade focuses on a question that gets too little attention: what needs to happen, technically and logistically, to make a drug developed for wealthy markets affordable and available in the countries hardest hit by HIV.
“I've spent much of my career developing HIV medicines, and one lesson I've learned is that regulatory approval and public health impact are two very different milestones. Historically, we've optimized development around approval in major markets, while affordability, manufacturing scale, and delivery in high-burden countries often come later. But there is no impact without access. That's why I believe access and implementation strategies must be core components of HIV drug development, with concrete plans in place well before we enter Phase 3.”
Why approval is just the starting line
A drug’s path from a lab in Research Triangle Park or London to a clinic in rural Kenya or Mozambique involves hurdles that have little to do with how well the drug works. Manufacturing is often the first constraint. Long-acting injectables typically require specialized formulation and fill-finish capacity that differs from the production lines used for oral pills. Expanding that capacity to meet demand across dozens of countries, rather than a handful of wealthy ones, takes years of investment and planning. That work usually begins only after a drug has secured its first approval.
Pricing is the second barrier, and perhaps the most visible one. A drug price set for reimbursement systems in the United States or Western Europe has little connection to what public health budgets in lower-income countries can sustain. Closing that gap generally requires a voluntary licensing agreement that allows generic manufacturers, often based in India or South Africa, to produce a lower-cost version for defined markets. These agreements can take months or years to negotiate. Once a license is in place, manufacturers still need the technical capability and a regulatory pathway to bring a generic version to market quickly.
“Licensing is essential, but a license alone doesn't put medicine in someone's hands. What makes these partnerships work is getting the timing, technology transfer, manufacturing readiness, and regulatory pathways aligned early enough that generic manufacturers can move quickly. Having worked on the industry side and now from a funder's perspective, I see how important it is to create the right incentives for everyone involved. The goal isn't simply to make a lower-cost version available eventually; it's to dramatically shorten the time between innovation and equitable access.”
Even when a lower-cost version exists, the health system needs to be ready to deliver it. That means training health workers to administer a new injectable regimen, ensuring supply chains can maintain cold storage where required, equipping clinics to manage scheduled injections rather than prescription refills, and updating national regulatory and treatment guidelines to include the new option. In many countries, these systems are already stretched by competing health priorities. A drug can be available in principle and still remain largely out of reach for the patients who need it.
Planning for access while a drug is still in development
People working to expand access say planning is beginning to happen earlier in the development process. Historically, the question of how a drug would reach lower-income countries was addressed after a wealthy-market launch, if it was addressed in a structured way at all. A growing number of global health experts argue that access needs to be built into a drug’s development plan from an earlier stage, alongside manufacturing scale-up and regulatory strategy. They want that work to begin before the drug has an established price and an approved label.
“I would start by changing the questions we ask at the very beginning of development. Can this medicine be manufactured affordably at scale? Can it be delivered in a resource-constrained health system? Are we generating the evidence that regulators and policymakers in high-burden countries will actually need? For long-acting HIV medicines, that means thinking about formulation, dosing intervals, manufacturing, and delivery models together, not sequentially. To me, the next frontier of HIV innovation is not just developing better medicines, but designing them from the outset to reach the people who need them most.”
Earlier planning could have benefits beyond the individual patients who receive these drugs. Public health officials have identified long-acting prevention and treatment options as among the most promising tools for reducing new HIV infections in the regions where the epidemic remains most severe. But those options can do little to reduce infections unless they reach the people who need them.
Closing this gap requires scientific, regulatory, financial, and operational work that rarely makes headlines in the way a new drug approval does. But for the millions of people living with HIV outside wealthy countries, that work may determine whether the last decade of innovation in HIV medicine ever reaches them at all.
About the Expert: Dr. Max Lataillade is a physician and infectious disease specialist who serves as Head of HIV Drug Development at the Gates Foundation. He previously held senior research and development leadership roles at ViiV Healthcare and Bristol Myers Squibb, where he contributed to the development of some of the industry’s most significant HIV therapies, including fostemsavir (Rukobia). He is a Yale-trained physician-scientist, holds multiple patents in HIV therapeutics, and has authored more than 45 scientific publications.
