NAIROBI, Kenya — Médecins Sans Frontières has renewed its calls for pharmaceutical giant Gilead Sciences to allow humanitarian organizations direct access to lenacapavir, the twice-yearly injectable HIV prevention drug that has been hailed as one of the most significant biomedical breakthroughs in decades. Gilead has refused multiple requests from MSF to purchase the drug for use in its global programmes, prompting accusations that corporate interests are being placed above the lives of vulnerable people.

Lenacapavir works as a long-acting form of pre-exposure prophylaxis, known as PrEP. Unlike daily oral PrEP pills, it requires only two injections per year — a dosing schedule that makes it dramatically more practical for populations with limited access to consistent healthcare, including people in humanitarian settings, sex workers, and adolescents in high-prevalence regions.

In an open letter addressed to Gilead’s leadership, MSF said blocking humanitarian access to lenacapavir represents a critical failure of the company’s stated public health commitments. The drug, which received accelerated approval pathways in both the United States and Europe, has been the subject of licensing deals with several generic manufacturers — but none of those arrangements cover humanitarian supply.

“This is a medicine that could transform HIV prevention for the people we serve,” the letter reads. “The current rollout falls catastrophically short of need. We are asking for a direct purchasing arrangement that would allow us to reach the communities we work with, without waiting for commercial distribution networks that may never arrive.”

Gilead has defended its licensing model, pointing to agreements with generic manufacturers in India and South Africa intended to supply low-income countries. But global health advocates say those timelines are too slow and volumes too limited for a drug that could realistically be used by millions of at-risk people across Sub-Saharan Africa.

Approximately 1.3 million people worldwide contract HIV every year. The vast majority of new infections occur in low- and middle-income countries, with Sub-Saharan Africa bearing the heaviest burden. Twice-yearly injectable PrEP would remove the adherence challenge that has limited the effectiveness of daily oral PrEP in many real-world settings.

The controversy comes at a time when the global HIV response is already under severe strain. Funding cuts from major donor governments have disrupted prevention and treatment programmes across dozens of countries. UNAIDS has warned that the world is facing the most serious setback in the HIV response in decades.

For MSF and the communities it serves, the refusal to grant direct access is more than a commercial dispute — it is a life-or-death question hanging over millions of people who cannot wait for market forces to eventually deliver a drug that already exists and already works.

Image: African healthcare workers. Photo by Tima Miroshnichenko via Pexels (free for commercial use).