Initial Distribution of Lenacapavir
Lenacapavir, a drug for HIV prevention manufactured by Gilead Sciences, has begun distribution in Eswatini and Zambia. The U.S. State Department announced on Wednesday that each country received 500 doses. This marks the initial distribution of the drug in low- and middle-income countries, following its approval in the United States five months prior.
Lenacapavir offers near-complete protection against HIV infection with two injections per year. Mitchell Warren, Executive Director of the AIDS Vaccine Advocacy Coalition (AVAC), commented on the rapid pace of this global health innovation's distribution to low- and middle-income countries. He characterized the initial 500 doses as foundational for future larger distributions.
Global Distribution Objectives
The delivery of these doses is the first stage in a wider objective to supply at least 2 million doses to countries with high HIV burdens, primarily in Africa, by 2028. This initiative is a collaboration between the Global Fund, Gilead Sciences, and the U.S. State Department.
Warren indicated that this drug rollout coincides with existing political and economic challenges within the global AIDS response. He stated that disrupted care could potentially contribute to an increased HIV burden. Warren also commented on the impact of foreign aid reductions on systems and programs designed for drug delivery.
Procurement and Supply Information
In September, the U.S. State Department committed to an investment in lenacapavir, aiming to provide up to 2 million doses by 2028. Jeremy Lewin, a senior official for Foreign Assistance, Humanitarian Affairs, and Religious Freedom at the State Department, stated that this target is anticipated to be met by mid-to-early 2027, with over half a million doses projected for procurement next year.
Gilead Sciences CEO Daniel O'Day confirmed that the initial 500 doses are being supplied at cost, without profit to the company. Gilead intends to provide up to 2 million doses before licensed generic manufacturers become operational. O'Day stated that Gilead has sufficient supply for markets that obtain regulatory approval and for replenishing stock in Eswatini and Zambia.
Regulatory Approvals and Expansion Plans
Lenacapavir received approval from the U.S. FDA in June, followed by the World Health Organization and the European Medicines Agency in July. Since then, Gilead has pursued regulatory approvals across sub-Saharan Africa. Zambia and South Africa have approved the drug. Eswatini's Ministry of Health issued a distinct import authorization. Lewin noted that the U.S. does not plan to fund lenacapavir doses for South Africa, encouraging the country to fund its own population's supply.
Gilead has submitted applications for approval in Botswana, Kenya, Malawi, Namibia, Rwanda, Tanzania, Uganda, and Zimbabwe, with further applications planned. O'Day stated that the company is prioritizing 18 countries identified as having high HIV burdens, collectively representing 70% of the HIV epidemic.
Implementation and Delivery Aspects
Health ministries are primarily responsible for the distribution of the drug. However, some governments have engaged community and non-governmental organizations for support. Lewin stated that this approach aligns with the U.S. America First Global Health Strategy's objective to strengthen national government self-reliance.
Warren stated that several health systems have relied on external organizations that have experienced funding reductions. He referenced an AVAC-supported program, designed to enhance health system capacity for delivering injectable HIV drugs, which he stated was inactive as of January and has not yet resumed full operation.
Warren emphasized that the effective utilization of drug doses depends on the presence of operational delivery programs.