Kenya officially received its first shipment of lenacapavir, the long‑acting injectable HIV pre‑exposure prophylaxis (PrEP), a milestone in the country’s fight against new infections.
Delivered on February 17, 2026, through a partnership with the Global Fund, the consignment includes 21,000 starter doses from the United States. These doses will anchor the first phase of the national rollout, reinforcing Kenya’s commitment to innovative, people‑centered approaches to ending the HIV epidemic.
The initial rollout begins in March 2026, targeting 15 high‑burden counties under the National AIDS Control Programme (NASCOP). Health Director General Dr. Patrick Amoth, who received the shipment, confirmed that an additional 12,000 continuation doses are expected by April to support patients already initiated on the drug. Another 25,000 doses from the U.S. Government will follow to strengthen early implementation.
What Is Lenacapavir?
Lenacapavir is a long‑acting antiretroviral developed by Gilead Sciences. Administered under the skin of the abdomen twice a year, each injection contains just 1–2 mL of liquid—roughly the size of a bottle cap.
The drug works by blocking HIV’s capsid, the protective shell the virus needs to invade human cells. Without access to the capsid, HIV cannot multiply or spread.
Global Access and Licensing
Gilead currently supplies Kenya, but voluntary licensing agreements with generic manufacturers—primarily in India are expected to expand access. By 2027, lower‑cost versions should reach low‑ and middle‑income countries, widening affordability.
Safety Evidence: WHO’s Findings
The World Health Organization (WHO) reviewed lenacapavir’s safety in two major trials, PURPOSE 1 and PURPOSE 2 (2021–2024).
WHO concluded that lenacapavir is safe, with mostly mild side effects, limited resistance concerns, and no evidence of harm during pregnancy. Ongoing monitoring in Kenya will remain critical.
“Overall rates of adverse events were similar between LEN and oral PrEP (TDF/FTC), and most events were mild or moderate,” WHO guidelines note.
Common Side Effects
Injection‑site reactions were the most frequent: nodules, redness, or mild pain.
- PURPOSE 1: 68.8% of participants reported reactions.
- PURPOSE 2: 83.2% reported reactions.
These effects decreased over time and rarely led to discontinuation.
Resistance Concerns
Two participants in PURPOSE 2 acquired HIV despite receiving LEN. Both carried a mutation (N74D) linked to resistance against capsid inhibitors.
WHO stresses that the public health impact remains limited:
“Given LEN’s high efficacy and the rarity of breakthrough infections, resistance is unlikely to have a significant impact at present.”
Pregnancy Outcomes
Among 193 pregnancies in PURPOSE 1, no increase in adverse outcomes was observed compared to oral PrEP. Rates of miscarriage, prematurity, and low birth weight were similar across groups.
WHO concluded that no dose adjustment is needed during pregnancy.
Trial Results: PURPOSE 1 and 2
- PURPOSE 1 (South Africa & Uganda): 5,338 young women (16–26 years) participated. None of the women receiving LEN contracted HIV.
- PURPOSE 2 (Latin America, Africa, Asia, U.S.): 3,267 participants enrolled. Among 2,180 who received LEN, only two infections occurred. In contrast, nine infections were recorded among 1,087 participants on daily oral PrEP.
That translates to 99.9% protection for those using LEN.
Daily oral PrEP remains effective, but adherence can be difficult due to stigma, pill fatigue, or inconsistent access. LEN’s twice‑yearly dosing offers a powerful alternative.
WHO Director General Tedros Adhanom Ghebreyesus summed it up:
“While an HIV vaccine remains elusive, lenacapavir is the next best thing—a long‑acting antiretroviral shown to prevent almost all HIV infections among those at risk.”
Kenya’s Milestone
Kenya’s rollout signals readiness to adopt innovative HIV prevention strategies.
- Cost: The government set the price at Ksh. 7,800 per patient annually, a dramatic reduction from the earlier estimate of Ksh. 4.2 million.
- Regulatory Approval: Lenacapavir was approved by the U.S. FDA in June 2025, endorsed by WHO, and registered by Kenya’s Pharmacy and Poisons Board in January 2026.
- Policy Impact: By offering a twice‑yearly alternative, Kenya aims to improve adherence, expand access, reduce mother‑to‑child transmission, and advance Universal Health Coverage (UHC) goals.
