Kenya to Make Monthly HIV Prevention Pill (Alimatravir)

A Kikuyu-based manufacturer is preparing to produce alimatravir, an investigational once-monthly HIV prevention tablet. Production will only go ahead if the drug clears clinical trials and is approved by regulators.

Alimatravir (also known as MK-8527) is being developed by Merck, which trades as MSD outside the United States and Canada. It is designed as a monthly form of pre-exposure prophylaxis (PrEP), a medicine that HIV-negative people take to lower their risk of infection.

Merck has signed seven non-exclusive, royalty-free licences with generic manufacturers, allowing them to make and sell the drug in 129 low- and lower-middle-income countries if it is approved. Three of the licensees are in sub-Saharan Africa: Universal Corporation Limited (UCL) in Kenya, Quality Chemical Industries Limited (Qcil) in Uganda and Aspen Pharmacare in South Africa. The other four are Indian firms: Aurobindo, Cipla, Emcure and Viatris. Merck says this is the first time African manufacturers have been included from the start of an HIV product licence.

Kenya’s role

UCL operates from Kikuyu, on the outskirts of Nairobi. The company says it holds WHO prequalification and supplies more than 23 countries, and its Kikuyu site appears on WHO’s prequalified list.

In July 2026, Unitaid announced it would help UCL, Qcil and Aspen prepare for possible production. The support comes through the Medicines Supply Resilience (MedSuRe) Africa programme, which is funded by Unitaid and the European Union and led by the US Pharmacopeia. The aim is to build capacity before approval rather than years after it.

Still an experimental drug

Alimatravir is not approved anywhere. It is being tested in two Phase 3 trials, both currently enrolling:

• EXPrESSIVE-10 is testing it in adolescent girls and young women in Kenya, South Africa and Uganda, in collaboration with the Gates Foundation.
• EXPrESSIVE-11 involves 4,390 participants in 16 countries, including Kenya. It enrols gay, bisexual and other men who have sex with men, along with transgender and gender non-binary people. It compares alimatravir with daily oral PrEP and is expected to run through July 2027. Some reports say final results will not arrive until late 2027.

Earlier research was more limited. A Phase 2 study gave 350 adults at low risk of HIV exposure monthly doses or placebo for six months. It was designed to test safety and drug levels, not protection. Merck reported similar rates of adverse events across groups and no clinically meaningful changes in average CD4 or lymphocyte counts. Independent coverage adds that two participants had CD4 or lymphocyte drops that met the study’s stopping rules, and both recovered within 11 weeks. That detail is worth watching, because an earlier drug from the same family raised CD4 concerns.

How the drug works

Merck describes alimatravir as a nucleoside reverse transcriptase translocation inhibitor. In simple terms, it interferes with the process HIV uses to copy its genetic material. Merck’s data suggest one dose could protect for a month, starting within about an hour. Whether it protects as well as existing options is what the Phase 3 trials will show.

Why local production matters

Kenya still imports an estimated 70 to 80 per cent of its medicines, according to WHO, and local firms produce only about 20 per cent of those on the Essential Medicines List. In June 2026 the government launched a 2026–2030 strategy to expand domestic production of medicines, vaccines and diagnostics.

Making a drug closer to patients could shorten supply chains and lower costs. Projections suggest a full year of pills, 12 tablets, could cost about $5 (roughly Sh645). That figure is an estimate and depends on approval and market conditions.

Limits of the plan

Licences and factory preparation are not approval, and they do not guarantee supply. Some advocates have also noted that the 129-country list leaves out several Latin American countries that are hosting the trials, and they have asked Merck for an access plan for those countries.

Other options in Kenya

Kenya already has a different long-acting prevention product. In February 2026, it received its first 21,000 doses of lenacapavir, an injection given twice a year and imported from Gilead. Alimatravir would be an additional oral option if it succeeds.

What happens next

The trials must finish, regulators must review the results, and governments must decide on purchasing and distribution. Until then, alimatravir remains a promising candidate rather than an approved medicine.