Nairobi, Kenya — September 26, 2025 (EAT).

Millions of people in Kenya and other low- and middle-income countries are poised to benefit from a breakthrough HIV prevention tool, with the cost of the twice-yearly injectable lenacapavir slated to drop dramatically under a new generics deal.

The Latest

• The Bill & Melinda Gates Foundation has partnered with Indian drug manufacturer Hetero Labs to facilitate the production of a low-cost generic version of lenacapavir, aiming to make it available at roughly US$40 per year(about KSh 5,100) after a short oral pre-treatment regimen. 

• This arrangement is part of a broader push: parallel deals between Unitaid, CHAI (Clinton Health Access Initiative), Wits RHI, and Dr. Reddy’s Laboratories intend to expand generic access across 120 low- and middle-income countries by 2027. 

• Lenacapavir was approved by the U.S. Food and Drug Administration and the European Commission earlier in 2025 as a PrEP option, delivering six months of HIV protection via a single injection. 

Context & Significance

• PrEP (Pre-Exposure Prophylaxis) has primarily relied on daily oral pills, which pose adherence challenges and stigma for some users. Lenacapavir’s six-month dosing could overcome those barriers. 

• Gilead Sciences, which developed lenacapavir (branded as Yeztugo / Yeytuo), had already granted royalty-free licenses to six generic manufacturers to supply in 120 countries. 

• The generics agreements are accompanied by volume guarantees, upfront funding, and support to accelerate regulatory approvals and market readiness. 

Risks, Implications & What It Could Mean for Kenya

Opportunities & Benefits

• If Kenya adopts lenacapavir early, the country could reach at-risk populations who struggle with daily pill regimens, particularly in high HIV prevalence counties (e.g. Homa Bay, Kisumu).

• The reduced cost might ease the burden on national health budgets, especially when combined with donor support, making scale-up more sustainable.

• The shift may accelerate reductions in new HIV infections if usage is scaled adequately across vulnerable groups.

Risks & Challenges

• Access is contingent on regulatory approvals in Kenya and procurement systems that can absorb the generic version.

• While the price is projected to be low, the injection requires cold chain, trained health personnel, and patient follow-up, which are logistical demands especially in rural areas.

• The 120-country licensing scheme excludes some regions, raising concerns about equity and access in countries not covered. 

What We Don’t Know Yet

• The exact timeline when Kenya will begin to roll out generic lenacapavir.

• The terms of government procurement and subsidy models—whether patients will pay or it will be offered free in public health facilities.

• Whether existing public health infrastructure (cold storage, injection capacity) can scale sufficiently.

• How demand will compare to supply, and whether there will be shortages or stockouts early on.

Timeline

• June 2025: U.S. FDA approves lenacapavir for PrEP use. 

• September 24, 2025: Gates Foundation & Hetero Labs announce partnership to produce affordable generics. 

• 2027 (projected): Generic lenacapavir expected to be widely available in 120 low- and middle-income countries. 

What to Watch

• Kenya’s Health Cabinet and Pharmacy & Poisons Board announcements on regulatory approval.

• Procurement frameworks from MoH and donors (Global Fund, PEPFAR) for the injection.

• Implementation in pilot counties or high-HIV zones, and monitoring uptake.

• Impact on oral PrEP usage, whether users switch or combine options.