A pill that could potentially offer a month of HIV protection with a single dose is moving closer to African production , but Kenyans will still have to wait for regulatory approval before it can become a prevention option.
Kenya has been selected to participate in plans to manufacture alimatravir, an investigational once monthly oral HIV pre-exposure prophylaxis (PrEP) drug being developed by Merck.
Kenyan pharmaceutical manufacturer Universal Corporation Limited (UCL) is among manufacturers that have entered voluntary licensing arrangements intended to support production of the drug in low and middle-income countries if it receives regulatory approval. Merck lists UCL among the manufacturers involved in its access strategy for the potential HIV prevention medicine.
Alimatravir is designed as a once monthly oral PrEP option, potentially offering an alternative to prevention methods that require more frequent dosing. Merck’s research programme describes the drug as an investigational candidate that could provide a month of HIV protection from a single tablet.
The drug is currently undergoing Phase 3 clinical trials, meaning researchers are evaluating its effectiveness and safety in much larger groups before regulators can consider an application for approval.
One of the Phase 3 studies, EXPrESSIVE-10, is being conducted among adolescent girls and young women in Kenya, South Africa and Uganda, with support from the Gates Foundation. Another Phase 3 study is being conducted across multiple countries involving people considered to have a greater likelihood of acquiring HIV.
Merck says it is investing in manufacturing capacity ahead of possible regulatory approval so that production can be scaled up in participating countries if the drug proves successful.
For Kenya, the development could further strengthen the country’s pharmaceutical manufacturing capacity and its role in producing medicines for the African market.
However, alimatravir is not yet an approved HIV prevention medicine. Its eventual availability will depend on the results of the ongoing trials and subsequent regulatory approvals.
