Kemri researchers inside a laboratory /photo courte/
Scientists at the Kenya Medical Research Institute (KEMRI) have urged the Kenyan government to expedite the approval of two promising new HIV prevention drugs that have shown exceptional efficacy in clinical trials.
KEMRI researchers are pushing for the Pharmacy and Poisons Board to greenlight the use of Cabotegravir and Lenacapavir—both long-acting injectable drugs that could provide a much-needed breakthrough in the fight against HIV in Kenya.
Francis Angira, the Clinical Trials Coordinator at KEMRI Kisumu, highlighted the significant potential of Cabotegravir—an injectable drug produced by GlaxoSmithKline (GSK). Despite its success in clinical trials, which show that it outperforms the widely used oral HIV prevention drug Truvada, Cabotegravir is still awaiting approval in Kenya.
“This injectable, administered every month for the first two months and then every two months thereafter, has shown a prevention rate three times higher than daily oral PrEP,” said Angira. He pointed to the drug’s approval by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as evidence of its effectiveness.
The second drug, Lenacapavir, developed by Gilead Sciences, offers even greater potential. With just two injections per year, it boasts nearly 100% efficacy in preventing HIV transmission.
However, both drugs come with a significant price tag. The annual cost of Cabotegravir is about USD 1,440 (Ksh 185,760), while Lenacapavir costs around USD 42,250 (Ksh 5.4 million) for a year’s supply. This high cost could limit accessibility, despite the drugs’ proven effectiveness.
Angira expressed frustration over the delay in the approval process for Cabotegravir in Kenya, despite the drug already being approved in other African countries that participated in the clinical trials. “We are appealing to the government to fast-track the approval process. These drugs have the potential to save countless lives and reduce the number of new HIV infections in Kenya,” he said.
In response, the Pharmacy and Poisons Board confirmed that Cabotegravir tablets and Cabotegravir injection were registered in Kenya on June 1, 2024, but clarified that no application has been submitted for Lenacapavir as of yet.
Despite effective biomedical prevention options like PrEP, Kenya continues to struggle with a high HIV prevalence, with more than 1.6 million people living with HIV, representing over 6% of the population. As the country works toward reducing HIV transmission, the availability of long-acting injectables like Cabotegravir could offer a significant advantage over daily oral medication, especially considering challenges related to adherence and stigma.
Global studies, including those conducted in sub-Saharan Africa, have shown that while oral PrEP use has increased substantially in recent years, coverage still falls short of the UNAIDS targets for HIV prevention. While more than 2.5 million people globally are now estimated to have used oral PrEP, many face difficulties maintaining a daily regimen.
The introduction of long-acting injectables could provide a much-needed alternative to oral PrEP, especially for those struggling with adherence or experiencing barriers to continued use. However, with Cabotegravir’s approval still pending and Lenacapavir yet to be submitted for review, it may take several more years before these drugs are widely available to Kenyans.
Nyanza region is currently experiencing a surge in the number of new infections with Homabay county leading with HIV prevalence of 26% followed by Kisumu and Migori with prevalence of 19.9% and 14.3% respectively.
