Research scientists at the Kenya Medical Research Institute (KEMRI) are urging the Kenyan government to expedite the approval of Cabotegravir and Lenacapavir, two new drugs demonstrating high efficacy in preventing HIV. These recommendations come as Kenya continues to grapple with a significant HIV burden, with over 1.6 million people living with HIV/AIDS, representing more than 6% of the population.
Cabotegravir: A Long-Acting Injectable Option
Francis Angira, the clinical trials coordinator at KEMRI Kisumu, highlighted the potential of Cabotegravir, a long-acting injectable drug manufactured by GlaxoSmithKline (GSK). Cabotegravir requires two initial injections one month apart, followed by injections every eight weeks. Clinical trials have demonstrated that Cabotegravir's prevention rate exceeds that of widely used oral HIV prevention drugs like Truvada. Angira noted that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have already approved the drug based on these positive trial results.
Studies have indicated that Cabotegravir long-acting (CAB-LA) results in a three times more efficient reduction in HIV risk compared to daily oral PrEP, where adherence to daily medication remains a challenge. The Pharmacy and Poisons Board has registered Cabotegravir Sodium (30mg) tablets (Apretude tablets by GlaxoSmithKline) and Cabotegravir 200mg/ml injection (Apretude Intramuscular Injection by GlaxoSmithKline) in Kenya on June 1, 2024.
Lenacapavir: Six-Monthly Protection
The second drug, Lenacapavir, developed by Gilead Sciences, is also an injectable. It offers protection with an injection every six months, boasting an almost 100 percent prevention rate, according to Angira. However, no application for Lenacapavir has been submitted by any Marketing Authorization Holder in Kenya.
Accessibility and Cost Challenges
Despite the promise of these drugs, accessibility remains a significant concern due to their high cost. A year's treatment with Cabotegravir costs $1,440 (Ksh185,760), while Lenacapavir costs $42,250 (approximately Ksh 5.4 million) for the same duration. Angira expressed frustration with the Kenya Pharmacy and Poisons Board's delay in approving Cabotegravir for use in Kenya, despite approvals in other African countries that participated in clinical trials.
Call to Action
KEMRI is appealing to the government, through the Pharmacy and Poisons Board, to expedite the approval process. Approving these two drugs could offer Kenyans a significant reprieve by reducing new HIV infections and saving lives. While the number of people using oral PrEP has increased globally, from 200,000 in 2017 to 2.5 million in 2023, PrEP coverage remains below UNAIDS targets for HIV pandemic control. The introduction of CAB-LA PrEP may face delays in Kenya due to pending regulatory approvals, despite its potential to overcome adherence challenges and stigma associated with oral PrEP, as demonstrated in studies across sub-Saharan Africa.
