Kenyan research scientists are urging the government to expedite the approval process for two revolutionary drugs—Cabotegravir and Lenacapavir—that promise to transform HIV prevention efforts. According to the Kenya Medical Research Institute (KEMRI), these drugs have demonstrated remarkable efficacy in reducing HIV infections, potentially offering a significant leap in the fight against the epidemic.
The Promise of Cabotegravir and Lenacapavir
Cabotegravir, an injectable drug manufactured by GlaxoSmithKline (GSK), has shown unparalleled effectiveness in clinical trials. Francis Angira, Clinical Trials Coordinator at KEMRI Kisumu, emphasizes its potential: “Cabotegravir long-acting injectable, administered as two initial doses one month apart and then every eight weeks, has shown a prevention rate surpassing that of widely used oral HIV prevention drugs like Truvada.”
The drug has already received approvals from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Studies indicate that Cabotegravir reduces HIV risk threefold compared to oral pre-exposure prophylaxis (PrEP), addressing adherence challenges associated with daily medication.
Lenacapavir, developed by Gilead Sciences, is another promising injectable that requires administration every six months. Boasting an almost 100% prevention rate, Lenacapavir represents a groundbreaking development in HIV prophylaxis. “Both drugs are significant advancements,” says Angira. However, their high costs—$1,440 (KES 185,760) annually for Cabotegravir and $42,250 (KES 5.4 million) annually for Lenacapavir—pose formidable accessibility challenges.
Regulatory Hurdles
Despite its potential, Cabotegravir’s journey to Kenyan markets has faced delays. Although the Kenya Pharmacy and Poisons Board registered Cabotegravir tablets and injections on June 1, 2024, KEMRI researchers express frustration at the prolonged process. Lenacapavir, on the other hand, has yet to receive any formal application for approval in Kenya.
Angira highlights the urgency: “If these drugs are approved and made accessible, we could significantly reduce new HIV infections and save countless lives.” He notes that other African countries involved in the clinical trials have already approved Cabotegravir, putting Kenya at risk of lagging behind in implementing cutting-edge prevention strategies.
The Burden of HIV in Kenya
With 1.6 million Kenyans living with HIV—over 6% of the population—the country faces an ongoing battle against the epidemic. Despite existing biomedical prevention options, new infections persist. Long-acting injectables like Cabotegravir and Lenacapavir could address adherence challenges and stigma that deter many from using oral PrEP.
Globally, the use of oral PrEP has risen from 200,000 people in 2017 to 2.5 million in 2023, yet this remains far below UNAIDS targets for controlling the HIV pandemic. CAB-LA (Cabotegravir Long-Acting) has the potential to bridge this gap by offering a less burdensome, highly effective prevention method.
Government Response
The Pharmacy and Poisons Board confirmed the registration of Cabotegravir in Kenya but noted the absence of an application for Lenacapavir. This highlights the need for proactive collaboration among stakeholders to accelerate access to these drugs. “We appeal to the government to fast-track the approval process and ensure equitable access,” Angira urges.
Conclusion
The introduction of Cabotegravir and Lenacapavir marks a critical turning point in HIV prevention. While their high costs and regulatory delays remain barriers, the potential benefits far outweigh the challenges. Expedited approval and strategic subsidization could enable Kenya to harness these advancements, moving closer to achieving global HIV prevention targets and saving lives in the process.
