Research scientists in Kenya are urging the government to expedite the approval process for Cabotegravir and Lenacapavir, two new injectable drugs demonstrating high efficacy in preventing HIV. These appeals come as Kenya continues to grapple with a significant HIV burden, with 1.6 million people living with HIV/AIDS, representing over 6% of the population.
Cabotegravir: A Long-Acting Injectable
Francis Angira, Clinical Trials Coordinator at KEMRI Kisumu, highlighted the efficacy of Cabotegravir, a long-acting injectable 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 surpasses that of widely used oral HIV prevention drugs like Truvada. Approvals have already been granted by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Studies have indicated that Cabotegravir results in a three-fold more efficient reduction in HIV risk compared to daily oral PrEP, where adherence to daily medication remains a significant 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
Lenacapavir, developed by Gilead Sciences, is another injectable drug that offers protection with an injection every six months, demonstrating an almost 100% prevention rate. According to Mr. Angira, Lenacapavir represents a significant advancement in HIV prevention. However, no application for Lenacapavir has been submitted by any Marketing Authorization Holder in Kenya.
Accessibility and Cost Concerns
Despite their efficacy, both drugs face accessibility challenges due to their high costs. A year's treatment with Cabotegravir is priced at U$1,440 (Kshs. 185,760), while Lenacapavir costs U$42,250 (approximately Ksh 5.4 million) for the same duration. These high costs pose a significant barrier to widespread adoption, particularly in resource-limited settings.
Call for Expedited Approval
KEMRI is appealing to the government, through the Pharmacy and Poisons Board, to fast-track the approval process for these drugs. Approving these drugs could significantly reduce new HIV infections and save lives. Despite efforts to reduce HIV prevalence, CAB-LA PrEP may not be widely available in Kenya for several years due to delays in regulatory approvals.
Studies worldwide, including those in sub-Saharan Africa, have demonstrated barriers to the continuation of oral PrEP, including adherence challenges and stigma. CAB-LA presents a viable alternative to address these issues. The number of people estimated globally to have ever used oral PrEP increased from 200,000 in 2017 to 2.5 million in 2023, but PrEP coverage remains below UNAIDS estimated targets for HIV pandemic control.
