Research scientists are calling on the government to faster the approval of two innovative HIV prevention drugs, Cabotegravir and Lenacapavir.
Studies show these drugs have the highest efficacy in reducing HIV transmission compared to existing options.
The Kenya Medical Research Institute (KEMRI) has appealed to the Pharmacy and Poisons Board to approve the two injectable drugs to alleviate the HIV burden in the country.
Francis Angira, a clinical trials coordinator at KEMRI Kisumu, highlighted the effectiveness of Cabotegravir, developed by GlaxoSmithKline (GSK).
“Clinical trials demonstrate that Cabotegravir, a long-acting injectable requiring just two initial doses one month apart and subsequent injections every eight weeks, significantly outperforms current prevention drugs like Truvada,” said Angira.
He also noted that the drug has already been approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Cabotegravir has been found to reduce the risk of HIV infection three times more effectively than oral PrEP (pre-exposure prophylaxis), which relies on strict daily adherence.
Meanwhile, Lenacapavir, developed by Gilead Sciences, offers protection with an injection every six months and boasts an almost 100% prevention rate.
“These drugs mark a significant advancement in HIV prevention,” Angira said.
Affordability
However, he acknowledged the challenge of affordability, with Cabotegravir costing $1,440 (approximately Ksh 185,760) per year and Lenacapavir priced at $42,250 (about Ksh 5.4 million) annually.
Despite Cabotegravir receiving registration approval in Kenya as of June 1, 2024, Angira expressed frustration over delays in its rollout and the lack of any application for Lenacapavir.
He urged the government to fast-track regulatory processes, emphasizing that timely access to these drugs could save countless lives.
“We humbly appeal to the government through the Pharmacy and Poisons Board to speed up approvals. Making these drugs accessible to Kenyans will help reduce new HIV infections and save lives,” Angira stated.
1.6 Million Kenyans living the HIV
Kenya continues to face a significant HIV burden, with 1.6 million people living with the virus, representing over 6% of the population.
Despite the availability of effective biomedical prevention options, challenges such as adherence to oral PrEP and social stigma persist.
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Injectable alternatives like Cabotegravir and Lenacapavir could address these barriers.
Globally, the use of oral PrEP has increased, with the number of users rising from 200,000 in 2017 to 2.5 million in 2023. However, PrEP coverage still falls short of the targets set by UNAIDS for controlling the HIV pandemic.
While the Pharmacy and Poisons Board confirmed the registration of Cabotegravir tablets and injections in Kenya, they noted that no application for Lenacapavir had been submitted by any marketing authorization holder.
Nevertheless, researchers hope that the government will prioritize access to these drugs to meet the country’s prevention goals and improve public health outcomes.
