Research scientists have asked the government of Kenya to hasten the process of approving two new drugs that study have the highest efficacy of preventing HIV.
The researchers at the Kenya Medical Research institute (KEMRI) want the pharmacy and poisons board to approve Cabotegravir and Lenacapavir to ease the burden for HIV in the country.
The clinical trials coordinator at KEMRI Kisumu, Francis Angira, said Cabotegravir, an injectable drug manufactured by GlaxoSmithKline (GSK), has not been approved by the government for use despite its remarkable efficacy in preventing HIV.
“I am acutely aware of the pressing battles faced by those living with HIV but from clinical trials, Cabotegravir long acting injectable, a drug which requires two injections 1 month apart, followed by injections every eight weeks, has shown a prevention rate that eclipsed that of the widely used HIV prevention drugs like Truvada.” Said Mr. Angira.
He went on: “The positive results from clinical trials have led to approvals from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA),”
Together, these landmark studies found that use of CAB-LA resulted in three times more efficient reduction in HIV risk compared with oral PrEP, where adherence to taking daily oral medication remains a challenge.
On the other hand, Mr. Angira says, the second drug, Lenacapavir, also an injectable and developed by Gilead Sciences can provide protection with an injection every six months, boasting an almost 100 percent prevention rate.
“Both of these drugs represent significant advancements in HIV prevention,” he said, arguing that, “But we face a formidable challenge of accessibility since they are very expensive.”
Cabotegravir goes for U$1,440 (Ksh185,760) for a year’s treatment whereas Lenacapavir goes for U$42,250—about Ksh 5.4 million—for a year of treatment.
He expressed frustrations that the Kenya Pharmacy and Poisons Board had been hesitant to approve Cabotegravir for use in Kenya for more than a year now despite the drugs getting approval in other African countries that participated in the clinical trials.
“As KEMRI, we are humbly appealing to the government through the Pharmacy and Poisons Board to fast track the approval process for Kenyans to find reprieve by reducing new HIV infections” he said, adding, “if the two drugs are approved and Kenyans get the treatment, we will save lives.”
Pharmacy and poisons Board in response said Cabotegravir Sodium (30mg) tablets (Apretude tablets by GlaxoSmithKline) was registered in Kenya on the 1st June, 2024.
Cabotegravir 200mg/ml injection (Apretude Intramuscular Injection by GlaxoSmithKline) was registered in Kenya on the 1st June, 2024 but no application of Lenakapavir has been made by any Marketing Authorization Holder in Kenya.
In Kenya, despite efficacious biomedical prevention options, HIV infections are ongoing with 1.6 million people living with HIV/AIDS which is more than 6 percent of the population.
Despite the efforts to reduce HIV prevalence and achieve the UN prevention goals, CAB-LA PrEP may not be widely available in Kenya for several years due to the government delay to complete the regulatory approvals.
Studies around the world, including those done in sub-Saharan Africa, demonstrate a range of barriers to continuation of oral PrEP during periods of risk, including adherence challenges and stigma and CAB-LA may be an option to this.
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.
