Gov’t Approves Twice-Yearly HIV PrEP Injection

The Ministry of Health has approved the use of the new long-acting HIV prevention injection in the country following rigorous regulatory processes.

In a statement on Saturday, January 10, Health Cabinet Secretary Aden Duale said the ministry has moved to clear the new HIV prevention medicine for use in the country through the Pharmacy and Poisons Board (PPB).

"The Ministry of Health, through the Pharmacy and Poisons Board, has recommended the registration of Lenacapavir 300 mg tablets and Lenacapavir 464 mg solution for injection, a long-acting antiretroviral medicine for HIV pre-exposure prophylaxis (PrEP)," the statement read.

According to Duale, the decision was not taken lightly and was based on a detailed review process that met both local and international regulatory requirements.

"This recommendation follows a comprehensive scientific assessment of the quality, safety, and efficacy of Lenacapavir, conducted in line with Kenyan law and applicable international regulatory standards," the statement added.

Duale noted that Kenya’s recommendation places the country at the forefront of regulatory action on the continent and reflects alignment with global public health guidance on HIV prevention innovations.

"Kenya is among the first African countries to recommend Lenacapavir for registration, a decision that aligns with recent global public health guidance, including recommendations by the World Health Organization, and reflects the country's growing regulatory capacity and leadership in enabling timely access to innovative health technologies of public health importance," the statement further read.

Duale explained that Lenacapavir prevents HIV infection by targeting key stages of the virus’s lifecycle and offers a major advantage over daily pills due to its long-acting nature.

"Lenacapavir works by interfering with critical stages of the human immunodeficiency virus (HIV) lifecycle, thereby preventing HIV infection. Its long-acting formulation allows it to be administered only twice a year, offering an important alternative to daily oral HIV prevention medicines. This is particularly beneficial for individuals who face challenges with taking pills every day," the statement continued.

While Kenya has expanded access to daily oral PrEP nationwide, Duale acknowledged that adherence challenges remain for some users, making long-acting options a critical addition to prevention strategies.

"Kenya has made significant progress in expanding access to daily oral PrEP across all 47 counties. However, some people experience difficulties with long-term daily pill use due to factors such as pill fatigue, stigma, or challenges with adherence. Long-acting injectable prevention options like Lenacapavir have the potential to address these challenges by reducing how often medicine needs to be taken and broadening access to effective HIV prevention," the statement noted.

Duale further revealed that Kenya has been selected as a priority country for the initial introduction of Lenacapavir, with planning already underway to ensure fair and timely access.

"Kenya has been prioritised for the initial rollout of Lenacapavir through global partnerships, and preparatory planning is underway to ensure the medicine is introduced in a timely, equitable, and responsible manner for populations at substantial risk of HIV infection," the statement concluded.

This comes barely a month after the Pharmacy and Poisons Board (PPB) issued a public notice warning manufacturers, importers, distributors, wholesalers, retailers and supermarkets against the sale and distribution of unregistered, falsified and counterfeit health products in Kenya.

In the notice dated Tuesday, December 9, the regulator also cautioned supermarkets, cosmetic shops, household goods stores, online sellers and other general retail outlets against stocking or selling prescription-only medicines, saying such practices violate the law and will attract regulatory action.

PPB warned that the importation, possession, distribution, sale or use of unregistered, falsified, counterfeit or recalled health products is illegal within the Republic of Kenya and will lead to serious consequences for those involved.

According to the regulator, individuals and entities found handling such products risk prosecution and criminal liability, including action against superintendent pharmacists or pharmaceutical technologists, persons acting under their direction, managers or persons in charge of premises, as well as directors and owners of the establishments.

The Board further said enforcement measures may include suspension or revocation of operating licences and the closure of premises found to be in violation of the law.

On the sale of medicines in retail outlets, PPB reiterated that supermarkets, cosmetic shops, household goods stores, online sellers and other general retailers are not authorised to stock, sell or supply prescription-only medicines.

The regulator warned that any outlet found contravening this requirement will be subject to regulatory sanctions, including prosecution of owners, managers and directors, and advised businesses unsure of which health products they may lawfully sell to seek guidance directly from the Board.