In the past 12 years, 6.2 million individuals globally have been prescribed PrEP since its initial approval by the US FDA. The majority of these prescriptions, 1.4 million, have been issued in the past two years. However, oral PrEP’s effectiveness is contingent on high adherence, posing challenges for certain high-risk groups. Research indicates that long-acting injectable PrEP (cabotegravir and Lenacapavir) surpasses oral PrEP in efficacy. LA PrEP offers a broader range of effective and acceptable prevention choices, overcoming oral tablet use challenges and enhancing prevention uptake.
Despite LA Cabotegravir (CAB) being approved by the US FDA in 2021 and by the WHO in 2022, its rollout has been sluggish. Only approximately 11,000 prescriptions for CAB LA have been issued in the US since approval, compared to an estimated 382,000 annual PrEP users. Globally, especially in the global South, CAB-LA has seen limited uptake, primarily through implementation science projects in Africa and Asia.
In the United States and high-income countries, the high cost of cabotegravir the intricate medication acquisition pathways for health centres delay national implementation. Healthcare organizations face intense staffing requirements for medication acquisition, insurance paperwork, process documentation, billing, injection administration, appointment scheduling, and client follow-up. Low- and middle-income countries (LMICs) face limited availability and access to cabotegravir. The production of generic medication is a lengthy process, with the first generic dose expected by 2027 for LMICs. PEPFAR’s potential aggressive rollout in Africa, which involved purchasing and distributing the medication, faces setbacks. Global Fund, PEPFAR, and the Bill and Melinda Gates Foundation (BMGF) announced efforts to ensure two million people have equitable access to affordable Lenacapavir for three years. Recent termination of several PEPFAR grants further complicates these efforts.
Overcoming the implementation challenges of cabotegravir, the first long-acting agent to market, will offer valuable lessons for future agents like Lenacapavir, administered every six months.The potential for LA PrEP to revolutionize HIV prevention is immense, but scaling it effectively requires addressing the aforementioned barriers and ensuring equitable access across different regions.