EXECUTIVE SUMMARY

Purpose
Achieving the Global AIDS target for 2025 of ensuring that 95% of people at risk of HIV acquisition have access to HIV prevention options requires a focus on expanding effective HIV prevention choices. Pre-exposure prophylaxis (PrEP) is a key component of combination HIV prevention. In 2015 the World Health Organization (WHO) recommended oral PrEP containing tenofovir disoproxil fumarate (TDF) for people at substantial risk of HIV (1) and, in 2021, recommended the dapivirine vaginal ring (DVR) for cisgender women at substantial risk of HIV (2). Although expansion of access to and uptake of oral PrEP has been slow, more countries are now including oral PrEP in their national guidelines and there is increasing access and uptake, especially in sub–Saharan Africa. Although some countries have begun to include the DVR in their national guidelines, no country has yet started to provide the DVR in their national programme. Potential barriers to the uptake and effective use of oral PrEP, such as not wanting to take an oral pill regularly, may be overcome with a long-acting injectable option. This new guidance recommends offering such an option: long-acting injectable cabotegravir (CAB-LA). Offering additional PrEP choices has the potential to increase uptake and effective use of PrEP, and HIV prevention overall, as it allows people to choose a method that they prefer.
Since the release of the recommendation for the DVR, included in the WHO 2021 Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring (3), new evidence from two randomized controlled trials (RCTs) has emerged on the efficacy of CAB-LA. Ministries of health, implementers and communities have asked WHO to review the evidence and provide guidance in a timely manner on this additional effective HIV PrEP option.
This guideline outlines the rationale and evidence for a new recommendation on HIV prevention. Consistent with previous WHO guidelines, this guideline is based on a public health approach that considers effectiveness, acceptability, feasibility and resource needs across a variety of settings. This guideline also highlights important considerations for effective implementation and the need for implementation science to address research gaps across a variety of geographies and populations.