World Health Organisation (WHO) has released new guidelines for the use of long-acting cabotegravir (CAB-LA) as pre-exposure prophylaxis (PrEP) for HIV.

Director of WHO’s Global HIV, Hepatitis and Sexually Transmitted Infections Programmes, Meg Doherty, called for countries to consider CAB-LA safe during the release of the new guidelines at a press conference on Thursday.

CAB-LA is an intramuscular injectable, long-acting form of PrEP, with the first 2 injections administered 4 weeks apart, followed thereafter by an injection every 8 weeks.

CAB-LA was shown to be safe and highly effective among cisgender women, cisgender men who have sex with men, and transgender women who have sex with men in 2 randomised controlled trials, HPTN 083 and HPTN 084.

At the briefing ahead of the 24th international AIDS conference (AIDS 2022) holding in Montréal, Canada, Doherty noted CAB-LA is highly effective prevention option for people at substantial risk of HIV infection.

She explained the guidelines will support countries as they plan for CAB-LA introduction and facilitate urgently needed operational research.

Consistent with previous WHO guidelines, the new CAB-LA guidelines are based on a public health approach that considers effectiveness, acceptability, feasibility and resource needs across a variety of settings.

The guidelines are designed to facilitate CAB-LA delivery and the operational research which is urgently needed to address implementation and safety issues.

These will inform decisions on how to successfully provide and scale up CAB-LA.

The guidelines highlight critical research gaps, including issues relating to HIV drug resistance, HIV testing, service delivery models, resource requirements, safety in pregnancy and breastfeeding, and provision of CAB-LA in geographies and for populations not included in the trials.

The guidelines also note that young people and key populations often experience challenges in accessing current PrEP services.

Doherty urged communities to be involved in developing and delivering HIV prevention services that are effective, acceptable and support choice.

President of AIDS 2022 host, the International AIDS Society (IAS), Prof Adeeba Kamarulzaman noted: “Long-acting PrEP could play a major role in ending the HIV pandemic, but right now, very few people can get it.”

The International Co-Chair of AIDS 2022 said: “Scaling up affordable access to this game-changing prevention tool must be a top global priority.”

Also at the briefing, researchers presented new data confirming that CAB-LA is safe and effective for PrEP in trans and cisgender women, ViiV Healthcare and the Medicines Patent Pool announced that they have signed a voluntary licensing agreement for patents relating to CAB-LA for PrEP.

WHO, Unitaid, UNAIDS and The Global Fund announced the launch of a global coalition to accelerate access to long-acting PrEP with AVAC as the secretariat.