Geneva, Switzerland · 28 July 2022 — The World Health Organization released new guidelines recommending long-acting injectable cabotegravir (CAB-LA) as pre-exposure prophylaxis (PrEP) for HIV prevention, calling on countries to offer this safe and highly effective option to people at substantial risk of HIV infection. The guidelines were released ahead of the 24th International AIDS Conference (AIDS 2022) in Montreal.
The recommendation arrived at a critical moment. HIV prevention efforts had stalled, with 1.5 million new HIV infections in 2021 — the same as 2020. There were 4,000 new infections every day, with key populations (sex workers, men who have sex with men, people who inject drugs, people in prisons, and transgender people) and their sexual partners accounting for 70% of HIV infections globally.
How CAB-LA Works
CAB-LA is an intramuscular injectable, long-acting form of PrEP. The regimen consists of the first two injections administered four weeks apart, followed by an injection every eight weeks thereafter. This bimonthly schedule eliminates the need for daily oral medication, addressing one of the most significant barriers to PrEP effectiveness — adherence fatigue.
The trials demonstrated safety and high efficacy among cisgender women, cisgender men who have sex with men, and transgender women who have sex with men. HPTN 084, conducted in seven African countries, was particularly significant for demonstrating efficacy in cisgender women — a population that has historically had fewer biomedical prevention options.
"Long-acting cabotegravir is a safe and highly effective HIV prevention tool, but isn't yet available outside study settings," said Dr Meg Doherty, Director of WHO's Global HIV, Hepatitis and Sexually Transmitted Infections Programmes. "We hope these new guidelines will help accelerate country efforts to start to plan and deliver CAB-LA alongside other HIV prevention options, including oral PrEP and the dapivirine vaginal ring."
A Coalition for Access
Alongside the guidelines, WHO announced the launch of a new coalition to accelerate global access to CAB-LA. Convened by WHO, Unitaid, UNAIDS, and The Global Fund, the coalition's mandate includes:
- Identifying market interventions needed to advance near- and long-term access
- Establishing financing and procurement mechanisms for the drug
- Providing implementation support to global HIV prevention programmes
- Issuing policy guidance
Overcoming Barriers in Low- and Middle-Income Countries
Rachel Baggaley, Lead of the Testing, Prevention and Populations Team at WHO's Global HIV, Hepatitis and STI Programmes, was direct about the challenges:
"To achieve UN prevention goals, we must push for rapid, equitable access to all effective prevention tools, including long-acting PrEP. That means overcoming critical barriers in low- and middle-income countries, including implementation challenges and costs."
The guidelines highlighted several critical research gaps that need addressing before CAB-LA can be scaled effectively:
| Research Gap | Significance |
|---|---|
| HIV drug resistance | Risk if CAB-LA is administered to someone with undiagnosed acute HIV infection |
| HIV testing | Need for more sensitive rapid tests to detect acute infection before injection |
| Service delivery models | How to integrate injections into existing HIV and community health systems |
| Resource requirements | Cost of drug, training, cold chain, and clinic infrastructure |
| Safety in pregnancy/breastfeeding | Limited trial data for pregnant populations |
| Geographic/population coverage | Trials did not include all populations at risk |
Prevention Choice, Not Replacement
WHO emphasised that CAB-LA should not replace oral PrEP but rather expand the menu of prevention options. Both oral PrEP and CAB-LA are highly effective, and some people will continue to prefer daily oral medication. CAB-LA is likely to be preferred by people who find it difficult to take tablets or do not want to do so.
The agency also released new guidance on Differentiated and Simplified PrEP at AIDS 2022, supporting easier access including community-based delivery models. The overarching principle is one of choice — offering multiple prevention modalities so individuals can select what works best for their lives and circumstances.
The Road Ahead
WHO outlined a series of concrete next steps:
- Supporting countries and partners to include CAB-LA safely and effectively in HIV prevention programmes
- Working with Unitaid and other partners to develop implementation science projects addressing outstanding safety and operational questions
- Collaborating with The Global Fund, PEPFAR, and the Bill & Melinda Gates Foundation to support inclusion of CAB-LA in donor-funded programmes
- Hosting webinars through the WHO Global PrEP Network to provide up-to-date information for countries, communities, and implementers
The guidelines also noted that young people and key populations often face significant barriers accessing current PrEP services. WHO stressed that communities must be involved in developing and delivering HIV prevention services that are effective, acceptable, and support genuine choice.
The release of the CAB-LA guidelines at AIDS 2022 — the first in-person International AIDS Conference since the onset of COVID-19 — signalled a recommitment to HIV prevention innovation after two years of pandemic-related disruption that had set back testing, treatment, and prevention services worldwide.
Sources
- World Health Organization, "WHO recommends long-acting cabotegravir for HIV prevention," 28 July 2022.
- WHO, "Guidelines on long-acting injectable cabotegravir for HIV prevention," 2022.
- UN News, "Amidst stalled HIV prevention, WHO supports new long-acting preventive option," 28 July 2022.
- HPTN 083 and HPTN 084 trial publications.
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Institutional Research Desk · Foresight Institute of Research and Translation
The collective editorial and research translation board of FIRAT, synthesising peer-reviewed evidence, policy briefs, and division milestones across our seven foundational research pillars.
