Learn About Cabotegravir PrEP and HIV Prevention Research

Pre exposure prophylaxis, commonly called PrEP, refers to the use of antiretroviral medicines by people who do not have HIV to reduce their risk of acquiring the infection. The World Health Organization recommends long acting injectable cabotegravir as an additional PrEP option for people at substantial risk of HIV infection. Cabotegravir works by inhibiting HIV integrase, an enzyme the virus needs to incorporate its genetic material into human cells.

Understanding Cabotegravir PrEP

Long acting cabotegravir provides an alternative to daily oral PrEP. In the United States, the FDA approved injectable cabotegravir for PrEP in 2021 for adults and adolescents weighing at least 35 kilograms who are at risk of sexually acquired HIV. It is administered by a healthcare professional as an intramuscular injection.

Important aspects of cabotegravir PrEP include:

• It is intended for people who are HIV negative and at risk of acquiring HIV.
• HIV testing is required before starting treatment and before subsequent injections.
• The medicine is administered as a long acting injection rather than a daily tablet.
• It is used as part of broader HIV prevention strategies.
• Cabotegravir does not prevent other sexually transmitted infections.

The requirement for HIV testing is particularly important because using cabotegravir PrEP during an undiagnosed HIV infection can contribute to drug resistance. The FDA prescribing information therefore emphasizes confirming HIV negative status before starting and before each injection.

What Research Shows About Cabotegravir

Clinical research has examined whether long acting cabotegravir can reduce HIV acquisition compared with daily oral PrEP. In the HPTN 083 randomized clinical trial, which included cisgender men who have sex with men and transgender women, participants receiving injectable cabotegravir experienced fewer HIV infections than participants receiving daily tenofovir disoproxil fumarate and emtricitabine. The trial included more than 4,500 participants and followed them for approximately three years.

Research findings have highlighted several areas:

• HPTN 083 demonstrated high efficacy of injectable cabotegravir in the studied population.
• Another phase III trial evaluated cabotegravir among women in sub Saharan Africa.
• Injection site reactions were common in clinical research, although most were considered manageable.
• Researchers have investigated HIV infections occurring during cabotegravir use and the possibility of integrase inhibitor resistance.
• Studies continue to examine how long acting PrEP can be delivered effectively in different populations and healthcare settings.

The WHO subsequently recommended long acting injectable cabotegravir as an additional HIV prevention choice in 2022, based on evidence from randomized controlled trials.

Cabotegravir is therefore one component of an expanding HIV prevention field. WHO currently recognizes several PrEP approaches, including oral tenofovir based PrEP, the dapivirine vaginal ring, long acting injectable cabotegravir, and long acting injectable lenacapavir.

Research into cabotegravir also considers practical issues such as access to HIV testing, healthcare delivery, injection schedules, cost, acceptability, and retention in prevention programs. These factors can influence how effectively a prevention method works at the population level, beyond its biological efficacy in clinical trials. WHO guidance also identifies implementation and research gaps that need continued attention.

Cabotegravir PrEP represents an important development in HIV prevention research because it provides a long acting alternative to daily oral medication. Evidence from clinical trials supports its effectiveness in reducing HIV acquisition among studied populations, while ongoing research continues to examine resistance, testing strategies, delivery models, and access. As additional long acting prevention medicines become available, understanding the evidence behind each option can help inform comprehensive HIV prevention programs.