- This practice brief provides guidance for clinicians regarding the implementation of injectable pre-exposure prophylaxis (PrEP) to prevent HIV infection in high-risk populations.
- Data strongly suggest that the use of injectable cabotegravir (600 mg/3mL) every two months, in concert with safer sex practices, reduces the risk of HIV-1 acquisition by approximately 99% — with only a very small number of infections (related to resistant HIV strains) occurring in those who are adherent.
- This administration approach might be beneficial to those at risk for HIV infection for which adherence may be challenging.
- Guidelines for injectable PrEP are written and updated by the U.S. Public Health Service, U.S. Department of Health and Human Services and the Centers for Disease Control and Prevention (CDC).
- All sexually active adults and adolescents should be educated about PrEP as a strategy to help prevent HIV.
- The U.S. Preventive Services Task Force (USPSTF) has assigned the use of daily oral PrEP to prevent HIV with a Grade A. However, concerns about the cost and access to injectable PrEP may be greater than those associated with oral PrEP. Drug manufacturers and public agencies can provide financial and access assistance.
- Injectable PrEP might be beneficial in young men who have sex with men (MSM), people with substance use disorders and those living in poverty or who have depression, conceal their use of PrEP or are otherwise challenged with adherence.
- Before starting injectable PrEP, patients should be screened for HIV, bacterial STIs and hepatitis B; baseline renal and hepatic function should also be assessed.
- MSM and persons who inject drugs (PWIDs) should also be screened for hepatitis C.
- A negative HIV screening should be obtained within one week of starting injectable cabotegravir.
- Using an injectable lead-in strategy, an initial dose of cabotegravir 600 mg (in 3 mL) is administered intramuscularly (IM) in the dorsal gluteal muscle; a second dose is given four weeks after this first dose and then every eight weeks thereafter. An oral lead-in approach uses this same schedule but is preceded by at least 28 days of daily oral cabotegravir 30 mg, with the first injectable dose given on the final day of the oral lead-in.
- Injectable PrEP patients should be screened for HIV one month after the first injection and at follow-up visits every two months (both HIV Ag/Ab test and HIV-1 RNA assay). MSM and transgender women who have sex with men should additionally be screened for bacterial sexually transmitted infections (oral, rectal, urine, blood) every four months, while sexually active heterosexual men and women should be screened (vaginal, rectal, urine — as indicated) every six months. Ongoing lipid and renal evaluations are unnecessary.
- Common adverse events associated with injectable cabotegravir include injection site reactions, diarrhea, headache, pyrexia and fatigue.
- Clinicians should provide continuing guidance on safer sexual decision-making and answer any questions that arise while using PrEP throughout the ongoing regimen.
- HIV continues to disproportionately affect MSM, African Americans and Latinx persons; and these persons are more likely to experience access challenges and may also experience financial barriers to PrEP.
- Knowledge of public health and drug manufacturer resources is essential to help patients overcome access and financial barriers to initiating and maintaining a PrEP regimen.
- Billing code considerations: Z91.89; Z79.899; Z29.9.
Centers for Disease Control and Prevention: U.S. Public Health Service. (2021). Preexposure prophylaxis for the prevention of HIV infection in the United States—2021 Update: a clinical practice guideline. https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf.
Christopher Blackwell, PhD, APRN, ANP-BC, AGACNP-BC, CNE, FAANP, FAAN
Reviewers and Contributors
Tina Bettin, DNP, MSN, RN, FNP-BC, APNP, FAANP
Leann Fowler, DNP, MBA, APRN, AGACNP-BC, CNE
Paula McCauley, DNP, APRN, ACNP-BC, CSC, CMC, FAANP
Anthony Roberson, PhD, PMHNP-BC, RN, FAANP
Nanette Alexander, DNP, APRN, ANP-BC, FAANP
Robin Arends, DNP, CNP, FNP-BC, CNE, FAANP
Karen Greco, PhD, ANP-BC, FAAN, FAANP
Tearsanee Davis, DNP, FNP-BC, FAANP
Diane Padden, PhD, CRNP, FAANP