What is the role of cabotegravir (CAB) injections in HIV (Human Immunodeficiency Virus) pre-exposure prophylaxis (PrEP)?

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Role of Cabotegravir Injections in HIV Pre-Exposure Prophylaxis (PrEP)

Long-acting cabotegravir injections are strongly recommended as a highly effective PrEP option for people at risk of sexual acquisition of HIV, with superior efficacy compared to daily oral PrEP regimens. 1

Efficacy and Indications

Cabotegravir (CAB) injections for PrEP have been approved based on two large randomized clinical trials that demonstrated superior efficacy compared to daily oral tenofovir-based regimens:

  • Highly effective for preventing sexual acquisition of HIV across populations (evidence rating: AIa) 1
  • 65-69% reduction in HIV acquisition risk compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) 2
  • Recommended for people who have sex with men, transgender women, and cisgender women at risk of HIV 1, 2
  • While data specifically for people who inject drugs (PWID) is limited, CAB-LA is recommended for PWID who are also at risk through sexual exposures (evidence rating: AIII) 1

Administration Protocol

Dosing Schedule

  • Initial dose: 600 mg (3 mL) administered via gluteal intramuscular injection
  • Second dose: 4 weeks after the first injection
  • Subsequent doses: Every 8 weeks thereafter (evidence rating: AIa) 1

Oral Lead-in Phase

  • Optional 4-5 week oral cabotegravir lead-in before starting injections
  • Specifically recommended for:
    • Patients with severe atopic histories
    • Patients who specifically request it (evidence rating: BIII)
  • Not recommended for patients who struggle with daily oral medication adherence (evidence rating: AIa) 1

Initial Protection Period

  • Protection is not immediate after first injection
  • Overlap with oral PrEP for 7 days after first injection is recommended (evidence rating: BIII)
  • For those transitioning from oral cabotegravir lead-in: continue oral cabotegravir for 7 days
  • For those starting without recent oral PrEP: use tenofovir-based oral PrEP during the first week 1

Monitoring and Follow-up

HIV Testing Requirements

  • Before starting: Confirm HIV-negative status with:
    • Laboratory-based antigen-antibody test AND
    • HIV RNA (viral load) test with lower limit of quantification ≤50 copies/mL (evidence rating: AIIa) 1
  • If RNA testing unavailable: Proceed with rapid point-of-care antibody test while awaiting laboratory-based testing (evidence rating: BIII) 1
  • Follow-up testing: Point-of-care rapid HIV antibody test and laboratory-based antigen/antibody test 1

Managing Delayed Injections

  • Patients should have a 1-month supply of tenofovir-based oral PrEP for use if injections are delayed by ≥7 days 1
  • If injections are resumed ≥8 weeks late (12+ weeks from previous for injection 2, or 16+ weeks from previous for injections 3+), "reloading" is required:
    • Two injections 4 weeks apart before returning to 8-week schedule (evidence rating: AIa) 1

Special Considerations

Drug Interactions

  • Dose adjustment required if coadministered with rifabutin
  • Should not be used with potent inducers of UGT1A1 (evidence rating: AIIa) 1
  • Use with caution in individuals with gluteal implants or fillers 1

Common Side Effects

  • Injection site reactions are common but typically diminish in severity over time 1
  • Injection site pain is reported by most recipients, but satisfaction with parenteral therapy remains high 3

Discontinuation

  • For individuals stopping injectable PrEP but still needing HIV protection:
    • Transition to another form of HIV prevention (evidence rating: AIII)
    • Options include tenofovir-based oral PrEP appropriate for the individual 1

Advantages Over Oral PrEP

  • Superior efficacy compared to daily oral TDF/FTC 2
  • Overcomes adherence challenges associated with daily oral medication 4
  • High patient satisfaction despite injection site reactions 3
  • Provides discreet option that doesn't require daily pill-taking 4

Potential Concerns

  • Risk of diagnostic delays and integrase strand-transfer inhibitor (INSTI) resistance if HIV infection occurs 2
  • Requires regular clinic visits for injections every 8 weeks
  • Limited data in certain populations (e.g., people who inject drugs) 1
  • Injection site reactions, though typically manageable 1

Injectable cabotegravir represents a significant advancement in HIV prevention, offering a highly effective alternative to daily oral PrEP that may improve adherence and protection for those at substantial risk of HIV acquisition.

References

1
Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

4
Research

An evaluation of cabotegravir for HIV treatment and prevention.

Expert opinion on pharmacotherapy, 2021

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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