Should a patient with a documented positive response to Apretude (cabotegravir) for HIV Pre-Exposure Prophylaxis (PrEP) and regular HIV monitoring continue with the current regimen of Apretude injections every 2 months?

Continuation of Apretude (Cabotegravir) for HIV Pre-Exposure Prophylaxis

Yes, this patient should continue Apretude injections every 2 months (every 8 weeks) as the current regimen meets all guideline-recommended criteria for ongoing PrEP coverage and demonstrates optimal adherence with documented HIV-negative status. 1

Verification of Continuation Criteria

HIV Monitoring Requirements Met

• The patient has consistently documented HIV-negative status every 2-3 months, with testing dates spanning from December 2023 through September 2025, which exceeds the guideline-recommended quarterly monitoring interval. 1
• The International Antiviral Society-USA Panel recommends combined HIV antibody and antigen testing quarterly for all PrEP users, which this patient is receiving appropriately. 1
• Point-of-care HIV testing should be performed on the day of each injection prior to administration, with laboratory-based antigen/antibody testing sent concurrently (injections should not be delayed pending laboratory results). 1

Documented Treatment Response and Adherence

• The patient is "doing well on Apretude injections" with documented adherence to the every-2-month injection schedule, which is the FDA-approved maintenance dosing regimen. 2, 3
• The patient continues to have ongoing HIV exposure risk (sexually active with multiple male partners), making continued PrEP medically necessary. 1
• Clinical trials demonstrate that cabotegravir long-acting injectable PrEP has superior efficacy compared to daily oral tenofovir disoproxil fumarate/emtricitabine, with hazard ratios of 0.31-0.35 for HIV prevention in men who have sex with men. 4

FDA-Approved Dosing Regimen Confirmed

• The requested dosing of 600 mg/3 mL intramuscular injection every 8 weeks matches the FDA-approved maintenance schedule after completion of the initiation phase (two injections separated by 4 weeks). 1, 2
• The International Antiviral Society-USA Panel 2024 guidelines confirm this as the standard maintenance regimen with the highest evidence rating (AIa). 1

Critical Monitoring Requirements for Continuation

HIV Testing Protocol

• HIV screening must include a fourth- or fifth-generation laboratory-based antigen-antibody assay before each injection. 1
• A rapid point-of-care HIV antibody test should be performed on the day of injection, with the laboratory-based test sent concurrently but not delaying injection administration. 1
• HIV RNA testing is recommended at initiation or resumption after hiatus of 6 months or longer, but is not required for routine monitoring between injections. 1

Additional Laboratory Monitoring

• Sexually transmitted infection testing (gonorrhea, chlamydia, syphilis) should be performed every 4 months (at every second injection visit). 1
• Liver enzyme tests should be administered every 6 months. 1
• The patient's current schedule of "labs at GHC every 2 months" exceeds minimum requirements and is appropriate. 1

Management of Potential Injection Delays

If Injection Delayed by 7 Days or Less

• Resume injections as soon as possible after HIV testing confirms negative status. 1, 2
• No additional bridging therapy or schedule modification is required. 2

If Injection Delayed by 8 or More Weeks

• The patient must restart with two "reloading" injections separated by 4 weeks before returning to the every-8-week maintenance schedule. 1, 2
• HIV testing (ideally including HIV RNA) must be performed before restarting. 1

Planned Missed Injections

• If the patient plans to miss a scheduled injection by more than 7 days, daily oral cabotegravir (30 mg) should be taken to replace one every-2-month injection. 2
• The first oral dose should be taken approximately 2 months after the last injection, with injection dosing restarted on the day oral dosing completes or within 3 days. 2

Common Pitfalls to Avoid

Inadequate HIV Testing

• Failure to perform comprehensive HIV testing (including laboratory-based antigen/antibody testing) before each injection could miss early HIV infection, particularly given the diagnostic delays that can occur with cabotegravir exposure. 1, 5, 4
• If HIV acquisition occurs while on cabotegravir PrEP, there is risk of integrase strand transfer inhibitor (INSTI) resistance mutations, making early detection critical. 1, 4

Injection Site Management

• Injection site reactions occur in up to 81% of patients but typically diminish over time; these should not be considered treatment failure unless severe. 1, 3
• Cabotegravir should be used with caution in individuals with gluteal implants or fillers. 1

Transition Planning

• If the patient ever needs to discontinue cabotegravir, transition to an appropriate tenofovir-based oral PrEP regimen should begin within 12 weeks after the last injection to maintain continuous HIV protection during the cabotegravir pharmacokinetic tail period. 6
• The patient should have a 1-month supply of appropriate tenofovir-based oral PrEP available for oral bridging in case of injection delays of 7 days or more. 5

Approval Recommendation

This prior authorization request should be approved for 12 months of continued Apretude therapy as the patient meets all three continuation criteria specified in the policy: (1) documented HIV-negative status with appropriate monitoring frequency, (2) documented positive response and adherence to the prescribed regimen, and (3) FDA-approved dosing schedule for maintenance PrEP. 1, 2