Is Apretude (Cabotegravir) 600mg/3ml IM every two months medically necessary and appropriate for HIV pre-exposure prophylaxis (PrEP) in a patient with impaired renal function and a history of oral PrEP use?

Medical Necessity Determination for Cabotegravir (Apretude) PrEP

Direct Recommendation

Yes, cabotegravir (Apretude) 600mg/3ml IM every two months is medically necessary and appropriate for this patient. The patient meets all FDA-approved indications, has documented HIV-negative status, qualifies for PrEP based on sexual risk factors, and has a compelling clinical indication (reduced renal function with single kidney) that makes long-acting injectable PrEP superior to oral alternatives. 1, 2

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Medical Necessity Justification

Patient Meets FDA-Approved Indications

The patient satisfies all regulatory requirements for cabotegravir PrEP:

• HIV-negative status confirmed: Multiple documented negative HIV 4th generation antibody/antigen tests (8/5/25,10/16/25, and prior dates) 1, 2
• At-risk population: Cisgender male sexually active with multiple partners and inconsistent condom use, meeting criteria for HIV prevention 2
• Weight requirement met: Patient weighs ≥35 kg (FDA requirement for cabotegravir use) 1
• Proper initiation protocol followed: Received initiation injections #1 on 7/8/2025 and #2 on 8/5/2025, with continuation injections appropriately scheduled 1, 2

Renal Impairment Creates Strong Clinical Indication

The patient's reduced kidney function with single kidney status makes cabotegravir the preferred PrEP option:

• Tenofovir-based oral PrEP carries nephrotoxicity risk: Guidelines mandate baseline urinalysis and creatinine clearance monitoring before initiating tenofovir products due to potential nephrotoxicity 2
• Cabotegravir has no renal dosing requirements: The FDA label explicitly states "no clinically significant differences in the pharmacokinetics of cabotegravir are expected with mild, moderate, or severe renal impairment" and cabotegravir is >99% protein bound, making it safe in renal disease 1
• Patient already on oral PrEP since July 2023: History of Descovy and Truvada use demonstrates ongoing need for HIV prevention, but switching to cabotegravir eliminates cumulative tenofovir exposure in a patient with compromised renal reserve 3, 4

Superior Efficacy Profile

Cabotegravir demonstrates superior HIV prevention efficacy compared to oral PrEP:

• Clinical trial evidence: Long-acting cabotegravir showed superior efficacy to daily oral tenofovir disoproxil fumarate/emtricitabine in preventing HIV-1 acquisition in at-risk cisgender men who have sex with men, with hazard ratio 0.31 (95% CI 0.17-0.58, p=0.0003) during blinded phase and 0.35 (0.18-0.69, p=0.002) during first unblinded year 5
• Adherence advantage: Injectable formulation eliminates daily pill burden, addressing adherence challenges inherent to oral PrEP 6, 7
• Evidence rating: International Antiviral Society-USA Panel provides AIa evidence rating (highest quality) for long-acting cabotegravir PrEP in people likely to be exposed to HIV sexually 2

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Standard of Care Confirmation

Guideline-Supported Intervention

Cabotegravir PrEP is established standard of care, not experimental:

• FDA-approved indication: Cabotegravir ER injectable suspension (Apretude) is approved in the USA for PrEP to reduce risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing ≥35 kg 1, 6
• International guidelines endorsement: The 2024 International Antiviral Society-USA Panel recommends long-acting cabotegravir for people likely to be exposed to HIV sexually with AIa evidence rating 2
• Proper dosing protocol: Patient receiving FDA-approved regimen of 600 mg (3 mL) gluteal injections, with first 2 injections separated by 4 weeks and subsequent injections every 8 weeks 1, 2

Patient-Specific Appropriateness

This patient has additional factors supporting cabotegravir use:

• Patient preference documented: Clinical notes indicate "requesting to switch to injectable today due to patient preference," which is a valid clinical consideration 2
• Oral lead-in not required: Guidelines state oral lead-in is optional and "not recommended in those challenged by adhering to daily dosing of oral tablets" (AIa evidence) 2
• Appropriate monitoring in place: Patient has proper follow-up scheduled with HIV testing at appropriate intervals 2

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Safety Considerations Addressed

Appropriate Screening Completed

Patient has undergone necessary baseline assessments:

• HIV testing protocol met: Multiple negative 4th generation HIV antibody/antigen tests documented, with most recent 10/16/25 2
• Hepatitis screening completed: Hepatitis C non-reactive, Hepatitis B immunity documented (reactive after HeplisavB series) 2, 3
• Renal monitoring established: Patient followed by nephrology after kidney donation, with report of stable function 2

Monitoring Plan Appropriate

Continuation injections require specific follow-up:

• HIV testing every 2 months: Should coincide with injection visits to detect any breakthrough infections 2
• STI screening quarterly: Three-site testing (oral, rectal, urogenital) for gonorrhea and chlamydia recommended 3
• Injection site reactions: Most common adverse event with cabotegravir; patient "noted to be tolerating injections/tx well" per 10/15 note 6, 5

Critical Caveat for Renal Patients

While cabotegravir itself has no renal contraindications, one important consideration:

• If patient discontinues cabotegravir: Should NOT return to tenofovir-based oral PrEP given single kidney status; alternative prevention strategies or careful risk-benefit analysis required 2, 4
• Bridging therapy if injections delayed: Guidelines recommend having 1-month supply of tenofovir-based oral PrEP for injection delays ≥7 days, but this patient's renal status complicates this recommendation 2

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Cost-Effectiveness Consideration

Economic analysis supports cabotegravir use:

• Cost-effectiveness established: Cabotegravir PrEP has incremental cost-effectiveness ratio of $46,843 per QALY gained versus generic oral PrEP, which is below standard willingness-to-pay thresholds in the USA 8
• Prevention of secondary infections: Model estimates 4.5 more primary and secondary HIV-1 infections prevented per 100 PrEP users with cabotegravir pathway 8

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Answers to Specific Questions

1. Is the treatment plan medically necessary?

Yes, absolutely. This patient has documented ongoing HIV risk (sexually active with multiple partners, inconsistent condom use), confirmed HIV-negative status, and a specific medical condition (reduced renal function with single kidney) that makes cabotegravir superior to oral alternatives. The patient has already demonstrated commitment to PrEP (on oral regimen since July 2023) and is tolerating injectable therapy well. 2, 1, 2

2. Is the treatment plan standard of care or experimental?

This is established standard of care, not experimental. Cabotegravir received FDA approval for PrEP based on two large randomized controlled trials (HPTN 083 and HPTN 084) demonstrating superior efficacy to oral PrEP. 1, 6, 5 The International Antiviral Society-USA Panel provides the highest evidence rating (AIa) for long-acting cabotegravir PrEP in at-risk populations. 2 The patient's dosing regimen, monitoring plan, and clinical indications all align with FDA labeling and current clinical guidelines. 1, 2