Is continuation of Cabenuva (Cabotegravir and Rilpivirine) therapy medically indicated for a male patient with impaired renal function, currently on Pre-Exposure Prophylaxis (PrEP) and HIV negative, who has been tolerating the medication without reactions?

Cabotegravir PrEP Continuation is NOT Medically Indicated in This Patient

Cabotegravir for PrEP should be discontinued immediately in this patient due to severe renal impairment (GFR 26 mL/min), as baseline renal function assessment is mandatory before initiation and ongoing monitoring is required, with no safety data available for patients with this degree of renal dysfunction. 1

Critical Safety Concerns with Severe Renal Impairment

Baseline Renal Function Requirements

• Baseline serum creatinine and estimated creatinine clearance are mandatory before cabotegravir initiation 1
• While the FDA label states "no clinically significant differences in the pharmacokinetics of cabotegravir are expected with mild, moderate, or severe renal impairment," this is based on pharmacokinetic modeling, not clinical safety data in patients with GFR <30 mL/min 2
• The patient's GFR of 26 mL/min represents severe renal impairment (Stage 4 chronic kidney disease), and cabotegravir has not been studied in end-stage renal disease 2

Pending Renal Biopsy Complicates Decision-Making

• The patient has a scheduled renal biopsy next month, indicating active investigation of progressive kidney disease 2
• Continuing a medication with unknown safety profile in severe renal impairment while the underlying etiology remains undiagnosed poses unacceptable risk 1
• The long half-life of cabotegravir (41 hours for oral formulation, significantly longer for injectable) means the drug will persist for months after discontinuation, making it impossible to rapidly reverse if renal function deteriorates further 2

Alternative PrEP Options for This Patient

Transition to Appropriate Oral PrEP

• Tenofovir-based oral PrEP regimens require renal monitoring but have established dosing adjustments for renal impairment 3
• For patients with CrCl 30-49 mL/min, tenofovir disoproxil fumarate/emtricitabine can be dose-adjusted (though this patient's GFR of 26 suggests CrCl likely <30) 3
• Tenofovir alafenamide (TAF)-based PrEP may be preferable given lower renal toxicity profile, though specific guidance for GFR <30 is limited 3

Clinical Monitoring During Transition

• HIV testing with both point-of-care rapid antibody test and laboratory-based fourth- or fifth-generation antigen/antibody test must be performed before any PrEP transition 3
• Given cabotegravir's prolonged half-life, the patient remains at risk for resistance if HIV infection occurs during the washout period 4, 1
• Cabotegravir can delay HIV seroconversion and mask early infection, requiring comprehensive HIV RNA testing if any suspicion of acute infection arises 4, 1

Insurance Criteria Misapplication

The Insurance Criteria References Treatment, Not PrEP

• The insurance criteria cited references "treatment of human immunodeficiency virus type 1 (HIV-1) infection" and virologic failure defined by "plasma HIV-1 RNA levels"—this patient is HIV-negative and using cabotegravir for prevention (PrEP), not treatment 3
• The Cabenuva formulation (cabotegravir + rilpivirine) is FDA-approved for HIV treatment in virologically suppressed patients, not for PrEP 5, 6, 7
• For PrEP, cabotegravir is used as monotherapy (not combined with rilpivirine), administered as 600 mg intramuscular injections every 8 weeks after initial loading doses 3, 8

Correct Medical Necessity Criteria for PrEP

• Cabotegravir PrEP is medically necessary for HIV-negative individuals at substantial risk of HIV acquisition who can tolerate the medication and have no contraindications 3, 8
• The patient's HIV-negative status and desire for protection meet the indication criteria 3
• However, severe renal impairment with pending diagnostic workup represents a critical safety concern that supersedes the indication 1, 2

Specific Recommendations for This Case

Immediate Actions Required

1. Discontinue cabotegravir PrEP immediately and document the reason as severe renal impairment with inadequate safety data 1, 2
2. Perform comprehensive HIV testing (antigen/antibody plus HIV RNA) to ensure no breakthrough infection occurred while on cabotegravir 3, 4
3. Consult nephrology regarding the pending renal biopsy and obtain guidance on PrEP options safe for GFR 26 mL/min 1

Bridge to Alternative PrEP After Renal Evaluation

• Wait for renal biopsy results and nephrology recommendations before initiating any alternative PrEP regimen 1
• If renal function stabilizes or improves, consider TAF-based oral PrEP with close renal monitoring 3
• Counsel patient on interim HIV prevention strategies including consistent condom use and risk reduction 3

Common Pitfall to Avoid

• Do not confuse Cabenuva (cabotegravir + rilpivirine for HIV treatment) with cabotegravir monotherapy for PrEP—these are different formulations with different indications 8, 5, 7
• The insurance criteria appear to reference the treatment indication, which is inappropriate for this PrEP case 6, 7