Is Yeztugo (lanacapavir) medically necessary and standard of care for PrEP in a patient with a history of HIV exposure and current health conditions?

Medical Necessity and Standard of Care Assessment for Yeztugo (Lanacapavir) PrEP

Yeztugo (lanacapavir) is medically necessary and represents FDA-approved standard of care for this patient, who has documented HIV exposure history and meets criteria for PrEP, though the presence of fatty liver disease and elevated liver enzymes requires careful monitoring.

Medical Necessity Analysis

Patient Risk Profile Justifies PrEP

• This patient has documented recent HIV exposure requiring post-exposure prophylaxis (biktarvy course completed), which automatically qualifies them for ongoing PrEP consideration 1
• The CDC and U.S. Preventive Services Task Force recommend offering PrEP to all persons at high risk of HIV acquisition, and prior use of PEP more than once in 12 months is a specific indication for PrEP 1, 2
• The patient's request for PrEP ("Interested in Yeztugo") is itself sufficient justification, as current guidelines recommend offering PrEP to all sexually active individuals and anyone requesting it, without requiring specific risk criteria 3

FDA Approval Establishes Standard of Care

• Yeztugo is FDA-approved specifically for PrEP in adults to reduce risk of sexually acquired HIV-1 infection (per the drug label provided)
• The indication requires only that individuals have negative HIV-1 testing and be at risk for HIV-1 acquisition, both of which this patient meets 2
• The dosing regimen prescribed (927 mg SC day 1 with 600 mg oral day 1-2, then 927 mg SC every 6 months) matches the exact FDA-approved dosing schedule from the drug label

Standard of Care Determination

Lanacapavir Represents Newest FDA-Approved Option

• While established PrEP guidelines focus on tenofovir-based regimens (TDF/FTC), Yeztugo's FDA approval for PrEP makes it standard of care by definition 2, 4
• The twice-yearly injectable formulation addresses adherence challenges that limit effectiveness of daily oral PrEP, where adherence is central to realizing PrEP's benefit 2
• Current PrEP options now include oral daily regimens, on-demand dosing, long-acting injectables, and vaginal rings, with extensive deployment of PrEP holding promise to significantly reduce the global HIV epidemic 4

Not Experimental or Investigational

• FDA approval for the specific indication (PrEP) definitively establishes this as non-experimental 2
• The treatment plan follows the exact FDA-approved dosing regimen without deviation
• Guidelines consistently support PrEP as highly effective when adherence is maintained, with convincing evidence that PrEP is of substantial benefit in decreasing HIV infection risk 2

Critical Safety Considerations for This Patient

Hepatic Monitoring Required

• The patient has fatty liver disease, elevated liver enzymes, and alcohol dependence, which necessitate baseline and ongoing liver function monitoring 1
• The FDA label requires HIV-1 screening prior to each injection and as clinically appropriate, but additional hepatic monitoring should occur at baseline, 1 month, then quarterly given this patient's liver disease 1, 3
• If the patient has chronic hepatitis B (HBsAg status not documented in the case), discontinuation of any tenofovir-based therapy could cause acute hepatitis flares or hepatic decompensation, particularly with cirrhosis 5, 3, 6

Renal Function Assessment

• Baseline creatinine clearance must be documented before initiating any PrEP regimen 6
• Quarterly monitoring of renal function is standard for all PrEP patients, with more frequent monitoring if baseline abnormalities exist 3, 6

Comprehensive Baseline Testing Required

• HIV-1 testing must be negative before each injection (per FDA label and all guidelines) 1, 3, 6
• Hepatitis B surface antigen, hepatitis C antibody, comprehensive STI screening, and pregnancy testing (if applicable) are required before prescribing 6
• The patient's documented immunity to hepatitis A and B from prior titers is appropriate baseline documentation 1

Addressing the "Not Sexually Active" Statement

Clinical Reality vs. Stated Behavior

• The patient states they have "not been sexually active since finished course of biktarvy for PEP," yet is requesting PrEP 3
• Guidelines recognize that PrEP should be offered to anyone requesting it due to the possibility of undisclosed exposures and anticipated future risk 3
• The patient's prior HIV exposure and completion of PEP indicate ongoing risk assessment is warranted regardless of current stated sexual activity 1

Algorithm for PrEP Approval Decision

1. Verify negative HIV-1 test (required before initiation) ✓
2. Confirm patient is at risk for HIV acquisition (prior PEP use = automatic qualification) ✓
3. Check FDA approval status for proposed medication (Yeztugo approved for PrEP) ✓
4. Verify dosing matches FDA label (matches exactly) ✓
5. Assess contraindications: Document baseline hepatic and renal function given patient's fatty liver and elevated LFTs
6. Approve with monitoring plan: Quarterly HIV testing, hepatic monitoring given liver disease, renal monitoring, STI screening

This treatment plan is medically necessary, FDA-approved standard of care, and should be approved with enhanced hepatic monitoring given the patient's liver disease. 2, 4