Is Cabotegravir (Integrase Strand Transfer Inhibitor) and Apretude (Cabotegravir) medically indicated for a patient with a history of unprotected sexual encounters and poor initial compliance to oral Truvada (Emtricitabine/Tenofovir Disoproxil Fumarate), who is at high risk for HIV exposure?

Cabotegravir (Apretude) is Medically Indicated for This Patient

Yes, injectable cabotegravir is medically indicated and represents the optimal PrEP strategy for this patient with documented poor oral adherence and ongoing high-risk HIV exposure. 1

Why This Patient is an Ideal Candidate

Primary Indication Met

• FDA approval specifically covers adults at risk for sexually acquired HIV-1 infection who have confirmed negative HIV testing prior to initiation, which directly matches this patient's profile 1
• The patient's history of unprotected sexual encounters establishes high-risk status, meeting the core indication for PrEP 2

Poor Oral Adherence Makes Injectable PrEP Superior

• Injectable cabotegravir demonstrated 66-69% risk reduction compared to oral Truvada in cisgender men/transgender women (HPTN 083) and 88-90% risk reduction in cisgender women (HPTN 084), establishing superiority over the oral regimen this patient already failed 1
• The bimonthly dosing schedule (after initial loading) eliminates daily adherence requirements that proved problematic with oral Truvada 3, 4
• Meta-analysis confirms long-acting cabotegravir carries significantly lower HIV acquisition risk than TDF-FTC (HR = 0.22,95% CI: 0.08-0.59) 5

Treatment Protocol Verification

Dosing Schedule is Correct

• The planned regimen of 600mg/3ml IM injections given 1 month apart for 2 consecutive months, then every 2 months thereafter, matches FDA-approved dosing exactly 1, 3
• Gluteal intramuscular administration is the standard route 6

HIV Testing Protocol is Appropriate

• Fourth-generation antigen/antibody testing before initiation and before each injection is mandatory to prevent integrase inhibitor resistance if undetected HIV infection exists 6
• The patient's confirmed negative 4th generation HIV test prior to each injection satisfies this critical safety requirement 2
• HIV RNA testing with lower limit of quantification ≤50 copies/mL should also be performed at initiation if any clinical suspicion of acute HIV exists 6

Critical Safety Considerations

Pre-Injection Testing Requirements

• Every single injection requires both point-of-care rapid HIV antibody test AND laboratory-based fourth/fifth-generation antigen/antibody test 6, 7
• Never skip pre-injection HIV testing—cabotegravir can delay seroconversion and mask early infection 7

Baseline Laboratory Work Required

• Serum creatinine and estimated creatinine clearance 6
• Hepatitis B surface antigen and hepatitis C antibody 2, 6
• STI screening (gonorrhea/chlamydia NAAT at all exposed sites) 2, 6
• Pregnancy test if applicable 6

One-Month Follow-Up Testing

• Perform both point-of-care rapid HIV antibody test AND laboratory fourth/fifth-generation antigen/antibody test at the 1-month visit 6
• HIV RNA testing is NOT routinely recommended at follow-up visits due to low positive predictive value and potential for false positives 6

Management of Potential Seroconversion

If HIV Infection is Detected

• Immediately obtain genotypic resistance testing including integrase mutations 7
• Switch to protease inhibitor or NNRTI-based antiretroviral regimen—NEVER continue an integrase inhibitor-based regimen due to high risk of multi-drug resistance 7
• This is the most critical pitfall to avoid, as continuing cabotegravir or switching to another integrase inhibitor will select for resistant virus 7

Common Pitfalls to Avoid

Injection Site Reactions

• Up to 81% of trial participants experienced injection site reactions, though these typically diminish over time 1, 4
• Counsel patient that this is expected and usually improves with subsequent injections 4

Missed Injection Management

• If injection delayed by 7 days or more, provide 1-month supply of oral tenofovir-based PrEP for bridging 6
• If delayed by 8 or more weeks, "reload" with two injections 4 weeks apart before returning to every-8-week schedule 6

Anatomical Considerations

• Use caution if patient has gluteal implants or fillers, as injection site may be compromised 6

Drug Interactions

• Avoid all potent UGT1A1 inducers (reduce cabotegravir concentrations) 6
• Rifabutin requires dose adjustment 6

Ongoing Monitoring Schedule

At Each Injection Visit (Every 8 Weeks After Loading)

• Point-of-care rapid HIV antibody test plus laboratory antigen/antibody test 6, 7
• STI screening based on sexual history and exposures 6
• Adherence assessment to injection schedule 6

Quarterly Monitoring

• Combined HIV antibody and antigen testing 2
• Estimated creatinine clearance at first quarterly visit, then annually 2

This patient's poor oral adherence history combined with ongoing high-risk exposure makes injectable cabotegravir not just medically indicated but clinically superior to continuing oral PrEP attempts. 1, 5