What is Apertude (cabotegravir) used for and what is the follow-up appointment schedule?

What is Apretude (Cabotegravir) and Follow-Up Schedule

Apretude (cabotegravir) is a long-acting injectable HIV pre-exposure prophylaxis (PrEP) medication given as intramuscular injections every 2 months after initial loading doses, specifically for adults and adolescents weighing ≥35 kg who are at risk for sexually acquired HIV-1 infection. 1, 2

Primary Indication

• Cabotegravir is an integrase strand transfer inhibitor approved for HIV-1 PrEP to reduce the risk of sexually acquired HIV infection in at-risk individuals who test HIV-negative before initiation 1, 2
• It demonstrated superior efficacy compared to daily oral tenofovir/emtricitabine in preventing HIV acquisition in cisgender men who have sex with men, transgender women, and cisgender women 2
• This is the first and only long-acting injectable option available for HIV prevention, eliminating the need for daily oral medication 2, 3

Injection Schedule (Follow-Up Appointments)

The dosing schedule requires close adherence to specific timing:

Initial Loading Phase

• First injection: 600 mg (3 mL) intramuscularly in the gluteal region 4, 5
• Second injection: 4 weeks after the first injection, same dose and site 4, 5

Maintenance Phase

• All subsequent injections: Every 8 weeks (every 2 months), 600 mg intramuscularly 4, 5, 2
• The long elimination half-life of approximately 40 days permits this infrequent dosing schedule 6

Critical Timing Considerations

• If an injection is delayed by 7 days or more, the patient needs a 1-month supply of oral tenofovir-based PrEP for bridging 5
• If injections are delayed by 8 or more weeks, "reloading" with two injections 4 weeks apart is required before returning to the every-8-week schedule 5

Mandatory Testing at Each Visit

Before EVERY injection (including the first), the following HIV testing protocol is non-negotiable:

Pre-Injection HIV Testing

• Point-of-care rapid HIV antibody test performed at the visit 5, 7
• Laboratory-based fourth- or fifth-generation antigen/antibody combination test 5, 7
• HIV RNA test with lower limit of quantification ≤50 copies/mL (required before first injection; at subsequent visits only if acute HIV suspected) 5, 7
• Never skip this testing—cabotegravir can delay HIV seroconversion and mask early infection, and missing undetected HIV can lead to integrase inhibitor resistance 5, 7

Additional Baseline Testing (Before First Injection Only)

• Serum creatinine and estimated creatinine clearance 5
• Hepatitis B surface antigen 5
• Hepatitis C antibody 5
• Pregnancy test for individuals of childbearing potential 4
• STI screening (gonorrhea and chlamydia) at all exposed sites 5

Ongoing Monitoring at Follow-Up Visits

• At 1 month after first injection: HIV testing (rapid antibody + laboratory antigen/antibody test), STI screening, adherence assessment 5
• Every 8 weeks (at each injection visit): HIV testing as described above, STI screening 4, 5
• Quarterly: Pregnancy testing if applicable 4
• Annually: Creatinine clearance (more frequently if kidney disease risk) 4

Important Safety Considerations

Common Side Effects

• Injection site reactions occur in up to 81% of participants but typically diminish over time 3
• These reactions are the most common adverse effect but rarely lead to discontinuation 3

Critical Contraindications and Cautions

• Do not use if HIV infection is present or suspected—comprehensive HIV testing must confirm negative status before initiation 5
• Use with caution in individuals with gluteal implants or fillers (injection site may be compromised) 5
• Avoid all potent UGT1A1 inducers as they reduce cabotegravir concentrations 5
• Rifabutin requires dose adjustment when coadministered 5

If Seroconversion Occurs While on Cabotegravir

• Immediately obtain genotypic resistance testing including integrase mutations 7
• Switch to a 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 a critical pitfall: continuing integrase inhibitors after seroconversion on cabotegravir will select for multi-drug resistant virus 7

Key Clinical Pearls

• The long-acting formulation is more resource-intensive than oral PrEP, requiring personnel for medication procurement, injection administration, and scheduling 4
• Patients unable to attend scheduled injections need close attention and interventions to return to care 4
• Cabotegravir does not provide protection against hepatitis B, so HBV screening and vaccination are essential 4
• The medication is particularly valuable for individuals who experience stigma or adverse consequences from taking daily oral pills 4