HIV Pre-Exposure Prophylaxis

Recommended Regimens

The American medical community recommends daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for all populations at risk for HIV (evidence rating: AIa) 1
On-demand (2-1-1) dosing of TDF/FTC is recommended for men who have sex with men (evidence rating: AIa) 1
Long-acting injectable cabotegravir every 8 weeks is recommended for cisgender men, transgender women, and cisgender women at risk of HIV (evidence rating: AIb) 2
The guideline recommends cabotegravir injections for people who have sex with men, transgender women, and cisgender women at risk of HIV, as well as for people who inject drugs (PWID) who are also at risk through sexual exposures (evidence rating: AIII) 2

Lenacapavir is being studied for HIV prevention in various populations, including cisgender women and people who inject drugs, and if approved, it would represent a significant advancement in PrEP options 2

Long-acting injectable cabotegravir eliminates daily pill burden and associated adherence challenges, improving adherence (evidence rating: AIa) 2, 1
Long-acting cabotegravir injections are strongly recommended as a highly effective PrEP option with superior efficacy compared to daily oral PrEP regimens (evidence rating: AIa) 1, 2
Consistent use of PrEP significantly reduces the risk of HIV acquisition in at-risk individuals, as reported by the JAMA 1, 2
Apretude has demonstrated superior efficacy to daily oral emtricitabine/tenofovir disoproxil fumarate in preventing HIV-1 acquisition in transgender women, cisgender men who have sex with men, and cisgender women, as reported by the JAMA 2

HIV testing, including rapid point-of-care HIV testing, is recommended prior to each injection (every 2 months) and at baseline, as recommended by the American College of Physicians and the Centers for Disease Control and Prevention (evidence rating: high-quality randomized trials) 1, 2
STI testing is advised every 4 months (every second injection) 1
Liver enzyme tests are recommended every 6 months 1
Monitoring for injection site reactions and adverse events is necessary 1

Patients with unknown or positive HIV-1 status are contraindicated for Apretude 2
Baseline assessments should include renal function (creatinine clearance ≥60 mL/min), hepatitis B screening, and complete STI screening, as recommended by the US Public Health Service (evidence rating: high-quality observational studies) 2, 3
Caution is advised in patients with gluteal implants or fillers, and those with a history of severe allergic reactions, as cabotegravir may persist in the body for up to 12 months after the last injection 2
Drug interactions, such as dose adjustment of rifabutin, should be considered when coadministering with Apretude, as recommended by the JAMA 2
Do not use Apretude with potent UGT1A1 inducers, and avoid use with rifampin, rifapentine, carbamazepine, oxcarbazepine, phenobarbital, and phenytoin, as recommended by the JAMA 2

The recommended dosing schedule for Apretude is an initial dose of 600 mg administered via gluteal intramuscular injection, followed by a second dose 4 weeks after the first injection, and subsequent doses every 8 weeks thereafter, according to guidelines from the JAMA 2
If injections are delayed by ≥7 days, a 1-month supply of tenofovir-based oral PrEP should be provided for use, and if injections are resumed ≥8 weeks late, "reloading" is recommended with two injections 4 weeks apart before returning to every-8-week dosing, as suggested by the JAMA 2
For patients switching from oral PrEP tablets to cabotegravir injections, continue the oral PrEP for 7 days after the first cabotegravir injection to ensure continuous protection during the transition period 2
Consider an oral cabotegravir lead-in of 4-5 weeks for patients with severe atopic histories or those who specifically request it, but not for patients who struggle with daily oral medication adherence (evidence rating: AIa) 2

Manage injection site reactions with topical/systemic analgesics and hot/cold packs, and monitor liver function tests every 6 months to detect potential hepatotoxicity (evidence rating: AIIa) 2, 1
If symptoms of acute HIV infection are present, perform HIV RNA testing and delay transition until confirmed negative, as suggested by the World Health Organization, based on moderate-quality observational studies 3