HIV Pre-Exposure Prophylaxis (PrEP) Guidelines

Introduction to PrEP

• The American College of Physicians recommends daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) 300mg/200mg as the standard first-line PrEP regimen for all populations at risk of HIV acquisition, with proven efficacy exceeding 90% when adherence is maintained 1, 2

Who Should Receive PrEP

• The Centers for Disease Control and Prevention (CDC) recommends offering PrEP to men who have sex with men (MSM) with any of the following risk factors: at least one episode of condomless anal intercourse in the past 6 months, multiple male sex partners, HIV-positive sex partner(s), recent sexually transmitted infection diagnosis, methamphetamine or other stimulant use, or a risk score ≥10 on validated assessment tools 1, 3
• The World Health Organization (WHO) strongly recommends PrEP for transgender women engaging in condomless anal intercourse or with multiple partners, despite limited specific efficacy data in this population 1, 3
• The CDC recommends offering PrEP to heterosexual individuals with an HIV-positive sexual partner, inconsistent condom use with partners of unknown HIV status, recent bacterial STI diagnosis, or an HIV incidence >2% per year in their sexual network 1, 4

PrEP Regimen Selection

• The CDC recommends TDF/FTC 300mg/200mg as the first-line PrEP regimen for MSM and transgender women, with an alternative option of TAF/FTC for those with creatinine clearance <60 mL/min, osteopenia/osteoporosis, or age >50 years 1, 2, 5
• The WHO recommends TDF/FTC 300mg/200mg as the first-line PrEP regimen for cisgender women, with a minimum 7-day lead-in period before protection is achieved 2, 4

Pre-Initiation Requirements

• The CDC recommends performing the following tests before prescribing PrEP: HIV testing, renal function, hepatitis B surface antigen, hepatitis C antibody, STI screening, and pregnancy testing for individuals of childbearing potential 1, 2, 4, 5

Monitoring Schedule During PrEP Use

• The CDC recommends HIV antibody/antigen testing at 1 month after initiation, and every 3 months thereafter, as well as STI screening and pregnancy testing for individuals of childbearing potential 1, 2, 4, 5
• The WHO recommends assessing renal function every 6 months, and more frequently for individuals with baseline creatinine clearance <90 mL/min or those with diabetes or hypertension 5

Special Populations

• The CDC recommends continuing TDF/FTC during pregnancy, as it is safe with no documented adverse fetal effects, and using TDF/FTC as the preferred regimen during pregnancy and breastfeeding 2, 4
• The WHO recommends considering indefinite continuation or transition to hepatitis B treatment if PrEP is stopped in HBsAg-positive individuals, and monitoring closely for hepatitis flares with ALT/AST testing 5

Efficacy and Adherence

• The CDC reports that PrEP efficacy exceeds 90% with detectable drug levels, and that efficacy is highly adherence-dependent, with a 44% reduction in efficacy with suboptimal adherence vs. 92% with detectable drug levels 6

PrEP Regimens and Recommendations for High-Risk Adolescents

Recommended PrEP Regimens

• The CDC and WHO classify adolescents in the same category as adults for PrEP prescribing, with TDF + 3TC (or FTC) as the preferred backbone regimen, according to the Clinical Infectious Diseases guidelines 7, 8, 9

Adherence and Efficacy

• Enhanced adherence counseling is recommended for all adolescents initiating PrEP, as efficacy is highly adherence-dependent, with 92% reduction in risk with detectable drug levels, as stated by the Clinical Infectious Diseases guidelines 7, 8, 9

HIV Pre-Exposure Prophylaxis with FTC/TAF: Clinical Considerations and Safety

Patient Selection and Monitoring

• The Centers for Disease Control and Prevention recommends immediate transition from post-exposure prophylaxis to PrEP for persons with anticipated repeat or ongoing HIV exposures, with HIV testing at completion of the nPEP regimen before transitioning to PrEP 10, 11
• HIV RNA testing is mandatory if acute HIV infection is suspected, and hepatitis C serologic testing is recommended at least annually 12
• The American Academy of HIV Medicine suggests that patients with hepatitis B co-infection should not discontinue FTC/TAF abruptly, as it can lead to acute hepatitis B flares or hepatic decompensation 12

Special Population Considerations

• The World Health Organization recommends that FTC/TAF is safe during pregnancy with no documented adverse fetal effects, and can be continued during pregnancy and breastfeeding as the preferred regimen 12
• For HBsAg-positive individuals, the European AIDS Clinical Society recommends consideration of indefinite continuation or transition to hepatitis B treatment if PrEP is stopped, with close monitoring using ALT/AST testing after discontinuation 12

PrEP Recommendations for Patients with Renal Impairment

Current Evidence-Based PrEP Recommendations

• The American College of Physicians recommends TDF/FTC (tenofovir disoproxil fumarate/emtricitabine) as the only recommended oral PrEP regimen with proven efficacy exceeding 90% when adherence is maintained, across all populations at risk of HIV acquisition 13
• TDF/FTC is recommended based on multiple randomized controlled trials (iPrEx, Partners PrEP, TDF2) demonstrating substantial risk reduction ranging from 44% to 86% depending on adherence, as stated by the Centers for Disease Control and Prevention 14, 15

Alternative for Specific Renal Situations

• The American College of Physicians recommends TAF/FTC (tenofovir alafenamide/emtricitabine) ONLY for men who have sex with men (MSM) with creatinine clearance between 30-60 mL/min who have osteopenia, osteoporosis, or are at high risk for these complications, with a strength of evidence rated as moderate 13

Critical Renal Function Thresholds

• The National Kidney Foundation states that TDF-based PrEP is contraindicated when creatinine clearance falls below 60 mL/min/1.73 m², with a high strength of evidence 13

Why Biktarvy Is Not Appropriate for PrEP

• The World Health Organization notes that Biktarvy contains bictegravir (an integrase inhibitor), which has never been studied for HIV prevention, and therefore no efficacy data exist for bictegravir in preventing HIV acquisition in uninfected individuals, with a low strength of evidence due to lack of studies 13, 15

Practical Algorithm for PrEP Selection in Renal Impairment

• The European AIDS Clinical Society recommends calculating creatinine clearance using the Cockcroft-Gault equation or eGFR measurement before any PrEP prescribing decision, with a moderate strength of evidence 13

Common Pitfalls to Avoid

• The Infectious Diseases Society of America advises against extrapolating treatment data to prevention, as the fact that Biktarvy is effective and well-tolerated for HIV treatment does not mean it prevents HIV acquisition in uninfected individuals, with a high strength of evidence 13
• The Centers for Disease Control and Prevention warns against using TAF/FTC for women with vaginal exposures, as TAF/FTC lacks efficacy data for receptive vaginal sex, with a moderate strength of evidence 15