What Pre-Exposure Prophylaxis (PrEP) options are contraindicated for individuals assigned female at birth?

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Last updated: November 23, 2025 • View editorial policy

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PrEP Options Not Indicated for Individuals Assigned Female at Birth

There are no PrEP formulations that are specifically contraindicated based solely on being assigned female at birth. The primary absolute contraindication for all PrEP candidates, regardless of sex assigned at birth, is having unknown or positive HIV status 1.

Universal Contraindications (Apply to All Individuals Including AFAB)

  • Unknown or positive HIV status is an absolute contraindication to PrEP initiation, as using PrEP in HIV-positive individuals can lead to drug resistance 1
  • Acute HIV infection symptoms (fever, headache, muscle soreness, sore throat, rash, swollen lymph nodes) require deferral from PrEP until HIV-negative status is confirmed 1
  • Creatinine clearance <60 mL/min makes TDF-based PrEP inappropriate due to renal toxicity risk 2
  • Pre-existing osteopenia or osteoporosis is a contraindication to TDF-based PrEP, as it causes 1-1.5% bone mineral density loss at 48 weeks 2

Important Considerations Specific to AFAB Individuals

Pregnancy Status

  • Pregnancy is NOT a contraindication to PrEP for individuals assigned female at birth 3, 2
  • TDF/FTC can be safely used during pregnancy, with no evidence of adverse fetal effects from studies in HIV-infected pregnant women 1, 3
  • Women of reproductive age should have documented pregnancy testing before initiating PrEP and at regular intervals while prescribed PrEP 1
  • If pregnancy occurs during PrEP use, providers should discuss risks and benefits to allow informed decision-making about continuation 1, 3
  • The increased HIV acquisition risk during pregnancy may actually indicate added value to continuing PrEP 1, 3

Breastfeeding

  • Do not prescribe PrEP to women who are breastfeeding due to limited safety data in this population 3
  • However, the CDC notes that breastfeeding while taking tenofovir-based PrEP is considered safe, with very low drug concentrations in breast milk 2

Available PrEP Formulations for AFAB Individuals

Oral TDF/FTC (Daily Dosing)

  • Daily oral TDF/FTC is safe and effective in reducing HIV acquisition risk in heterosexual women when consistently used 1
  • Efficacy is highly dependent on medication adherence, with 75% reduction in HIV incidence in Partners PrEP study and 62% in TDF2 study 1
  • The FEM-PrEP trial showed no efficacy in heterosexual women, attributed to low medication adherence rather than biological factors 1

Event-Driven/On-Demand PrEP

  • On-demand PrEP (2-1-1 dosing) is NOT recommended for individuals assigned female at birth 1
  • This regimen has only been studied and validated in men who have sex with men 1
  • AFAB individuals should use daily dosing exclusively due to different pharmacokinetics in vaginal tissue 1

Clinical Algorithm for PrEP Eligibility in AFAB Individuals

  1. Confirm HIV-negative status using fourth-generation antigen-antibody assay 2
  2. Screen for acute HIV infection symptoms - if present, defer until confirmed negative 1, 2
  3. Calculate creatinine clearance using Cockcroft-Gault formula - must be ≥60 mL/min 2
  4. Screen for osteopenia/osteoporosis - if present, TDF-based PrEP is not recommended 2
  5. Document pregnancy status - if pregnant, engage in shared decision-making about continuation 1
  6. Assess breastfeeding status - conflicting guidance exists, with CDC noting safety but other sources recommending avoidance 3, 2
  7. If all criteria met, prescribe daily oral TDF/FTC (never on-demand dosing for AFAB individuals) 1

Common Pitfalls to Avoid

  • Do not assume pregnancy is a contraindication - this outdated approach denies protection to high-risk pregnant individuals 3, 2
  • Do not prescribe on-demand/event-driven PrEP to AFAB individuals, as this has not been validated in this population 1
  • Do not rely on self-reported adherence alone - the FEM-PrEP trial failure demonstrates that objective adherence monitoring is critical in AFAB populations 1
  • Do not forget regular pregnancy testing throughout PrEP use in individuals of reproductive age 1

References

1
Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

2
Guideline

HIV PrEP During Pregnancy

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

3
Guideline

PrEP During Pregnancy: Safety and Recommendations

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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