PrEP for Women: Recommended Regimen and Implementation
Daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) 300mg/200mg taken once daily is the recommended PrEP regimen for all women at risk of HIV infection. 1, 2, 3
Critical Timing Consideration for Women
Women require at least 7 consecutive days of daily dosing before achieving maximum protection, unlike men who have sex with men who achieve protection within 24 hours. 3 This difference exists because tenofovir concentrates at 10-fold lower levels in vaginal tissue compared to rectal tissue, with faster drug clearance. 1, 3 Daily adherence is absolutely critical for women—there is no on-demand or event-driven dosing option for women. 1, 3
Who Should Receive PrEP
Offer PrEP to women with any of the following risk factors: 2, 3
- HIV-positive sexual partner
- Inconsistent condom use with partners of unknown HIV status
- Recent bacterial sexually transmitted infection diagnosis
- Sexual network with HIV incidence >2% per year
- Multiple sexual partners
- Injection drug use
Pre-Initiation Requirements
Before prescribing PrEP, obtain the following tests: 1, 2, 3
- Combined HIV antibody and antigen testing (if acute HIV suspected based on symptoms, add HIV RNA testing)
- Serum creatinine with estimated creatinine clearance calculation
- Hepatitis B surface antigen (HBsAg)
- Hepatitis C antibody
- Nucleic acid amplification testing for gonorrhea and chlamydia (genital and extragenital sites)
- Syphilis serology
- Pregnancy test
Do not initiate PrEP if HIV infection cannot be excluded. 1
Monitoring Schedule During PrEP Use
At 1 Month
Every 3 Months (Quarterly)
- Combined HIV antibody/antigen test 1, 2, 3
- STI screening (gonorrhea, chlamydia, syphilis) 1, 3
- Pregnancy testing 1, 3
- Estimated creatinine clearance 1, 3
Every 6-12 Months
- Hepatitis C antibody testing 1, 2
- More frequent renal monitoring if baseline creatinine clearance <90 mL/min, diabetes, or hypertension 2, 3
Special Populations
Pregnancy and Breastfeeding
Continue TDF/FTC during pregnancy and breastfeeding—it is safe with no documented adverse fetal effects. 2, 3 This is the preferred regimen during pregnancy. 2
Hepatitis B Co-infection
For HBsAg-positive women, do not abruptly discontinue TDF/FTC as this can cause acute hepatitis B flares or hepatic decompensation. 2 Consider indefinite continuation or transition to hepatitis B treatment if stopping PrEP, with close ALT/AST monitoring after discontinuation. 2, 3
Renal Impairment
TDF/FTC is not recommended for women with creatinine clearance <60 mL/min. 1 Consider tenofovir alafenamide/emtricitabine (TAF/FTC) as an alternative, though this has less robust efficacy data in women. 1, 2
Efficacy and Adherence
PrEP efficacy exceeds 90% when adherence is maintained with detectable drug levels. 2, 3 However, efficacy drops dramatically to 44% with suboptimal adherence. 3 Enhanced adherence counseling is essential for all women initiating PrEP. 3, 4 Meta-analysis data show that with 75% adherence, oral PrEP achieves significant effectiveness in women (relative risk 0.39). 5
Discontinuation Protocol
When stopping PrEP, continue daily dosing for 7 days after the last at-risk sexual exposure. 3 This extended tail-off period is necessary due to the slower drug accumulation in vaginal tissue. 1
Critical Pitfalls to Avoid
- Never use on-demand "2-1-1" dosing in women—this regimen is only validated for men who have sex with men. 1, 3
- Do not assume protection before 7 days of daily dosing—counsel women about this critical lead-in period. 2, 3
- PrEP does not prevent other STIs—condoms remain recommended for comprehensive STI prevention. 1, 3
- Screen for acute HIV infection symptoms before initiation—starting PrEP during unrecognized acute HIV can lead to resistance. 1