Contraindications for Oral Tenofovir-Based HIV PrEP (F/TDF or F/TAF)
Oral PrEP with tenofovir disoproxil fumarate/emtricitabine (F/TDF) or tenofovir alafenamide/emtricitabine (F/TAF) should not be used in persons with unknown or positive HIV-1 status because of risk for drug-resistant HIV. [1][2] Severe renal impairment limits use of both oral regimens, with specific creatinine clearance thresholds for initiation. [1][3]
HIV Status (Known Positive or Unknown)
- F/TDF (Truvada) is contraindicated for HIV-1 PrEP in individuals with unknown or positive HIV-1 status. [2]
- F/TAF (Descovy) is contraindicated for HIV-1 PrEP in individuals with unknown or positive HIV-1 status. [1]
- Acute HIV infection should be excluded before initiation to reduce development of drug-resistant HIV when PrEP is taken during undiagnosed early infection. [2][3]
Tenofovir Disoproxil Fumarate/Emtricitabine Renal Contraindication Threshold
- F/TDF is not recommended for HIV-1 PrEP in HIV-1 uninfected individuals with estimated creatinine clearance (eCrCl) below 60 mL/min. [2][3]
- CDC specifies eCrCl thresholds for oral PrEP as ≥60 mL/min for F/TDF. [3]
Tenofovir Alafenamide/Emtricitabine Renal Contraindication Threshold
- F/TAF is not recommended for HIV-1 PrEP in individuals with eCrCl 15 to below 30 mL/min. [1]
- CDC specifies eCrCl thresholds for oral PrEP as ≥30 mL/min for F/TAF. [3]
Hepatitis B Infection Considerations for Tenofovir-Containing PrEP
- F/TDF and F/TAF are tenofovir-containing regimens that require hepatitis B virus (HBV) assessment prior to or when initiating therapy, because discontinuation of tenofovir-based therapy in HBV infection can lead to severe hepatic events. [1]
- Active HBV infection is not listed as a contraindication on labeling summaries; instead, HBV status testing and monitoring are required when using these agents. [1][2]
Indication-Specific Contraindication for F/TAF Populations (Not a Renal or HIV-Status Contraindication)
- F/TAF (Descovy) is not indicated for HIV-1 prevention for receptive vaginal sex because effectiveness in that exposure category is not established. [1]
- CDC’s clinical guidance reflects organism- and exposure-specific use constraints for available oral PrEP options. [3]