EMTRICITABINE/ TENOFOVIR TAB
Clinical Criteria Summary
Indications & Target Populations
- HIV preexposure prophylaxis (PrEP) for men who have sex with men (MSM), transgender women (TGW), cisgender men, and cisgender women at risk for HIV sexual acquisition.
- Patients at very high risk of transmission (e.g., frequent condom-less sexual encounters, partners with uncontrolled HIV infection).
Renal & Skeletal Considerations
- Alternative to oral PrEP for patients with renal dysfunction.
- Unlikely to impact renal function or bone mineral density.
- Appropriate alternative for patients with osteoporosis or osteopenia.
Adherence & Behavioral Factors
- Beneficial for patients unable to adhere to daily oral dosing due to unstable housing, stigma, cognitive difficulties, uncontrolled mental illness, or substance use disorders.
- Requires patient agreement to comply with a strict every-2-month injection and testing schedule.
- Long half-life may pose a risk if therapy is abruptly discontinued while continuing high-risk behaviors (subtherapeutic concentrations may persist for up to 1 year, increasing resistance risk).
Contraindications & Drug Interactions
- Should not be used in patients receiving strong CYP inducers.
- Indicated for patients with contraindications or intolerance to tenofovir or emtricitabine.
Monitoring & Testing Requirements
- HIV must be excluded at baseline and at least every 2 months while on therapy.
- Adherence counseling and support required; patients educated on side effects, particularly during the first month of therapy.
- Additional monitoring (e.g., sexually transmitted infections, serum lipids, weight) per CDC/USPSTF guidelines.
Administration & Prescribing Requirements
- Long-acting intramuscular injection formulation.
- Oral lead-in is optional but may be used to assess early tolerance prior to long-lasting injection; oral CAB must be procured from Theracom.
- Prior authorization (PA-F) on the VA National Formulary (VANF).
- Must be prescribed by Infectious Diseases, HIV, or other PrEP providers with training/experience in managing HIV PrEP patients.