Oral Pre-Exposure Prophylaxis for HIV Prevention
Clinical Practice Brief
Introduction
- This practice brief provides guidance for clinicians regarding the implementation of pre-exposure prophylaxis (PrEP) to prevent HIV infection in high-risk populations.
- Data strongly suggest the use of once-daily oral emtricitabine-tenofovir disoproxil fumarate (FTC/TDF) 200mg/300mg or once-daily oral emtricitabine-tenofovir alafenamide (FTC/TAF) 200mg/25mg, in concert with safer sex practices, reduces the risk of HIV-1 acquisition by approximately 99%, with only a very small number of infections (related to resistant HIV strains) occurring in those who are adherent.
- Guidelines for oral PrEP are written and updated by the U.S. Public Health Service, U.S. Department of Health and Human Services and the Centers for Disease Control and Prevention (CDC).
- All sexually active adults and adolescents should be educated about PrEP as a strategy to help prevent HIV.
- The United States Preventive Task Force (USPTF) has assigned use of daily oral PrEP to prevent HIV with a Grade A.
- While cost and access are concerns, this USPTF Grade A mandates insurance coverage for PrEP medications and follow-up care.
- In addition, drug manufacturers and public agencies can provide financial and access assistance.
Guideline Summary
- Before starting PrEP, patients should be screened for HIV, syphilis (S), gonorrhea (G), chlamydia (C) and hepatitis B; baseline renal function should also be assessed.
- Men who have sex with men (MSM), transgender women (TGW) and injecting drug users (IDUs) should also be screened for hepatitis C.
- Patients who will be prescribed FTC/TAF for PrEP should also have a baseline lipid panel.
- Clinicians can prescribe a 90-day supply of once-daily oral FTC/TDF 200mg/300mg or once-daily oral FTC/TAF 200mg/25mg for PrEP in those who are HIV negative and who have creatinine clearance (eCrCl) > 60 mL/min (FTC/TDF) or > 30 mL/min (FTC/TAF).
- Patients actively taking PrEP should be screened for HIV every three months; MSM and TGW should additionally be screened for S/G/C every three months, while all others should be assessed for S/G/C every six months.
- Patients taking FTC/TAF should have an annual lipid panel evaluation.
- MSM, TGW and IDUs should also be screened for hepatitis C annually.
- Patients > age 50 with an eCrCl < 90 at PrEP initiation should have their eCrCl assessed every six months, while those < age 50 and eCrCl > 90 should have their eCrCl assessed annually.
- Common adverse events associated with FTC/TDF and FTC/TAF are similar and rare (2%) and include diarrhea, nausea, headache, fatigue and abdominal pain.
- Rare cases of associated renal dysfunction and bone demineralization have also been reported, with slightly fewer cases of these reported with the use of FTC/TAF.
- Treatment should not be abruptly discontinued in patients with hepatitis B infection.
- Clinicians should provide continuing guidance on safer sexual decision-making and answer any questions that arise while using PrEP throughout the ongoing regimen.
Considerations
- HIV continues to disproportionately affect MSM, African Americans and Latin persons, and these persons are more likely to experience access challenges and may also experience financial barriers to PrEP.
- Knowledge of public health and drug manufacturer resources is essential to help patients overcome access and financial barriers to initiating and maintaining a PrEP regimen.
- Follow-up visits can incorporate the use of telehealth.
- Billing code considerations: Z91.89; Z79.899; Z29.9.
Reference
Centers for Disease Control and Prevention: U.S. Public Health Service. (2021). Preexposure prophylaxis for the prevention of HIV infection in the United States—2021 Update: a clinical practice guideline.
https://www.cdc.gov/hiv/pdf/ri....