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Oral PrEP Guidelines

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Academy Guidelines and Recommendations for Oral Pre-Exposure Prophylaxis (PrEP)

OVERARCHING BARRIERS TO PrEP UPTAKE AND RETENTION
  • Frequency of in-person medical appointments
  • Frequency of laboratory monitoring and HIV/STI testing
  • Patient costs of labs and follow-up care
  • Incapacity for oral, rectal, and vaginal self-swabs for STIs in many commercial labs
  • Confidentiality concerns for young PrEP candidates who are on their parents’ health insurance
  • Inconsistent messaging about could benefit from PrEP
  • Extensive and time-consuming CDC Guidelines (94 pages) is daunting for new prescribers
  • Prescribing providers are understaffed for patient tracking and retention needs for patients lost to PrEP care
ORAL PrEP - WHO QUALIFIES

All sexually active adults and adolescents should be asked if they have heard about PrEP and given information on PrEP in a non-stigmatizing way.
    F/TDF Daily: All sexually active adults and adolescents (>35kg/77lbs) who report sexual behaviors that place them at ongoing risk for exposure to HIV and acquisition and/or anyone who asks for PrEP

    F/TDF Event/2:1:1 Dosing (off label): Only for adult MSM who have sex less than two times per week and can anticipate sex 

    F/TAF Daily: Only Cisgender Men or Transgender Women 

    The efficacy and safety of other daily oral antiretroviral medications for PrEP, either in place of or in addition to, F/TDF or F/TAF, have not been studied extensively and are not recommended.
CLINICAL ELIGIBILITY FOR ORAL PrEP - ALL OF THESE CONDITIONS MUST BE MET
  • Documented negative HIV Ag/Ab test result within one week of initial prescription
  • No signs/symptoms of acute HIV infection
  • Estimated creatinine clearance ≥ 30 ml/min
  • For F/TDF the creatinine clearance should be >60 ml/min
  • No contraindicated medications
FOLLOW-UP CARE
    Every 3 months/90 days
    • HIV Ag/Ab test and HIV-1 RNA assay, medication adherence and behavioral risk reduction support
    • Bacterial STI screening and testing for MSM and transgender women who have sex with men (oral, rectal, urine, blood)
    Every 6 months/180 days
    • Assess renal function for patients ≥50 years or who have an eCrCl <90 ml/min at PrEP initiation
    • Bacterial STI screening and testing for all sexually active patients (vaginal, oral, rectal, urine as indicated) and blood
    Every 12 months/365 days
    • Assess renal function for all patients
    • Chlamydia screening heterosexually active women and men (vaginal, urine)
    • Assess weight, triglyceride and cholesterol levels for patients on F/TAF
RECOMMENDED BILLING AND CODING GUIDANCE
    In light of the US Preventive Services Task Force’s  "A" grade of oral PrEP, the Academy recommends using the ICD-10 Codes with the 33 modifier to maximize patient savings. Modifier 33 is a CPT modifier used to identify medical care whose primary purpose is delivery of an evidence-based service, based on recommendations from the US Preventive Services Task Force. You may also want to use Modifier 90 when laboratory procedures are performed by a party other than the treating or reporting physician and the laboratory bills the physician for the service.

    • Z20.2 – Contact with and suspected exposure to infections with a predominantly sexual mode of transmission
    • Z20.6 – Contact with and suspected exposure to human immunodeficiency virus (for serodiscordant couples)
    • Z29.8 – Other Specified Prophylaxis
    • Z29.9 – Unspecified Prophylaxis
    • Z70.8 – Safe Sex and STI Prevention Counseling
    • Z72.51 – High-risk heterosexual behavior (recommend not using considered to be stigmatizing)
    • Z72.52 – High-risk homosexual behavior (recommend not using considered to be stigmatizing)
OTHER CONSIDERATIONS TO EXPAND PrEP ACCESS AND RETENTION
  • Prescribers DO NOT have to see patients every 90 days IF requisite laboratory monitoring and testing results are not abnormal. Consider standing lab orders for patients and issue 90-day refills upon receipt of labs.
  • For adolescent males under the age of 19, prescribers may want to offer F/TAF preferentially, as bone density scores did not improve upon stopping F/TDF and lower bone density is correlated with adherence.
  • For males who opt for event-based (2:1:1) dosing, prescribe an initial 90 day supply and follow recommended 90-day follow-up care, but communicate with patients regarding the need for additional prescribed doses.
  • Consider standardizing follow-up care orders in electronic medical records systems.
  • Include the whole care team in offering information about PrEP.
  • Familiarize yourself with taking a sexual history that is non-stigmatizing and shaming. Consider training on implicit bias and non-stigmatizing language to talk with patients openly and honestly about their sexual behaviors.
  • Decouple medical visits with laboratory monitoring by incorporating telemedicine visits, standing lab orders, walk-in lab appointments, at-home HIV testing and swabbing to decrease patient time burdens.
  • If the patient is established and routinely getting laboratory monitoring and HIV/STI testing, remove follow-up burdens. See the patient in person once per year or every six months.
  • Prescribe PrEP for EVERY patient who asks for PrEP.
This activity is supported by an independent educational grant from Gilead Sciences.