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Injectable PrEP Guidelines

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Academy Guidelines and Recommendations for Long-Acting Injectable 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
INJECTABLE 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.
    Injectable extended-release cabotegravir PrEP has been approved for all sexually active adults and adolescents (>35kg/77lbs) who report sexual behaviors that place them at ongoing risk for exposure to and acquisition of HIV and people who inject drugs (PWID) with an HIV-positive injection partner or share injection equipment.

    Injectable PrEP is given in two initiation injections administered one month apart, then every two months thereafter. Patents can start with either an injection or take oral cabotegravir for four weeks to assess tolerance.

    The efficacy and safety of other antiretroviral medications for PrEP, either in place of or in addition to oral F/TDF, oral F/TAF or injectable cabotegravir have not been studied extensively and are not recommended.
CLINICAL ELIGIBILITY FOR INJECTABLE PrEP - ALL OF THESE CONDITIONS ARE MET
  • Documented negative HIV Ag/Ab test result within one week of initial injection/prescription
    • Before starting injectable PrEP, the guidelines recommend providers assess HIV status using RNA instead of an HIV Ag/Ab test
  • No signs/symptoms of acute HIV infection
  • No contraindicated medications
FOLLOW-UP CARE
    One Month/30 Days after First Injection (Second Injection – Month 1)
    • HIV Ag/Ab test and HIV-1 RNA assay*
    Every Two Months (Third Injection – Month 3)
    • HIV Ag/Ab test and HIV-1 RNA assay*
    • Access to clean needles/syringes and drug treatment services for PWID
    Every Four Months (Third Injection – Month 3)
    • Bacterial STI testing for MSM and transgender women who have sex with men (oral, rectal, urine, blood)
    Every Six Months (Fifth Injection – Month 7)
    • Bacterial STI testing for all heterosexually active women and men (vaginal, oral, urine, blood – as indicated)
    Every 12 Months
    • Assess desire to continue injections as PrEP
    • Chlamydia screening for heterosexually active women and men (vaginal, urine)
    When Discontinuing Cabotegravir Injections for PrEP
    • Re-educate patients about the “tail” and risks of declining cab levels
    • Assess HIV risks and ongoing prevention plans
    • If PrEP is indicated, prescribe oral F/TDF or F/TAF as indicated beginning within 8 weeks of last injection
    • Continue follow-up visits with HIV testing quarterly for 12 months

    Because of the long duration of drug exposure following injection, exclusion of acute HIV infection is necessary with the most sensitive test available, an HIV-1 RNA assay

RECOMMENDED BILLING AND CODING GUIDANCE
    We recommend 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
  • Consider standardizing follow-up care orders in electronic medical records systems.
  • Consider booking patient appointments in 6-month intervals and encourage the patient to pick a date and time that is easily remembered.
  • 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.
  • Prescribe PrEP for EVERY patient who asks for PrEP.
This activity is supported by an independent educational grant from Gilead Sciences.