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Prospective Use of Urine Tenofovir€¦ · Grant RM et al, 2010; K. R. Amico et al, 2013; J. M. Baeten et al, 2012; Hosek et al, 2015; Koenig HC et al, 2015 . Objectives For a high-risk

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  • Prospective Use of Urine Tenofovir

    Assay to Monitor Adherence to PrEP

    Helen C. Koenig, MD, MPH

    Medical Director, PrEP Program, Philadelphia FIGHT

    Clinical Assistant Professor, Hospital of the University of Pennsylvania

    Philadelphia, PA

  • Conflict of Interest Disclosure Helen C. Koenig, MD, MPH

    Consulting Fees: Gilead Sciences, Inc

    Contracted Research: Gilead Sciences, Inc

  • Background

    Adherence to PrEP is critical, but current

    adherence measurements are inadequate

    Young MSM of color and transwomen are at

    greatest risk yet adherence has not been

    adequate in this group

    We previously developed and validated a non-

    invasive, inexpensive, and highly acceptable

    urine assay to measure tenofovir (TFV) in HIV-

    negative subjects

    Grant RM et al, 2010; K. R. Amico et al, 2013; J. M. Baeten et al, 2012; Hosek et al, 2015; Koenig HC et al, 2015

  • Objectives

    For a high-risk yMSM of color and transwomen

    population over a 48 week study period:

    1) Assess adherence to PrEP using the urine assay

    2) Assess retention in care, defined as a) Completed >50% medication pick-up visits

    b) Had a visit at 48 weeks (within study window)

    3) Assess changes in rates of STIs

    4) Assess attitude toward PrEP by study subjects

  • Methods: Urine Assay

    Uses liquid chromatography/mass spectrometry

    Assay has high sensitivity and specificity for TFV

    100% concordance btw TFV in blood & urine

    TFV detected >7d in urine

  • Methods: Study Design

    48w prospective study of retention/adherence

    Subjects recruited from “I Am Men’s Health”

    PrEP Program at Y-HEP for high-risk youth

    PrEP administered weekly, biweekly, or monthly

    at Y-HEP with intensive adherence support

    Inclusion criteria: age 18-30, male sex at birth

    Risk behaviors were assessed through STI rates

    and Risk Assessment Battery (RAB) survey

  • Retention in Care, 36 weeks

    70% subjects

    retained in

    care at 36

    weeks

  • Adherence to PrEP

    At 24 wks:

    83% subjects with

    protective urine

    TFV values

    12% subjects with

    low-positive (not

    protective) urine

    TFV values

    5% subjects with

    negative values

    (not protective)

  • In Practice: Patient with Consistent Adherence

  • In Practice: Patient with Inconsistent Adherence

  • STI Rates 15 7 15 14

  • Perspectives on PrEP

  • Conclusions

    • Urine TFV testing allowed us to monitor PrEP

    adherence among high-risk youth in a CBO

    • Adherence > 83% at 24 wks by urine

    • Retention 70% at 36 weeks

    • High rates of other STIs throughout study period

    • Future Directions

    • Demonstrate urine assay increases adherence

    • Develop urine assay into point-of-care test

  • Acknowledgements

    Philadelphia FIGHT and Y-HEP, especially all PrEP participants

    PrEP research team:

    •L. Lalley-Chareczko

    •D. Clark

    •S. C. Conyngham

    •C. Sloan

    •G. Daughtridge

    Mentors: Dr. Tebas Dr. Mounzer CHOP Pharmacology Unit Dr. Ganesh Moorthy Dr. Athena Zuppa Jessica Sima

    Penn CFAR Luis Montaner Evelyn Olivieri Jim Hoxie Ron Collman Robert Gross


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