An HIV Preexposure Prophylaxis Demonstration Project and Safety Study for Young MSM

P REVENTION S CIENCE An HIV Preexposure Prophylaxis Demonstration Project and Safety Study for Young MSM Sybil G. Hosek, PhD,* Bret Rudy, MD,† Raphael Landovitz, MD,‡ Bill Kapogiannis, MD,§ George Siberry, MD,§ Brandy Rutledge, PhD,k Nancy Liu, MPH,k Jennifer Brothers, MPH,* Kathleen Mulligan, PhD,¶ Gregory Zimet, PhD,# Michelle Lally, MD,** Kenneth H. Mayer, MD,†† Peter Anderson, PharmD,‡‡ Jennifer Kiser, PharmD,‡‡ James F. Rooney, MD,§§ and Craig M. Wilson, MD,kk the Adolescent Trials Network (ATN) for HIV/AIDS Interventions Background: Young men who have sex with men (YMSM) are a key population for implementation of preexposure prophylaxis (PrEP) interventions. This open-label study examined adherence to PrEP and assessed sexual behavior among a diverse sample of YMSM in 12 US cities. Methods: Eligible participants were 18- to 22-year-old HIV- uninfected MSM who reported HIV transmission risk behavior in the previous 6 months. Participants were provided daily tenofovir disoproxil fumarate/emtricitabine (Truvada). Study visits occurred at baseline, monthly through week 12, and then quarterly through week 48. Dried blood spots were serially collected for the quantification of tenofovir diphosphate (TFV-DP). Results: Between March and September 2013, 2186 individuals were approached and 400 were found to be preliminarily eligible. Of those 400, 277 were scheduled for an in-person screening visit and 200 were enrolled (mean age = 20.2; 54.5% black, 26.5% Latino). Diagnosis of sexually transmitted infections, including urethral and rectal chlamydial/gonococcal infection and syphilis, at baseline was 22% and remained high across visits. At week 4, 56% of participants had TFV-DP levels consistent with $4 pills per week. By week 48, 34% of participants had TFV-DP levels consistent with $4 pills per week, with a noticeable drop-off occurring at week 24. Four HIV seroconversions occurred on study (3.29/100 person-years). Con- domless sex was reported by .80% of participants, and condomless anal sex with last partner was associated with higher TFV-DP levels. Conclusions: Acceptability of PrEP was high, and most partic- Received for publication February 6, 2016; accepted August 26, 2016. From the *John Stroger Hospital of Cook County, Chicago, IL; †New York University Medical Center, New York, NY; ‡University of California Los Angeles, Los Angeles, CA; §NICHD/MPIDB, Bethesda, MD; kWestat, Rockville, MD; ¶University of California San Francisco, San Francisco, CA; #Indiana University, Indianapolis, IN; **Alpert Medical School of Brown University and Lifespan Hospital System, Providence, RI; ††Fenway Health, Boston, MA; ‡‡University of Colorado, Denver, CO; §§Gilead Sciences, Foster City, CA; and kkUniversity of Alabama at Birmingham, Birmingham, AL. This study was funded under cooperative agreements U01 HD040533 and U01 HD040474 from the National Institutes of Health through the Eunice Kennedy Shriver National Institute of Child Health and Human Devel- opment with supplemental funding from the National Institute on Drug Abuse and National Institute of Mental Health. Study drug was donated by Gilead Sciences, Inc., along with supplemental funds for a portion of the dried blood spot testing. Supported by The Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) from the National Institutes of Health (U01 HD 040533 and U01 HD 040474) through the National Institute of Child Health and Human Development (B.K. and S. Lee), with supplemental funding from the National Institutes on Drug Abuse (K. Davenny and S. Kahana) and Mental Health (P. Brouwers, S. Allison). Study drug was donated by Gilead Sciences. K.M. has received unrestricted research grants from Gilead Sciences and ViiV. P.A. receives donated study drug and contract work from Gilead. J. F.R. is employed by Gilead Sciences, the maker of the study drug. The remaining authors have no funding or conflicts of interest to disclose. The comments and views of the authors do not necessarily represent the views of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Correspondence to: Sybil G. Hosek, PhD, Department of Psychiatry, John Stroger Hospital of Cook County, 1900 W Polk Street, room 854, Chicago, IL 60612 (e-mail: shosek@cookcountyhhs.org). Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. ipants achieved protective drug levels during monthly visits. As visit frequency decreased, so did adherence. YMSM in the United States may need PrEP access in youth-friendly settings with tailored adherence support and potentially augmented visit schedules. Key Words: preexposure prophylaxis, youth, men who have sex with men (J Acquir Immune Defic Syndr 2017;74:21–29) INTRODUCTION Young men who have sex with men (YMSM), particu- larly black and Latino YMSM, are the group most affected by HIV in the United States, 1 making them a key domestic population for implementation of HIV preexposure prophylaxis (PrEP) interventions. Based on evidence from multiple clinical trials of PrEP, 2–4 the US Food and Drug Administration approved daily use of tenofovir disoproxil fumarate/emtricita- bine (TDF/FTC) for the prevention of sexually acquired HIV in July 2012. In anticipation of this new drug indication, several open-label demonstration projects were launched to evaluate PrEP safety and adherence outside of a placebo-controlled trial setting; effective PrEP implementation strategies for specific at- risk populations are also being evaluated. Although not placebo controlled, the more recent PROUD study used an open-label randomized controlled design of either immediate or delayed PrEP to pilot test the implementation of PrEP in the public health system of the J Acquir Immune Defic Syndr Volume 74, Number 1, January 1, 2017 www.jaids.com | Copyright O 2016 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.