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Title: MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel
Authors: Ross D. Cranston
Javier R. Lama
Barbra A. Richardson
Alex Carballo-Diéguez
Ratiya Pamela Kunjara Na Ayudhya
Karen Liu
Karen B. Patterson
Cheng Shiun Leu
Beth Galaska
Cindy E. Jacobson
Urvi M. Parikh
Mark A. Marzinke
Craig W. Hendrix
Sherri Johnson
Jeanna M. Piper
Cynthia Grossman
Ken S. Ho
Jonathan Lucas
Jim Pickett
Linda Gail Bekker
Suwat Chariyalertsak
Anupong Chitwarakorn
Pedro Gonzales
Timothy H. Holtz
Albert Y. Liu
Kenneth H. Mayer
Carmen Zorrilla
Jill L. Schwartz
James Rooney
Ian McGowan
Keywords: Medicine
Issue Date: 1-Jan-2017
Abstract: © The Author 2017. Background. Human immunodeficiency virus (HIV) disproportionately affects men who have sex with men (MSM) and transgender women (TGW). Safe and acceptable topical HIV prevention methods that target the rectum are needed. Methods. MTN-017 was a phase 2, 3-period, randomized sequence, open-label, expanded safety and acceptability crossover study comparing rectally applied reduced-glycerin (RG) 1% tenofovir (TFV) and oral emtricitabine/TFV disoproxil fumarate (FTC/ TDF). In each 8-week study period participants were randomized to RG-TFV rectal gel daily, or RG-TFV rectal gel before and after receptive anal intercourse (RAI; or at least twice weekly in the event of no RAI), or daily oral FTC/TDF. Results. MSM and TGW (n = 195) were enrolled from 8 sites in the United States, Thailand, Peru, and South Africa with mean age of 31.1 years (range 18-64). There were no differences in ≥grade 2 adverse event rates between daily gel (incidence rate ratio [IRR], 1.09; P = .59) or RAI gel (IRR, 0.90; P = .51) compared to FTC/TDF. High adherence (≥80% of prescribed doses assessed by unused product return and Short Message System reports) was less likely in the daily gel regimen (odds ratio [OR], 0.35; P < .001), and participants reported less likelihood of future daily gel use for HIV protection compared to FTC/TDF (OR, 0.38; P < .001). Conclusions. Rectal application of RG TFV gel was safe in MSM and TGW. Adherence and product use likelihood were similar for the intermittent gel and daily oral FTC/TDF regimens, but lower for the daily gel regimen.
ISSN: 15376591
Appears in Collections:CMUL: Journal Articles

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