MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel
© 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 sequenc...
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th-cmuir.6653943832-578412018-09-05T03:50:48Z MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel 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 Medicine © 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. 2018-09-05T03:50:48Z 2018-09-05T03:50:48Z 2017-01-01 Journal 15376591 10584838 2-s2.0-85018192380 10.1093/cid/ciw832 https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85018192380&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/57841 |
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Medicine 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 MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel |
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© 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. |
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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 |
author_facet |
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 |
author_sort |
Ross D. Cranston |
title |
MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel |
title_short |
MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel |
title_full |
MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel |
title_fullStr |
MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel |
title_full_unstemmed |
MTN-017: A rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel |
title_sort |
mtn-017: a rectal phase 2 extended safety and acceptability study of tenofovir reduced-glycerin 1% gel |
publishDate |
2018 |
url |
https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85018192380&origin=inward http://cmuir.cmu.ac.th/jspui/handle/6653943832/57841 |
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1681424953691340800 |