Jill Blumenthal1, Sonia Jain2, Feng He2, K Rivet Amico3, Ryan Kofron4, Eric Ellorin1, Jamila K Stockman1, Christina Psaros5, Gifty M Ntim4, Karen Chow1, Peter L Anderson6, Richard Haubrich7, Katya Corado8, David J Moore9, Sheldon Morris1, Raphael J Landovitz4. 1. Department of Medicine, University of California San Diego, San Diego, California, USA. 2. Department of Family Medicine and Public Health, University of California San Diego, San Diego, California, USA. 3. Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA. 4. Department of Medicine, Ronald Reagan UCLA Medical Center, University of California Los Angeles, Los Angeles, California, USA. 5. Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA. 6. Department of Pharmaceutical Sciences, University of Colorado, Denver, Colorado, USA. 7. Gilead Sciences, Foster City, California, USA. 8. Department of Medicine, Harbor-UCLA Medical Center, Torrance, California, USA. 9. Department of Psychiatry, University of California San Diego, San Diego, California, USA.
Abstract
BACKGROUND: Daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is effective for reducing human immunodeficiency virus (HIV) acquisition among cisgender women. We report results from the first US observational open-label demonstration project of pre-exposure prophylaxis (PrEP) among at-risk cisgender women. METHODS: Adherence Enhancement Guided by Individualized Texting and Drug Levels was a 48-week, single-arm, open-label demonstration study of daily oral TDF/FTC in cisgender women ≥18 years old at risk for HIV. Adherence was supported using 2-way text messaging and titrated adherence counseling based on rapid-turnaround tenofovir diphosphate concentrations from dried blood spots. Study visits occurred at baseline, weeks 4 and 12, and quarterly through week 48. Outcomes included TDF/FTC adherence, retention, and persistence. RESULTS: From June 2016 to October 2018, 136 cisgender women enrolled (mean age, 40 years (standard deviation, 11); 38% non-Hispanic Black and 19% Latina). At 48 weeks, 84 (62%) participants were retained and 62 (46%) remained on PrEP. More than one-third (12/31) of those on study but off PrEP throughout the study discontinued TDF/FTC because of side effects, and 1 adverse event led to study discontinuation. Of 120 participants with drug concentrations measured, 67 (56%) had at least 1 concentration consistent with 6 doses/week; 22 (18%) had consistent ≥6 doses/week across all study visits attended. There were no incident HIV infections and 4 incident bacterial sexually transmitted infections. CONCLUSION: Adequate PrEP adherence for protective drug concentrations was not achieved for most study participants. More work needs to be done to fully explicate the reasons for nonadherence and low retention in cisgender women.
BACKGROUND: Daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is effective for reducing human immunodeficiency virus (HIV) acquisition among cisgender women. We report results from the first US observational open-label demonstration project of pre-exposure prophylaxis (PrEP) among at-risk cisgender women. METHODS: Adherence Enhancement Guided by Individualized Texting and Drug Levels was a 48-week, single-arm, open-label demonstration study of daily oral TDF/FTC in cisgender women ≥18 years old at risk for HIV. Adherence was supported using 2-way text messaging and titrated adherence counseling based on rapid-turnaround tenofovir diphosphate concentrations from dried blood spots. Study visits occurred at baseline, weeks 4 and 12, and quarterly through week 48. Outcomes included TDF/FTC adherence, retention, and persistence. RESULTS: From June 2016 to October 2018, 136 cisgender women enrolled (mean age, 40 years (standard deviation, 11); 38% non-Hispanic Black and 19% Latina). At 48 weeks, 84 (62%) participants were retained and 62 (46%) remained on PrEP. More than one-third (12/31) of those on study but off PrEP throughout the study discontinued TDF/FTC because of side effects, and 1 adverse event led to study discontinuation. Of 120 participants with drug concentrations measured, 67 (56%) had at least 1 concentration consistent with 6 doses/week; 22 (18%) had consistent ≥6 doses/week across all study visits attended. There were no incident HIV infections and 4 incident bacterial sexually transmitted infections. CONCLUSION: Adequate PrEP adherence for protective drug concentrations was not achieved for most study participants. More work needs to be done to fully explicate the reasons for nonadherence and low retention in cisgender women.
Authors: Julia L Marcus; Leo B Hurley; Charles Bradley Hare; Dong Phuong Nguyen; Tony Phengrasamy; Michael J Silverberg; Juliet E Stoltey; Jonathan E Volk Journal: J Acquir Immune Defic Syndr Date: 2016-12-15 Impact factor: 3.731
Authors: David J Moore; Sonia Jain; Michael P Dubé; Eric S Daar; Xiaoying Sun; Jason Young; Katya Corado; Eric Ellorin; Joel Milam; Deborah Collins; Jill Blumenthal; Brookie M Best; Peter Anderson; Richard Haubrich; Sheldon R Morris Journal: Clin Infect Dis Date: 2018-05-02 Impact factor: 9.079
Authors: Raphael J Landovitz; Matthew Beymer; Ryan Kofron; Kathy Rivet Amico; Christina Psaros; Lane Bushman; Peter L Anderson; Risa Flynn; David P Lee; Robert K Bolan; Wilbert C Jordan; Chi-Hong Tseng; Rhodri Dierst-Davies; Jim Rooney; Amy Rock Wohl Journal: J Acquir Immune Defic Syndr Date: 2017-12-15 Impact factor: 3.731
Authors: Jia-Hua Zheng; Caitlin Rower; Kevin McAllister; Jose Castillo-Mancilla; Brandon Klein; Amie Meditz; L Anthony Guida; Jennifer J Kiser; Lane R Bushman; Peter L Anderson Journal: J Pharm Biomed Anal Date: 2016-01-21 Impact factor: 3.935
Authors: Roy M Gulick; Timothy J Wilkin; Ying Q Chen; Raphael J Landovitz; K Rivet Amico; Alicia M Young; Paul Richardson; Mark A Marzinke; Craig W Hendrix; Susan H Eshleman; Ian McGowan; Leslie M Cottle; Adriana Andrade; Cheryl Marcus; Karin L Klingman; Wairimu Chege; Alex R Rinehart; James F Rooney; Philip Andrew; Robert A Salata; Marc Siegel; Yukari C Manabe; Ian Frank; Ken Ho; Jorge Santana; Joanne D Stekler; Shobha Swaminathan; Marybeth McCauley; Sally Hodder; Kenneth H Mayer Journal: Ann Intern Med Date: 2017-08-22 Impact factor: 25.391