Increase in Single-Tablet Regimen Use and Associated Improvements in Adherence-Related Outcomes in HIV-Infected Women

Hanna, David B. PhD*; Hessol, Nancy A. MSPH; Golub, Elizabeth T. PhD; Cocohoba, Jennifer M. PharmD; Cohen, Mardge H. MD§; Levine, Alexandra M. MD; Wilson, Tracey E. PhD; Young, Mary MD#; Anastos, Kathryn MD*,**; Kaplan, Robert C. PhD*

JAIDS Journal of Acquired Immune Deficiency Syndromes: 15 April 2014 - Volume 65 - Issue 5 - p 587–596
doi: 10.1097/QAI.0000000000000082
Epidemiology and Prevention

Introduction: The use of single-tablet antiretroviral therapy (ART) regimens and its implications on adherence among HIV-infected women have not been well described.

Methods: Participants were enrolled in the Women's Interagency HIV Study, a longitudinal study of HIV infection in US women. We examined semiannual trends in single-tablet regimen use and ART adherence, defined as self-reported 95% adherence in the past 6 months, during 2006–2013. In a nested cohort study, we assessed the comparative effectiveness of a single-tablet versus a multiple-tablet regimen with respect to adherence, virologic suppression, quality of life, and AIDS-defining events, using propensity score matching to account for demographic, behavioral, and clinical confounders. We also examined these outcomes in a subset of women switching from a multiple- to single-tablet regimen using a case-crossover design.

Results: We included 15,523 person-visits, representing 1727 women (53% black, 29% Hispanic, 25% IDU, median age 47). Use of single-tablet regimens among ART users increased from 7% in 2006% to 27% in 2013; adherence increased from 78% to 85% during the same period (both P < 0.001). Single-tablet regimen use was significantly associated with increased adherence (adjusted risk ratio: 1.05; 95% confidence interval: 1.03 to 1.08) and virologic suppression (risk ratio: 1.06; 95% confidence interval: 1.01 to 1.11), while associations with improved quality of life and fewer AIDS-defining events did not achieve statistical significance. Similar findings were observed among the subset of switchers.

Conclusions: Single-tablet regimen use was associated with increased adherence and virologic suppression. Despite this, 15% of women prescribed ART were still not optimally adherent; additional interventions are needed to maximize therapeutic benefits.

*Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY;

Department of Clinical Pharmacy, University of California—San Francisco, San Francisco, CA;

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD;

§Department of Medicine, Cook County Health and Hospitals System and Rush University, Chicago, IL;

City of Hope National Medical Center, Duarte, CA;

Department of Community Health Sciences, SUNY Downstate Medical Center, Brooklyn, NY;

#Department of Medicine, Georgetown University Medical Center, Washington, DC; and

**Department of Medicine, Montefiore Medical Center, Bronx, NY.

Correspondence to: David B. Hanna, PhD, Department of Epidemiology and Population Health, Albert Einstein College of Medicine, 1300 Morris Park Avenue, Belfer 13th floor, Bronx, NY 10461 (e-mail: david.hanna@einstein.yu.edu).

The Women's Interagency HIV Study is funded by the National Institute of Allergy and Infectious Diseases (UO1-AI-35004, UO1-AI-31834, UO1-AI-34994, UO1-AI-34989, UO1-AI-34993, and UO1-AI-42590) and by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (UO1-HD-32632). The study is cofunded by the National Cancer Institute, the National Institute on Drug Abuse, and the National Institute on Deafness and Other Communication Disorders. Funding is also provided by the National Center for Research Resources (UCSF-CTSI grant no. UL1 RR024131).

Preliminary findings were presented at the eighth International Conference on HIV Treatment and Prevention Adherence, June 2–4, 2013, Miami, FL.

J.M.C. reports an unrelated past grant from Gilead. K.A. reports an unrelated past consultancy with Bristol-Myers Squibb. The remaining authors have no funding or conflicts of interest to disclose.

D.B.H. conceived and designed the study, conducted the main analysis, and drafted the article. N.A.H. and R.C.K. contributed to the study design. All authors contributed substantially to the interpretation of the data, revised the article critically for important intellectual content, and gave approval of the final version.

The contents of this publication are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health.

Received May 31, 2013

Accepted November 22, 2013

© 2014 by Lippincott Williams & Wilkins