Consequences and Determinants of Adherence to Antiretroviral Medication: Results from Adult Aids Clinical Trials Group Protocol 370

Jeannette R. Ickovics(Yale University), Ann Cameron(Yale University), Robert Zackin(Cancer Research And Biostatistics), Roland L. Bassett(Cancer Research And Biostatistics), Margaret A. Chesney(University of California, San Francisco), Victoria A. Johnson(University of Alabama at Birmingham), Daniel R. Kuritzkes(University of Colorado Health), ACTG 370 Protocol Team, Edward P. Acosta, Ronald L. Barnett, Dawn Bell, S Cannmann, Joseph J. Eron, Margaret A. Fischl, Ian C. Marschner, Ana Martı́nez, Gene D. Morse, C B Pettinelli, J P Sommadossi, K Wood, Robert L. Murphy, N Priller, Beverly E. Sha, Nigel French(University of North Carolina at Chapel Hill), Chantal M.A.M. van der Horst(University of North Carolina at Chapel Hill), Cheryl Marcus(University of North Carolina at Chapel Hill), T. Lane(University of North Carolina at Chapel Hill), Janet K. Horton(University of North Carolina at Chapel Hill), Robert T. Schooley(University of Colorado Health), B. Putnam(University of Colorado Health), David Shugarts(University of Colorado Health), Steven C. Johnson(University of Colorado Health), K H Fife(Indiana University), Jonathan Black(Indiana University), Daniel Heise(Indiana University), KE Todd(University of Puerto Rico System), JL Santana Bagur(University of Puerto Rico System), G. Vázquez(University of Puerto Rico System), Iker López(University of Puerto Rico System), V.D. Ramírez(University of Puerto Rico System), Richard L. Hill(University of Alabama at Birmingham), Stephen Wright(University of Alabama at Birmingham), Brad McCulloch(University of Alabama at Birmingham), Michael S. Saag(University of Alabama at Birmingham), Debbie Slamowitz(Stanford University), Patricia Cain(Stanford University), T. C. Merigan(Stanford University), V Benjamín Tallman(University of Rochester), Carol Greisberger(University of Rochester), M Shoemaker(University of Rochester), Meghan Lewis(University of Rochester), R. M. Hewitt(University of California San Diego), Diane V. Havlir(University of California San Diego), Kathleen Nuffer(University of California San Diego), DA Wininger(The Ohio State University), Scott L. Watson(The Ohio State University), Joseph F. Clark(The Ohio State University), Claire Jackson(University of Miami), Allan Rodríguez(University of Miami), Ernesto G. Scerpella(University of Miami), Pablo Tebas, Troy A. Stiffler, Michael Royal, William G. Powderly(University of Washington), Ann C. Collier(University of Washington), Sharon Storey(University of Washington), L Houseworth(University of Washington), NJ Conley(Western University), Michael M. Lederman(Western University), Bernard S. Kalayjian(Western University), K Ingersol(Western University), Rhona J. McVey(Western University), Stephen J. Gluckman(California University of Pennsylvania), CP Helker(California University of Pennsylvania), Roberto Kappes(California University of Pennsylvania), Dong Kim(Harvard University Press), Mary Albrecht(Harvard University Press), Claudia Koziol(Harvard University Press), T Govan(University of California, Los Angeles), Steven A. Miles(University of California, Los Angeles), Suzette Chafey(University of California, Los Angeles), Ronald T. Mitsuyasu(University of California, Los Angeles), Henry S. Sacks(Hadassah Medical Center), Donna Mildvan(University of Hawaii System), Cecilia M. Shikuma(University of Hawaii System), Monica Millard(University of Hawaii System), Scott A. Souza(University of Hawaii System)
Antiviral Therapy
April 1, 2002
10.1177/135965350200700308
Cited by 128Open Access
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Abstract

OBJECTIVES: (1) To document rates and patterns of adherence from enrollment until week 24 of an AIDS clinical trial; (2) to examine the association of adherence to clinical end-points including plasma HIV-1 RNA level and CD4 cell count; and (3) to identify predictors of adherence from clinical, behavioural, psychosocial and demographic factors. DESIGN: Sub-study of a multicentre, randomised, open-label, comparison-controlled trial; 21 collaborating units of the Adult AIDS Clinical Trials Group. Observational, prospective analysis. METHODS: Ninety-three subjects with baseline plasma HIV-1 RNA levels >500 copies/ml, who completed clinical assessment, plasma HIV-1 RNA titres and CD4 cell counts at study entry, weeks 2, 4 and every 4 weeks thereafter until week 24. All patients were antiretroviral-experienced but were naive to non-nucleoside reverse transcriptase inhibitors and protease inhibitors. Self-reported adherence to antiretroviral therapies prescribed as part of the trial was assessed every 4 weeks from trial, week 4 until week 24. RESULTS: Average adherence was high, with 63% of subjects reporting >95% adherence across the trial. However, there was a significant decline in adherence over time on trial. After controlling for potential confounding variables, patients who were less than 95% adherent to medications were 3.5-times more likely to have treatment failure (HIV-1 RNA >50 copies/ml) than subjects with adherence rates of 95-100%. The strongest predictor of adherence was adverse clinical events (for example, dermatological, gastrointestinal symptoms): patients with adverse events were 12.8-times less likely to have 95-100% adherence. Other clinical, demographic, psychosocial and behavioural factors were also significant predictors of adherence. CONCLUSIONS: Adherence influences virological outcome even in AIDS clinical trials where overall adherence rates are high and should therefore be monitored in future trials. Intervention may be warranted to enhance adherence for subjects who have early toxicities, express concern about taking medications as directed, and for women and minorities.

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