title: Four measures of antiretroviral medication adherence and virologic response in AIDS clinical trials group study 359.
abstract: AIDS Clinical Trials Group (ACTG) 359 was a randomized, partially double-blinded factorial study of 6 antiretroviral regimens, all including saquinavir, among HIV-infected persons in whom prior therapy had failed (n = 258). Counts of remaining saquinavir capsules were determined between weeks 0 and 4; at weeks 4, 8, and 16, self-reported adherence was estimated from 2-day report of doses skipped, therapeutic coverage, and percent of doses taken were determined by electronic monitoring devices applied to saquinavir bottles, and the saquinavir 24-hour area under the curve (AUC) was estimated. Relationships were evaluated among these 4 adherence measures and the primary endpoint of week 16 HIV RNA change. Thirty percent of 254 subjects had HIV RNA < or =500 copies/mL at week 16. Only self-reported adherence and saquinavir AUC were significantly associated with week 16 HIV RNA change (P = 0.019 and 0.023, respectively), and these measures were higher in subjects with week 16 HIV RNA < or =500 copies/mL (P = 0.03 and 0.008, respectively). The ability to detect a correlation between electronically monitored adherence and virologic response was limited by the small sample size. Self-reported adherence and saquinavir AUC were significant predictors of virologic response, in this evaluation. These findings provide insight into methods of assessing and improving adherence to antiretroviral regimens.
authors.affiliation: Department of Clinical Pharmacy, University of Colorado Health Sciences Center, Denver, CO 80262, USA. courtney.fletcher@uchsc.edu
authors.forename: Courtney V
authors.initials: CV
authors.lastname: Fletcher
authors.forename: Marcia A
authors.initials: MA
authors.lastname: Testa
authors.forename: Richard C
authors.initials: RC
authors.lastname: Brundage
authors.forename: Margaret A
authors.initials: MA
authors.lastname: Chesney
authors.forename: Richard
authors.initials: R
authors.lastname: Haubrich
authors.forename: Edward P
authors.initials: EP
authors.lastname: Acosta
authors.forename: Ana
authors.initials: A
authors.lastname: Martinez
authors.forename: Hongyu
authors.initials: H
authors.lastname: Jiang
authors.forename: Roy M
authors.initials: RM
authors.lastname: Gulick
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D000284:Administration, Oral; D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D002214:Capsules / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D006678:HIV / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D008297:Male; D010349:Patient Compliance / Q000706:statistics & numerical data*; D012367:RNA, Viral / Q000032:analysis; D019258:Saquinavir / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use; D012648:Self Care; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D044966:Anti-Retroviral Agents; D002214:Capsules; D012367:RNA, Viral; D019258:Saquinavir