title: Characteristics associated with virologic failure in high-risk HIV-positive participants with prior failure: a post hoc analysis of ACTG 5251.
abstract: Patients with prior virologic failure (VF) are at an increased risk of subsequent failure, emergence of resistance, and death. This analysis identifies outcomes and correlates of VF in a high-risk population.
  
  
  
  A5251 was designed to evaluate an enhanced adherence counseling intervention delivered by nurses from a central call site on virologic suppression. Due to slow enrollment, the study was closed prematurely and revised study endpoints were evaluated (week 24 VF (HIV-1 RNA ≥200 copies/ml) and non-perfect adherence (<100% self-reported using both the ACTG adherence questionnaire and visual analog scale (VAS)).
  
  
  
  Fifty-nine participants were enrolled, 43 (73%) black non-Hispanic and 23 (39%) women. Median prior antiretroviral regimen changes were three and the co-morbidity in this population was higher than typical for HIV clinical trials. At week 24 (n = 41), 24 (59%) failed to reach virologic suppression (HIV-1 RNA <200 copies/ml) and 25 (63%) reported non-perfect adherence. Higher depression (CES-D10) and adverse illness perceptions (IPQ-B) were associated with week 24 non-adherence. Early clinical assessments (week 12 HIV-RNA ≥200 copies/mL and non-perfect adherence) as well as higher depression and adverse illness perceptions were associated with week 24 VF.
  
  
  
  In this high-risk population, the proportion of participants with suboptimal adherence and VF was unacceptably high. Interventions to address this treatment gap are clearly needed. Depression and a higher illness perception score, failure to achieve virologic suppression by week 12, and less than perfect adherence could be used to target individuals for early interventions in treatment-experienced, high-risk individuals at high risk for VF.
authors.affiliation: a Massachusetts General Hospital/Harvard Medical School , Boston, MA , USA.
authors.forename: Gregory K
authors.initials: GK
authors.lastname: Robbins
authors.affiliation: b Department of Medicine , Northwestern University Feinberg School of Medicine , Chicago, IL , USA.
authors.forename: Susan E
authors.initials: SE
authors.lastname: Cohn
authors.affiliation: c Center for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health , Boston, MA , USA.
authors.forename: Linda J
authors.initials: LJ
authors.lastname: Harrison
authors.affiliation: c Center for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health , Boston, MA , USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Smeaton
authors.affiliation: d Social and Scientific Systems, Inc , Silver Spring, MD , USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Moran
authors.affiliation: e Frontier Science & Technology Research Foundation , Amherst, NY , USA.
authors.forename: David
authors.initials: D
authors.lastname: Rusin
authors.affiliation: f National Institute of Allergy and Infectious Diseases, National Institutes of Health , Bethesda, MD , USA.
authors.forename: Marjorie
authors.initials: M
authors.lastname: Dehlinger
authors.affiliation: a Massachusetts General Hospital/Harvard Medical School , Boston, MA , USA.
authors.forename: Theresa
authors.initials: T
authors.lastname: Flynn
authors.affiliation: a Massachusetts General Hospital/Harvard Medical School , Boston, MA , USA.
authors.forename: Sara
authors.initials: S
authors.lastname: Lammert
authors.affiliation: g Johns Hopkins Bloomberg School of Public Health , Baltimore, MD , USA.
authors.forename: Albert W
authors.initials: AW
authors.lastname: Wu
authors.affiliation: h Department of Psychology , University of Miami , Coral Gables, FL , USA.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Safren
authors.affiliation: i School of Nursing , Yale University , New Haven, CT , USA.
authors.forename: Nancy R
authors.initials: NR
authors.lastname: Reynolds
mesh_terms: D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000494:pharmacology / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active; D018791:CD4 Lymphocyte Count; D024882:Drug Resistance, Viral; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology*; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D012307:Risk Factors; D059039:Standard of Care; D013997:Time Factors; D017211:Treatment Failure; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents
keywords: Adherence; Antiretroviral therapy; Center for Epidemiological Studies Depression Scale (CES-D10); Combination antiretroviral therapy (ART); High risk populations; Human immunodeficiency virus (HIV); IPQ-B Brief Illness Perception Questionnaire (IPQ-B); Virologic failure; Visual Analog Scale (VAS)