Gregory K Robbins1, Susan E Cohn2, Linda J Harrison3, Laura Smeaton3, Laura Moran4, David Rusin5, Marjorie Dehlinger6, Theresa Flynn1, Sara Lammert1, Albert W Wu7, Steven A Safren8, Nancy R Reynolds9. 1. a Massachusetts General Hospital/Harvard Medical School , Boston, MA , USA. 2. b Department of Medicine , Northwestern University Feinberg School of Medicine , Chicago, IL , USA. 3. c Center for Biostatistics in AIDS Research, Harvard TH Chan School of Public Health , Boston, MA , USA. 4. d Social and Scientific Systems, Inc , Silver Spring, MD , USA. 5. e Frontier Science & Technology Research Foundation , Amherst, NY , USA. 6. f National Institute of Allergy and Infectious Diseases, National Institutes of Health , Bethesda, MD , USA. 7. g Johns Hopkins Bloomberg School of Public Health , Baltimore, MD , USA. 8. h Department of Psychology , University of Miami , Coral Gables, FL , USA. 9. i School of Nursing , Yale University , New Haven, CT , USA.
Abstract
UNLABELLED: 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. METHODS: 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)). RESULTS: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. DISCUSSION: 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.
RCT Entities:
UNLABELLED: 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. METHODS: 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)). RESULTS: 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. DISCUSSION: 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.
Entities:
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)
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