Characteristics associated with virologic failure in high-risk HIV-positive participants with prior failure: a post hoc analysis of ACTG 5251

Gregory K. Robbins, Susan E. Cohn, Linda J. Harrison, Laura Smeaton, Laura Moran, David Rusin, Marjorie Dehlinger, Theresa Flynn, Sara Lammert, Albert W. Wu, Steven Safren, Nancy R. Reynolds

Research output: Contribution to journalArticle

4 Citations (Scopus)

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. 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.

Original languageEnglish (US)
Pages (from-to)165-172
Number of pages8
JournalHIV Clinical Trials
Volume17
Issue number4
DOIs
StatePublished - Jul 3 2016

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HIV
RNA
Depression
HIV-1
Population
Visual Analog Scale
Counseling
Nurses
Clinical Trials
Morbidity
Therapeutics

Keywords

  • Adherence
  • Antiretroviral therapy
  • High risk populations
  • Virologic failure

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

Cite this

Characteristics associated with virologic failure in high-risk HIV-positive participants with prior failure : a post hoc analysis of ACTG 5251. / Robbins, Gregory K.; Cohn, Susan E.; Harrison, Linda J.; Smeaton, Laura; Moran, Laura; Rusin, David; Dehlinger, Marjorie; Flynn, Theresa; Lammert, Sara; Wu, Albert W.; Safren, Steven; Reynolds, Nancy R.

In: HIV Clinical Trials, Vol. 17, No. 4, 03.07.2016, p. 165-172.

Research output: Contribution to journalArticle

Robbins, GK, Cohn, SE, Harrison, LJ, Smeaton, L, Moran, L, Rusin, D, Dehlinger, M, Flynn, T, Lammert, S, Wu, AW, Safren, S & Reynolds, NR 2016, 'Characteristics associated with virologic failure in high-risk HIV-positive participants with prior failure: a post hoc analysis of ACTG 5251', HIV Clinical Trials, vol. 17, no. 4, pp. 165-172. https://doi.org/10.1080/15284336.2016.1189754
Robbins, Gregory K. ; Cohn, Susan E. ; Harrison, Linda J. ; Smeaton, Laura ; Moran, Laura ; Rusin, David ; Dehlinger, Marjorie ; Flynn, Theresa ; Lammert, Sara ; Wu, Albert W. ; Safren, Steven ; Reynolds, Nancy R. / Characteristics associated with virologic failure in high-risk HIV-positive participants with prior failure : a post hoc analysis of ACTG 5251. In: HIV Clinical Trials. 2016 ; Vol. 17, No. 4. pp. 165-172.
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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. 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.",
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