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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.
Acknowledgments
The authors are grateful for the patients’ commitment and participation in this study and the New Start Call Center (Kirsis Ham NP, Valery Hughes NP, Christina Megill PA and Todd Stroberg). The findings and conclusions in this manuscript are those of the authors and do not necessarily represent the views of the Office of the Global AIDS Coordinator, the National Institutes of Health, or the U.S. Department of State. The following individuals assisted in conducting A5251: Beverly E. Sha, MD and Tondria Green, RN, BSN, ACRN – Rush University Medical Center (Site 2702) Grant AI069471; Miriam Chicurel-Bayard RN BSN and Erin Elizabeth Hoffman BS – Chapel Hill CRS (Site 3201) ACTG CTU Grant UM1 AI069423, CTSA: 1UL1TR001111 CFAR: P30 AI50410; Shobha Swaminathan, MD and Christie Lyn Costanza, MPH – Rutgers New Jersey Medical School CRC (Site 31786) Grant 2UM1AI069419; Kerry Upton, RN and Karen Savage, RN – Alabama Therapeutics CRS (Site 31788) Grant UM1AI069452; Kim Whitely and Traci Davis – MetroHealth CRS (Site 2503) Grant 1U01AI069501-01; Susan E. Cohn, MD, MPH, Nina Lambert, BSN – Northwestern University CRS (Site 2701) Grant AI 069471; Elizabeth Fletcher MS APN-C and Yolanda Smith BA – Cooper University Hospital (Site 31476) Grant UM1 AI069503; Amy Sbrolla RN BSN and Teri Flynn ANP-BC – Massachusetts General Hospital (Site 101); Albert Wu, MD AI069465 Johns Hopkins University. Grant 2UM1AI069412-08; Kirsis Ham NP, Valery Hughes NP, Christina Megill PA-C and Todd Stroberg RN – Weill Cornell Chelsea CRS (Site 7804) Grant UM1AI069419 and CTSC UL1TR000457; Roger Bedimo MD and Michelle Mba MPH – Trinity Health & Wellness Center (Site 31443) Grant UM1AI069471; Linda Meixner RN and Edward Seefried RN – UCSD (Site 701) Grant AI069432; Brenda Jackson, RN and Becky Basham, Regulatory – Vanderbilt Therapeutics Clinical Research (Site 3652) Grant 2UM1AI069439-08 and Vanderbilt CTSA grant UL1 TR000445 from NCATS/NIH; and UM1 AI068634 ACTG Statistical and Data Management Center.