Racial differences in virologic failure associated with adherence and quality of life on efavirenz-containing regimens for initial HIV therapy: results of ACTG A5095.

TitleRacial differences in virologic failure associated with adherence and quality of life on efavirenz-containing regimens for initial HIV therapy: results of ACTG A5095.
Publication TypeJournal Article
Year of Publication2007
AuthorsSchackman BR, Ribaudo HJ, Krambrink A, Hughes V, Kuritzkes DR, Gulick RM
JournalJ Acquir Immune Defic Syndr
Volume46
Issue5
Pagination547-54
Date Published2007 Dec 15
ISSN1525-4135
KeywordsAfrican Continental Ancestry Group, Anti-HIV Agents, Antiretroviral Therapy, Highly Active, Benzoxazines, Continental Population Groups, Double-Blind Method, European Continental Ancestry Group, Hispanic Americans, HIV Infections, Humans, Quality of Life, Risk Factors, Treatment Failure, Treatment Refusal, United States
Abstract

BACKGROUND: Blacks had higher rates of virologic failure than whites on efavirenz-containing regimens in the AIDS Clinical Trials Group (ACTG) A5095 study; preliminary analyses also suggested an association with adherence. We rigorously examined associations over time among race, virologic failure, 4 self-reported adherence metrics, and quality of life (QOL).

METHODS: ACTG A5095 was a double-blind placebo-controlled study of treatment-naive HIV-positive patients randomized to zidovudine/lamivudine/abacavir versus zidovudine/lamivudine plus efavirenz versus zidovudine/lamivudine/abacavir plus efavirenz. Virologic failure was defined as confirmed HIV-1 RNA >or=200 copies/mL at >or=16 weeks on study. The zidovudine/lamivudine/abacavir arm was discontinued early because of virologic inferiority. We examined virologic failure differences for efavirenz-containing arms according to missing 0 (adherent) versus at least 1 dose (nonadherent) during the past 4 days, alternative self-reported adherence metrics, and QOL. Analyses used the Fisher exact, log rank tests, and Cox proportional hazards models.

RESULTS: The study population included white (n = 299), black (n = 260), and Hispanic (n = 156) patients with >or=1 adherence evaluation. Virologic failure was associated with week 12 nonadherence during the past 4 days for blacks (53% nonadherent failed vs. 25% adherent; P < 0.001) but not for whites (20% nonadherent failed vs. 20% adherent; P = 0.91). After adjustment for baseline covariates and treatment, there was a significant interaction between race and week 12 adherence (P = 0.02). In time-dependent Cox models using self-reports over time to reflect recent adherence, there was a significantly higher failure risk for nonadherent subjects (hazard ratio [HR] = 2.07; P < 0.001). Significant race-adherence interactions were seen in additional models of adherence: missing at least 1 medication dose ever (P = 0.04), past month (P < 0.01), or past weekend (P = 0.05). Lower QOL was significantly associated with virologic failure (P < 0.001); there was no evidence of an interaction between QOL and race (P = 0.39) or adherence (P = 0.51) in predicting virologic failure.

CONCLUSIONS: There was a greater effect of nonadherence on virologic failure in blacks given efavirenz-containing regimens than in whites. Self-reported adherence and QOL are independent predictors of virologic failure.

Alternate JournalJ. Acquir. Immune Defic. Syndr.
PubMed ID18193496
Grant ListAI 27659 / AI / NIAID NIH HHS / United States
AI 51966 / AI / NIAID NIH HHS / United States
AI 68634 / AI / NIAID NIH HHS / United States
AI 68636 / AI / NIAID NIH HHS / United States
AI 69419 / AI / NIAID NIH HHS / United States
DA 017179 / DA / NIDA NIH HHS / United States
M01RR 00047 / RR / NCRR NIH HHS / United States
RR 02635 / RR / NCRR NIH HHS / United States