Archive for June 15, 2011
No Risk of Myocardial Infarction Associated With Initial Antiretroviral Treatment Containing Abacavir: Short and Long-Term Results from ACTG A5001/ALLRT
Clinical Infectious Diseases 1 April 2011 V.52 N.7 P.929-940
Heather J. Ribaudo1, Constance A. Benson2, Yu Zheng1, Susan L. Koletar3, Ann C. Collier4, Judith J. Lok1, Marlene Smurzynski1, Ronald J. Bosch1, Barbara Bastow5, and Jeffrey T. Schouten4, for the ACTG A5001/ALLRT Protocol Team
1Center for Biostatistics in AIDS Research, Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts
2Division of Infectious Disease, University of California, San Diego
3Division of Infectious Diseases, Ohio State University, Columbus
4School of Medicine, University of Washington, Seattle
5Social & Scientific Systems, Silver Spring, Maryland
Abstract
Background
Observational and retrospective clinical trial cohorts have reported conflicting results for the association of abacavir use with risk of myocardial infarction (MI), possibly related to issues that may bias estimation of treatment effects, such as time-varying confounders, informative dropout, and cohort loss due to competing events.
Methods
We analyzed data from 5056 individuals initiating randomized antiretroviral treatment (ART) in AIDS Clinical Trials Group studies; 1704 started abacavir therapy. An intent-to-treat analysis adjusted for pretreatment covariates and weighting for informative censoring was used to estimate the hazard ratio (HR) of MIs after initiation of a regimen with or without abacavir.
Results
Through 6 years after ART initiation, 36 MIevents were observed in 17,404 person-years of follow-up. No evidence of an increased hazard of MI in subjects using abacavir versus no abacavir was seen (over a 1-year period: P =.50; HR, 0.7 [95% confidence interval {CI}, 0.2-2.4]); over a 6-year period: P= .24; HR, 0.6 [95% CI, 0.3-1.4]); these results were robust over as-treated and sensitivity analyses. Although the risk of MI decreased over time, there was no evidence to suggest a time-dependent abacavir effect. Classic
cardiovascular disease (CVD) risk factors were the strongest predictors of MI.
Conclusion
We find no evidence to suggest that initial ART containing abacavir increases MI risk over short-term and long-term periods in
this population with relatively low MI risk. Traditional CVD risk factors should be the main focus in assessing CVD risk in individuals with human immunodeficiency virus infection.
abstract
http://cid.oxfordjournals.org/content/52/7/929.abstract