Journal Article

Comparative Efficacy versus Effectiveness of Initial Antiretroviral Therapy in Clinical Trials versus Routine Care

Justin S. Routman, James H. Willig, Andrew O. Westfall, Sarah R. Abroms, Mohit Varshney, Sunil Adusumilli, Jeroan J. Allison, Karen G. Savage, Michael S. Saag and Michael J. Mugavero

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 50, issue 4, pages 574-584
Published in print February 2010 | ISSN: 1058-4838
Published online February 2010 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/650004
Comparative Efficacy versus Effectiveness of Initial Antiretroviral Therapy in Clinical Trials versus Routine Care

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The applicability of clinical trial findings (efficacy) to the routine care setting (effectiveness) may be limited. The present study found that first-year virological and CD4+ cell count outcomes among antiretroviral-naive patients treated through routine care were similar to outcomes among patients participating in clinical trials.

Background. The applicability of clinical trial findings (efficacy) to the routine care setting (effectiveness) may be limited because of study eligibility criteria and volunteer bias. Although well-chronicled in many conditions, the efficacy versus effectiveness of antiretroviral therapy (ART) remains understudied.

Methods. A retrospective study of the University of Alabama at Birmingham 1917 Clinic Cohort evaluated ART-naive patients who started ART from 1 January 2000 through 31 December 2006. Patients received ART through clinical trials or routine care. Multivariable logistic and linear regression models were fit to evaluate factors associated with virological failure (virological failure was defined as a viral load >50 copies/mL) and change from baseline CD4+ cell count 6 and 12 months after ART initiation. Sensitivity analyses evaluated the impact of missing data on outcomes.

Results. Among 570 patients starting ART during the study period, 121 (21%) enrolled in clinical trials, and 449 (79%) received ART via routine care. ART receipt through routine care was not associated with viral failure at either 6 months (odds ratio [OR], 1.00; 95% confidence interval [CI], 0.54–1.86) or 12 months (OR, 1.56; 95% CI, 0.80–3.05) in primary analyses. No statistically significant differences in CD4+ cell count responses at 6 and 12 months were observed.

Conclusions. Although marked differences in efficacy versus effectiveness have been observed in the therapeutic outcomes of other conditions, our analyses found no evidence of such divergence among our patients who initiated antiretroviral therapy for human immunodeficiency virus infection.

Journal Article.  5003 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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