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Does short-term virologic failure translate to clinical events in antiretroviral-naïve patients initiating antiretroviral therapy in clinical practice?

The Antiretroviral Therapy Cohort Collaboration (ART-CC)

doi: 10.1097/QAD.0b013e328318f130
Clinical Science

Objective: To determine whether differences in short-term virologic failure among commonly used antiretroviral therapy (ART) regimens translate to differences in clinical events in antiretroviral-naïve patients initiating ART.

Design: Observational cohort study of patients initiating ART between January 2000 and December 2005.

Setting: The Antiretroviral Therapy Cohort Collaboration (ART-CC) is a collaboration of 15 HIV cohort studies from Canada, Europe, and the United States.

Study participants: A total of 13 546 antiretroviral-naïve HIV-positive patients initiating ART with efavirenz, nevirapine, lopinavir/ritonavir, nelfinavir, or abacavir as third drugs in combination with a zidovudine and lamivudine nucleoside reverse transcriptase inhibitor backbone.

Main outcome measures: Short-term (24-week) virologic failure (>500 copies/ml) and clinical events within 2 years of ART initiation (incident AIDS-defining event, death, and a composite measure of these two outcomes).

Results: Compared with efavirenz as initial third drug, short-term virologic failure was more common with all other third drugs evaluated; nevirapine (adjusted odds ratio = 1.87, 95% confidence interval (CI) = 1.58–2.22), lopinavir/ritonavir (1.32, 95% CI = 1.12–1.57), nelfinavir (3.20, 95% CI = 2.74–3.74), and abacavir (2.13, 95% CI = 1.82–2.50). However, the rate of clinical events within 2 years of ART initiation appeared higher only with nevirapine (adjusted hazard ratio for composite outcome measure 1.27, 95% CI = 1.04–1.56) and abacavir (1.22, 95% CI = 1.00–1.48).

Conclusion: Among antiretroviral-naïve patients initiating therapy, between-ART regimen, differences in short-term virologic failure do not necessarily translate to differences in clinical outcomes. Our results should be interpreted with caution because of the possibility of residual confounding by indication.

* A complete listing of the ART-CC steering committee, coordinating team, and contributing cohorts is given in Acknowledgement section.

Received 19 March, 2008

Revised 8 September, 2008

Accepted 11 September, 2008

Correspondence to Michael J. Mugavero, MD, MHSc, CCB 178 1530, 3rd Avenue S., Birmingham, AL 35294-2050, USA. E-mail: mmugavero@uab.edu

© 2008 Lippincott Williams & Wilkins, Inc.