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. 2011;6(7):e21824.
doi: 10.1371/journal.pone.0021824. Epub 2011 Jul 13.

Does HAART efficacy translate to effectiveness? Evidence for a trial effect

Prema Menezes  1 , William C Miller, David A Wohl, Adaora A Adimora, Peter A Leone, William C Miller, Joseph J Eron Jr
Affiliations

Does HAART efficacy translate to effectiveness? Evidence for a trial effect

Prema Menezes et al. PLoS One. 2011.

Abstract

Background: Patients who participate in clinical trials may experience better clinical outcomes than patients who initiate similar therapy within clinical care (trial effect), but no published studies have evaluated a trial effect in HIV clinical trials.

Methods: To examine a trial effect we compared virologic suppression (VS) among patients who initiated HAART in a clinical trial versus in routine clinical care. VS was defined as a plasma HIV RNA ≤ 400 copies/ml at six months after HAART initiation and was assessed within strata of early (1996-99) or current (2000-06) HAART periods. Risk ratios (RR) were estimated using binomial models.

Results: Of 738 persons initiating HAART, 30.6% were women, 61.7% were black, 30% initiated therapy in a clinical trial and 67% (n = 496) had an evaluable six month HIV RNA result. HAART regimens differed between the early and current periods (p < 0.001); unboosted PI regimens (55.6%) were more common in the early and NNRTI regimens (46.4%) were more common in the current period. Overall, 78% (95%CI 74, 82%) of patients achieved VS and trial participants were 16% more likely to achieve VS (unadjusted RR 1.16, 95%CI 1.06, 1.27). Comparing trial to non-trial participants, VS differed by study period. In the early period, trial participants initiating HAART were significantly more likely to achieve VS than non-trial participants (adjusted RR 1.33; 95%CI 1.15, 1.54), but not in the current period (adjusted RR 0.98; 95%CI 0.87, 1.11).

Conclusions: A clear clinical trial effect on suppression of HIV replication was observed in the early HAART period but not in the current period.

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Conflict of interest statement

Competing Interests: There is no conflict of interest for Drs. Menezes, Adimora, Leone and Miller. Dr. David Wohl is a speaker for Gilead Sciences, Abbott, BMS, Tibotec, Merck and GSK. He has grant support from GSK, Merck and Tibotec. Dr. Joseph Eron has grant support from GSK, Merck, TakMed. He is a consultant for BMS, Merck, GSK, Tobira and Tibotec. This does not alter the authors' adherence to all the PLoS One Policies on sharing data and materials.

Figures

Figure 1
Figure 1. Antiretroviral treatment by trial participation.
Figure 2
Figure 2. Sensitivity Analyis: Risk Ratios for viral suppression following different adjustment schema for missing data.
See this image and copyright information in PMC

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