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Regimen selection in the OPTIONS trial of HIV salvage therapy: drug resistance,
prior therapy, and race-ethnicity determine the degree of regimen complexity
#MMPMID26212575
Tashima KT
; Mollan KR
; Na L
; Gandhi RT
; Klingman KL
; Fichtenbaum CJ
; Andrade A
; Johnson VA
; Eron JJ
; Smeaton L
; Haubrich RH
HIV Clin Trials
2015[Aug]; 16
(4
): 147-56
PMID26212575
show ga
BACKGROUND: Regimen selection for highly treatment-experienced patients is
complicated. METHODS: Using a web-based utility, study team members reviewed
antiretroviral (ARV) history and resistance data and recommended individual ARV
regimens and nucleoside reverse transcriptase inhibitor (NRTI) options for
treatment-experienced participants consisting of 3-4 of the following agents:
raltegravir (RAL), darunavir (DRV)/ritonavir, tipranavir (TPV)/ritonavir,
etravirine (ETR), maraviroc (MVC), and enfuvirtide (ENF). We evaluated team
recommendations and site selection of regimen and NRTIs. Associations between
baseline factors and the selection of a complex regimen (defined as including
four ARV agents or ENF) were explored with logistic regression. RESULTS: A total
of 413 participants entered the study. Participants initiated the first or second
recommended regimen 86% of the time and 21% of participants started a complex
regimen. In a multivariable model, ARV resistance to NRTI (odds ratio
[OR]?=?2.2), non-nucleoside reverse transcriptase inhibitor (NNRTI, OR?=?6.2) or
boosted protease inhibitor (PI, OR?=?6.6), prior use of integrase strand transfer
inhibitor (INSTI, OR?=?25), and race-ethnicity (all P???0.01) were associated
with selection of a complex regimen. Black non-Hispanic (OR?=?0.5) and Hispanic
participants from the continental US (OR?=?0.2) were less likely to start a
complex regimen, compared to white non-Hispanics. CONCLUSIONS: In this
multi-center trial, we developed a web-based utility that facilitated treatment
recommendations for highly treatment-experienced patients. Drug resistance, prior
INSTI use, and race-ethnicity were key factors in decisions to select a more
complex regimen.
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