Regimen Selection in the OPTIONS Trial of HIV Salvage Therapy Regimen Selection in the OPTIONS Trial of HIV Salvage Therapy: Drug Resistance, Prior Therapy, and Race-ethnicity Determine the Degree of Regimen Complexity.


HIV Prevention


Tashima KT, Mollan KR, Na L, Gandhi RT, Klingman KL, Fichtenbaum CJ, Andrade A, Johnson VA, Eron JJ, Smeaton L, Haubrich RH. 

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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.

HIV Clin Trials. 2015 Aug;16(4):147-56. doi: 10.1179/1945577115Y.0000000001. Epub 2015 Jul 27. PMID: 26212575



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