title: Regimen selection in the OPTIONS trial of HIV salvage therapy: drug resistance, prior therapy, and race-ethnicity determine the degree of regimen complexity.
abstract: Regimen selection for highly treatment-experienced patients is complicated.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.forename: Karen T
authors.initials: KT
authors.lastname: Tashima
authors.forename: Katie R
authors.initials: KR
authors.lastname: Mollan
authors.forename: Lumine
authors.initials: L
authors.lastname: Na
authors.forename: Rajesh T
authors.initials: RT
authors.lastname: Gandhi
authors.forename: Karin L
authors.initials: KL
authors.lastname: Klingman
authors.forename: Carl J
authors.initials: CJ
authors.lastname: Fichtenbaum
authors.forename: Adriana
authors.initials: A
authors.lastname: Andrade
authors.forename: Victoria A
authors.initials: VA
authors.lastname: Johnson
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Eron
authors.forename: Laura
authors.initials: L
authors.lastname: Smeaton
authors.forename: Richard H
authors.initials: RH
authors.lastname: Haubrich
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D000069454:Darunavir / Q000627:therapeutic use; D024882:Drug Resistance, Viral; D000077560:Enfuvirtide; D005260:Female; D015700:HIV Envelope Protein gp41 / Q000627:therapeutic use; D015658:HIV Infections / Q000188:drug therapy* / Q000208:ethnology / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles; D010446:Peptide Fragments / Q000627:therapeutic use; D011724:Pyridazines / Q000627:therapeutic use; D011743:Pyrimidines; D000068898:Raltegravir Potassium / Q000627:therapeutic use; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use; D019438:Ritonavir / Q000627:therapeutic use; D016879:Salvage Therapy
chemical_list: D019380:Anti-HIV Agents; D044966:Anti-Retroviral Agents; D015700:HIV Envelope Protein gp41; D009570:Nitriles; D010446:Peptide Fragments; D011724:Pyridazines; D011743:Pyrimidines; D018894:Reverse Transcriptase Inhibitors; C451734:etravirine; D000077560:Enfuvirtide; D000068898:Raltegravir Potassium; D019438:Ritonavir; D000069454:Darunavir
keywords: Antiretroviral therapy; HIV drug resistance,; Phenotypic susceptibility score,; Treatment-experienced,; Tropism,; cPSS,