title: Durable efficacy of enfuvirtide over 48 weeks in heavily treatment-experienced HIV-1-infected patients in the T-20 versus optimized background regimen only 1 and 2 clinical trials.
abstract: BACKGROUND
  The T-20 Versus Optimized Background Regimen Only (TORO) 1 and TORO 2 clinical trials are open-label, controlled, parallel-group, phase 3 studies comparing enfuvirtide plus an optimized background (OB) of antiretrovirals (n = 661) with OB alone (n = 334) in treatment-experienced HIV-1-infected patients.
  
  
  METHODS
  The primary objective at week 48 was to investigate durability of efficacy, as measured by the percentage of patients maintaining their week 24 response or improving. Efficacy analyses used the intent-to-treat population.
  
  
  RESULTS
  A total of 73.7% of patients randomized to the enfuvirtide group remained on treatment through week 48 versus 21.3% originally randomized to the control group. At week 48, a higher proportion of week 24 responders maintained their response or were new responders in the enfuvirtide group than in the control group in each responder category: HIV-1 RNA level > or =1.0 log(10) change from baseline, <400 copies/mL and <50 copies/mL (37.4%, 30.4%, and 18.3% in the enfuvirtide group vs. 17.1%, 12.0%, and 7.8% in the control group, respectively; P < 0.0001 for all comparisons). CD4 cell count increases from baseline were twice as great in the enfuvirtide group as in the control group.
  
  
  CONCLUSIONS
  These data demonstrate durable efficacy of enfuvirtide plus OB over 48 weeks.
authors.affiliation: Chelsea and Westminster Hospital, London, United Kingdom. mark.nelson@chelwest.nhs.uk
authors.forename: Mark
authors.initials: M
authors.lastname: Nelson
authors.forename: Keikawus
authors.initials: K
authors.lastname: Arastéh
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
authors.forename: David A
authors.initials: DA
authors.lastname: Cooper
authors.forename: Keith
authors.initials: K
authors.lastname: Henry
authors.forename: Christine
authors.initials: C
authors.lastname: Katlama
authors.forename: Jacob P
authors.initials: JP
authors.lastname: Lalezari
authors.forename: Adriano
authors.initials: A
authors.lastname: Lazzarin
authors.forename: Julio S G
authors.initials: JS
authors.lastname: Montaner
authors.forename: Mary
authors.initials: M
authors.lastname: O'Hearn
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Piliero
authors.forename: Jacques
authors.initials: J
authors.lastname: Reynes
authors.forename: Benoit
authors.initials: B
authors.lastname: Trottier
authors.forename: Sharon L
authors.initials: SL
authors.lastname: Walmsley
authors.forename: Calvin
authors.initials: C
authors.lastname: Cohen
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Eron
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Kuritzkes
authors.forename: Joep
authors.initials: J
authors.lastname: Lange
authors.forename: Hans-Jürgen
authors.initials: HJ
authors.lastname: Stellbrink
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Delfraissy
authors.forename: Neil E
authors.initials: NE
authors.lastname: Buss
authors.forename: Lucille
authors.initials: L
authors.lastname: Donatacci
authors.forename: Cynthia
authors.initials: C
authors.lastname: Wat
authors.forename: Lynn
authors.initials: L
authors.lastname: Smiley
authors.forename: Martin
authors.initials: M
authors.lastname: Wilkinson
authors.forename: Adeline
authors.initials: A
authors.lastname: Valentine
authors.forename: Denise
authors.initials: D
authors.lastname: Guimaraes
authors.forename: Ralph
authors.initials: R
authors.lastname: Demasi
authors.forename: Jain
authors.initials: J
authors.lastname: Chung
authors.forename: Miklos P
authors.initials: MP
authors.lastname: Salgo
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D004359:Drug Therapy, Combination; D000077560:Enfuvirtide; D005260:Female; D015700:HIV Envelope Protein gp41 / Q000008:administration & dosage / Q000627:therapeutic use*; D023581:HIV Fusion Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000008:administration & dosage / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D013997:Time Factors; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D015700:HIV Envelope Protein gp41; D023581:HIV Fusion Inhibitors; D010446:Peptide Fragments; D012367:RNA, Viral; D000077560:Enfuvirtide