Safety of enfuvirtide in combination with an optimized background of antiretrovirals in treatment-experienced HIV-1-infected adults over 48 weeks

Benoit Trottier, Sharon Walmsley, Jacques Reynes, Peter Piliero, Mary O'Hearn, Mark Nelson, Julio Montaner, Adriano Lazzarin, Jacob Lalezari, Christine Katlama, Keith Henry, David Cooper, Bonaventura Clotet, Keikawus Arastéh, Jean François Delfraissy, Hans Jürgen Stellbrink, Joep Lange, Daniel Kuritzkes, Joseph J. Eron, Calvin CohenTosca Kinchelow, Anne Bertasso, Emily Labriola-Tompkins, Anna Shikhman, Belinda Atkins, Laurence Bourdeau, Christopher Natale, Fiona Hughes, Jain Chung, Denise Guimaraes, Claude Drobnes, Silvia Bader-Weder, Ralph DeMasi, Lynn Smiley, Miklos P. Salgo, N. Buss

Research output: Contribution to journalArticlepeer-review

77 Scopus citations


Background: Antiretroviral tolerability is a critical factor contributing to treatment outcome. The T-20 Versus Optimized Background Regimen Only (TORO) studies assessed the safety and efficacy of enfuvirtide in treatment-experienced HIV-1-infected patients. Methods: A total of 997 patients were randomized at a 2:1 ratio to an optimized background antiretroviral regimen plus enfuvirtide (n = 663) or an optimized background regimen alone (control group; n = 334). Control patients could switch to enfuvirtide on virologic failure. Results: In total, 26.5% of patients randomized to enfuvirtide and 36.6% to the control group discontinued study treatment before week 48; the percentage of patients withdrawn for safety reasons (including adverse events [AEs], deaths, and laboratory abnormalities) was 14.0% in the enfuvirtide group and 11.6% in the control group. Injection site reactions (ISRs) occurred in 98% of enfuvirtide patients and led to treatment discontinuation in 4.4%. Treatment-related (defined as possibly, probably, or remotely) AE rates per 100 patient-years were lower with enfuvirtide (96.2) than in the control group (149.9); diarrhea, nausea, and fatigue, the most frequently reported AEs, were significantly less frequent with enfuvirtide than in the control group. Pneumonia was significantly more frequent in patients treated with enfuvirtide (6.7 vs. 0.6 events per 100 patient-years), although the incidence was within expected ranges for this population. Lymphadenopathy was also higher in enfuvirtide-treated patients (7.1 vs. 1.2 events per 100 patient-years) for control patients. Conclusion: The addition of enfuvirtide to an optimized background regimen does not exacerbate AEs commonly associated with antiretrovirals. ISRs limited treatment in <5% of patients.

Original languageEnglish (US)
Pages (from-to)413-421
Number of pages9
JournalJournal of Acquired Immune Deficiency Syndromes
Issue number4
StatePublished - Dec 2005
Externally publishedYes


  • Antiretroviral therapy
  • Enfuvirtide
  • Fusion inhibitor
  • HIV
  • Safety
  • T-20

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)


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