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

Mark Nelson, Keikawus Arastéh, Bonaventura Clotet, David A. Cooper, Keith Henry, Christine Katlama, Jacob P. Lalezari, Adriano Lazzarin, Julio S.G. Montaner, Mary O'Hearn, Peter J. Piliero, Jacques Reynes, Benoit Trottier, Sharon L. Walmsley, Calvin Cohen, Joseph J. Eron, Daniel R. Kuritzkes, Joep Lange, Hans Jürgen Stellbrink, Jean François DelfraissyNeil E. Buss, Lucille Donatacci, Cynthia Wat, Lynn Smiley, Martin Wilkinson, Adeline Valentine, Denise Guimaraes, Ralph DeMasi, Jain Chung, Miklos P. Salgo

Research output: Contribution to journalArticlepeer-review

128 Scopus citations

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 ≥1.0 log10 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. Conclusion: These data demonstrate durable efficacy of enfuvirtide plus OB over 48 weeks.

Original languageEnglish (US)
Pages (from-to)404-412
Number of pages9
JournalJournal of Acquired Immune Deficiency Syndromes
Volume40
Issue number4
DOIs
StatePublished - Dec 2005
Externally publishedYes

Keywords

  • Efficacy
  • Enfuvirtide
  • Fusion inhibitor
  • HIV
  • Subgroups
  • TORO

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