TORO: Ninety-six-week virologic and immunologic response and safety evaluation of enfuvirtide with an optimized background of antiretrovirals

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

Research output: Contribution to journalArticle

40 Scopus citations

Abstract

The additional 48-week optional treatment extension of the T-20 versus Optimized Regimen Only (TORO) studies evaluated long-term safety and efficacy of enfuvirtide (ENF) through week 96 in patients receiving ENF plus optimized background (OB) and patients switching to ENF plus OB from OB alone. Patient randomization was 2:1 to ENF plus OB (n = 663) and OB (n = 334), of which 89.7% and 89.8% were male, 89.3% and 88.6% were Caucasian, and median age was 41 and 42 years, respectively. HIV risk factors were comparable between the ENF plus OB and OB groups with the major factors being 65.2% versus 66.2% homosexual contact, 17.8% versus 19.8% heterosexual contact, 4.1% versus 4.8% bisexual contact, respectively, and 6.9% injection drug use in both groups. OB patients were allowed to switch to ENF plus OB at virologic failure before week 48 and required to switch at week 48 to continue in the study (n = 230). Efficacy and safety assessments were conducted for each group. At week 96, 55% of ENF plus OB subjects completed the study and 26.5% achieved a viral load of less than 400 copies per milliliter (17.5% achieved less than 50 copies per milliliter). Viral load and CD4 mean change from baseline was -2.1 and -1.1 log10 HIV-1-RNA copies per milliliter and +166 and +116 CD4 cells/mm3 for ENF plus OB and switch patients, respectively. No new ENF-related safety issues emerged in weeks 48-96. Injection site reactions led to discontinuation in 7% and 10% of ENF plus OB and switch patients, respectively. In conclusion, these data demonstrate durable efficacy and safety of ENF over 96 weeks and that early use of ENF in combination with other agents for the treatment of antiretroviral-experienced HIV-infected subjects is beneficial.

Original languageEnglish (US)
Pages (from-to)533-543
Number of pages11
JournalAIDS Patient Care and STDs
Volume21
Issue number8
DOIs
StatePublished - Aug 2007

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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    Reynes, J., Arastéh, K., Clotet, B., Cohen, C., Cooper, D. A., Delfraissy, J. F., Eron, J. J., Henry, K., Katlama, C., Kuritzkes, D. R., Lalezari, J. P., Lange, J., Lazzarin, A., Montaner, J. S. G., Nelson, M., O'Hearn, M., Stellbrink, H. J., Trottier, B., Walmsley, S. L., ... Salgo, M. P. (2007). TORO: Ninety-six-week virologic and immunologic response and safety evaluation of enfuvirtide with an optimized background of antiretrovirals. AIDS Patient Care and STDs, 21(8), 533-543. https://doi.org/10.1089/apc.2006.0174