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 Delfraissy; Neil E. Buss; Lucille Donatacci; Cynthia Wat; Lynn Smiley; Martin Wilkinson; Adeline Valentine; Denise Guimaraes; Ralph DeMasi; Jain Chung; Miklos P. Salgo

doi:10.1097/01.qai.0000185314.56556.c3

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

IRCCS Ospedale San Raffaele

Research output: Contribution to journal › Article

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,

Original language	English
Pages (from-to)	404-412
Number of pages	9
Journal	Journal of Acquired Immune Deficiency Syndromes
Volume	40
Issue number	4
DOIs	https://doi.org/10.1097/01.qai.0000185314.56556.c3
Publication status	Published - Dec 2005

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Keywords

Efficacy
Enfuvirtide
Fusion inhibitor
HIV
Subgroups
TORO

ASJC Scopus subject areas

Virology
Immunology

Cite this

Nelson, M., Arastéh, K., Clotet, B., Cooper, D. A., Henry, K., Katlama, C., Lalezari, J. P., Lazzarin, A., Montaner, J. S. G., O'Hearn, M., Piliero, P. J., Reynes, J., Trottier, B., Walmsley, S. L., Cohen, C., Eron, J. J., Kuritzkes, D. R., Lange, J., Stellbrink, H. J., ... Salgo, M. P. (2005). 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. Journal of Acquired Immune Deficiency Syndromes, 40(4), 404-412. https://doi.org/10.1097/01.qai.0000185314.56556.c3

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

In: Journal of Acquired Immune Deficiency Syndromes, Vol. 40, No. 4, 12.2005, p. 404-412.

Research output: Contribution to journal › Article

Nelson, M, Arastéh, K, Clotet, B, Cooper, DA, Henry, K, Katlama, C, Lalezari, JP, Lazzarin, A, Montaner, JSG, O'Hearn, M, Piliero, PJ, Reynes, J, Trottier, B, Walmsley, SL, Cohen, C, Eron, JJ, Kuritzkes, DR, Lange, J, Stellbrink, HJ, Delfraissy, JF, Buss, NE, Donatacci, L, Wat, C, Smiley, L, Wilkinson, M, Valentine, A, Guimaraes, D, DeMasi, R, Chung, J & Salgo, MP 2005, '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', Journal of Acquired Immune Deficiency Syndromes, vol. 40, no. 4, pp. 404-412. https://doi.org/10.1097/01.qai.0000185314.56556.c3

Nelson M, Arastéh K, Clotet B, Cooper DA, Henry K, Katlama C et al. 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. Journal of Acquired Immune Deficiency Syndromes. 2005 Dec;40(4):404-412. https://doi.org/10.1097/01.qai.0000185314.56556.c3

Nelson, Mark ; Arastéh, Keikawus ; Clotet, Bonaventura ; Cooper, David A. ; Henry, Keith ; Katlama, Christine ; Lalezari, Jacob P. ; Lazzarin, Adriano ; Montaner, Julio S G ; O'Hearn, Mary ; Piliero, Peter J. ; Reynes, Jacques ; Trottier, Benoit ; Walmsley, Sharon L. ; Cohen, Calvin ; Eron, Joseph J. ; Kuritzkes, Daniel R. ; Lange, Joep ; Stellbrink, Hans Jürgen ; Delfraissy, Jean François ; Buss, Neil E. ; Donatacci, Lucille ; Wat, Cynthia ; Smiley, Lynn ; Wilkinson, Martin ; Valentine, Adeline ; Guimaraes, Denise ; DeMasi, Ralph ; Chung, Jain ; Salgo, Miklos P. / 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. In: Journal of Acquired Immune Deficiency Syndromes. 2005 ; Vol. 40, No. 4. pp. 404-412.

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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 ≥1.0 log10 change from baseline, ",

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T1 - 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

AU - Nelson, Mark

AU - Arastéh, Keikawus

AU - Clotet, Bonaventura

AU - Cooper, David A.

AU - Henry, Keith

AU - Katlama, Christine

AU - Lalezari, Jacob P.

AU - Lazzarin, Adriano

AU - Montaner, Julio S G

AU - O'Hearn, Mary

AU - Piliero, Peter J.

AU - Reynes, Jacques

AU - Trottier, Benoit

AU - Walmsley, Sharon L.

AU - Cohen, Calvin

AU - Eron, Joseph J.

AU - Kuritzkes, Daniel R.

AU - Lange, Joep

AU - Stellbrink, Hans Jürgen

AU - Delfraissy, Jean François

AU - Buss, Neil E.

AU - Donatacci, Lucille

AU - Wat, Cynthia

AU - Smiley, Lynn

AU - Wilkinson, Martin

AU - Valentine, Adeline

AU - Guimaraes, Denise

AU - DeMasi, Ralph

AU - Chung, Jain

AU - Salgo, Miklos P.

PY - 2005/12

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N2 - 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,

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10.1097/01.qai.0000185314.56556.c3