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 Cohen & 16 others Tosca 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 journalArticle

70 Citations (Scopus)

Abstract

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to enfuvirtide and 36.6% to the control group discontinued study treatment before week 48; the percentage of patients withdrawn for safety reasons (including adverse events [AEs], deaths, and laboratory abnormalities) was 14.0% in the enfuvirtide group and 11.6% in the control group.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

Original languageEnglish
Pages (from-to)413-421
Number of pages9
JournalJournal of Acquired Immune Deficiency Syndromes
Volume40
Issue number4
DOIs
Publication statusPublished - Dec 2005

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HIV-1
Safety
Control Groups
Therapeutics
enfuvirtide
Injections
Patient Safety
Nausea
Fatigue
Diarrhea
Pneumonia
Incidence

Keywords

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

ASJC Scopus subject areas

  • Virology
  • Immunology

Cite this

Safety of enfuvirtide in combination with an optimized background of antiretrovirals in treatment-experienced HIV-1-infected adults over 48 weeks. / Trottier, Benoit; Walmsley, Sharon; Reynes, Jacques; Piliero, Peter; O'Hearn, Mary; Nelson, Mark; Montaner, Julio; Lazzarin, Adriano; Lalezari, Jacob; Katlama, Christine; Henry, Keith; Cooper, David; Clotet, Bonaventura; Arastéh, Keikawus; Delfraissy, Jean François; Stellbrink, Hans Jürgen; Lange, Joep; Kuritzkes, Daniel; Eron, Joseph J.; Cohen, Calvin; Kinchelow, Tosca; Bertasso, Anne; Labriola-Tompkins, Emily; Shikhman, Anna; Atkins, Belinda; Bourdeau, Laurence; Natale, Christopher; Hughes, Fiona; Chung, Jain; Guimaraes, Denise; Drobnes, Claude; Bader-Weder, Silvia; DeMasi, Ralph; Smiley, Lynn; Salgo, Miklos P.; Buss, N.

In: Journal of Acquired Immune Deficiency Syndromes, Vol. 40, No. 4, 12.2005, p. 413-421.

Research output: Contribution to journalArticle

Trottier, B, Walmsley, S, Reynes, J, Piliero, P, O'Hearn, M, Nelson, M, Montaner, J, Lazzarin, A, Lalezari, J, Katlama, C, Henry, K, Cooper, D, Clotet, B, Arastéh, K, Delfraissy, JF, Stellbrink, HJ, Lange, J, Kuritzkes, D, Eron, JJ, Cohen, C, Kinchelow, T, Bertasso, A, Labriola-Tompkins, E, Shikhman, A, Atkins, B, Bourdeau, L, Natale, C, Hughes, F, Chung, J, Guimaraes, D, Drobnes, C, Bader-Weder, S, DeMasi, R, Smiley, L, Salgo, MP & Buss, N 2005, 'Safety of enfuvirtide in combination with an optimized background of antiretrovirals in treatment-experienced HIV-1-infected adults over 48 weeks', Journal of Acquired Immune Deficiency Syndromes, vol. 40, no. 4, pp. 413-421. https://doi.org/10.1097/01.qai.0000185313.48933.2c
Trottier, Benoit ; Walmsley, Sharon ; Reynes, Jacques ; Piliero, Peter ; O'Hearn, Mary ; Nelson, Mark ; Montaner, Julio ; Lazzarin, Adriano ; Lalezari, Jacob ; Katlama, Christine ; Henry, Keith ; Cooper, David ; Clotet, Bonaventura ; Arastéh, Keikawus ; Delfraissy, Jean François ; Stellbrink, Hans Jürgen ; Lange, Joep ; Kuritzkes, Daniel ; Eron, Joseph J. ; Cohen, Calvin ; Kinchelow, Tosca ; Bertasso, Anne ; Labriola-Tompkins, Emily ; Shikhman, Anna ; Atkins, Belinda ; Bourdeau, Laurence ; Natale, Christopher ; Hughes, Fiona ; Chung, Jain ; Guimaraes, Denise ; Drobnes, Claude ; Bader-Weder, Silvia ; DeMasi, Ralph ; Smiley, Lynn ; Salgo, Miklos P. ; Buss, N. / Safety of enfuvirtide in combination with an optimized background of antiretrovirals in treatment-experienced HIV-1-infected adults over 48 weeks. In: Journal of Acquired Immune Deficiency Syndromes. 2005 ; Vol. 40, No. 4. pp. 413-421.
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abstract = "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",
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T1 - Safety of enfuvirtide in combination with an optimized background of antiretrovirals in treatment-experienced HIV-1-infected adults over 48 weeks

AU - Trottier, Benoit

AU - Walmsley, Sharon

AU - Reynes, Jacques

AU - Piliero, Peter

AU - O'Hearn, Mary

AU - Nelson, Mark

AU - Montaner, Julio

AU - Lazzarin, Adriano

AU - Lalezari, Jacob

AU - Katlama, Christine

AU - Henry, Keith

AU - Cooper, David

AU - Clotet, Bonaventura

AU - Arastéh, Keikawus

AU - Delfraissy, Jean François

AU - Stellbrink, Hans Jürgen

AU - Lange, Joep

AU - Kuritzkes, Daniel

AU - Eron, Joseph J.

AU - Cohen, Calvin

AU - Kinchelow, Tosca

AU - Bertasso, Anne

AU - Labriola-Tompkins, Emily

AU - Shikhman, Anna

AU - Atkins, Belinda

AU - Bourdeau, Laurence

AU - Natale, Christopher

AU - Hughes, Fiona

AU - Chung, Jain

AU - Guimaraes, Denise

AU - Drobnes, Claude

AU - Bader-Weder, Silvia

AU - DeMasi, Ralph

AU - Smiley, Lynn

AU - Salgo, Miklos P.

AU - Buss, N.

PY - 2005/12

Y1 - 2005/12

N2 - 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

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KW - Antiretroviral therapy

KW - Enfuvirtide

KW - Fusion inhibitor

KW - HIV

KW - Safety

KW - T-20

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