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Efficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies: final results of two randomised, placebo-controlled trials

Summary Background Two randomised, placebo-controlled trials—BENCHMRK-1 and BENCHMRK-2—investigated the efficacy and safety of raltegravir, an HIV-1 integrase strand-transfer inhibitor. We report final results of BENCHMRK-1 and BENCHMRK-2 combined at 3 years (the end of the double-blind phase) and 5... Full description

Journal Title: The Lancet infectious diseases 2013, Vol.13 (7), p.587-596
Main Author: Eron, Joseph J, Prof
Other Authors: Cooper, David A, Prof , Steigbigel, Roy T, Prof , Clotet, Bonaventura, MD , Gatell, Jose M, Prof , Kumar, Princy N, Prof , Rockstroh, Jurgen K, Prof , Schechter, Mauro, Prof , Markowitz, Martin, Prof , Yeni, Patrick, MD , Loutfy, Mona R, MD , Lazzarin, Adriano, Prof , Lennox, Jeffrey L, Prof , Strohmaier, Kim M, BS , Wan, Hong, MS , Barnard, Richard JO, PhD , Nguyen, Bach-Yen T, MD , Teppler, Hedy, MD
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Language: English
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Quelle: Alma/SFX Local Collection
Publisher: London: Elsevier Ltd
ID: ISSN: 1473-3099
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recordid: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6083850
title: Efficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies: final results of two randomised, placebo-controlled trials
format: Article
creator:
  • Eron, Joseph J, Prof
  • Cooper, David A, Prof
  • Steigbigel, Roy T, Prof
  • Clotet, Bonaventura, MD
  • Gatell, Jose M, Prof
  • Kumar, Princy N, Prof
  • Rockstroh, Jurgen K, Prof
  • Schechter, Mauro, Prof
  • Markowitz, Martin, Prof
  • Yeni, Patrick, MD
  • Loutfy, Mona R, MD
  • Lazzarin, Adriano, Prof
  • Lennox, Jeffrey L, Prof
  • Strohmaier, Kim M, BS
  • Wan, Hong, MS
  • Barnard, Richard JO, PhD
  • Nguyen, Bach-Yen T, MD
  • Teppler, Hedy, MD
subjects:
  • Adult
  • Anti-HIV Agents - administration & dosage
  • Anti-HIV Agents - adverse effects
  • Antibiotics. Antiinfectious agents. Antiparasitic agents
  • Antiviral agents
  • Article
  • Biological and medical sciences
  • CD4 Lymphocyte Count
  • Clinical trials
  • Double-Blind Method
  • Drug-Related Side Effects and Adverse Reactions - epidemiology
  • Drug-Related Side Effects and Adverse Reactions - pathology
  • Female
  • HIV Infections - drug therapy
  • HIV Infections - immunology
  • HIV Infections - virology
  • HIV-1 - isolation & purification
  • Human immunodeficiency virus
  • Human immunodeficiency virus 1
  • Human viral diseases
  • Humans
  • Immunodeficiencies
  • Immunodeficiencies. Immunoglobulinopathies
  • Immunopathology
  • Infectious Disease
  • Infectious diseases
  • Male
  • Medical sciences
  • Middle Aged
  • Pharmacology. Drug treatments
  • Placebos - administration & dosage
  • Placebos - adverse effects
  • Pyrrolidinones - administration & dosage
  • Pyrrolidinones - adverse effects
  • Raltegravir Potassium
  • Salvage Therapy - adverse effects
  • Salvage Therapy - methods
  • Treatment Outcome
  • Viral diseases
  • Viral diseases of the lymphoid tissue and the blood. Aids
  • Viral Load
ispartof: The Lancet infectious diseases, 2013, Vol.13 (7), p.587-596
description: Summary Background Two randomised, placebo-controlled trials—BENCHMRK-1 and BENCHMRK-2—investigated the efficacy and safety of raltegravir, an HIV-1 integrase strand-transfer inhibitor. We report final results of BENCHMRK-1 and BENCHMRK-2 combined at 3 years (the end of the double-blind phase) and 5 years (the end of the study). Methods Integrase-inhibitor-naive patients with HIV resistant to three classes of drug and who were failing antiretroviral therapy were enrolled. Patients were randomly assigned (2:1) to raltegravir 400 mg twice daily or placebo, both with optimised background treatment. Patients and investigators were masked to treatment allocation until week 156, after which all patients were offered open-label raltegravir until week 240. The primary endpoint was previously assessed at 16 weeks. We assessed long-term efficacy with endpoints of the proportion of patients with an HIV viral load of less than 50 copies per mL and less than 400 copies per mL, and mean change in CD4 cell count, at weeks 156 and 240. Findings 1012 patients were screened for inclusion. 462 were treated with raltegravir and 237 with placebo. At week 156, 51% in the raltegravir group versus 22% in the placebo group (non-completer classed as failure) had viral loads of less than 50 copies per mL, and 54% versus 23% had viral loads of less than 400 copies per mL. Mean CD4 cell count increase (analysed by an observed failure approach) was 164 cells per μL versus 63 cells per μL. After week 156, 251 patients (54%) from the raltegravir group and 47 (20%) from the placebo group entered the open-label raltergravir phase; 221 (47%) versus 44 (19%) completed the entire study. At week 240, viral load was less than 50 copies per mL in 193 (42%) of all patients initially assigned to raltegravir and less than 400 copies per mL in 210 (45%); mean CD4 cell count increased by 183 cells per μL. Virological failure occurred in 166 raltegravir recipients (36%) during the double-blind phase and in 17 of all patients (6%) during the open-label phase. The most common drug-related adverse events at 5 years in both groups were nausea, headache, and diarrhoea, and occurred in similar proportions in each group. Laboratory test results were similar in both treatment groups and showed little change after year 2. Interpretation Raltegravir has a favourable long-term efficacy and safety profile in integrase-inhibitor-naive patients with triple-class resistant HIV in whom antiretroviral therapy is faili
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 1473-3099
fulltext: fulltext
issn:
  • 1473-3099
  • 1474-4457
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titleEfficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies: final results of two randomised, placebo-controlled trials
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creatorEron, Joseph J, Prof ; Cooper, David A, Prof ; Steigbigel, Roy T, Prof ; Clotet, Bonaventura, MD ; Gatell, Jose M, Prof ; Kumar, Princy N, Prof ; Rockstroh, Jurgen K, Prof ; Schechter, Mauro, Prof ; Markowitz, Martin, Prof ; Yeni, Patrick, MD ; Loutfy, Mona R, MD ; Lazzarin, Adriano, Prof ; Lennox, Jeffrey L, Prof ; Strohmaier, Kim M, BS ; Wan, Hong, MS ; Barnard, Richard JO, PhD ; Nguyen, Bach-Yen T, MD ; Teppler, Hedy, MD
creatorcontribEron, Joseph J, Prof ; Cooper, David A, Prof ; Steigbigel, Roy T, Prof ; Clotet, Bonaventura, MD ; Gatell, Jose M, Prof ; Kumar, Princy N, Prof ; Rockstroh, Jurgen K, Prof ; Schechter, Mauro, Prof ; Markowitz, Martin, Prof ; Yeni, Patrick, MD ; Loutfy, Mona R, MD ; Lazzarin, Adriano, Prof ; Lennox, Jeffrey L, Prof ; Strohmaier, Kim M, BS ; Wan, Hong, MS ; Barnard, Richard JO, PhD ; Nguyen, Bach-Yen T, MD ; Teppler, Hedy, MD ; for the BENCHMRK Study Teams ; BENCHMRK Study Teams
descriptionSummary Background Two randomised, placebo-controlled trials—BENCHMRK-1 and BENCHMRK-2—investigated the efficacy and safety of raltegravir, an HIV-1 integrase strand-transfer inhibitor. We report final results of BENCHMRK-1 and BENCHMRK-2 combined at 3 years (the end of the double-blind phase) and 5 years (the end of the study). Methods Integrase-inhibitor-naive patients with HIV resistant to three classes of drug and who were failing antiretroviral therapy were enrolled. Patients were randomly assigned (2:1) to raltegravir 400 mg twice daily or placebo, both with optimised background treatment. Patients and investigators were masked to treatment allocation until week 156, after which all patients were offered open-label raltegravir until week 240. The primary endpoint was previously assessed at 16 weeks. We assessed long-term efficacy with endpoints of the proportion of patients with an HIV viral load of less than 50 copies per mL and less than 400 copies per mL, and mean change in CD4 cell count, at weeks 156 and 240. Findings 1012 patients were screened for inclusion. 462 were treated with raltegravir and 237 with placebo. At week 156, 51% in the raltegravir group versus 22% in the placebo group (non-completer classed as failure) had viral loads of less than 50 copies per mL, and 54% versus 23% had viral loads of less than 400 copies per mL. Mean CD4 cell count increase (analysed by an observed failure approach) was 164 cells per μL versus 63 cells per μL. After week 156, 251 patients (54%) from the raltegravir group and 47 (20%) from the placebo group entered the open-label raltergravir phase; 221 (47%) versus 44 (19%) completed the entire study. At week 240, viral load was less than 50 copies per mL in 193 (42%) of all patients initially assigned to raltegravir and less than 400 copies per mL in 210 (45%); mean CD4 cell count increased by 183 cells per μL. Virological failure occurred in 166 raltegravir recipients (36%) during the double-blind phase and in 17 of all patients (6%) during the open-label phase. The most common drug-related adverse events at 5 years in both groups were nausea, headache, and diarrhoea, and occurred in similar proportions in each group. Laboratory test results were similar in both treatment groups and showed little change after year 2. Interpretation Raltegravir has a favourable long-term efficacy and safety profile in integrase-inhibitor-naive patients with triple-class resistant HIV in whom antiretroviral therapy is failing. Raltegravir is an alternative for treatment-experienced patients, particularly those with few treatment options. Funding Merck Sharp & Dohme.
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languageeng
publisherLondon: Elsevier Ltd
subjectAdult ; Anti-HIV Agents - administration & dosage ; Anti-HIV Agents - adverse effects ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiviral agents ; Article ; Biological and medical sciences ; CD4 Lymphocyte Count ; Clinical trials ; Double-Blind Method ; Drug-Related Side Effects and Adverse Reactions - epidemiology ; Drug-Related Side Effects and Adverse Reactions - pathology ; Female ; HIV Infections - drug therapy ; HIV Infections - immunology ; HIV Infections - virology ; HIV-1 - isolation & purification ; Human immunodeficiency virus ; Human immunodeficiency virus 1 ; Human viral diseases ; Humans ; Immunodeficiencies ; Immunodeficiencies. Immunoglobulinopathies ; Immunopathology ; Infectious Disease ; Infectious diseases ; Male ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Placebos - administration & dosage ; Placebos - adverse effects ; Pyrrolidinones - administration & dosage ; Pyrrolidinones - adverse effects ; Raltegravir Potassium ; Salvage Therapy - adverse effects ; Salvage Therapy - methods ; Treatment Outcome ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Viral Load
ispartofThe Lancet infectious diseases, 2013, Vol.13 (7), p.587-596
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2Steigbigel, Roy T, Prof
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4Gatell, Jose M, Prof
5Kumar, Princy N, Prof
6Rockstroh, Jurgen K, Prof
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9Yeni, Patrick, MD
10Loutfy, Mona R, MD
11Lazzarin, Adriano, Prof
12Lennox, Jeffrey L, Prof
13Strohmaier, Kim M, BS
14Wan, Hong, MS
15Barnard, Richard JO, PhD
16Nguyen, Bach-Yen T, MD
17Teppler, Hedy, MD
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0Efficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies: final results of two randomised, placebo-controlled trials
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descriptionSummary Background Two randomised, placebo-controlled trials—BENCHMRK-1 and BENCHMRK-2—investigated the efficacy and safety of raltegravir, an HIV-1 integrase strand-transfer inhibitor. We report final results of BENCHMRK-1 and BENCHMRK-2 combined at 3 years (the end of the double-blind phase) and 5 years (the end of the study). Methods Integrase-inhibitor-naive patients with HIV resistant to three classes of drug and who were failing antiretroviral therapy were enrolled. Patients were randomly assigned (2:1) to raltegravir 400 mg twice daily or placebo, both with optimised background treatment. Patients and investigators were masked to treatment allocation until week 156, after which all patients were offered open-label raltegravir until week 240. The primary endpoint was previously assessed at 16 weeks. We assessed long-term efficacy with endpoints of the proportion of patients with an HIV viral load of less than 50 copies per mL and less than 400 copies per mL, and mean change in CD4 cell count, at weeks 156 and 240. Findings 1012 patients were screened for inclusion. 462 were treated with raltegravir and 237 with placebo. At week 156, 51% in the raltegravir group versus 22% in the placebo group (non-completer classed as failure) had viral loads of less than 50 copies per mL, and 54% versus 23% had viral loads of less than 400 copies per mL. Mean CD4 cell count increase (analysed by an observed failure approach) was 164 cells per μL versus 63 cells per μL. After week 156, 251 patients (54%) from the raltegravir group and 47 (20%) from the placebo group entered the open-label raltergravir phase; 221 (47%) versus 44 (19%) completed the entire study. At week 240, viral load was less than 50 copies per mL in 193 (42%) of all patients initially assigned to raltegravir and less than 400 copies per mL in 210 (45%); mean CD4 cell count increased by 183 cells per μL. Virological failure occurred in 166 raltegravir recipients (36%) during the double-blind phase and in 17 of all patients (6%) during the open-label phase. The most common drug-related adverse events at 5 years in both groups were nausea, headache, and diarrhoea, and occurred in similar proportions in each group. Laboratory test results were similar in both treatment groups and showed little change after year 2. Interpretation Raltegravir has a favourable long-term efficacy and safety profile in integrase-inhibitor-naive patients with triple-class resistant HIV in whom antiretroviral therapy is failing. Raltegravir is an alternative for treatment-experienced patients, particularly those with few treatment options. Funding Merck Sharp & Dohme.
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1Anti-HIV Agents - administration & dosage
2Anti-HIV Agents - adverse effects
3Antibiotics. Antiinfectious agents. Antiparasitic agents
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6Biological and medical sciences
7CD4 Lymphocyte Count
8Clinical trials
9Double-Blind Method
10Drug-Related Side Effects and Adverse Reactions - epidemiology
11Drug-Related Side Effects and Adverse Reactions - pathology
12Female
13HIV Infections - drug therapy
14HIV Infections - immunology
15HIV Infections - virology
16HIV-1 - isolation & purification
17Human immunodeficiency virus
18Human immunodeficiency virus 1
19Human viral diseases
20Humans
21Immunodeficiencies
22Immunodeficiencies. Immunoglobulinopathies
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24Infectious Disease
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32Pyrrolidinones - administration & dosage
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titleEfficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies: final results of two randomised, placebo-controlled trials
authorEron, Joseph J, Prof ; Cooper, David A, Prof ; Steigbigel, Roy T, Prof ; Clotet, Bonaventura, MD ; Gatell, Jose M, Prof ; Kumar, Princy N, Prof ; Rockstroh, Jurgen K, Prof ; Schechter, Mauro, Prof ; Markowitz, Martin, Prof ; Yeni, Patrick, MD ; Loutfy, Mona R, MD ; Lazzarin, Adriano, Prof ; Lennox, Jeffrey L, Prof ; Strohmaier, Kim M, BS ; Wan, Hong, MS ; Barnard, Richard JO, PhD ; Nguyen, Bach-Yen T, MD ; Teppler, Hedy, MD
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atitleEfficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies: final results of two randomised, placebo-controlled trials
jtitleThe Lancet infectious diseases
addtitleLancet Infect Dis
date2013
risdate2013
volume13
issue7
spage587
epage596
pages587-596
issn1473-3099
eissn1474-4457
codenLANCAO
notes
0Brazil: B Grinsztejn, J V Madruga, M Schecter. Canada: J-G Baril, M R Loutfy, J S Montaner, C Tremblay, CM Tsoukas, S Vezina. Colombia: J A Cortes, H Mendoza, J Velez. Mexico: N Quintero Perez, J Ramos, E Rodriguez. Puerto Rico: J O Morales-Ramirez, G E Sepulveda. USA: J Aberg, G W Beatty, P Benson, R K Bolon, U F Bredeek, C Bruno, T Campbell, R Campo, G O Coodley, R B Corales, E DeJesus, J J Eron, W J Fessel, R J Fetchick, C J Gonzalez, C Hicks, M A Horberg, D B Klein, M J Kozal, P N Kumar, A LaMarca, J L Lennox, K A Lichtenstein, R Liporace, S J Little, A Luetkemeyer, F Mariuz, M Markowitz, D K McMahon, G Perez, G Pierone, R C Reichman, F Rhame, P Shalit, P Sklar, W Short, P R Skolnik, R T Steigbigel, E M Tedaldi, D J Ward, A A Wiznia, D P Wright.
1Australia: A Allworth, J Anderson, M Bloch, D A Cooper, J Hoy, C Workman. Belgium: N Clumeck, R Colebunders, M Moutschen; Denmark: J Gerstoft, C Larsen, L Mathiesen, C Pedersen. France: J F Delfraissy, P Dellamonica, C Katlama, J M Molina, F Raffi, J Reynes, D Vittecoq, P Yeni. Germany: K Arasteh, G Fatkenheuer, H Jaeger, J Rockstroh, A Stoehr. Italy: F Aiuti, G Carosi, R Cauda, F Chiodo, G Di Perri, G Filice, M Galli, A Lazzarin, V Vullo. Peru: M Castaneda, A Florez, F Mendo, A Paredes, R Salazar, E Ticona. Portugal: R Antunes, A Diniz, K Mansinho, J Saraiva da Cunha, R Sarmento, E Teofilo, J Vera. Spain: J Arrizabalaga, B Clotet, P Domingo Pedrol, J Gatell Artigas, S Moreno Guillen, V Soriano Vazquez. Switzerland: B Hirschel, M Opravil. Taiwan: H-H Lin, W-H Sheng, J-H Wang. Thailand: S Sungkanuparph, S Suwanagool.
2Principal investigators of BENCHMRK-1
3Principal investigators of BENCHMRK-2
abstractSummary Background Two randomised, placebo-controlled trials—BENCHMRK-1 and BENCHMRK-2—investigated the efficacy and safety of raltegravir, an HIV-1 integrase strand-transfer inhibitor. We report final results of BENCHMRK-1 and BENCHMRK-2 combined at 3 years (the end of the double-blind phase) and 5 years (the end of the study). Methods Integrase-inhibitor-naive patients with HIV resistant to three classes of drug and who were failing antiretroviral therapy were enrolled. Patients were randomly assigned (2:1) to raltegravir 400 mg twice daily or placebo, both with optimised background treatment. Patients and investigators were masked to treatment allocation until week 156, after which all patients were offered open-label raltegravir until week 240. The primary endpoint was previously assessed at 16 weeks. We assessed long-term efficacy with endpoints of the proportion of patients with an HIV viral load of less than 50 copies per mL and less than 400 copies per mL, and mean change in CD4 cell count, at weeks 156 and 240. Findings 1012 patients were screened for inclusion. 462 were treated with raltegravir and 237 with placebo. At week 156, 51% in the raltegravir group versus 22% in the placebo group (non-completer classed as failure) had viral loads of less than 50 copies per mL, and 54% versus 23% had viral loads of less than 400 copies per mL. Mean CD4 cell count increase (analysed by an observed failure approach) was 164 cells per μL versus 63 cells per μL. After week 156, 251 patients (54%) from the raltegravir group and 47 (20%) from the placebo group entered the open-label raltergravir phase; 221 (47%) versus 44 (19%) completed the entire study. At week 240, viral load was less than 50 copies per mL in 193 (42%) of all patients initially assigned to raltegravir and less than 400 copies per mL in 210 (45%); mean CD4 cell count increased by 183 cells per μL. Virological failure occurred in 166 raltegravir recipients (36%) during the double-blind phase and in 17 of all patients (6%) during the open-label phase. The most common drug-related adverse events at 5 years in both groups were nausea, headache, and diarrhoea, and occurred in similar proportions in each group. Laboratory test results were similar in both treatment groups and showed little change after year 2. Interpretation Raltegravir has a favourable long-term efficacy and safety profile in integrase-inhibitor-naive patients with triple-class resistant HIV in whom antiretroviral therapy is failing. Raltegravir is an alternative for treatment-experienced patients, particularly those with few treatment options. Funding Merck Sharp & Dohme.
copLondon
pubElsevier Ltd
pmid23664333
doi10.1016/S1473-3099(13)70093-8
oafree_for_read