Randomized Trial Comparing Dose Reduction and Growth Factor Supplementation for Management of Hematological Side Effects in HIV/HCV Patients Receiving Pegylated-Interferon and Ribavirin

INTRODUCTION: Pegylated-interferon (PEG-IFN) and ribavirin (RBV), current standard treatment for hepatitis C virus (HCV) infection, is frequently associated with neutropenia and anemia, leading to high treatment discontinuation rates in HIV/HCV coinfected patients. Our objective was to compare the e...

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Main Authors: Talal, Andrew H., Liu, Ruei-Chi, Zeremski, Marija, Dimova, Rositsa, Dove, Lorna, Pearce, Daniel, Hassanein, Tarek, Doonquah, Leleka, Aboulafia, David, Rodriguez, Jorge, Bonilla, Hector, Galpin, Jeffrey, Aberg, Judy A., Johnston, Barbara, Glesby, Marshall J., Jacobson, Ira M.
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Idioma:Inglês
Publicado em: 2011
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Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3386143/
https://ncbi.nlm.nih.gov/pubmed/21876446
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1097/QAI.0b013e3182324af9
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spelling pubmed-33861432012-11-01 Randomized Trial Comparing Dose Reduction and Growth Factor Supplementation for Management of Hematological Side Effects in HIV/HCV Patients Receiving Pegylated-Interferon and Ribavirin Talal, Andrew H. Liu, Ruei-Chi Zeremski, Marija Dimova, Rositsa Dove, Lorna Pearce, Daniel Hassanein, Tarek Doonquah, Leleka Aboulafia, David Rodriguez, Jorge Bonilla, Hector Galpin, Jeffrey Aberg, Judy A. Johnston, Barbara Glesby, Marshall J. Jacobson, Ira M. J Acquir Immune Defic Syndr Article INTRODUCTION: Pegylated-interferon (PEG-IFN) and ribavirin (RBV), current standard treatment for hepatitis C virus (HCV) infection, is frequently associated with neutropenia and anemia, leading to high treatment discontinuation rates in HIV/HCV coinfected patients. Our objective was to compare the effectiveness of intervening with hematologic growth factors versus dose reductions of standard HCV therapy for the management of treatment-induced hematologic disorders. METHODS: Ninety-two HIV/HCV coinfected, therapy-naive subjects received PEG-IFN alfa-2b 1.5 μg/kg/wk and RBV 13 ± 2 mg/kg/day for up to 48 weeks. Before treatment initiation, subjects were randomized to subsequently receive growth factors, recombinant human erythropoietin (rHuEPO) and/or granulocyte-colony stimulating factor (G-CSF), or dose reduction (RBV and/or PEG-IFN) for anemia and neutropenia management, respectively. We analyzed the ability of each management strategy to control anemia and neutropenia and the percentage of subjects who achieved a successful treatment outcome among subjects according to the different management strategies. RESULTS: During treatment, 43 subjects developed anemia (HuEPO, n=24; dose reduction, n=19) while 25 subjects developed neutropenia (G-CSF, n=10; dose reduction, n=15). Following the intervention, the increase in both hemoglobin and absolute neutrophil counts also did not differ between the two side effect management strategies. Sustained response percentages were similar comparing anemic and neutropenic subjects regardless of management strategy (anemia: rHuEPO, 29% versus dose reduction, 21%, p=0.92; neutropenia: G-CSF, 40% versus dose reduction, 20%, p=0.46). CONCLUSIONS: Growth factor supplementation and dose reduction do not appear to differ as management strategies for anemia and neutropenia in HIV/HCV co-infected individuals treated with PEG-IFN/RBV. 2011-11-01 /pmc/articles/PMC3386143/ /pubmed/21876446 http://dx.doi.org/10.1097/QAI.0b013e3182324af9 Text en
institution US NLM
collection PubMed Central
language Inglês
format Artigo
topic Article
spellingShingle Article
Talal, Andrew H.
Liu, Ruei-Chi
Zeremski, Marija
Dimova, Rositsa
Dove, Lorna
Pearce, Daniel
Hassanein, Tarek
Doonquah, Leleka
Aboulafia, David
Rodriguez, Jorge
Bonilla, Hector
Galpin, Jeffrey
Aberg, Judy A.
Johnston, Barbara
Glesby, Marshall J.
Jacobson, Ira M.
Randomized Trial Comparing Dose Reduction and Growth Factor Supplementation for Management of Hematological Side Effects in HIV/HCV Patients Receiving Pegylated-Interferon and Ribavirin
description INTRODUCTION: Pegylated-interferon (PEG-IFN) and ribavirin (RBV), current standard treatment for hepatitis C virus (HCV) infection, is frequently associated with neutropenia and anemia, leading to high treatment discontinuation rates in HIV/HCV coinfected patients. Our objective was to compare the effectiveness of intervening with hematologic growth factors versus dose reductions of standard HCV therapy for the management of treatment-induced hematologic disorders. METHODS: Ninety-two HIV/HCV coinfected, therapy-naive subjects received PEG-IFN alfa-2b 1.5 μg/kg/wk and RBV 13 ± 2 mg/kg/day for up to 48 weeks. Before treatment initiation, subjects were randomized to subsequently receive growth factors, recombinant human erythropoietin (rHuEPO) and/or granulocyte-colony stimulating factor (G-CSF), or dose reduction (RBV and/or PEG-IFN) for anemia and neutropenia management, respectively. We analyzed the ability of each management strategy to control anemia and neutropenia and the percentage of subjects who achieved a successful treatment outcome among subjects according to the different management strategies. RESULTS: During treatment, 43 subjects developed anemia (HuEPO, n=24; dose reduction, n=19) while 25 subjects developed neutropenia (G-CSF, n=10; dose reduction, n=15). Following the intervention, the increase in both hemoglobin and absolute neutrophil counts also did not differ between the two side effect management strategies. Sustained response percentages were similar comparing anemic and neutropenic subjects regardless of management strategy (anemia: rHuEPO, 29% versus dose reduction, 21%, p=0.92; neutropenia: G-CSF, 40% versus dose reduction, 20%, p=0.46). CONCLUSIONS: Growth factor supplementation and dose reduction do not appear to differ as management strategies for anemia and neutropenia in HIV/HCV co-infected individuals treated with PEG-IFN/RBV.
author Talal, Andrew H.
Liu, Ruei-Chi
Zeremski, Marija
Dimova, Rositsa
Dove, Lorna
Pearce, Daniel
Hassanein, Tarek
Doonquah, Leleka
Aboulafia, David
Rodriguez, Jorge
Bonilla, Hector
Galpin, Jeffrey
Aberg, Judy A.
Johnston, Barbara
Glesby, Marshall J.
Jacobson, Ira M.
author_facet Talal, Andrew H.
Liu, Ruei-Chi
Zeremski, Marija
Dimova, Rositsa
Dove, Lorna
Pearce, Daniel
Hassanein, Tarek
Doonquah, Leleka
Aboulafia, David
Rodriguez, Jorge
Bonilla, Hector
Galpin, Jeffrey
Aberg, Judy A.
Johnston, Barbara
Glesby, Marshall J.
Jacobson, Ira M.
author_sort Talal, Andrew H.
title Randomized Trial Comparing Dose Reduction and Growth Factor Supplementation for Management of Hematological Side Effects in HIV/HCV Patients Receiving Pegylated-Interferon and Ribavirin
title_short Randomized Trial Comparing Dose Reduction and Growth Factor Supplementation for Management of Hematological Side Effects in HIV/HCV Patients Receiving Pegylated-Interferon and Ribavirin
title_full Randomized Trial Comparing Dose Reduction and Growth Factor Supplementation for Management of Hematological Side Effects in HIV/HCV Patients Receiving Pegylated-Interferon and Ribavirin
title_fullStr Randomized Trial Comparing Dose Reduction and Growth Factor Supplementation for Management of Hematological Side Effects in HIV/HCV Patients Receiving Pegylated-Interferon and Ribavirin
title_full_unstemmed Randomized Trial Comparing Dose Reduction and Growth Factor Supplementation for Management of Hematological Side Effects in HIV/HCV Patients Receiving Pegylated-Interferon and Ribavirin
title_sort randomized trial comparing dose reduction and growth factor supplementation for management of hematological side effects in hiv/hcv patients receiving pegylated-interferon and ribavirin
publishDate 2011
url https://ncbi.nlm.nih.gov/pmc/articles/PMC3386143/
https://ncbi.nlm.nih.gov/pubmed/21876446
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1097/QAI.0b013e3182324af9
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