Effectiveness of hepatitis c treatment with pegylated interferon and ribavirin in urban minority patients

Paul Feuerstadt, Ari L. Bunim, Heriberto Garcia, Jordan J. Karlitz, Hatef Massoumi, Amar J. Thosani, Andrew Pellecchia, Allan W. Wolkoff, Paul J. Gaglio, John F. Reinus

Research output: Contribution to journalArticle

49 Citations (Scopus)

Abstract

Randomized controlled trials of hepatitis C virus (HCV) therapy with pegylated interferon and ribavirin have demonstrated sustained viral response rates (SVRs) of 54%-63% (effi-cacy). Treatment results in clinical practice (effectiveness) may not be equivalent. The goal of this study was to assess the effectiveness of HCV treatment with pegylated interferon and ribavirin in a treatment-naý̈ve, human immunodeficiency virus (HIV)-negative, United States urban population with many ethnic minority patients. We evaluated 2,370 outpatients for HCV therapy from 2001 to 2006 in the Faculty Practice of the Albert Einstein College of Medicine or the attending-supervised Montefiore Medical Center Liver Clinic. Care was supervised by one experienced physician under conditions of everyday clinical practice, and appropriate ancillary resources were made available to all patients. Two hundred fifty-five patients were treated with amean age of 50 years (60% male, 40% female; 58% Hispanic, 20% African American, 9% Caucasian, 13% other; 68% genotype 1, the remainder genotypes 2 or 3). Patients had at least one liver biopsy. Intention-to-treat analysis (ITT) showed SVR in 14% of genotype 1 patients and 37% in genotype 2/3 patients (P < 0.001). SVR was significantly higher in faculty practice (27%) than in clinic patients (15%) by intention-to-treat (P β 0.01) but not per-protocol analysis (46% faculty practice, 34% clinic). 3.3% of 1,656 treatment-naý̈ve, HIV antibody-negative individuals ultimately achieved SVR. Current hepatitis C therapies may sometimes be unavailable to, inappropriate for, and ineffective in United States urban patients. Treatment with pegylated interferon and ribavirin was less effective in this population than is implied by multinational phase III controlled trials. New strategies are needed to care for such patients.

Original languageEnglish (US)
Pages (from-to)1137-1143
Number of pages7
JournalHepatology
Volume51
Issue number4
DOIs
StatePublished - Apr 2010

Fingerprint

Ribavirin
Interferons
Hepatitis
Genotype
Hepacivirus
Therapeutics
HIV
Intention to Treat Analysis
Urban Population
Liver
Hepatitis C
Hispanic Americans
African Americans
Patient Care
Outpatients
Randomized Controlled Trials
Medicine
Physicians
Biopsy
Antibodies

ASJC Scopus subject areas

  • Hepatology

Cite this

Feuerstadt, P., Bunim, A. L., Garcia, H., Karlitz, J. J., Massoumi, H., Thosani, A. J., ... Reinus, J. F. (2010). Effectiveness of hepatitis c treatment with pegylated interferon and ribavirin in urban minority patients. Hepatology, 51(4), 1137-1143. https://doi.org/10.1002/hep.23429

Effectiveness of hepatitis c treatment with pegylated interferon and ribavirin in urban minority patients. / Feuerstadt, Paul; Bunim, Ari L.; Garcia, Heriberto; Karlitz, Jordan J.; Massoumi, Hatef; Thosani, Amar J.; Pellecchia, Andrew; Wolkoff, Allan W.; Gaglio, Paul J.; Reinus, John F.

In: Hepatology, Vol. 51, No. 4, 04.2010, p. 1137-1143.

Research output: Contribution to journalArticle

Feuerstadt, P, Bunim, AL, Garcia, H, Karlitz, JJ, Massoumi, H, Thosani, AJ, Pellecchia, A, Wolkoff, AW, Gaglio, PJ & Reinus, JF 2010, 'Effectiveness of hepatitis c treatment with pegylated interferon and ribavirin in urban minority patients', Hepatology, vol. 51, no. 4, pp. 1137-1143. https://doi.org/10.1002/hep.23429
Feuerstadt P, Bunim AL, Garcia H, Karlitz JJ, Massoumi H, Thosani AJ et al. Effectiveness of hepatitis c treatment with pegylated interferon and ribavirin in urban minority patients. Hepatology. 2010 Apr;51(4):1137-1143. https://doi.org/10.1002/hep.23429
Feuerstadt, Paul ; Bunim, Ari L. ; Garcia, Heriberto ; Karlitz, Jordan J. ; Massoumi, Hatef ; Thosani, Amar J. ; Pellecchia, Andrew ; Wolkoff, Allan W. ; Gaglio, Paul J. ; Reinus, John F. / Effectiveness of hepatitis c treatment with pegylated interferon and ribavirin in urban minority patients. In: Hepatology. 2010 ; Vol. 51, No. 4. pp. 1137-1143.
@article{3c2acfde41cd4bf79a47a83fdc7b07b3,
title = "Effectiveness of hepatitis c treatment with pegylated interferon and ribavirin in urban minority patients",
abstract = "Randomized controlled trials of hepatitis C virus (HCV) therapy with pegylated interferon and ribavirin have demonstrated sustained viral response rates (SVRs) of 54{\%}-63{\%} (effi-cacy). Treatment results in clinical practice (effectiveness) may not be equivalent. The goal of this study was to assess the effectiveness of HCV treatment with pegylated interferon and ribavirin in a treatment-na{\'y}̈ve, human immunodeficiency virus (HIV)-negative, United States urban population with many ethnic minority patients. We evaluated 2,370 outpatients for HCV therapy from 2001 to 2006 in the Faculty Practice of the Albert Einstein College of Medicine or the attending-supervised Montefiore Medical Center Liver Clinic. Care was supervised by one experienced physician under conditions of everyday clinical practice, and appropriate ancillary resources were made available to all patients. Two hundred fifty-five patients were treated with amean age of 50 years (60{\%} male, 40{\%} female; 58{\%} Hispanic, 20{\%} African American, 9{\%} Caucasian, 13{\%} other; 68{\%} genotype 1, the remainder genotypes 2 or 3). Patients had at least one liver biopsy. Intention-to-treat analysis (ITT) showed SVR in 14{\%} of genotype 1 patients and 37{\%} in genotype 2/3 patients (P < 0.001). SVR was significantly higher in faculty practice (27{\%}) than in clinic patients (15{\%}) by intention-to-treat (P β 0.01) but not per-protocol analysis (46{\%} faculty practice, 34{\%} clinic). 3.3{\%} of 1,656 treatment-na{\'y}̈ve, HIV antibody-negative individuals ultimately achieved SVR. Current hepatitis C therapies may sometimes be unavailable to, inappropriate for, and ineffective in United States urban patients. Treatment with pegylated interferon and ribavirin was less effective in this population than is implied by multinational phase III controlled trials. New strategies are needed to care for such patients.",
author = "Paul Feuerstadt and Bunim, {Ari L.} and Heriberto Garcia and Karlitz, {Jordan J.} and Hatef Massoumi and Thosani, {Amar J.} and Andrew Pellecchia and Wolkoff, {Allan W.} and Gaglio, {Paul J.} and Reinus, {John F.}",
year = "2010",
month = "4",
doi = "10.1002/hep.23429",
language = "English (US)",
volume = "51",
pages = "1137--1143",
journal = "Hepatology",
issn = "0270-9139",
publisher = "John Wiley and Sons Ltd",
number = "4",

}

TY - JOUR

T1 - Effectiveness of hepatitis c treatment with pegylated interferon and ribavirin in urban minority patients

AU - Feuerstadt, Paul

AU - Bunim, Ari L.

AU - Garcia, Heriberto

AU - Karlitz, Jordan J.

AU - Massoumi, Hatef

AU - Thosani, Amar J.

AU - Pellecchia, Andrew

AU - Wolkoff, Allan W.

AU - Gaglio, Paul J.

AU - Reinus, John F.

PY - 2010/4

Y1 - 2010/4

N2 - Randomized controlled trials of hepatitis C virus (HCV) therapy with pegylated interferon and ribavirin have demonstrated sustained viral response rates (SVRs) of 54%-63% (effi-cacy). Treatment results in clinical practice (effectiveness) may not be equivalent. The goal of this study was to assess the effectiveness of HCV treatment with pegylated interferon and ribavirin in a treatment-naý̈ve, human immunodeficiency virus (HIV)-negative, United States urban population with many ethnic minority patients. We evaluated 2,370 outpatients for HCV therapy from 2001 to 2006 in the Faculty Practice of the Albert Einstein College of Medicine or the attending-supervised Montefiore Medical Center Liver Clinic. Care was supervised by one experienced physician under conditions of everyday clinical practice, and appropriate ancillary resources were made available to all patients. Two hundred fifty-five patients were treated with amean age of 50 years (60% male, 40% female; 58% Hispanic, 20% African American, 9% Caucasian, 13% other; 68% genotype 1, the remainder genotypes 2 or 3). Patients had at least one liver biopsy. Intention-to-treat analysis (ITT) showed SVR in 14% of genotype 1 patients and 37% in genotype 2/3 patients (P < 0.001). SVR was significantly higher in faculty practice (27%) than in clinic patients (15%) by intention-to-treat (P β 0.01) but not per-protocol analysis (46% faculty practice, 34% clinic). 3.3% of 1,656 treatment-naý̈ve, HIV antibody-negative individuals ultimately achieved SVR. Current hepatitis C therapies may sometimes be unavailable to, inappropriate for, and ineffective in United States urban patients. Treatment with pegylated interferon and ribavirin was less effective in this population than is implied by multinational phase III controlled trials. New strategies are needed to care for such patients.

AB - Randomized controlled trials of hepatitis C virus (HCV) therapy with pegylated interferon and ribavirin have demonstrated sustained viral response rates (SVRs) of 54%-63% (effi-cacy). Treatment results in clinical practice (effectiveness) may not be equivalent. The goal of this study was to assess the effectiveness of HCV treatment with pegylated interferon and ribavirin in a treatment-naý̈ve, human immunodeficiency virus (HIV)-negative, United States urban population with many ethnic minority patients. We evaluated 2,370 outpatients for HCV therapy from 2001 to 2006 in the Faculty Practice of the Albert Einstein College of Medicine or the attending-supervised Montefiore Medical Center Liver Clinic. Care was supervised by one experienced physician under conditions of everyday clinical practice, and appropriate ancillary resources were made available to all patients. Two hundred fifty-five patients were treated with amean age of 50 years (60% male, 40% female; 58% Hispanic, 20% African American, 9% Caucasian, 13% other; 68% genotype 1, the remainder genotypes 2 or 3). Patients had at least one liver biopsy. Intention-to-treat analysis (ITT) showed SVR in 14% of genotype 1 patients and 37% in genotype 2/3 patients (P < 0.001). SVR was significantly higher in faculty practice (27%) than in clinic patients (15%) by intention-to-treat (P β 0.01) but not per-protocol analysis (46% faculty practice, 34% clinic). 3.3% of 1,656 treatment-naý̈ve, HIV antibody-negative individuals ultimately achieved SVR. Current hepatitis C therapies may sometimes be unavailable to, inappropriate for, and ineffective in United States urban patients. Treatment with pegylated interferon and ribavirin was less effective in this population than is implied by multinational phase III controlled trials. New strategies are needed to care for such patients.

UR - http://www.scopus.com/inward/record.url?scp=77950602777&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77950602777&partnerID=8YFLogxK

U2 - 10.1002/hep.23429

DO - 10.1002/hep.23429

M3 - Article

VL - 51

SP - 1137

EP - 1143

JO - Hepatology

JF - Hepatology

SN - 0270-9139

IS - 4

ER -