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Peginterferon alfa-2b and ribavirin: effective in patients with hepatitis C who failed interferon alfa/ribavirin therapy

Thierry Poynard, Massimo Colombo, Jordi Bruix, Eugene Schiff, Ruben Terg, Steven Flamm, Ricardo Moreno-Otero, Flair Carrilho, Warren Schmidt and Thomas Berg, et al. (2009) GASTROENTEROLOGY. 136(5). p.1618-1628
abstract
Background & Aims: Treatment with peginterferon alfa and ribavirin produces a sustained virologic response (SVR) in approximately 60% of hepatitis C virus (HCV)-infected patients. Alternate options are needed for patients who relapse or do not respond to therapy. Methods: This prospective, international, multicenter, open-label study evaluated efficacy and safety of peginterferon alfa-2b (1.5 mu g/kg/wk) plus weight-based ribavirin (800-1400 mg/day) in 2333 chronic HCV-infected patients with significant fibrosis/cirrhosis whose previous interferon alfa/ribavirin therapy failed. Patients with undetectable HCV-RNA at treatment week (TW) 12 received 48 weeks of therapy; patients with detectable HCV-RNA at TW12 could enter maintenance studies at TW18; 188 patients with low/detectable HCV-RNA at TW12 continued therapy at the investigator's request. Results: Overall, 22% of the patients attained SVR (56% with undetectable HCV-RNA and 12% with low/detectable HCV-RNA at TW12). SVR was better in relapsers (38%) than nonresponders (14%), regardless of previous treatment, and in patients previously treated with interferon-alfa/ribavirin (25%) than peginterferon alfa-ribavirin (17%). Predictors of response in patients with undetectable HCV-RNA at TW12 were genotype (2/3 vs 1, respectively; odds ratio [OR] 2.4; P < .0001), fibrosis score (F2 vs F4; OR, 2.2; F3 vs F4; OR, 1.7; P < .0001), and baseline viral load (<= 600,000 vs >600,000 IU/mL; OR, 1.4; P = .0223). These factors plus previous treatment and response were overall predictors of SVR. Safety was similar among fibrosis groups. Conclusions: Peginterferon alfa-2b plus weight-based ribavirin is effective and safe in patients who failed interferon alfa/ribavirin therapy. Genotype, baseline viral load, and fibrosis stage were predictors of response.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
journal title
GASTROENTEROLOGY
Gastroenterology
volume
136
issue
5
pages
1618 - 1628
conference name
43rd Annual meeting of the European Association for the Study of the Liver
conference location
Milan, Italy
conference start
2008-04-23
conference end
2008-04-27
Web of Science type
Proceedings Paper
Web of Science id
000265730800025
JCR category
GASTROENTEROLOGY & HEPATOLOGY
JCR impact factor
12.899 (2009)
JCR rank
1/64 (2009)
JCR quartile
1 (2009)
ISSN
0016-5085
DOI
10.1053/j.gastro.2009.01.039
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
834686
handle
http://hdl.handle.net/1854/LU-834686
date created
2010-01-22 12:26:42
date last changed
2011-05-20 15:27:00
@article{834686,
  abstract     = {Background \& Aims: Treatment with peginterferon alfa and ribavirin produces a sustained virologic response (SVR) in approximately 60\% of hepatitis C virus (HCV)-infected patients. Alternate options are needed for patients who relapse or do not respond to therapy. Methods: This prospective, international, multicenter, open-label study evaluated efficacy and safety of peginterferon alfa-2b (1.5 mu g/kg/wk) plus weight-based ribavirin (800-1400 mg/day) in 2333 chronic HCV-infected patients with significant fibrosis/cirrhosis whose previous interferon alfa/ribavirin therapy failed. Patients with undetectable HCV-RNA at treatment week (TW) 12 received 48 weeks of therapy; patients with detectable HCV-RNA at TW12 could enter maintenance studies at TW18; 188 patients with low/detectable HCV-RNA at TW12 continued therapy at the investigator's request. Results: Overall, 22\% of the patients attained SVR (56\% with undetectable HCV-RNA and 12\% with low/detectable HCV-RNA at TW12). SVR was better in relapsers (38\%) than nonresponders (14\%), regardless of previous treatment, and in patients previously treated with interferon-alfa/ribavirin (25\%) than peginterferon alfa-ribavirin (17\%). Predictors of response in patients with undetectable HCV-RNA at TW12 were genotype (2/3 vs 1, respectively; odds ratio [OR] 2.4; P {\textlangle} .0001), fibrosis score (F2 vs F4; OR, 2.2; F3 vs F4; OR, 1.7; P {\textlangle} .0001), and baseline viral load ({\textlangle}= 600,000 vs {\textrangle}600,000 IU/mL; OR, 1.4; P = .0223). These factors plus previous treatment and response were overall predictors of SVR. Safety was similar among fibrosis groups. Conclusions: Peginterferon alfa-2b plus weight-based ribavirin is effective and safe in patients who failed interferon alfa/ribavirin therapy. Genotype, baseline viral load, and fibrosis stage were predictors of response.},
  author       = {Poynard, Thierry and Colombo, Massimo and Bruix, Jordi and Schiff, Eugene and Terg, Ruben and Flamm, Steven and Moreno-Otero, Ricardo and Carrilho, Flair and Schmidt, Warren and Berg, Thomas and McGarrity, Thomas and Heathcote, E Jenny and Goncales, Fernando and Diago, Moises and Craxi, Antonio and Silva, Marcelo and Bedossa, Pierre and Mukhopadhyay, Pabak and Griffel, Louis and Burroughs, Margaret and Brass, Clifford and Albrecht, Janice and EPIC Study Group,   and Van Vlierberghe, Hans},
  issn         = {0016-5085},
  journal      = {GASTROENTEROLOGY},
  language     = {eng},
  location     = {Milan, Italy},
  number       = {5},
  pages        = {1618--1628},
  title        = {Peginterferon alfa-2b and ribavirin: effective in patients with hepatitis C who failed interferon alfa/ribavirin therapy},
  url          = {http://dx.doi.org/10.1053/j.gastro.2009.01.039},
  volume       = {136},
  year         = {2009},
}

Chicago
Poynard, Thierry, Massimo Colombo, Jordi Bruix, Eugene Schiff, Ruben Terg, Steven Flamm, Ricardo Moreno-Otero, et al. 2009. “Peginterferon Alfa-2b and Ribavirin: Effective in Patients with Hepatitis C Who Failed Interferon Alfa/ribavirin Therapy.” Gastroenterology 136 (5): 1618–1628.
APA
Poynard, T., Colombo, M., Bruix, J., Schiff, E., Terg, R., Flamm, S., Moreno-Otero, R., et al. (2009). Peginterferon alfa-2b and ribavirin: effective in patients with hepatitis C who failed interferon alfa/ribavirin therapy. GASTROENTEROLOGY, 136(5), 1618–1628. Presented at the 43rd Annual meeting of the European Association for the Study of the Liver.
Vancouver
1.
Poynard T, Colombo M, Bruix J, Schiff E, Terg R, Flamm S, et al. Peginterferon alfa-2b and ribavirin: effective in patients with hepatitis C who failed interferon alfa/ribavirin therapy. GASTROENTEROLOGY. 2009;136(5):1618–28.
MLA
Poynard, Thierry, Massimo Colombo, Jordi Bruix, et al. “Peginterferon Alfa-2b and Ribavirin: Effective in Patients with Hepatitis C Who Failed Interferon Alfa/ribavirin Therapy.” GASTROENTEROLOGY 136.5 (2009): 1618–1628. Print.