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A randomized, open-label, multicenter study evaluating the efficacy of peginterferon alfa-2a versus interferon alfa-2a, in combination with ribavirin, in naïve and relapsed chronic hepatitis C patients

Frederik Nevens, Hans Van Vlierberghe UGent, F D'Heygere, J Delwaide, M Adler, J Henrion, A Lenaerts, A Hendlisz, P Michielsen, B Bastens, et al. (2010) ACTA GASTRO-ENTEROLOGICA BELGICA. 73(2). p.223-228
abstract
Background/Aims : A large multicenter trial to compare the efficacy of peginterferon alfa-2a with interferon alfa-2a, in combination with ribavirin, in chronic hepatitis C patients. Efficacy data for prior relapsers are reported because treatment recommendations for this patient population are not well defined. Patients and methods : This study was a multicenter, prospective, randomized clinical trial. The primary efficacy endpoint was sustained virologic response in naive patients (n = 348) and relapsers (n = 95). Results : Sustained virologic response rates were similar in naive patients and relapsers, both for non-pegylated and pegylated interferon (respectively 27 and 26% and 54 and 43%). Pegylated interferon given for 48 weeks did not improved the relapse rate : 15.9 and 27.3% for non-pegylated and 16.7 and 30.4% for pegylated interferon, naive vs relapsers respectively. Stepwise logistic regression analysis revealed a significant association between slow response (detectable HCV RNA at week 12 and undetectable at week 24) and relapse in patients with an end-of-treatment response (55% versus 13% respectively; p = 0.02; odds ratio = 6.07). Conclusions : This trial confirms the value of using peginterferon alfa-2a in both naive and relapsed patients and provides support for a more tailored approach to treatment for relapsers and particulary for patients with a slow viral response.
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author
organization
alternative title
A randomized, open-label, multicenter study evaluating the efficacy of peginterferon alfa-2a versus interferon alfa-2a, in combination with ribavirin, in naive and relapsed chronic hepatitis C patients
year
type
journalArticle (original)
publication status
published
subject
keyword
TREATMENT DURATION, THERAPY, PLUS RIBAVIRIN, Slow viral response, Relapse treatment, Pegylated interferon, Chronic Hepatitis C, TRIAL, RETREATMENT
journal title
ACTA GASTRO-ENTEROLOGICA BELGICA
Acta Gastro-Enterol. Belg.
volume
73
issue
2
pages
223 - 228
Web of Science type
Article
Web of Science id
000280316400003
JCR category
GASTROENTEROLOGY & HEPATOLOGY
JCR impact factor
0.648 (2010)
JCR rank
63/71 (2010)
JCR quartile
4 (2010)
ISSN
0001-5644
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
1001904
handle
http://hdl.handle.net/1854/LU-1001904
date created
2010-07-02 16:07:21
date last changed
2016-12-19 15:46:53
@article{1001904,
  abstract     = {Background/Aims : A large multicenter trial to compare the efficacy of peginterferon alfa-2a with interferon alfa-2a, in combination with ribavirin, in chronic hepatitis C patients. Efficacy data for prior relapsers are reported because treatment recommendations for this patient population are not well defined.
Patients and methods : This study was a multicenter, prospective, randomized clinical trial. The primary efficacy endpoint was sustained virologic response in naive patients (n = 348) and relapsers (n = 95).
Results : Sustained virologic response rates were similar in naive patients and relapsers, both for non-pegylated and pegylated interferon (respectively 27 and 26\% and 54 and 43\%). Pegylated interferon given for 48 weeks did not improved the relapse rate : 15.9 and 27.3\% for non-pegylated and 16.7 and 30.4\% for pegylated interferon, naive vs relapsers respectively. Stepwise logistic regression analysis revealed a significant association between slow response (detectable HCV RNA at week 12 and undetectable at week 24) and relapse in patients with an end-of-treatment response (55\% versus 13\% respectively; p = 0.02; odds ratio = 6.07).
Conclusions : This trial confirms the value of using peginterferon alfa-2a in both naive and relapsed patients and provides support for a more tailored approach to treatment for relapsers and particulary for patients with a slow viral response.},
  author       = {Nevens, Frederik and Van Vlierberghe, Hans and D'Heygere, F and Delwaide, J and Adler, M and Henrion, J and Lenaerts, A and Hendlisz, A and Michielsen, P and Bastens, B and Brenard, R and Laureys, A and BERNAR-1 Study Group,  },
  issn         = {0001-5644},
  journal      = {ACTA GASTRO-ENTEROLOGICA BELGICA},
  keyword      = {TREATMENT DURATION,THERAPY,PLUS RIBAVIRIN,Slow viral response,Relapse treatment,Pegylated interferon,Chronic Hepatitis C,TRIAL,RETREATMENT},
  language     = {eng},
  number       = {2},
  pages        = {223--228},
  title        = {A randomized, open-label, multicenter study evaluating the efficacy of peginterferon alfa-2a versus interferon alfa-2a, in combination with ribavirin, in na{\"i}ve and relapsed chronic hepatitis C patients},
  volume       = {73},
  year         = {2010},
}

Chicago
Nevens, Frederik, Hans Van Vlierberghe, F D’Heygere, J Delwaide, M Adler, J Henrion, A Lenaerts, et al. 2010. “A Randomized, Open-label, Multicenter Study Evaluating the Efficacy of Peginterferon Alfa-2a Versus Interferon Alfa-2a, in Combination with Ribavirin, in Naïve and Relapsed Chronic Hepatitis C Patients.” Acta Gastro-enterologica Belgica 73 (2): 223–228.
APA
Nevens, Frederik, Van Vlierberghe, H., D’Heygere, F., Delwaide, J., Adler, M., Henrion, J., Lenaerts, A., et al. (2010). A randomized, open-label, multicenter study evaluating the efficacy of peginterferon alfa-2a versus interferon alfa-2a, in combination with ribavirin, in naïve and relapsed chronic hepatitis C patients. ACTA GASTRO-ENTEROLOGICA BELGICA, 73(2), 223–228.
Vancouver
1.
Nevens F, Van Vlierberghe H, D’Heygere F, Delwaide J, Adler M, Henrion J, et al. A randomized, open-label, multicenter study evaluating the efficacy of peginterferon alfa-2a versus interferon alfa-2a, in combination with ribavirin, in naïve and relapsed chronic hepatitis C patients. ACTA GASTRO-ENTEROLOGICA BELGICA. 2010;73(2):223–8.
MLA
Nevens, Frederik, Hans Van Vlierberghe, F D’Heygere, et al. “A Randomized, Open-label, Multicenter Study Evaluating the Efficacy of Peginterferon Alfa-2a Versus Interferon Alfa-2a, in Combination with Ribavirin, in Naïve and Relapsed Chronic Hepatitis C Patients.” ACTA GASTRO-ENTEROLOGICA BELGICA 73.2 (2010): 223–228. Print.