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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

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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.
Keywords
TREATMENT DURATION, THERAPY, PLUS RIBAVIRIN, Slow viral response, Relapse treatment, Pegylated interferon, Chronic Hepatitis C, TRIAL, RETREATMENT

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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.
@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},
}

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