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Effectiveness and tolerability of pegylated interferon alfa-2b in combination with ribavirin for treatment of chronic hepatitis C: the PegIntrust Study

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Abstract
Background and study aims : Large international clinical trials conducted in the past 5 years rapidly improved the treatment of chronic hepatitis C; however, it is unclear whether the advances seen in clinical trials are being paralleled by similar improvements in routine clinical practice. PegIntrust is a Belgian community-based trial evaluating the sustained virological response. Patients and Methods : Observational study of 219 patients receiving pegylated interferon alfa-2b (1.5 mu g/kg/wk) and weight. based ribavirin (800-1200 mg/day) for 48 weeks. Primary study end point was sustained virological response (SVR), defined as undetectable HCV RNA 6 months after the completion of treatment. Results : In total, 108 patients (49.3 %) had undetectable HCV RNA at the end of therapy, 91(41.6%) attaining SVR. Of the 111 patients without an end-of-treatment response, 28 were non-responders, and 21 had virological breakthrough. In total, 134 patients attained early virological response (EVR); 88 (65.7%) of those patients attained SVR. In contrast, 82 (96.5 %) of the 85 patients who did not attain EVR also did not attain SVR. Age, fibrosis score and baseline viral load were identified as important predictors of treatment outcome. The most frequently reported serious adverse events resulting in treatment discontinuation were anemia (n = 10), fatigue/asthenia/malaise (n = 6) and fever (n = 3). Conclusion : Our data indicate that treatment of chronic hepatitis C with PEG-IFN alfa-2b plus weight-based ribavirin results in favourable treatment outcomes in a Belgian cohort of patients treated in community-based clinical practice. (Ada gastroenterol. belg., 2010, 73, 5-11).
Keywords
hepatitis C virus, community-based, pegylated interferon alfa-2b, ribavirin, tolerability, treatment, SVR, ALPHA-2B PLUS RIBAVIRIN, VIROLOGICAL RESPONSE, BELGIUM, THERAPY

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Chicago
Van Vlierberghe, Hans, M Adler, B Bastens, Isabelle Colle, J Delwaide, J Henrion, Y Horsmans, et al. 2010. “Effectiveness and Tolerability of Pegylated Interferon Alfa-2b in Combination with Ribavirin for Treatment of Chronic Hepatitis C: The PegIntrust Study.” Acta Gastro-enterologica Belgica 73 (1): 5–11.
APA
Van Vlierberghe, H., Adler, M., Bastens, B., Colle, I., Delwaide, J., Henrion, J., Horsmans, Y., et al. (2010). Effectiveness and tolerability of pegylated interferon alfa-2b in combination with ribavirin for treatment of chronic hepatitis C: the PegIntrust Study. ACTA GASTRO-ENTEROLOGICA BELGICA, 73(1), 5–11.
Vancouver
1.
Van Vlierberghe H, Adler M, Bastens B, Colle I, Delwaide J, Henrion J, et al. Effectiveness and tolerability of pegylated interferon alfa-2b in combination with ribavirin for treatment of chronic hepatitis C: the PegIntrust Study. ACTA GASTRO-ENTEROLOGICA BELGICA. 2010;73(1):5–11.
MLA
Van Vlierberghe, Hans, M Adler, B Bastens, et al. “Effectiveness and Tolerability of Pegylated Interferon Alfa-2b in Combination with Ribavirin for Treatment of Chronic Hepatitis C: The PegIntrust Study.” ACTA GASTRO-ENTEROLOGICA BELGICA 73.1 (2010): 5–11. Print.
@article{1002280,
  abstract     = {Background and study aims : Large international clinical trials conducted in the past 5 years rapidly improved the treatment of chronic hepatitis C; however, it is unclear whether the advances seen in clinical trials are being paralleled by similar improvements in routine clinical practice. PegIntrust is a Belgian community-based trial evaluating the sustained virological response.

Patients and Methods : Observational study of 219 patients receiving pegylated interferon alfa-2b (1.5 mu g/kg/wk) and weight. based ribavirin (800-1200 mg/day) for 48 weeks. Primary study end point was sustained virological response (SVR), defined as undetectable HCV RNA 6 months after the completion of treatment.
Results : In total, 108 patients (49.3 \%) had undetectable HCV RNA at the end of therapy, 91(41.6\%) attaining SVR. Of the 111 patients without an end-of-treatment response, 28 were non-responders, and 21 had virological breakthrough. In total, 134 patients attained early virological response (EVR); 88 (65.7\%) of those patients attained SVR. In contrast, 82 (96.5 \%) of the 85 patients who did not attain EVR also did not attain SVR. Age, fibrosis score and baseline viral load were identified as important predictors of treatment outcome. The most frequently reported serious adverse events resulting in treatment discontinuation were anemia (n = 10), fatigue/asthenia/malaise (n = 6) and fever (n = 3).
Conclusion : Our data indicate that treatment of chronic hepatitis C with PEG-IFN alfa-2b plus weight-based ribavirin results in favourable treatment outcomes in a Belgian cohort of patients treated in community-based clinical practice. (Ada gastroenterol. belg., 2010, 73, 5-11).},
  author       = {Van Vlierberghe, Hans and Adler, M and Bastens, B and Colle, Isabelle and Delwaide, J and Henrion, J and Horsmans, Y and Michielsen, P and Golstein, P and Mulkays, JP and Van Steenbergen, W and Yap, P and Nevens, F and Denys, AM and Brasseur, JP},
  issn         = {0001-5644},
  journal      = {ACTA GASTRO-ENTEROLOGICA BELGICA},
  language     = {eng},
  number       = {1},
  pages        = {5--11},
  title        = {Effectiveness and tolerability of pegylated interferon alfa-2b in combination with ribavirin for treatment of chronic hepatitis C: the PegIntrust Study},
  volume       = {73},
  year         = {2010},
}

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