[en] 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 μg/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.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Van Vlierberghe, H.
Adler, M.
Bastens, B.
Colle, I.
Delwaide, Jean ; Université de Liège - ULiège > Gastro-Entérologie-Hépatologie
