51. Effectiveness and tolerability of pegylated interferon alfa-2b in combination with ribavirin for treatment of chronic hepatitis C: the PegIntrust Study
- Author
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Hans Van Vlierberghe, Adler, M., Bastens, B., Isabelle Colle, Delwaide, J., Henrion, J., Horsmans, Y., Michielsen, P., Golstein, P., Mulkays, Jp, Steenbergen, W., Yap, P., Nevens, F., Denys, Am, Brasseur, Jp, Haon, Marie Laure, Ghent University Hospital, Kennedy Krieger Institute, Centre Hospitalier St. Joseph, Department of Gastroenterology, CHU de Liège, University of Liège, Department of Hepatogastroenterology, Université Catholique de Louvain = Catholic University of Louvain (UCL), University Hospital Antwerp, Division of Hepatogastroenterology, Centre d'Immunologie de Marseille - Luminy (CIML), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Université libre de Bruxelles (ULB), Alexandra Hospital (MRCP), Department of Geriatric Medicine, Clinique St Pierre, and Service de médecine physique réadaptation et rhumatologie
- Subjects
Adult ,Male ,MESH: Antiviral Agents ,hepatitis C virus ,MESH: Interferon Alfa-2b ,SVR ,[SDV.IMM] Life Sciences [q-bio]/Immunology ,ribavirin ,BELGIUM ,Interferon alpha-2 ,Antiviral Agents ,THERAPY ,Polyethylene Glycols ,Cohort Studies ,Belgium ,MESH: Belgium ,MESH: Ribavirin ,Ribavirin ,Medicine and Health Sciences ,Humans ,community-based ,pegylated interferon alfa-2b ,tolerability ,MESH: Cohort Studies ,MESH: Treatment Outcome ,MESH: Middle Aged ,MESH: Humans ,treatment ,Interferon-alpha ,virus diseases ,MESH: Adult ,ALPHA-2B PLUS RIBAVIRIN ,Hepatitis C, Chronic ,Middle Aged ,Recombinant Proteins ,MESH: Male ,MESH: Hepatitis C, Chronic ,VIROLOGICAL RESPONSE ,MESH: Drug Therapy, Combination ,Treatment Outcome ,MESH: Polyethylene Glycols ,[SDV.IMM]Life Sciences [q-bio]/Immunology ,Drug Therapy, Combination ,Female ,MESH: Female - 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).