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Efficacy of an escalating dose regimen of pegylated interferon alpha-2a plus ribavirin in the early phase of HCV reinfection after liver transplantation.

Abstract

We evaluated the safety and efficacy of an escalating dose regimen of pegylated interferon alpha-2a (PEG-IFN(alpha-2a)) and ribavirin in the early phase of recurrent hepatitis C after orthotopic liver transplantation (OLT). In this prospective study, 26 patients transplanted for hepatitis C virus cirrhosis with recurrent hepatitis C were treated 3.4 +/- 3.6 months after OLT and compared with an untreated historical control. PEG-IFN(alpha-2a) was initiated as monotherapy, following stepwise dose escalation up to 180 mug/week and the addition of ribavirin up to 1200 mg/day or maximally tolerated doses for 48 weeks. In the intent-to-treat analysis, 38% showed an early virological response (EVR), 35% an end of treatment response (ETR) and 19% a sustained virological response (SVR). SVR was associated with EVR (P = 0.0001) and cumulative PEG-IFN(alpha-2a) dose (P = 0.04). There was no significant histological improvement compared with untreated patients. There were no treatment-related serious adverse events. Adverse events included leucopenia (77%) and thrombocytopenia (46%). Three patients discontinued therapy due to side effects, fourteen were nonresponders and four relapsers. Treatment with PEG-IFN(alpha-2a) and ribavirin in the acute phase of post-transplant recurrent hepatitis C yielded an EVR of 38% and an SVR of 19%. The combination was safe and well tolerated.

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  • Authors+Show Affiliations

    ,

    1st Department of Medicine, University of Mainz, Langenbeck Strasse 1, 55101 Mainz, Germany.

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    Source

    MeSH

    Aged
    Alanine Transaminase
    Antiviral Agents
    Cohort Studies
    Female
    Hepacivirus
    Hepatitis C
    Humans
    Interferon alpha-2
    Interferon-alpha
    Liver Cirrhosis
    Liver Transplantation
    Male
    Middle Aged
    Polyethylene Glycols
    Postoperative Complications
    RNA, Viral
    Recombinant Proteins
    Recurrence
    Ribavirin
    Treatment Outcome

    Pub Type(s)

    Journal Article

    Language

    eng

    PubMed ID

    17433090

    Citation

    Zimmermann, Tim, et al. "Efficacy of an Escalating Dose Regimen of Pegylated Interferon Alpha-2a Plus Ribavirin in the Early Phase of HCV Reinfection After Liver Transplantation." Transplant International : Official Journal of the European Society for Organ Transplantation, vol. 20, no. 7, 2007, pp. 583-90.
    Zimmermann T, Böcher WO, Biesterfeld S, et al. Efficacy of an escalating dose regimen of pegylated interferon alpha-2a plus ribavirin in the early phase of HCV reinfection after liver transplantation. Transpl Int. 2007;20(7):583-90.
    Zimmermann, T., Böcher, W. O., Biesterfeld, S., Zimmermann, A., Kanzler, S., Greif-Higer, G., ... Schuchmann, M. (2007). Efficacy of an escalating dose regimen of pegylated interferon alpha-2a plus ribavirin in the early phase of HCV reinfection after liver transplantation. Transplant International : Official Journal of the European Society for Organ Transplantation, 20(7), pp. 583-90.
    Zimmermann T, et al. Efficacy of an Escalating Dose Regimen of Pegylated Interferon Alpha-2a Plus Ribavirin in the Early Phase of HCV Reinfection After Liver Transplantation. Transpl Int. 2007;20(7):583-90. PubMed PMID: 17433090.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy of an escalating dose regimen of pegylated interferon alpha-2a plus ribavirin in the early phase of HCV reinfection after liver transplantation. AU - Zimmermann,Tim, AU - Böcher,Wulf O, AU - Biesterfeld,Stefan, AU - Zimmermann,Anca, AU - Kanzler,Stefan, AU - Greif-Higer,Gertrud, AU - Barreiros,Ana Paula, AU - Sprinzl,Martin F, AU - Wörns,Marcus A, AU - Lohse,Ansgar W, AU - Mönch,Christian, AU - Otto,Gerd, AU - Galle,Peter R, AU - Schuchmann,Marcus, Y1 - 2007/04/13/ PY - 2007/4/17/pubmed PY - 2007/8/1/medline PY - 2007/4/17/entrez SP - 583 EP - 90 JF - Transplant international : official journal of the European Society for Organ Transplantation JO - Transpl. Int. VL - 20 IS - 7 N2 - We evaluated the safety and efficacy of an escalating dose regimen of pegylated interferon alpha-2a (PEG-IFN(alpha-2a)) and ribavirin in the early phase of recurrent hepatitis C after orthotopic liver transplantation (OLT). In this prospective study, 26 patients transplanted for hepatitis C virus cirrhosis with recurrent hepatitis C were treated 3.4 +/- 3.6 months after OLT and compared with an untreated historical control. PEG-IFN(alpha-2a) was initiated as monotherapy, following stepwise dose escalation up to 180 mug/week and the addition of ribavirin up to 1200 mg/day or maximally tolerated doses for 48 weeks. In the intent-to-treat analysis, 38% showed an early virological response (EVR), 35% an end of treatment response (ETR) and 19% a sustained virological response (SVR). SVR was associated with EVR (P = 0.0001) and cumulative PEG-IFN(alpha-2a) dose (P = 0.04). There was no significant histological improvement compared with untreated patients. There were no treatment-related serious adverse events. Adverse events included leucopenia (77%) and thrombocytopenia (46%). Three patients discontinued therapy due to side effects, fourteen were nonresponders and four relapsers. Treatment with PEG-IFN(alpha-2a) and ribavirin in the acute phase of post-transplant recurrent hepatitis C yielded an EVR of 38% and an SVR of 19%. The combination was safe and well tolerated. SN - 0934-0874 UR - https://www.unboundmedicine.com/medline/citation/17433090/Efficacy_of_an_escalating_dose_regimen_of_pegylated_interferon_alpha_2a_plus_ribavirin_in_the_early_phase_of_HCV_reinfection_after_liver_transplantation_ L2 - https://doi.org/10.1111/j.1432-2277.2007.00481.x DB - PRIME DP - Unbound Medicine ER -