Peginterferon-α-2b and ribavirin for hepatitis C recurrence postorthotopic liver transplantation

Fredric D. Gordon, Paul Kwo, Reem Ghalib, Jeffrey Crippin, Hugo E Vargas, Kimberly A. Brown, Thomas Schiano, Eirum Chaudhri, Lisa D. Pedicone, Robert S. Brown

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

Goals: To evaluate the safety and efficacy of peginterferon-α-2b plus ribavirin in patients with recurrent hepatitis C after orthotopic liver transplant. Background: Reinfection of liver allografts in hepatitis C virus -infected transplant recipients begins immediately after transplantation. Treatment of these patients is challenging because of poor tolerability. Study: A multicenter, open-label study enrolling patients with persistent viremia after primary orthotopic liver transplant for cirrhosis related to hepatitis C virus infection. Patients received peginterferon-α-2b (1.5 μg/kg/wk) plus ribavirin (400 to 1200 mg/d administered using a dose-escalating regimen and according to body weight) for 48 weeks. The primary endpoint was sustained virologic response (SVR). Results: In total, 125 patients started treatment and 58.4% completed 48 weeks. SVR rate was 28.8% (G1, 23.8%; G2/3, 55.0%), end-of-treatment response rate was 40.8%, and relapse rate was 18.2%. SVR was 55% among patients who completed treatment. Genotype 2/3 infection, male sex, baseline hemoglobin>14 g/dL, 80:80:80 compliance, rapid virologic response (RVR), and complete early virologic response (cEVR) were predictors of SVR. SVR was higher among patients with RVR compared with those without RVR (83.3% vs. 25.7%; P=0.0098), and among patients with cEVR compared with those without EVR (66.7% vs. 1.8%; P<0.0001). Thirty-eight patients discontinued because of an adverse event and 69 required dose reduction or interruption. Anemia (74%) and neutropenia (30%) were common, and rejection was low (3.2%). Conclusions: SVR was low in this study. Anemia was a particular challenge in achieving maximal ribavirin therapeutic exposure and may account in part for the lower SVR.

Original languageEnglish (US)
Pages (from-to)700-708
Number of pages9
JournalJournal of Clinical Gastroenterology
Volume46
Issue number8
DOIs
StatePublished - Sep 2012

Fingerprint

Ribavirin
Hepatitis C
Liver Transplantation
Recurrence
Hepacivirus
Anemia
Transplants
Therapeutics
Liver
Viremia
Virus Diseases
Sustained Virologic Response
Neutropenia
Liver Cirrhosis
Compliance
Multicenter Studies
Allografts
Hemoglobins
Transplantation
Genotype

Keywords

  • anemia
  • genotype
  • hepatitis
  • multicenter
  • peginterferon
  • predictor
  • prospective
  • ribavirin
  • transplant

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Peginterferon-α-2b and ribavirin for hepatitis C recurrence postorthotopic liver transplantation. / Gordon, Fredric D.; Kwo, Paul; Ghalib, Reem; Crippin, Jeffrey; Vargas, Hugo E; Brown, Kimberly A.; Schiano, Thomas; Chaudhri, Eirum; Pedicone, Lisa D.; Brown, Robert S.

In: Journal of Clinical Gastroenterology, Vol. 46, No. 8, 09.2012, p. 700-708.

Research output: Contribution to journalArticle

Gordon, FD, Kwo, P, Ghalib, R, Crippin, J, Vargas, HE, Brown, KA, Schiano, T, Chaudhri, E, Pedicone, LD & Brown, RS 2012, 'Peginterferon-α-2b and ribavirin for hepatitis C recurrence postorthotopic liver transplantation', Journal of Clinical Gastroenterology, vol. 46, no. 8, pp. 700-708. https://doi.org/10.1097/MCG.0b013e31825833be
Gordon, Fredric D. ; Kwo, Paul ; Ghalib, Reem ; Crippin, Jeffrey ; Vargas, Hugo E ; Brown, Kimberly A. ; Schiano, Thomas ; Chaudhri, Eirum ; Pedicone, Lisa D. ; Brown, Robert S. / Peginterferon-α-2b and ribavirin for hepatitis C recurrence postorthotopic liver transplantation. In: Journal of Clinical Gastroenterology. 2012 ; Vol. 46, No. 8. pp. 700-708.
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abstract = "Goals: To evaluate the safety and efficacy of peginterferon-α-2b plus ribavirin in patients with recurrent hepatitis C after orthotopic liver transplant. Background: Reinfection of liver allografts in hepatitis C virus -infected transplant recipients begins immediately after transplantation. Treatment of these patients is challenging because of poor tolerability. Study: A multicenter, open-label study enrolling patients with persistent viremia after primary orthotopic liver transplant for cirrhosis related to hepatitis C virus infection. Patients received peginterferon-α-2b (1.5 μg/kg/wk) plus ribavirin (400 to 1200 mg/d administered using a dose-escalating regimen and according to body weight) for 48 weeks. The primary endpoint was sustained virologic response (SVR). Results: In total, 125 patients started treatment and 58.4{\%} completed 48 weeks. SVR rate was 28.8{\%} (G1, 23.8{\%}; G2/3, 55.0{\%}), end-of-treatment response rate was 40.8{\%}, and relapse rate was 18.2{\%}. SVR was 55{\%} among patients who completed treatment. Genotype 2/3 infection, male sex, baseline hemoglobin>14 g/dL, 80:80:80 compliance, rapid virologic response (RVR), and complete early virologic response (cEVR) were predictors of SVR. SVR was higher among patients with RVR compared with those without RVR (83.3{\%} vs. 25.7{\%}; P=0.0098), and among patients with cEVR compared with those without EVR (66.7{\%} vs. 1.8{\%}; P<0.0001). Thirty-eight patients discontinued because of an adverse event and 69 required dose reduction or interruption. Anemia (74{\%}) and neutropenia (30{\%}) were common, and rejection was low (3.2{\%}). Conclusions: SVR was low in this study. Anemia was a particular challenge in achieving maximal ribavirin therapeutic exposure and may account in part for the lower SVR.",
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AU - Vargas, Hugo E

AU - Brown, Kimberly A.

AU - Schiano, Thomas

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N2 - Goals: To evaluate the safety and efficacy of peginterferon-α-2b plus ribavirin in patients with recurrent hepatitis C after orthotopic liver transplant. Background: Reinfection of liver allografts in hepatitis C virus -infected transplant recipients begins immediately after transplantation. Treatment of these patients is challenging because of poor tolerability. Study: A multicenter, open-label study enrolling patients with persistent viremia after primary orthotopic liver transplant for cirrhosis related to hepatitis C virus infection. Patients received peginterferon-α-2b (1.5 μg/kg/wk) plus ribavirin (400 to 1200 mg/d administered using a dose-escalating regimen and according to body weight) for 48 weeks. The primary endpoint was sustained virologic response (SVR). Results: In total, 125 patients started treatment and 58.4% completed 48 weeks. SVR rate was 28.8% (G1, 23.8%; G2/3, 55.0%), end-of-treatment response rate was 40.8%, and relapse rate was 18.2%. SVR was 55% among patients who completed treatment. Genotype 2/3 infection, male sex, baseline hemoglobin>14 g/dL, 80:80:80 compliance, rapid virologic response (RVR), and complete early virologic response (cEVR) were predictors of SVR. SVR was higher among patients with RVR compared with those without RVR (83.3% vs. 25.7%; P=0.0098), and among patients with cEVR compared with those without EVR (66.7% vs. 1.8%; P<0.0001). Thirty-eight patients discontinued because of an adverse event and 69 required dose reduction or interruption. Anemia (74%) and neutropenia (30%) were common, and rejection was low (3.2%). Conclusions: SVR was low in this study. Anemia was a particular challenge in achieving maximal ribavirin therapeutic exposure and may account in part for the lower SVR.

AB - Goals: To evaluate the safety and efficacy of peginterferon-α-2b plus ribavirin in patients with recurrent hepatitis C after orthotopic liver transplant. Background: Reinfection of liver allografts in hepatitis C virus -infected transplant recipients begins immediately after transplantation. Treatment of these patients is challenging because of poor tolerability. Study: A multicenter, open-label study enrolling patients with persistent viremia after primary orthotopic liver transplant for cirrhosis related to hepatitis C virus infection. Patients received peginterferon-α-2b (1.5 μg/kg/wk) plus ribavirin (400 to 1200 mg/d administered using a dose-escalating regimen and according to body weight) for 48 weeks. The primary endpoint was sustained virologic response (SVR). Results: In total, 125 patients started treatment and 58.4% completed 48 weeks. SVR rate was 28.8% (G1, 23.8%; G2/3, 55.0%), end-of-treatment response rate was 40.8%, and relapse rate was 18.2%. SVR was 55% among patients who completed treatment. Genotype 2/3 infection, male sex, baseline hemoglobin>14 g/dL, 80:80:80 compliance, rapid virologic response (RVR), and complete early virologic response (cEVR) were predictors of SVR. SVR was higher among patients with RVR compared with those without RVR (83.3% vs. 25.7%; P=0.0098), and among patients with cEVR compared with those without EVR (66.7% vs. 1.8%; P<0.0001). Thirty-eight patients discontinued because of an adverse event and 69 required dose reduction or interruption. Anemia (74%) and neutropenia (30%) were common, and rejection was low (3.2%). Conclusions: SVR was low in this study. Anemia was a particular challenge in achieving maximal ribavirin therapeutic exposure and may account in part for the lower SVR.

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