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
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

Gordon, F. D., Kwo, P., Ghalib, R., Crippin, J., Vargas, H. E., Brown, K. A., ... Brown, R. S. (2012). Peginterferon-α-2b and ribavirin for hepatitis C recurrence postorthotopic liver transplantation. Journal of Clinical Gastroenterology, 46(8), 700-708. https://doi.org/10.1097/MCG.0b013e31825833be

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 - Brown, Kimberly A.

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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.

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