Double-blind comparison of hepatitis C histological recurrence rate in HCV+ Liver Transplant Recipients Given Basiliximab+Steroids or Basiliximab+Placebo, in addition to Cyclosporine and Azathioprine

Franco Filipponi, Francesco Callea, Mauro Salizzoni, Gian Luca Grazi, Luigi Rainero Fassati, Massimo Rossi, Andrea Risaliti, Patrizia Burra, Salvatore Agnes, Luciano De Carlis, Umberto Valente, Roberto Ferrara, Roberto Pisati

Research output: Contribution to journalArticle

75 Citations (Scopus)

Abstract

Background. Hepatitis C virus (HCV) recurrence in HCV+liver transplant recipients is almost inevitable and may be promoted by immunosuppression. We compared the amount of liver damage with regard to usage of steroids and basiliximab. Methods. A total of 140 HCV+ adult liver transplant recipients were randomly allocated to basiliximab+steroids or basiliximab+placebo (plus cyclosporine and azathioprine). Primary endpoint: hepatitis C histological recurrence (liver damage as for Ishak grading score ≥8 by biopsy at 12 months); secondary endpoints: treatment failure (death, graft loss, patient withdrawal), biopsy proven acute rejection (BPAR), treated acute rejection (tAR), allograft and patient survival rates at 12 months. Results. Any significant difference has been observed in the 12-month hepatitis C histological recurrence rate (41.2% basiliximab+steroids, 37.5% basiliximab+placebo, P=0.354). The treatment failure rate was significantly higher in basiliximab+steroids (28.8%) than in basiliximab+placebo (15.6%), P=0.03; the combination test for the evaluation of the joint hypothesis resulted in a borderline nonsignificant overall result (P=0.059). BPAR rate was significantly lower in the group treated with steroids (24.3% basiliximab+steroids, 39.4% basiliximab+placebo, P=0.04), while the tAR rate was similar (29.7% basiliximab+steroids and 37.9% basiliximab+placebo). Any significant differences in 1-year graft and patient survival rates have been observed (72.9% and 84.8% basiliximab+steroids; 81.5% and 89.0% basiliximab+placebo). Conclusions. Results suggest that steroid-free therapy is associated with a significantly lower treatment failure rate, although histological recurrence rate of hepatitis C is similar in the two groups. This benefit is not offset by an evident increase in graft rejection rate requiring treatment.

Original languageEnglish
Pages (from-to)1488-1495
Number of pages8
JournalTransplantation
Volume78
Issue number10
DOIs
Publication statusPublished - Nov 27 2004

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Azathioprine
Hepatitis C
Hepacivirus
Cyclosporine
Steroids
Placebos
Recurrence
Liver
Treatment Failure
Biopsy
basiliximab
Transplant Recipients
Survival Rate
Graft Rejection
Graft Survival
Immunosuppression
Allografts
Joints

Keywords

  • Basiliximab
  • HCV
  • Hepatitis C recurrence
  • Liver transplant
  • Steroids

ASJC Scopus subject areas

  • Transplantation
  • Immunology

Cite this

Double-blind comparison of hepatitis C histological recurrence rate in HCV+ Liver Transplant Recipients Given Basiliximab+Steroids or Basiliximab+Placebo, in addition to Cyclosporine and Azathioprine. / Filipponi, Franco; Callea, Francesco; Salizzoni, Mauro; Grazi, Gian Luca; Fassati, Luigi Rainero; Rossi, Massimo; Risaliti, Andrea; Burra, Patrizia; Agnes, Salvatore; De Carlis, Luciano; Valente, Umberto; Ferrara, Roberto; Pisati, Roberto.

In: Transplantation, Vol. 78, No. 10, 27.11.2004, p. 1488-1495.

Research output: Contribution to journalArticle

Filipponi, Franco ; Callea, Francesco ; Salizzoni, Mauro ; Grazi, Gian Luca ; Fassati, Luigi Rainero ; Rossi, Massimo ; Risaliti, Andrea ; Burra, Patrizia ; Agnes, Salvatore ; De Carlis, Luciano ; Valente, Umberto ; Ferrara, Roberto ; Pisati, Roberto. / Double-blind comparison of hepatitis C histological recurrence rate in HCV+ Liver Transplant Recipients Given Basiliximab+Steroids or Basiliximab+Placebo, in addition to Cyclosporine and Azathioprine. In: Transplantation. 2004 ; Vol. 78, No. 10. pp. 1488-1495.
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abstract = "Background. Hepatitis C virus (HCV) recurrence in HCV+liver transplant recipients is almost inevitable and may be promoted by immunosuppression. We compared the amount of liver damage with regard to usage of steroids and basiliximab. Methods. A total of 140 HCV+ adult liver transplant recipients were randomly allocated to basiliximab+steroids or basiliximab+placebo (plus cyclosporine and azathioprine). Primary endpoint: hepatitis C histological recurrence (liver damage as for Ishak grading score ≥8 by biopsy at 12 months); secondary endpoints: treatment failure (death, graft loss, patient withdrawal), biopsy proven acute rejection (BPAR), treated acute rejection (tAR), allograft and patient survival rates at 12 months. Results. Any significant difference has been observed in the 12-month hepatitis C histological recurrence rate (41.2{\%} basiliximab+steroids, 37.5{\%} basiliximab+placebo, P=0.354). The treatment failure rate was significantly higher in basiliximab+steroids (28.8{\%}) than in basiliximab+placebo (15.6{\%}), P=0.03; the combination test for the evaluation of the joint hypothesis resulted in a borderline nonsignificant overall result (P=0.059). BPAR rate was significantly lower in the group treated with steroids (24.3{\%} basiliximab+steroids, 39.4{\%} basiliximab+placebo, P=0.04), while the tAR rate was similar (29.7{\%} basiliximab+steroids and 37.9{\%} basiliximab+placebo). Any significant differences in 1-year graft and patient survival rates have been observed (72.9{\%} and 84.8{\%} basiliximab+steroids; 81.5{\%} and 89.0{\%} basiliximab+placebo). Conclusions. Results suggest that steroid-free therapy is associated with a significantly lower treatment failure rate, although histological recurrence rate of hepatitis C is similar in the two groups. This benefit is not offset by an evident increase in graft rejection rate requiring treatment.",
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AU - Filipponi, Franco

AU - Callea, Francesco

AU - Salizzoni, Mauro

AU - Grazi, Gian Luca

AU - Fassati, Luigi Rainero

AU - Rossi, Massimo

AU - Risaliti, Andrea

AU - Burra, Patrizia

AU - Agnes, Salvatore

AU - De Carlis, Luciano

AU - Valente, Umberto

AU - Ferrara, Roberto

AU - Pisati, Roberto

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N2 - Background. Hepatitis C virus (HCV) recurrence in HCV+liver transplant recipients is almost inevitable and may be promoted by immunosuppression. We compared the amount of liver damage with regard to usage of steroids and basiliximab. Methods. A total of 140 HCV+ adult liver transplant recipients were randomly allocated to basiliximab+steroids or basiliximab+placebo (plus cyclosporine and azathioprine). Primary endpoint: hepatitis C histological recurrence (liver damage as for Ishak grading score ≥8 by biopsy at 12 months); secondary endpoints: treatment failure (death, graft loss, patient withdrawal), biopsy proven acute rejection (BPAR), treated acute rejection (tAR), allograft and patient survival rates at 12 months. Results. Any significant difference has been observed in the 12-month hepatitis C histological recurrence rate (41.2% basiliximab+steroids, 37.5% basiliximab+placebo, P=0.354). The treatment failure rate was significantly higher in basiliximab+steroids (28.8%) than in basiliximab+placebo (15.6%), P=0.03; the combination test for the evaluation of the joint hypothesis resulted in a borderline nonsignificant overall result (P=0.059). BPAR rate was significantly lower in the group treated with steroids (24.3% basiliximab+steroids, 39.4% basiliximab+placebo, P=0.04), while the tAR rate was similar (29.7% basiliximab+steroids and 37.9% basiliximab+placebo). Any significant differences in 1-year graft and patient survival rates have been observed (72.9% and 84.8% basiliximab+steroids; 81.5% and 89.0% basiliximab+placebo). Conclusions. Results suggest that steroid-free therapy is associated with a significantly lower treatment failure rate, although histological recurrence rate of hepatitis C is similar in the two groups. This benefit is not offset by an evident increase in graft rejection rate requiring treatment.

AB - Background. Hepatitis C virus (HCV) recurrence in HCV+liver transplant recipients is almost inevitable and may be promoted by immunosuppression. We compared the amount of liver damage with regard to usage of steroids and basiliximab. Methods. A total of 140 HCV+ adult liver transplant recipients were randomly allocated to basiliximab+steroids or basiliximab+placebo (plus cyclosporine and azathioprine). Primary endpoint: hepatitis C histological recurrence (liver damage as for Ishak grading score ≥8 by biopsy at 12 months); secondary endpoints: treatment failure (death, graft loss, patient withdrawal), biopsy proven acute rejection (BPAR), treated acute rejection (tAR), allograft and patient survival rates at 12 months. Results. Any significant difference has been observed in the 12-month hepatitis C histological recurrence rate (41.2% basiliximab+steroids, 37.5% basiliximab+placebo, P=0.354). The treatment failure rate was significantly higher in basiliximab+steroids (28.8%) than in basiliximab+placebo (15.6%), P=0.03; the combination test for the evaluation of the joint hypothesis resulted in a borderline nonsignificant overall result (P=0.059). BPAR rate was significantly lower in the group treated with steroids (24.3% basiliximab+steroids, 39.4% basiliximab+placebo, P=0.04), while the tAR rate was similar (29.7% basiliximab+steroids and 37.9% basiliximab+placebo). Any significant differences in 1-year graft and patient survival rates have been observed (72.9% and 84.8% basiliximab+steroids; 81.5% and 89.0% basiliximab+placebo). Conclusions. Results suggest that steroid-free therapy is associated with a significantly lower treatment failure rate, although histological recurrence rate of hepatitis C is similar in the two groups. This benefit is not offset by an evident increase in graft rejection rate requiring treatment.

KW - Basiliximab

KW - HCV

KW - Hepatitis C recurrence

KW - Liver transplant

KW - Steroids

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