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.
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 >or=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.
Filipponi
Franco
F
Liver Transplantation Unit, University of Pisa, Hospital of Cisanello, Via Paradisa 2, 56100 Pisa, Italy. f.filipponi@med.unipi.it
Callea
Francesco
F
Salizzoni
Mauro
M
Grazi
Gian Luca
GL
Fassati
Luigi Rainero
LR
Rossi
Massimo
M
Risaliti
Andrea
A
Burra
Patrizia
P
Agnes
Salvatore
S
De Carlis
Luciano
L
Valente
Umberto
U
Ferrara
Roberto
R
Pisati
Roberto
R
D000305:Adrenal Cortex Hormones / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D001379:Azathioprine / Q000627:therapeutic use*; D000077552:Basiliximab; D016572:Cyclosporine / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006085:Graft Survival; D016174:Hepacivirus / Q000302:isolation & purification / Q000502:physiology*; D006526:Hepatitis C / Q000453:epidemiology* / Q000473:pathology / Q000601:surgery*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016031:Liver Transplantation / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use*; D012008:Recurrence; D013997:Time Factors; D014779:Virus Replication
D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D010919:Placebos; D011993:Recombinant Fusion Proteins; D016572:Cyclosporine; D000077552:Basiliximab; D001379:Azathioprine