Long-term leukocyte natural α-interferon and ribavirin treatment in hepatitis C virus recurrence after liver transplantation

AIM:To evaluate the effect of long-term treatment with leukocyte natural-interferon(ln-α-IFN)plus ribavirin(RBV).METHODS:Forty-six patients with hepatitis C virus(HCV)recurrence received 3 MU three times a week of ln-α-IFN plus RBV for 1 mo;then,patients with good tolerability(n=30)were switched to daily IFN administration,while the remaining were treated with the same schedule.Patients have been treated for 12 mo after viral clearance while non-responders(NR)entered in the longterm treatment group.Liver biopsies were planned at baseline,1 year after sustained virological response(SVR)and at 36 mo after start of therapy in NR.MedCalc software package was used for statistical analysis.RESULTS:About 16.7%of genotype 1-4 and 70%of genotype 2-3 patients achieved SVR.Nine patients withdrew therapy because of non-tolerance or noncompliance.A significant improvement in serum biochemistry and histological activity was observed in all SVR patients and long-term treated;100%of patients with SVR achieved a histological response(fibrosis stabilization or improvement)with a significant reduction in mean staging value(from 2.1 to 1.0;P=0.0031);histological response was observed in 84%of long-term treated patients compared to 57%of drop-out.Six patients died during the entire study period(follow-up 40.6±7.7 mo);of them,5 presented with severe HCV recurrence on enrollment.Diabetes(OR=0.38,95%CI:0.08-0.59,P=0.01),leukopenia(OR=0.54,95%CI:0.03-0.57,P=0.03)and severe HCV recurrence(OR=0.51,95%CI:0.25-0.69,P=0.0003)were variables associated to survival.Long-term treatment was well tolerated;no patients developed rejection or autoimmune disease.CONCLUSION:Long-term treatment improves histology in SVR patients and slows disease progression also in NR,leading to a reduction in liver decompensation,graft failure and liver-related death.