***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: This r and omized , prospect i ve , multicenter trial compared the safety and efficacy of steroid-free immunosuppression ( IS ) to the safety and efficacy of 2 st and ard IS regimens in patients undergoing transplantation for hepatitis C virus ( HCV ) infection . The outcome measures were acute cellular rejection ( ACR ) , severe HCV recurrence , and survival .  The patients were r and omized ( 1:1:2 ) to tacrolimus ( TAC ) and corticosteroids ( arm 1 ; n = 77 ) , mycophenolate mofetil ( MMF ) , TAC , and corticosteroids ( arm 2 ; n = 72 ) , or  MMF , TAC , and daclizumab induction with no corticosteroids  ( arm 3 ; n = 146 ) . In all , 295 HCV RNA-positive subjects were enrolled . At 2 years , there were no differences in ACR , HCV recurrence ( biochemical evidence ) , patient survival , or graft survival rates . The side effects of IS did not differ , although there was a trend toward less diabetes in the steroid-free group . Liver biopsy sample s revealed no significant differences in the proportions of patients in arms 1 , 2 , and 3 with advanced HCV recurrence ( ie , an inflammation grade ≥ 3 and /or a fibrosis stage ≥ 2 ) in years 1 ( 48.2 % , 50.4 % , and 43.0 % , respectively ) and 2 ( 69.5 % , 75.9 % , and 68.1 % , respectively ) . Although we have found that steroid-free IS is safe and effective for liver transplant recipients with chronic HCV , steroid sparing has no clear advantage in comparison with traditional IS The aim of this prospect i ve r and omized trial was to study the efficacy and safety of tacrolimus monotherapy ( TACRO ) and compare it with our st and ard treatment of tacrolimus plus steroids ( TACRO + ST )  after liver transplant ( LT ) . Furthermore , the impact of steroid-free immunosuppression on outcome of hepatitis C virus ( HCV ) was analysed . Between 1998 and 2000 , 60 patients ( mean age : 57 years ) were included in the study and r and omized to receive TACRO  ( n = 28 ) or  TACRO + ST ( n = 32 ) . Indication for LT was postnecrotic cirrhosis in all cases ( 58.3 % were HCV-positive ) . Mean follow-up was 44 months . Survival , incidence of rejection , infection and side-effects were compared between the two groups . In patients with HCV infection , incidence and severity of acute hepatitis C , long-term outcome of recurrent hepatitis C and survival were studied in an intention-to-treat analysis or in the real group analysis ( real-TACRO versus real-TACRO + ST ) . Patient survival at 1 , 3 and 5 years , tacrolimus pharmacokinetics , incidence of rejection infections and side-effects were similar . In patients with HCV , the incidence and severity of graft hepatitis C tended to be lower in TACRO ( 47 % ) compared with TACRO + ST ( 67 % ) ( P = NS ) , and also in real-TACRO ( 42 % ) compared with real-TACRO + ST ( 61 % ) ( P = NS ) . A poor outcome considered as evolution to cirrhosis at 3 years was observed in one ( 9 % ) living patient in real-TACRO and nine ( 45 % ) in real-TACRO + ST ( P = 0.04 ) . Patient survival at 1 , 3 and 5 years was 92 % , 92 % and 73 % for real-TACRO and 78 % , 61 % and 51 % for real TACRO + ST ( P = 0.07 ) . Steroid-free immunosuppression appears to be safe and efficacious . The main advantage of this regimen could be in HCV patients , as recurrence of hepatitis in the graft was less severe in the group of patients in whom steroids could be avoided completely This open , r and omized ( 1 : 1 ) , multicenter , 3-month study compared a dual tacrolimus plus steroids ( Tac / steroids ) regimen with a steroid-free immunosuppressive regimen of tacrolimus following daclizumab induction therapy ( Tac / Dac ) in adult liver transplant recipients . The full analysis set comprised 347 patients in the Tac / steroids group and 351 in the Tac / Dac group . Mean  tacrolimus dose during month 3 was 0.11 mg/kg/day in both groups ; mean whole-blood trough levels during month 3 were 10.9 ng/mL ( Tac / steroids ) and 10.6 ng/mL ( Tac / Dac ) . The incidence of biopsy-confirmed acute rejection that required treatment was similar in both groups : 26.5 % in the Tac / steroids group and 25.4 % in the Tac / Dac group ( P = .727 ) . However , the incidence of biopsy-confirmed corticosteroid-resistant acute rejection was higher in the Tac / steroids group than in the Tac / Dac group ( 6.3 vs. 2.8 % ; P = .027 ) . Kaplan-Meier estimates of graft survival ( 92.2 vs. 90.5 % ) and patient survival ( 94.5 vs. 93.7 % ) were similar in both groups . While also the overall adverse event profiles were similar , the incidences of diabetes mellitus ( 15.3 vs. 5.7 % , respectively ; P < .001 ) and cytomegalovirus infection ( 11.5 vs. 5.1 % , respectively ; P = .002 ) were higher in the Tac / steroids group compared with the Tac / Dac group . Mean cholesterol levels increased by 16 % in the Tac / steroids group , but were unchanged in the Tac / Dac group during the study . In conclusion , tacrolimus monotherapy following daclizumab induction is an effective and safe regimen , with an advantage over concomitant steroid-maintenance therapy in terms of a lower incidence of diabetes and viral infection , and a lower incidence of steroid-resistant acute rejection Steroid-free immunosuppressive regimens reduce corticosteroid-related side effects in liver transplant recipients although their efficacy is very variable . We evaluated the efficacy and safety of a steroid-free regimen in a 6-month , open-label , multicenter , pilot study , which involved 102 liver transplant patients treated with daclizumab ( 2 mg/kg within 6 h following transplant and 1 mg/kg on day 7 ) , mycophenolate mofetil ( MMF  , 1 g b.i.d ) and tacrolimus  ( trough levels of 5 - 15 ng/ml in the first month and 5 - 10 ng/ml thereafter ) . One intra-operative dose of methylprednisolone was administered . At 6 months , the acute rejection rate was 9.8 % , and patient and graft survival rates were 96 % and 95 % , respectively . Acute rejection rates were similar for hepatitis C-positive patients ( 8.6 % ) and hepatitis C-negative patients ( 10.4 % ) . Infections occurred in 22 % of patients ; most cases were considered mild or moderate . Post-transplantation hypertension and diabetes mellitus developed in 37 % and 14 % of patients , respectively , during the study period , but were markedly less frequent ( 8 % and 6 % , respectively ) at 6 months . Hypercholesterolemia was observed in only 2 % of patients . In conclusion , the steroid-free immunosuppressive regimen of daclizumab , MMF , and tacrolimus effectively prevents acute rejection after liver transplantation without decreasing safety Background . Due to the known high recurrence rate of hepatitis C virus ( HCV ) among orthotopic liver transplant ( OLT ) recipients who receive tacrolimus+corticosteroid maintenance , use of steroid-free induction was considered . Methods . OLT recipients with HCV were r and omized to receive tacrolimus+daclizumab ( steroid-free ) vs. tacrolimus+corticosteroids during 1999–2001 and then tacrolimus+mycophenolate mofetil (MMF)+daclizumab ( steroid-free ) vs. tacrolimus+MMF+corticosteroids during 2002–2005 . Patients in the steroid-free arm of both periods received no steroids except for treating biopsy-proven rejection . Primary objective was to compare mean fibrosis stage at the 1-year protocol biopsy , between the steroid-free and corticosteroid arms , stratifying by period . Results . No noticeable differences in mean fibrosis stage between the two treatment arms , either averaging across periods ( P=0.99 ) or during either period ( P>0.35 ) were found . Occurrence of acute rejection during the first year was the only factor associated with a significantly increased fibrosis stage at 1 year ( P=0.0003 ) ; stage ≥2 was seen in 63 % ( 17 of 27 ) vs. 19 % ( 8 of 43 ) of those with vs. without rejection . In addition , MMF use was associated with significantly fewer patients experiencing acute rejection during the first 6 and 12 months posttransplant ( P=0.006 and 0.046 ) . Regarding steroid-related side effects , posttransplant diabetes mellitus occurred in 10 % vs. 45 % , and wound infection in 6 % vs. 31 % of steroid-free vs. corticosteroid patients ( P=0.003 and 0.01 ) . Conclusions . OLT recipients with HCV tolerated the steroid-free protocol with fewer side effects ; however , its use had no apparent impact on hepatic fibrosis progression . Occurrence of acute rejection was strongly associated with increased hepatic fibrosis at 1 year , and MMF use appears to have significantly reduced the rejection rate BACKGROUND / AIMS To assess the effect of long-term maintenance of steroids on HCV recurrence  after liver transplantation ( LT ) , that is still controversial , a prospect i ve multicentre trial was conducted at the centres of Bologna and Padua , Italy . METHODS From September 2002 , 47 eligible HCV positive LT recipients were r and omized to receive 2 different steroid schedules in association with tacrolimus : group A : rapid tapering and withdrawal 91 days after LT group B : slow tapering and withdrawal 25 months after LT . Thirty-nine patients were assessable : 23 in group A and 16 in group B. Donor and recipient characteristics were similar in the two groups . Median follow-up was 841 days ( 130 - 1376 ) . One hundred liver biopsies were performed , and every patient had a biopsy at month 12 . RESULTS Twenty-two out of 23 ( 95 , 65 % ) patients in group A and 15 out of 16 ( 93 , 75 % ) in group B had histologically-confirmed HCV recurrence . Twelve-month histology showed advanced fibrosis ( score 3 or 4 ) in 42.1 % of the patients in group A versus 7.6 % in group B ( P=0.03 ) . One- and 2-year advanced fibrosis-free survival were 65.2 and 60.8 in group A and 93.7 % in group B ( P=0.03 and = 0.02 , respectively ) . CONCLUSIONS Slow tapering of steroids reduced the progression of recurrent hepatitis C after LT UNLABELLED Steroid bolus therapy for acute rejection after liver transplantation for hepatitis C virus ( HCV ) cirrhosis often results in graft loss due to adverse effects . The efficacy and safety of basiliximab for the treatment of acute cellular rejection ( ACR ) in adult liver transplantation has not been adequately evaluated . Three patients received basiliximab as rescue therapy for acute rejection . The outcome and biochemical parameters were recorded before and after treatment with basiliximab . These results were compared to 11 patients who received steroid therapy for ACR . The median time from transplantation to the development of ACR was 19 days ( range , 9 - 49 days ) . The degree of ACR was mild or moderate . Resolution of rejection was obtained in all patients and the median time from the onset to resolution of ACR was 16 days ( range , 6 - 41 days ) . A steroid resistant reaction occurred in 2 of 11 patients and OKT3 was used , and the rejection eventually resolved in all patients . Five patients died within 2 to 22 months after transplantation and four of them died from graft failure . In the basiliximab group , there were no significant immediate adverse effects . One patient died from pneumonia 8 months after transplantation . IN CONCLUSION Basiliximab can be safely used as rescue therapy for ACR without significant adverse effects in patients who underwent liver transplantation for HCV cirrhosis Abstract : Background / aims : Steroids are traditionally used in liver transplantation as a part of a triple or quadruple immunosuppressive regimen . Steroids act non‐specifically and cause multiple side 
    Output:
    
In summary , our study indicate that rapid discontinuation of steroid in the Tac-based immunosuppressive regimen may not lead to an increased risk of morbidity and rejection rate