Rejection rates in a randomised trial of tacrolimus monotherapy versus triple therapy in liver transplant recipients with hepatitis C virus cirrhosis

Samonakis, Dimitrios; Mela, Maria; Quaglia, Alberto; Triantos, Christos; Thalheimer, Ulrich; Leandro, Gioacchino; Pesci, Alberto; Raimondo, Maria; Dhillon, Amar P.; Rolles, K; Davidson, Brian R; Patch, David; Burroughs, Andrew K.

doi:10.1111/j.1399-3062.2006.00124.x

Cited by 33 publications

(36 citation statements)

References 47 publications

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“…This was independent of other known factors affecting fibrosis (e.g. donor age) and the fact that more rejection using protocol biopsies was seen in the triple therapy group [31]. There were no survival differences between the two treatment arms.…”

Section: Clinical Studies -Observationalmentioning

confidence: 86%

“…Clinical studies -randomized trials and meta-analyses In our recent randomised trial of 103 LT patients, [30], despite more histologically proven and treated rejection episodes (identified by protocol biopsies) [31], treatment with Tac and maintenance steroids and long term AZA resulted in slower onset of histologically proven severe fibrosis and portal hypertension, without statistical differences in the rates of renal dysfunction, retransplantation and death. The fibrosis progression rate in this group is the lowest reported to date (Ishak stage 4 at 3 years 23%).…”

Section: Maintenance Steroidsmentioning

confidence: 99%

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Immunosuppression and HCV recurrence after liver transplantation

Samonakis¹,

Germani²,

Burroughs³

2012

Journal of Hepatology

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HCV related liver disease is the most common indication for liver transplantation. Recurrence of HCV infection is universal and has a substantial impact on patient and graft survival. Immunosuppression is a major factor responsible for the accelerated recurrence and compressed natural history of recurrent HCV infection. Accumulating experience has provided data to support certain strategies for immunosuppressive regimens. From the available evidence, more severe recurrence results from repeated bolus corticosteroid therapy and anti-lymphocyte antibodies used to treat rejection. Low dose and slow tapering of steroids are better than high dose maintenance and/or rapid tapering. Recent meta-analyses favour steroid-free regimens but these are complicated to interpret as the absence of steroids may simply represent less immunopotency. There is no difference in HCV recurrence between tacrolimus and cyclosporine regimens, but tacrolimus increases graft and patient survival in HCV transplanted patients. There may be a beneficial effect of maintenance azathioprine given for 6 months or longer. There is no conclusive evidence for benefit of mycophenolate and interleukin-2 receptor blockers. Few data are available for mTOR inhibitors. Better evidence is needed to establish the optimal immunosuppressive regimen for HCV recipients and more randomized trials should be performed.

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Section: Clinical Studies -Observationalmentioning

confidence: 86%

Section: Maintenance Steroidsmentioning

confidence: 99%

Immunosuppression and HCV recurrence after liver transplantation

Samonakis¹,

Germani²,

Burroughs³

2012

Journal of Hepatology

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“…In 103 liver transplant recipients randomized to tacrolimus monotherapy vs tacrolimus, azathioprine and low dose steroids, fibrosis progression was much lower in the latter group [55]. In a comparative study by Berenguer et al implementation of two strategies in HCV transplant recipients was beneficial in reducing HCV recurrence.…”

Section: Immunosuppressionmentioning

confidence: 96%

Management of post liver transplantation recurrent hepatitis C infection with directly acting antiviral drugs: a review

2016

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Recurrent HCV infection (rHCV) of the liver allograft following transplantation is universal and is associated with poor graft and patient survival in comparison with other indications. Treatment of rHCV infection in the previous era with pegylated interferon and ribavirin was associated with low sustained virological response (SVR) due to poor tolerability, adverse events and graft rejection. Recently, directly acting antiviral drugs (DAA) have been approved for the treatment of hepatitis C infection and a number of clinical trials have been conducted across various centers in the management of rHCV infection of the graft. In this review we discuss about recent studies that have emerged on the use of NS5b polymerase inhibitor, sofosbuvir in combination with second generation protease inhibitor, simeprevir, fixed dose ledipasvir or daclatasvir with or without ribavirin in the treatment of post transplant rHCV infection.

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“…Cyclosporine or tacrolimus were used as monotherapy in 2 and 19, respectively, or combined with azathioprine (£1 mg/kg) and prednisolone (20 mg/day reducing over 3 months and stopping between 3 and 6 months) in 23 and 11 patients, respectively. Tacrolimus as part of triple therapy [31,32] or monotherapy [32] was used in randomized trials. Immunosuppressive doses were adjusted as described previously [11].…”

Section: Immunosuppressive Regimensmentioning

confidence: 99%

Clinical outcome of HCV-related graft cirrhosis and prognostic value of hepatic venous pressure gradient

Kalambokis

Manousou

Samonakis

et al. 2008

Transplant International

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Hepatitis C virus (HCV) allograft cirrhosis may progress rapidly requiring re-transplantation but its course is little studied. We evaluated serially biopsied patients who developed HCV-related allograft cirrhosis. We assessed outcome of graft cirrhosis in 55 out of 234 consecutive patients and predictors of decompensation and mortality, including hepatic venous pressure gradient (HVPG) in 38. Allograft cirrhosis (Ishak stage 6, 60%; stage 5, 40%) was diagnosed between 12 and 172 months (median, 52) from transplantation; subsequent follow up was 22 (1-78) months. Faster development (or=48 months) was associated with tacrolimus and nonuse of azathioprine and prednisolone. Decompensation occurred in 22% with a probability of not developing decompensation reaching 60% at 5 years. Survival among compensated patients was 77% at 5 years, but fell rapidly after decompensation (12% at 1 year). Decompensation and mortality were independently associated with HVPG or= 10 mmHg, Child-Pugh score or= 7, and albumin levels or= 32 g/dl but not with fibrosis stage 5 or 6, HCV genotype (1b, 34%) or immunosuppression used after diagnosis of cirrhosis. In conclusion, Ishak stage 5 and 6 HCV-related cirrhosis have similar prognosis after liver transplantation. An HVPG or= 10 mmHg, in addition to liver dysfunction, gives independent prognostic information prior to decompensation, allowing early relisting before prognosis becomes extremely poor

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Rejection rates in a randomised trial of tacrolimus monotherapy versus triple therapy in liver transplant recipients with hepatitis C virus cirrhosis

Abstract: Tacrolimus monotherapy is a viable immunosuppressive strategy in HCV-infected liver transplant recipients.

Cited by 33 publications

References 47 publications

Immunosuppression and HCV recurrence after liver transplantation

Immunosuppression and HCV recurrence after liver transplantation

Management of post liver transplantation recurrent hepatitis C infection with directly acting antiviral drugs: a review

Clinical outcome of HCV-related graft cirrhosis and prognostic value of hepatic venous pressure gradient

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