REFINE: A Randomized Trial Comparing Cyclosporine A and Tacrolimus on Fibrosis After Liver Transplantation for Hepatitis C

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F14%3A00059153" target="_blank" >RIV/00023001:_____/14:00059153 - isvavai.cz</a>

Výsledek na webu

<a href="http://onlinelibrary.wiley.com/doi/10.1111/ajt.12620/pdf" target="_blank" >http://onlinelibrary.wiley.com/doi/10.1111/ajt.12620/pdf</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/ajt.12620" target="_blank" >10.1111/ajt.12620</a>

Jazyk výsledku

angličtina

Název v původním jazyce

REFINE: A Randomized Trial Comparing Cyclosporine A and Tacrolimus on Fibrosis After Liver Transplantation for Hepatitis C

Popis výsledku v původním jazyce

REFINE was a 12-month, prospective, open-label study in 356 patients receiving de novo liver transplantation for hepatitis C virus (HCV) cirrhosis, randomized to cyclosporine A (CsA) or tacrolimus with (i) no steroids, IL-2 receptor antibody induction and mycophenolic acid, or (ii) slow steroid tapering. The primary analysis population based on availability of liver biopsies comprised 165 patients (88 CsA, 77 tacrolimus). There was no difference in the primary endpoint, fibrosis stage 2 at 12 months, which occurred in 63/88 CsA-treated patients (71.6%) and 52/77 tacrolimus-treated patients (67.5%) (odds ratio [OR] 1.11; 95% CI 0.56, 2.21; p=0.759). Similarly, no significant between-group difference occurred at month 24 (OR 1.15; 95% CI 0.47, 2.80; p=0.767). Among steroid-free patients, fibrosis score 2 was significantly less frequent with CsA versus tacrolimus at month 12 (7/37 [18.9%] vs. 16/38 [42.1%]; p=0.029). HCV viral load was similar in both the tacrolimus- and CsA-treated cohor

Název v anglickém jazyce

REFINE: A Randomized Trial Comparing Cyclosporine A and Tacrolimus on Fibrosis After Liver Transplantation for Hepatitis C

Popis výsledku anglicky

REFINE was a 12-month, prospective, open-label study in 356 patients receiving de novo liver transplantation for hepatitis C virus (HCV) cirrhosis, randomized to cyclosporine A (CsA) or tacrolimus with (i) no steroids, IL-2 receptor antibody induction and mycophenolic acid, or (ii) slow steroid tapering. The primary analysis population based on availability of liver biopsies comprised 165 patients (88 CsA, 77 tacrolimus). There was no difference in the primary endpoint, fibrosis stage 2 at 12 months, which occurred in 63/88 CsA-treated patients (71.6%) and 52/77 tacrolimus-treated patients (67.5%) (odds ratio [OR] 1.11; 95% CI 0.56, 2.21; p=0.759). Similarly, no significant between-group difference occurred at month 24 (OR 1.15; 95% CI 0.47, 2.80; p=0.767). Among steroid-free patients, fibrosis score 2 was significantly less frequent with CsA versus tacrolimus at month 12 (7/37 [18.9%] vs. 16/38 [42.1%]; p=0.029). HCV viral load was similar in both the tacrolimus- and CsA-treated cohor

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FJ - Chirurgie včetně transplantologie

OECD FORD obor

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Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2014

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

American journal of transplantation

ISSN

1600-6135

e-ISSN

—

Svazek periodika

14

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

12

Strana od-do

635-646

Kód UT WoS článku

000331783200019

EID výsledku v databázi Scopus

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