studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 283A
tion, kidney failure, encephalopathy, variceal hemorrhage).
Patients were censored at the time of liver transplantation or
spontaneous bacterial peritonitis. Results: 291 patients were
enrolled rather than the projected 392 because of slow recruitment
and termination of funding. Excessive alcohol consumption
was the cause of cirrhosis in 115 patients (79.9%) of the
norfloxacin group and 108 patients (73.5%) of the placebo
group. By 6 months, 19 deaths (13.2%) occurred in the norfloxacin
group as compared with 27 deaths (18.4%) in the
placebo group, with a hazard ratio (HR) for death at 6 months
of 0.69 (95% confidence interval [CI], 0.38 to 1.24; P=0.21).
The HR for death at 3 months and 12 months were 0.53 (95%
CI, 0.28 to 1.02; P=0.05) and 0.76 (0.48 to 1.22; P=0.26),
respectively. There were no significant differences in terms of
6-month rates of infections (20.8% vs. 22.4%), kidney failure
(6.9% vs. 7.5%), encephalopathy (16.7% vs. 19.0%), variceal
hemorrhage (3.5% vs. 4.1%). Post-hoc analysis showed that at
enrollment, there were 56 patients (39.2%) in the norfloxacin
group and 63 (42.9%) in the placebo group who had histological
features of alcoholic hepatitis (P=0.52). In this subgroup
of patients, the HR for death at 3 months, 6 months and 12
months were 0.32 (95% CI, 0.12 to 0.86; P=0.01), 0.49
(95% CI, 0.21 to 1.15; P=0.09) and 0.47 (95% CI, 0.23 to
0.97; P=0.03), respectively. Conclusions: In this study, 6-month
oral norfloxacin therapy did not improve overall survival and
did not affect the development of liver-related complications
in patients with Child-Pugh class C cirrhosis. In the subgroup
of patients with alcoholic hepatitis, norfloxacin therapy may
increase 3-month overall survival suggesting early beneficial
effects of the antibiotic in this subgroup of patients.
Disclosures:
Christophe Bureau - Speaking and Teaching: Gore
Jean-Marc Perarnau - Consulting: Gore and Associates
Faouzi Saliba - Advisory Committees or Review Panels: Novartis, Roche, Genzyme,
Vital therapies; Grant/Research Support: Astellas; Speaking and Teaching:
Gambro, MSD, Gilead
Isabelle Ollivier-Hourmand - Speaking and Teaching: gilead, jansen, bayer
Vincent Di Martino - Advisory Committees or Review Panels: Gilead, France,
Abbvie, BMS France; Board Membership: MSD France; Consulting: Gilead,
France; Speaking and Teaching: Janssen, BMS France, Gilead France
Pierre-Emmanuel Rautou - Speaking and Teaching: Gilead
The following authors have nothing to disclose: Richard Moreau, Laure Elkrief,
Thierry Thevenot, Alexandre Louvet, Pierre Nahon, Frédéric Oberti, Rodolphe
Anty, Sophie Hillaire, Blandine Pasquet, Violaine Ozenne, Marika Rudler, Marie
Angele Robic, Louis d’Alteroche, Nathalie Gault, Didier Lebrec
146
Ischemic hepatitis following acute variceal bleed is
ameliorated by N- acetyl cysteine (NAC) in cirrhotics: A
prospective randomized controlled trial
Avinash Kumar, Ankur Jindal, Rakhi Maiwall, Lovkesh Anand, Amrish
Sahney, Shiv K. Sarin; Institute Of Liver and Biliary Sciences,
New Delhi, India
Background & aims. Ischemic hepatitis (IH) following acute
variceal bleed (AVB) in cirrhotics carries ominous prognosis.
Consequent hypotension & hepatic ischemia may result in centrilobular
necrosis . N-acetylcysteine (NAC), a potent anti-oxidant
may prevent cell injury & improve tissue oxygen delivery.
We investigated the efficacy & safety of NAC in the prevention
of IH & survival. Methods: Of 530 consecutive patients
admitted with UGI bleed (Aug 2013-Apr 2015), cirrhotics with
acute variceal bleed (n=214) were randomized in a prospective
open label study (NCT02015403) to receive either standard
of care (SOC; iv fluids, terlipressin, endoscopic variceal
ligation, blood/blood products & antibiotics) plus NAC (150
mg/kg/hr for 1 h followed by 12.5mg/kg/hr for 4 h, followed
by 6.25 mg/kg for 67 hrs) [Group A(GrA), n=107) or
SOC alone [Group B(GrB),n=107]. Patients were monitored
for presence & severity of IH (increase in AST of ≥5 X ULN &
bilirubin ≥1.5 X ULN in