TY - JOUR AU - Liu L. AU - Woodward Mark AU - Chang C. AU - Patel N. AU - Perumalswami P. AU - Bichoupan K. AU - Ku L. AU - Yalamanchili R. AU - Harty A. AU - Motamed D. AU - Khaitova V. AU - Grewal P. AU - Schiano T. AU - Dieterich D. AU - Branch A. AB -

To conduct surveillance and determine the safety profile of new hepatitis C virus treatments in real-world clinical practice. Hepatic decompensation and other serious adverse events were investigated in an observational cohort study of 511 patients treated with regimens containing sofosbuvir, December 2013-June 2014. Among 499 previously stable patients (no history of hepatic decompensation during the previous 12 months), a nested case-control study was performed to identify predictors of decompensation/serious adverse event. Cases and controls were matched 1:5 based on treatment regimen and duration. Matched conditional logistic regression was used for analysis. Providers scored the likelihood that events were treatment-related (scale = 0-4). The cumulative incidence of decompensation/events was 6.4% for the total cohort. Among 499 previously stable patients, the incidence of decompensation/events was 4.5%; the mortality rate was 0.6%. Sixteen of the 499 experienced one or more serious complications considered to be at least potentially treatment-related, and the sustained virological response rate was 7/16 (44%). Two cases, both on sofosbuvir/simeprevir (without interferon or ribavirin), had complications consistent with autoimmune events (score 3, 'likely treatment-related'), and one experienced a flare of autoimmune hepatitis. Compared to controls, cases had higher baseline median model for end-stage liver disease scores (14 vs 8, P < 0.01). Decompensation/events was independently associated with lower baseline albumin (OR = 0.12/g/dL, P = 0.01) and higher total bilirubin (OR = 4.31/mg/dL, P = 0.01). Reduced hepatic function at baseline increased the risk of liver decompensation/events.

AD - Division of Liver Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Recanati Miller Transplant Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Nuffield Department of Population Health, The George Institute for Global Health, University of Oxford, Oxford, UK.
The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia. AN - 26989855 BT - Journal of Viral Hepatitis DP - NLM ET - 2016/03/19 LA - Eng LB - AUS
UK
PROF
FY16 N1 - Perumalswami, P V
Patel, N
Bichoupan, K
Ku, L
Yalamanchili, R
Harty, A
Motamed, D
Khaitova, V
Chang, C
Grewal, P
Liu, L
Schiano, T D
Woodward, M
Dieterich, D T
Branch, A D
J Viral Hepat. 2016 Mar 17. doi: 10.1111/jvh.12530. N2 -

To conduct surveillance and determine the safety profile of new hepatitis C virus treatments in real-world clinical practice. Hepatic decompensation and other serious adverse events were investigated in an observational cohort study of 511 patients treated with regimens containing sofosbuvir, December 2013-June 2014. Among 499 previously stable patients (no history of hepatic decompensation during the previous 12 months), a nested case-control study was performed to identify predictors of decompensation/serious adverse event. Cases and controls were matched 1:5 based on treatment regimen and duration. Matched conditional logistic regression was used for analysis. Providers scored the likelihood that events were treatment-related (scale = 0-4). The cumulative incidence of decompensation/events was 6.4% for the total cohort. Among 499 previously stable patients, the incidence of decompensation/events was 4.5%; the mortality rate was 0.6%. Sixteen of the 499 experienced one or more serious complications considered to be at least potentially treatment-related, and the sustained virological response rate was 7/16 (44%). Two cases, both on sofosbuvir/simeprevir (without interferon or ribavirin), had complications consistent with autoimmune events (score 3, 'likely treatment-related'), and one experienced a flare of autoimmune hepatitis. Compared to controls, cases had higher baseline median model for end-stage liver disease scores (14 vs 8, P < 0.01). Decompensation/events was independently associated with lower baseline albumin (OR = 0.12/g/dL, P = 0.01) and higher total bilirubin (OR = 4.31/mg/dL, P = 0.01). Reduced hepatic function at baseline increased the risk of liver decompensation/events.

PY - 2016 SN - 1365-2893 (Electronic)
1352-0504 (Linking) T2 - Journal of Viral Hepatitis TI - High baseline bilirubin and low albumin predict liver decompensation and serious adverse events in HCV-infected patients treated with sofosbuvir-containing regimens Y2 - FY16 ER -