studies

1130A AASLD ABSTRACTS HEPATOLOGY, October, 2015
Table 1.
CI: 95% confidence intervals; AUC: Area under Receiver Operating
Curve; LR-likelihood ratio
Disclosures:
Keyur Patel - Advisory Committees or Review Panels: Merck; Consulting: Gilead
Sciences, Santaris, Akros, Nitto Denko; Grant/Research Support: Bristol Myers
Squibb
The following authors have nothing to disclose: Bassem Matta, Julius M. Wilder,
Tzu-Hao Lee
1888
The use of hepatitis C core antigen assay in the monitoring
of treatment with direct antiviral agents in patients
with chronic hepatitis C
Elisabetta Loggi 1 , Carmela Cursaro 1 , Alessandra Scuteri 1 , Ranka
Vukotic 1 , Martina Pirillo 1 , Marzia Margotti 1 , Valeria Guarneri 1 ,
Silvia Galli 2 , Giuliano Furlini 2 , Claudio Galli 3 , Maria Paola Landini
2 , Pietro Andreone 1 ; 1 Medical and Surgical Sciences, University
of Bologna, Bologna, Italy; 2 OU Microbiology and Virology,
Azienda Ospedaliera di Bologna, Bologna, Italy; 3 Scientific
Affairs, Abbott Diagnostics, Rome, Italy
Background and Aim: Treatment of chronic hepatitis C (CHC)
with direct antiviral antigens (DAAs) achieve high rates of sustained
virological response (SVR), accompanied by few side
effects, short duration, and a simplified route of administration.
The implementation of these therapies have to face the problems
of high costs and their management, that includes the efficacy
monitoring. While HCV-RNA measured by sensitive molecular
amplification techniques represents the gold standard, hepatitis
C core antigen (HCV-Ag) is emerging as an interesting new
tool in diagnosis and treatment monitoring for CHC. However,
its role in DAAs therapies has not been still evaluated. The aim
of our ongoing study is to evaluate the accuracy of HCV-Ag
measurement in CHC patients treated with different schedules
of DAAs. Methods: To date, 27 patients (21 male, median
age 55, range 25-78) have started interferon-free (IFN-f) DAAs
treatment for 12 or 24 weeks, and 11 completed the therapy
course. Sero-virological testing was carried out at baseline,
after 1-2 weeks and every 4 weeks thereafter. HCV-RNA was
quantified by real time PCR (Amplicor, Roche; limit of detection
15 IU/mL); HCV-Ag was assessed by an automated chemiluminescent
two-step immunoassay (Abbott HCV core antigen
assay; limit of detection 3 fmol/L). Results: HCV-RNA and
HCV-Ag were highly correlated, considering both only baseline
values (Spearman r =0.93, p