studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 805A
C trough
levels were higher in patients with more advanced liver
fibrosis; they correlated particularly strongly with type 4 collagen
7S, WFA + -M2BP, and FIB-4 levels. ASV C trough
prediction
of hepatic transaminase elevations or VBT was difficult, and
elevated ASV C trough
levels were not observed even in patients
with compromised renal function.
Disclosures:
Itaru Ozeki - Speaking and Teaching: BMS
Disclosures:
Kian Bichoupan - Consulting: Janssen Pharmaceuticals, Gilead Sciences
Alyson Harty - Advisory Committees or Review Panels: Gilead; Consulting: Gilead,
Jannsen, Acaria Pharmacy, Abbvie
Douglas Dieterich - Advisory Committees or Review Panels: Gilead, BMS, Abbvie,
Janssen, Merck, Achillion
Andrea D. Branch - Grant/Research Support: Gilead, Janssen
The following authors have nothing to disclose: Sweta Chekuri, Sanders Chang,
Neal M. Patel, Ponni V. Perumalswami, David P. Del Bello, Rachna Yalamanchili
1203
Clinical Significance of Blood Asunaprevir Concentrations
Levels during Combined Daclatasvir and Asunaprevir
Therapy
Itaru Ozeki; Department of Gastroenterology, Sapporo Kosei General
Hospital, Sapporo, Japan
[Objectives] This study evaluated the clinical significance of
blood asunaprevir (ASV) concentrations levels during combined
daclatasvir+ASV therapy in patients with genotype 1
chronic hepatitis C. [Subjects and Methods] The study included
116 patients (36 males [31.0%]; median age, 73 years) starting
this combination therapy. Liver cirrhosis (LC) was present
in 62 (53.4%) patients. The median estimated glomerular filtration
rate (eGFR) was 65.5 mL/min/1.73 m 2 . ASV C trough
levels
were analyzed by background variables, and then analyzed
according to the presence/absence of hepatic transaminase
elevations, virological breakthrough (VBT), and renal dysfunction.
Liver fibrosis was determined using Fibroscan ® EI values as
well as FIB-4 and Wisteria floribunda agglutinin-positive human
Mac-2-binding protein (WFA + -M2BP) levels. Serum WFA + -
M2BP levels were measured with HISCL ® M2BPGi reagent (Sysmex
Co., Kobe, Japan). ASV C trough
levels were measured using
HPLC in patients receiving blood sampling 8-12 hours after
oral administration of ASV 1 week after starting ASV treatment.
Hepatic transaminase elevations was defined as cases higher
than twice the upper limit of the normal range. Each parameter
was expressed as the median. [Results] 1) Analysis of ASV
C trough
levels by background variables revealed that the levels
did not vary with age, gender, body mass index, or eGFR, but
it was significantly higher in the LC group (119 ng/mL; n=62)
than in the non-LC group (52 ng/mL; n=54) (p=0.001) . 2)
Analysis of the correlation of ASV C trough
levels with factors possibly
associated with liver fibrosis (platelet, albumin, hyaluronic
acid, type 4 collagen 7S, FIB-4, WFA + -M2BP, and FS EI values)
revealed that all were significant (p