studies

1084A AASLD ABSTRACTS HEPATOLOGY, October, 2015
The following authors have nothing to disclose: Jean Harbonnier, Leon Gomberoff,
Sylvie Balteau, Fadi Meroueh, Beatrice Stambul, Rolland Le Hello, Brigitte
Reiller, Xavier Richen, Elisabeth Avril, Jean-Pierre Daulouede, Anne Borgne,
Veronique Latour, Jean-Baptiste Hiriart
1797
Hepatitis C RNA assay differences in results around 6
million IU/mL: Potential clinical implications for shortened
Ledipasvir/Sofosbuvir therapy
Gavin A. Cloherty 1 , Christoph Sarrazin 2 , Vera Holzmayer 3 , Jordan
J. Feld 4 , Benjamin Maasoumy 5 , Johannes Vermehren 2 , Stephane
Chevaliez 6 , Heiner Wedemeyer 5 , Jean-Michel Pawlotsky 6 , George
Dawson 3 ; 1 R&D, Abbott Molecular, Des Plaines, IL; 2 Goeth Universtiy,
Frankfurt, Germany; 3 R&D, Abbott Diagnostics, Abbott Park,
IL; 4 Universtiy of Toronto, Toronto, ON, Canada; 5 Hannover Medical
School, Hannover, Germany; 6 Hopital Henri Mondor, Paris,
France
Background/Aims:FDA approval of Ledipasvir/Sofosbuvir for
the treatment of hepatitis C (HCV) includes the truncation of
therapy from 12 to 8 weeks in treatment naïve, non-cirrhotic
patients with HCV RNA levels 6 million and ART 3 on liver biopsy
or APRI >1.5), ELSD (presence of ascites, esophageal varices,
hepatic encephalopathy, or coagulopathy), HCC, and LRD
(including liver transplantation) by using a Cox proportional
hazards model. The model for advanced fibrosis and ESLD was
adjusted for HCV genotype (1, 2, and 3), age at cohort entry,
heavy alcohol use (average >50grams/day), obesity (body
mass index [BMI] >30), and type II diabetes (DM2). The model
for HCC risk was adjusted for HCV genotype, age at cohort
entry, and sex. The model for LRD risk was adjusted for HCV
genotype, age at cohort entry, and heavy alcohol use. Of the
1068 participants, 66%, 19%, and 14% were infected with
HCV genotype 1, 2, and 3, respectively. Compared with genotype
1, genotype 3 was significantly associated with advanced
fibrosis, ESLD, HCC and LRD (Table). Other age-adjusted significant
risk factors for developing advanced fibrosis were heavy
alcohol use (aHR: 2.0; CI: 1.5–2.7), obesity (aHR: 1.3; CI:
1.0–1.7; p = 0.04), and DM2 (aHR: 1.6; CI: 1.1–2.2). Significant
risk factors for developing ESLD were heavy alcohol use
(aHR: 2.2; CI: 1.6–3.2), obesity (aHR: 1.4; CI: 1.0–1.9; p =
0.03), and DM2 (aHR: 1.5; CI: 1.0–2.3; p = 0.03). Another
significant risk factor for developing HCC was male sex (aHR:
3.6; CI: 1.6–8.2) and for developing LRD was heavy alcohol
use (aHR: 2.9; CI: 1.8–4.6). At 15 years of follow-up, twothirds
(68%) with genotype 3 were predicted to have developed
advanced fibrosis and half (48%) ESLD. Conclusions: