studies

714A AASLD ABSTRACTS HEPATOLOGY, October, 2015
1034
Approved All-oral Sofosbuvir Regimens are Safe and
Highly Effective in Patients with Hereditary Bleeding
Disorders
Christopher Walsh 1 , Kimberly Workowski 2 , Norah Terrault 3 , Paul
Sax 4 , Alice Cohen 5 , Christopher L. Bowlus 6 , Arthur Y. Kim 7 , Robert
H. Hyland 8 , Jing Wang 8 , Luisa M. Stamm 8 , Diana M. Brainard 8 ,
John G. McHutchison 8 , Annette Von Drygalski 9 , Frank S. Rhame 10 ,
Michael W. Fried 11 , Peter Kouides 12 , Gayle Balba 13 , K. Rajender
Reddy 14 ; 1 Mount Sinai Hospital, New York, NY; 2 Emory University,
Atlanta, GA; 3 University of California, San Francisco, San
Francisco, CA; 4 Brigham and Women’s Hospital, Boston, MA;
5 Newark Beth Israel Center - Barnabas Health, Newark, NJ; 6 University
of California, Davis, Sacremento, CA; 7 Massachusetts General
Hospital, Boston, MA; 8 Gilead Sciences, Inc, Foster City, CA;
9 University of California, San Diego, San Diego, CA; 10 Abbott
NW Infectious Disease Clinic, Minneapolis, MN; 11 University of
North Carolina at Chapel Hill, Chapel Hill, NC; 12 The Mary M
Gooley Hemophilia Center, Rochester, NY; 13 Georgetown University
Hospital, Washington, DC; 14 University of Pennsylvania,
Philadelphia, PA
Background: Patients with bleeding disorders have high rates
of Hepatitis C Virus (HCV) infection due to exposure to contaminated
blood products prior to 1992. They have historically
been excluded from HCV clinical trials due to concern for
unique adverse events, comorbidities, and/or their underlying
diagnosis. This study evaluated the safety and efficacy of ledipasvir/sofosbuvir
(LDV/SOF, genotype [GT] 1 and 4 infection)
and SOF+RBV (GT 2 and 3 infection) in patients with bleeding
disorders with or without HIV coinfection. Methods: GT1 or
4 HCV-infected patients received LDV/SOF (90mg/400mg)
fixed dose combination daily for 12 weeks; treatment was
extended to 24 weeks for those who were treatment experienced
with cirrhosis following FDA approval of LDV/SOF.
GT 2 or 3 HCV-infected patients received SOF 400 mg daily
+RBV (1000 or 1200 mg/day divided BID) for 12 weeks or
24 weeks, respectively. Results: 120 patients were enrolled at
13 sites in the USA. The majority were male (94%), Caucasian
(76%), and IL28B non-CC genotype (69%). 103 patients were
infected with GT1 HCV infection, 10 with GT2, 6 with GT3,
and 1 with GT4. The most common bleeding disorders were
Hemophilia A (65%) and Hemophilia B (26%). Patients with
Type 1 or 3 Von Willebrand’s Disease (3% each), Type 2 Von
Willebrand’s Disease (2%), and Factor XI deficiency (