studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 339A
with and without cirrhosis. There were no discontinuations due
to adverse events and a lower incidence of fatigue, insomnia
and irritability in patients treated with SOF/GS-5816 for
12 weeks compared to patients treated with SOF+RBV for 24
weeks.
Nezam H. Afdhal - Advisory Committees or Review Panels: Trio Helath Care;
Board Membership: Journal Viral hepatitis; Consulting: Merck, EchoSens, BMS,
Achillion, GlaxoSmithKline, Springbank, Gilead, AbbVie; Grant/Research Support:
Gilead; Stock Shareholder: Springbank
Graham R. Foster - Advisory Committees or Review Panels: GlaxoSmithKline,
Novartis, Boehringer Ingelheim, Tibotec, Chughai, Gilead, Janssen, Idenix,
GlaxoSmithKline, Novartis, Roche, Tibotec, Chughai, Gilead, Merck, Janssen,
Idenix, BMS; Board Membership: Boehringer Ingelheim; Grant/Research Support:
Chughai, Roche, Chughai; Speaking and Teaching: Roche, Gilead, Tibotec,
Merck, BMS, Boehringer Ingelheim, Gilead, Janssen
The following authors have nothing to disclose: Francesco Mazzotta, Lingling
Han
Disclosures:
Alessandra Mangia - Advisory Committees or Review Panels: ROCHE, Janssen,
MSD, ROCHE, Janssen, MSD, Boheringer ; Consulting: Gilead; Grant/Research
Support: Shering-Plough, Shering-Plough
Stuart K. Roberts - Board Membership: AbbVie, Gilead
Stephen Pianko - Advisory Committees or Review Panels: Roche, Novartis, GIL-
EAD, Roche, Novartis; Consulting: GILEAD; Speaking and Teaching: JANSSEN
Alex J. Thompson - Advisory Committees or Review Panels: Gilead, Abbvie,
BMS, Merck, Spring Bank Pharmaceuticals, Arrowhead, Roche; Grant/Research
Support: Gilead, Abbvie, BMS, Merck; Speaking and Teaching: Roche, Gilead,
Abbvie, BMS
Curtis Cooper - Advisory Committees or Review Panels: Gilead, Abbvie, MERCK;
Grant/Research Support: MERCK, Gilead, Abbvie; Speaking and Teaching:
MERCK, Abbvie, Gilead
Brian Conway - Advisory Committees or Review Panels: Vertex Pharmaceuticals,
Merck, Boehringer Ingelheim, Jannsen Pharmaceuticals; Grant/Research Support:
Vertex Pharmaceuticals, Merck, Boehringer Ingelheim, Jannsen Pharmaceuticals,
AbbVie, Gilead Sciences, Gilead Sciences
Marc Bourlière - Advisory Committees or Review Panels: Schering-Plough,
Bohringer inghelmein, Schering-Plough, Bohringer inghelmein, Transgene; Board
Membership: Bristol-Myers Squibb, Gilead, Idenix; Consulting: Roche, Novartis,
Tibotec, Abott, glaxo smith kline, Merck, Bristol-Myers Squibb, Novartis, Tibotec,
Abott, glaxo smith kline; Speaking and Teaching: Gilead, Roche, Merck, Bristol-Myers
Squibb
Tarik Asselah - Advisory Committees or Review Panels: AbbVie, Merck, Gilead,
BMS, Roche, Janssen
Thomas Berg - Advisory Committees or Review Panels: Gilead, BMS, Roche,
Tibotec, Vertex, Jannsen, Novartis, Abbott, Merck, Abbvie; Consulting: Gilead,
BMS, Roche, Tibotec; Vertex, Janssen; Grant/Research Support: Gilead, BMS,
Roche, Tibotec; Vertex, Jannssen, Merck/MSD, Boehringer Ingelheim, Novartis,
Abbvie; Speaking and Teaching: Gilead, BMS, Roche, Tibotec; Vertex, Janssen,
Merck/MSD, Novartis, Merck, Bayer, Abbvie
Stefan Zeuzem - Consulting: Abbvie, Bristol-Myers Squibb Co., Gilead, Merck
& Co., Janssen
William M. Rosenberg - Advisory Committees or Review Panels: Janssen, Merk,
Gilead, Merk, Gilead, GSK; Board Membership: iQur Limited, iQur Limited;
Consulting: siemens; Speaking and Teaching: siemens, Roche
Kosh Agarwal - Advisory Committees or Review Panels: Gilead, BMS, Novartis,
Janssen, AbbVie, Gilead; Consulting: MSD, Janssen; Grant/Research Support:
Roche, Gilead, BMS, BMS; Speaking and Teaching: Astellas
Edward J. Gane - Advisory Committees or Review Panels: Novira, AbbVie, Janssen,
Gilead Sciences, Janssen Cilag, Achillion, Merck, Tekmira; Speaking and
Teaching: AbbVie, Gilead Sciences, Merck
Catherine A. Stedman - Advisory Committees or Review Panels: MSD, Abbvie;
Speaking and Teaching: Gilead, Abbvie
Tram T. Tran - Advisory Committees or Review Panels: Gilead, Bristol Myers
Squibb; Consulting: Gilead, AbbVie, Janssen; Grant/Research Support: Bristol
Myers Squibb; Speaking and Teaching: Gilead
Stuart C. Gordon - Advisory Committees or Review Panels: Janssen; Consulting:
Merck, Gilead, BMS, CVS Caremark, Amgen, AbbVie; Grant/Research Support:
Merck, Gilead, AbbVie, Intercept Pharmaceuticals, Exalenz Sciences, Inc., BMS
Evguenia S. Svarovskaia - Employment: Gilead Sciences Inc; Stock Shareholder:
Gilead Sciences Inc
John McNally - Employment: Gilead Sciences, Inc; Stock Shareholder: Gilead
Sciences, Inc
Anu Osinusi - Employment: gilead sciences
Diana M. Brainard - Employment: Gilead Sciences; Stock Shareholder: Gilead
Sciences
John G. McHutchison - Employment: Gilead Sciences; Stock Shareholder: Gilead
Sciences
250
High SVR4 Rates Achieved With the Next Generation
NS3/4A Protease Inhibitor ABT-493 and NS5A Inhibitor
ABT-530 in Non-Cirrhotic Treatment-Naïve and Treatment-Experienced
Patients With HCV Genotype 2 Infection
(SURVEYOR-2)
David L. Wyles 2 , Mark S. Sulkowski 3 , Stanley Wang 1 , Michael
Bennett 4 , Hugo E. Vargas 5 , J. Scott Overcash 6 , Benedict Maliakkal
7 , Asma Siddique 8 , Bal R. Bhandari 9 , Fred Poordad 10 , Sandra
S. Lovell 1 , Chih-Wei Lin 1 , Teresa Ng 1 , Federico J. Mensa 1 , Jens
Kort 1 ; 1 AbbVie, Inc., North Chicago, IL; 2 University of California
San Diego, La Jolla, CA; 3 Johns Hopkins University School of Medicine,
Baltimore, MD; 4 San Diego Digestive Disease Consultants,
Inc., and Medical Associates Research Group, Inc., San Diego,
CA; 5 Mayo Clinic, Pheonix, AZ; 6 eStudySite, San Diego, CA;
7 University of Rochester Medical Center, Rochester, NY; 8 Virginia
Mason Hospital and Medical Center, Seattle, WA; 9 Gastroenterology
& Nutritional Medical Services, Bastrop, LA; 10 Texas Liver Institute,
University of Texas Health Science Center, San Antonio, TX
Background: The next-generation HCV direct acting antivirals
(DAAs) ABT-493, an NS3/4A protease inhibitor identified by
AbbVie and Enanta, and ABT-530, an NS5A inhibitor, are
characterized by potent pan-genotypic in vitro antiviral activity
and a high barrier to resistance selection with retention of
activity against key resistance-associated variants. ABT-493
and ABT-530 each provided a mean 4 log 10
IU/mL decline
from baseline in HCV plasma viral load after 3 day monotherapy
in genotype (GT) 1-infected subjects and have comparable
in vitro antiviral potency against GT2. Purpose: To
evaluate the efficacy and safety of ABT-493 and ABT-530
with or without ribavirin (RBV) in non-cirrhotic GT2-infected
treatment-naïve (TN) and pegylated interferon/RBV (pegIFN/
RBV) treatment experienced (TE) subjects Methods: Subjects
received 12 weeks of ABT-493 300 mg+ABT-530 120 mg
(Arm A), ABT-493 200 mg+ABT-530 120 mg (Arm B), or ABT-
493 200 mg+ABT-530 120 mg+RBV (Arm C). DAAs were
dosed once daily; weight-based RBV (1000 or 1200 mg) was
dosed twice daily. Subjects were then followed for 24 weeks.
The primary efficacy endpoint is sustained virologic response
12 weeks after the last dose of study drug (SVR12); we present
post-treatment week 4 data (SVR4) here. Safety was evaluated
by monitoring adverse events (AEs), laboratory tests,
and vital signs. Demographics and safety are presented on
all randomized subjects. Efficacy is presented on all subjects
confirmed to have GT2 infection. Results: 75 subjects were
treated in Arms A–C (n=25 each); 74 had GT2, and 1 subject
initially randomized to Arm B was determined to have GT3a
infection. Subjects were male, 63%; median (range) age, 57.0
(20.0–69.0) years; GT2b, 81%; TN, 88%; TE, 12%; F0–F2,
87%; F3, 13%; median (range) baseline HCV RNA log 10
IU/
mL, 7.1 (4.7–7.8). No subjects have experienced virologic
failure. One subject in Arm A prematurely discontinued study
drugs and is lost to follow-up. The SVR4 rates (ITT analysis) are
96% (24/25), 100% (24/24), and 100% (25/25) in Arms