studies

226A AASLD ABSTRACTS HEPATOLOGY, October, 2015
†All liver transplant patients had cirrhosis, ‡Includes 3 liver transplant
patients
Disclosures:
Tania M. Welzel - Advisory Committees or Review Panels: Novartis, Janssen,
Gilead, Abbvie, Boehringer-Ingelheim+, BMS
Joerg Petersen - Advisory Committees or Review Panels: Bristol-Myers Squibb,
Gilead, Novartis, Merck, Bristol-Myers Squibb, Gilead, Novartis, Merck; Grant/
Research Support: Roche, GlaxoSmithKline, Roche, GlaxoSmithKline; Speaking
and Teaching: Abbott, Tibotec, Merck, Abbott, Tibotec, Merck
Peter Ferenci - Advisory Committees or Review Panels: Idenix, Gilead, MSD,
Janssen, Salix, AbbVie, BMS; Patent Held/Filed: Madaus Rottapharm; Speaking
and Teaching: Gilead, Roche
Michael Gschwantler - Advisory Committees or Review Panels: Janssen, BMS,
Gilead, AbbVie; Speaking and Teaching: Janssen, BMS, Gilead, AbbVie
Markus Cornberg - Advisory Committees or Review Panels: Merck (MSD Germamny),
Roche, Gilead, Novartis, Abbvie, Janssen Cilag, BMS; Grant/Research
Support: Merck (MSD Germamny), Roche; Speaking and Teaching: Merck (MSD
Germamny), Roche, Gilead, BMS, Novartis, Falk, Abbvie
Eckart Schott - Advisory Committees or Review Panels: Gilead, Roche, Bayer,
BMS, Abbvie; Speaking and Teaching: Gilead, Novartis, Roche, MSD, Bayer,
Falk, BMS, Janssen, Abbvie
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
Ola Weiland - Advisory Committees or Review Panels: Merk, BMS, Medivir, Gilead,
AbbVie; Grant/Research Support; Speaking and Teaching: Merk, Roche,
BMS, Novartis, Janssen, Medivir, Gilead, AbbVie
Marc van der Valk - Advisory Committees or Review Panels: gilead, msd, bms,
abbvie, janssen cilag, viiV, roche
Andreas Geier - Advisory Committees or Review Panels: AbbVie, Janssen; Speaking
and Teaching: BMS, Gilead, Sequana, Falk, Novartis
Jürgen K. Rockstroh - Advisory Committees or Review Panels: Abbvie, BI, BMS,
Merck, Roche, Tibotec, Abbvie, Bionor, Tobira, ViiV, Gilead, Janssen; Consulting:
Novartis; Grant/Research Support: Merck; Speaking and Teaching: Abbott,
BI, BMS, Merck, Roche, Tibotec, Gilead, Janssen, ViiV
Markus Peck-Radosavljevic - Advisory Committees or Review Panels: Bayer, Gilead,
Janssen, BMS, AbbVie; Consulting: Bayer, Boehringer-Ingelheim, Jennerex,
Eli Lilly, AbbVie; Grant/Research Support: Bayer, Roche, Gilead, MSD, AbbVie;
Speaking and Teaching: Bayer, Roche, Gilead, MSD, Eli Lilly, AbbVie, Bayer
Maria Jesus Jimenez Exposito - Employment: Bristol-Myers Squibb
Stefan Zeuzem - Consulting: Abbvie, Bristol-Myers Squibb Co., Gilead, Merck
& Co., Janssen
The following authors have nothing to disclose: Kerstin Herzer, Ulrich Spengler,
Yue Zhao
38
Sofosbuvir/GS-5816+GS-9857 for 6 or 8 Weeks in
Genotype 1 or 3 HCV-infected Patients
Edward J. Gane 1 , Robert H. Hyland 2 , Yin Yang 2 , Luisa M. Stamm 2 ,
Diana M. Brainard 2 , John G. McHutchison 2 , Catherine A. Stedman
3 ; 1 Auckland Clinical Studies, Auckland, New Zealand; 2 Gilead
Sciences, Inc, Foster City, CA; 3 Christchurch Clinical Studies
Trust, Christchurch, New Zealand
Background: Sofosbuvir (SOF), GS-5816, and GS-9857 target
3 distinct viral proteins, NS5B, NS5A, and NS3, respectively.
The combination of these pangenotypic agents has the potential
to improve efficacy and may reduce treatment duration
across different patient populations. We previously reported
safety and efficacy of SOF/GS-5816 + GS-9857 administered
for 4 or 6 weeks in patients with HCV genotype 1 (GT1) infection,
including treatment-naïve (TN) GT1 patients without cirrhosis;
TN GT1 patients with cirrhosis; and GT1 patients who had
failed a regimen containing at least 2 direct antiviral agents.
We now evaluate the safety and efficacy of this regimen
administered for 6 or 8 weeks in more difficult-to-treat populations,
including treatment experienced (TE) GT 1 patients with
cirrhosis who had failed PEG/RBV; TE GT 1 patients who had
failed protease inhibitor (PI) + PEG/RBV; TN GT 3 patients with
cirrhosis; and TE GT 3 patients with cirrhosis who had failed
PEG/RBV. Methods: All patients received once daily SOF/
GS-5816 400mg/100mg in a fixed dose combination, plus
GS-9857 100mg. Treatment duration of each group differed
according to the patient’s baseline characteristics: 8 weeks
for TE GT 1 patients who had failed prior PEG/RBV, 8 weeks
for TE GT 1 patients who had failed PI + PEG/RBV, 6 weeks
for TN GT 3 patients and 8 weeks for TE GT 3 patients. The
primary efficacy endpoint was SVR12, defined as HCV RNA