studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 717A
pts with stage 4 or 5 CKD in this ongoing trial, 3D+/-RBV has
been well tolerated, with no premature treatment discontinuations.
Hemoglobin decreases were managed with RBV interruption,
which does not appear to affect efficacy. There have been
no virologic failures to date.
Cohort 1: Baseline characteristics.
Disclosures:
Paul J. Pockros - Advisory Committees or Review Panels: Janssen, Merck, BMS,
Gilead, AbbVie; Consulting: Lumena, Beckman Coulter; Grant/Research Support:
Intercept, Janssen, BMS, Gilead, Lumena, Beckman Coulter, AbbVie, RMS,
Merck; Speaking and Teaching: AbbVie, Janssen, Gilead
K. Rajender Reddy - Advisory Committees or Review Panels: Merck, Janssen,
Vertex, Gilead, BMS, Abbvie; Grant/Research Support: Merck, BMS, Ikaria,
Gilead, Janssen, AbbVie
Parvez S. Mantry - Consulting: Salix, Gilead, Janssen, Abbvie, BMS; Grant/
Research Support: Salix, Merck, Gilead, Boehringer-Ingelheim, Mass Biologics,
Vital Therapies, Santaris, mass biologics, Bristol-Myers Squibb, Abbive, Bayer-Onyx,
Shinogi, Tacere, Intercept; Speaking and Teaching: Gilead, Janssen,
Salix
Mark S. Sulkowski - Advisory Committees or Review Panels: Merck, AbbVie,
Janssen, Gilead, BMS; Grant/Research Support: Merck, AbbVie, Janssen, Gilead,
BMS
David Bernstein - Advisory Committees or Review Panels: Gilead; Consulting:
Abbvie, BMS, Merck, Janssen; Grant/Research Support: Gilead, Abbvie, BMS,
Merck, Janssen, Genentech; Speaking and Teaching: Abbvie, BMS, Merck,
Gilead
Thomas Podsadecki - Employment: AbbVie; Stock Shareholder: AbbVie
Daniel E. Cohen - Employment: AbbVie; Stock Shareholder: AbbVie
Nancy Shulman - Employment: Abbvie
Deli Wang - Employment: AbbVie Inc
Amit Khatri - Employment: AbbVie, Inc; Patent Held/Filed: AbbVie, Inc; Stock
Shareholder: AbbVie, Inc
Manal Abunimeh - Employment: AbbVie
Eric Lawitz - Advisory Committees or Review Panels: AbbVie, Achillion Pharmaceuticals,
Regulus, Theravance, Enanta, Idenix Pharmaceuticals, Janssen, Merck
& Co, Novartis, Gilead; Grant/Research Support: AbbVie, Achillion Pharmaceuticals,
Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmith-
Kline, Idenix Pharmaceuticals, Intercept Pharmaceuticals, Janssen, Merck & Co,
Novartis, Nitto Denko, Theravance, Salix, Enanta; Speaking and Teaching: Gilead,
Janssen, AbbVie, Bristol Meyers Squibb
The following authors have nothing to disclose: Eric Cohen, Michael Bennett
1040
Impact of baseline albumin levels in a Phase 3 study
(OPTIMIST-2) of 12 weeks of simeprevir (SMV) plus
sofosbuvir (SOF) in treatment-naïve or -experienced
patients with chronic HCV genotype 1 infection and cirrhosis
Eric Lawitz 1 , Eric M. Yoshida 2 , Reem H. Ghalib 3 , Marcelo Kugelmas
4 , Ronald Kalmeijer 5 , Katrien Janssen 6 , Oliver Lenz 6 , Bart
Fevery 6 , Guy De La Rosa 7 , Rekha Sinha 5 , James Witek 5 ; 1 Texas
Liver Institute, University of Texas Health Science Center, San Antonio,
TX; 2 University of British Columbia, Vancouver, BC, Canada;
3 Texas Clinical Research Institute, Arlington, TX; 4 South Denver
Gastroenterology, PC, Denver, CO; 5 Janssen Research & Development,
LLC, Titusville, NJ; 6 Janssen Infectious Diseases BVBA,
Beerse, Belgium; 7 Janssen Global Services, LLC, Titusville, NJ
Purpose: In the Phase 3 OPTIMIST-2 (NCT02114151) study
in HCV GT1-infected pts with cirrhosis, SMV+SOF for 12wks
achieved superiority in sustained virologic response 12wks
after end of treatment (SVR12) vs a historical control. This analysis
evaluated SVR12 by baseline (BL) albumin. Methods: Pts
with documented cirrhosis received 12wks of SMV 150mg
QD+SOF 400mg QD. Primary endpoint: SVR12. Univariate
logistic regression established the relationship between BL albumin
and SVR12. SVR12 rates were evaluated post hoc by
BL albumin and presence of other factors: BL Q80K polymorphism;
IL28B genotype; BMI; platelet count; prior treatment;
sex. Results are presented for the non-VR excluded population.
Results: 100pts were treated (male 81%; median age 58yrs;
Black/African American 18%; IL28B non-CC 72%; GT1a 69%
[of these: +/- Q80K 46/54%]; treatment-naïve 49%; BL albumin,
median 39 [range 29–47] g/L). Overall SVR12 was 85%.
A strong univariate relationship was observed between BL albumin
and SVR12 (AUC ROC 0.79). Analysis of the correlation
of BL albumin and SVR12 rates identified a level of 40g/L as
an optimal cut-off. 51% and 49% pts had BL albumin