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766A AASLD ABSTRACTS HEPATOLOGY, October, 2015 Table 1. Mean changes in clinical parameters through Week 12 on treatment Disclosures: Paul Martin - Advisory Committees or Review Panels: BMS; Grant/Research Support: Merck, Gilead, Janssen, Abbvie 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 Lin Liu - Employment: Gilead Sciences, Inc. Karim Sajwani - Employment: Gilead Sciences, Inc. Brian Kirby - Employment: Gilead Sciences Jill M. Denning - Employment: Gilead Sciences, Inc. Luisa M. Stamm - Employment: Gilead Sciences Diana M. Brainard - Employment: Gilead Sciences; Stock Shareholder: Gilead Sciences John G. McHutchison - Employment: Gilead Sciences; Stock Shareholder: Gilead Sciences 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 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 The following authors have nothing to disclose: Grisell Ortiz-Lasanta, Richard A. Robson 1129 A Meta-Analysis of the Association Between Pre-Treatment Variables and SVR Amongst Genotype 1 Patients Treated with ABT-450/r–Ombitasvir and Dasabuvir (VIEKIRA PAK) plus Ribavirin for 12 Weeks Gregory J. Botwin 2 , Timothy R. Morgan 1,3 ; 1 Gastroenterology (11), VA Long Beach Healthcare System, Long Beach, CA; 2 Research Service, VA Long Beach Healthcare System, Long Beach, CA; 3 Division of Gastroenterology, University of California - Irvine, Irvine, CA Background: VIEKIRA PAK plus Ribavirin (RBV) is a potent, all oral, treatment regimen indicated for the treatment of chronic hepatitis C (HCV) genotype (GT)-1. Due to the overall high rates of sustained virologic response (SVR) achieved in Phase II and Phase III clinical trials, little is known about the association between pre-treatment variables and SVR. Purpose: To perform a meta-analysis to examine the association between pre-treatment variables and SVR in GT-1 patients. Methods: We reviewed all registration trials for VIEKIRA PAK. Trials that treated GT-1a, or GT-1a and GT-1b, monoinfected, non-cirrhotic, HCV patients for 12 weeks with VIEKIRA PAK plus RBV were included in our initial analysis. Trials that enrolled exclusively GT-1b patients were excluded due to the overall high SVR rates. Relative risk (RR) was calculated for the following pre-treatment variables: age, body-mass index (BMI), ethnicity, IL28B, race, sex, and viral load (VL). A binary random effects model was used in the meta-analysis. Results: Three studies (SAPPHIRE-I and II, and PEARL-IV) and 870 patients met the criteria. Of the evaluated patients 595 were genotype 1a, and 297 were treatment experienced. Compared with patients with a BMI < 30, a BMI ≥ 30 was associated with a reduced RR of SVR, 0.948 (95% confidence-interval [CI], 0.903-0.995, p=0.029). The overall SVR in each group was 92% (139/151; BMI ≥ 30) and 97% (699/719; BMI < 30). Patients with a VL ≥ 800,000IU/mL (SVR 96%, 686/716) also had a reduced RR of SVR, 0.973 (CI 0.948-0.999, p=0.041) compared to patients with a VL below this level (SVR 99%, 152/154). Neither age < 55 years, Hispanic ethnicity, IL28B CC genotype, African American race, nor male sex were found to be significantly positively or negatively associated with SVR. When 380 GT-1 cirrhotic patients, treated for 12 or 24 weeks (TUR- QUOISE-II) were included in the analysis, only BMI remained significantly associated with SVR (RR 0.956, CI 0.921-0.993, p=0.021). Conclusion: Genotype 1 non-cirrhotic patients with an elevated BMI or VL are associated with a reduced chance of achieving SVR when treated with VIEKIRA PAK plus RBV for 12 weeks. Research evaluating the mechanism for these differences may be warranted. Pre-Treatment Variables Association with SVR Disclosures: Timothy R. Morgan - Grant/Research Support: Merck, Abbvie, Genentech, Gilead, Bristol Myers Squibb The following authors have nothing to disclose: Gregory J. Botwin 1130 On-treatment HCV RNA Decline in Pre-and Post-Liver Transplant Patients with Different Degrees of Fibrosis and Cirrhosis: a combined analysis of the SOLAR trials Tania M. Welzel 1 , K. Rajender Reddy 2 , Michael P. Manns 3 , Steven L. Flamm 4 , David J. Mutimer 5 , Edward J. Gane 6 , Robert H. Hyland 7 , Ming Lin 7 , Phillip S. Pang 7 , John G. McHutchison 7 , Didier Samuel 8 , Michael R. Charlton 9 , Xavier Forns 10 , Gregory T. Everson 11 , Stefan Zeuzem 1 , Nezam H. Afdhal 12 ; 1 Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany; 2 University of Pennsylvania School of Medicine, Philadelphia, PA; 3 Hannover Medical School, Hannover, Germany; 4 Northwestern University Feinberg School of Medicine, Chicago, IL; 5 Queen Elizabeth Hospital and University of Birmingham, Birmingham, United Kingdom; 6 University of Auckland, Auckland, New Zealand; 7 Gilead Sciences, Inc, Foster City, CA; 8 Université Paris-Sud, Villejuif, France; 9 Intermountain Medical Center, Murray, UT; 10 Liver Unit, IDIBAPS and CIBEREHD, Barcelona, Spain; 11 University of Colorado Denver, Aurora, CO; 12 Beth Israel Deaconess Medical Center, Boston, MA Background and Aims: In the SOLAR-1 and SOLAR-2 studies, ledipasvir/sofosbuvir (LDV/SOF)+ribavirin (RBV) for 12 or 24 weeks resulted in high SVR rates in genotype 1 or 4 HCV-infected patients with decompensated cirrhosis or who were liver transplant recipients. In this large combined post hoc analysis of on-treatment HCV RNA levels in SOLAR-1 and SOLAR-2 study participants we investigate whether on-treatment response varied by patient population and/or was predictive of treatment outcome. Methods: Data from the identically designed SOLAR1 (NCT01938430) and SOLAR 2 (NCT02010255) studies were combined. Six groups of genotype 1 or 4 HCV-infected patients were randomized to receive 12 or 24 weeks of LDV/SOF+RBV treatment: patients without transplant and either 1) Child-Pugh- Turcotte (CPT) B cirrhosis, or 2) CPT C cirrhosis; or patients who have undergone transplantation and who were either 3) without cirrhosis (F0 to F3), 4) CPT A cirrhosis, 5) CPT B cirrhosis, or 6) CPT C cirrhosis. Patients with FCH were excluded
HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 767A from this analysis. For analysis of early viral kinetics, the 12 and 24 week treatment durations were combined. Serum HCV RNA was quantified using Roche CAP/CTM v2.0 with a lower limit of quantitation (LLOQ) of 15 IU/mL. Results: Patients with advanced liver disease had SVR12 rates of 86-89%. Patients who were post liver transplant had SVR rates that ranged from 96%-98% in those with F0-F3 fibrosis to 60-75% of patients with severe hepatic impairment. Rapid HCV RNA declines were observed in all treatment groups. The majority of subjects achieved HCV RNA
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