Program Schedule

1222
ABT-450/r/Ombitasvir and Dasabuvir with Ribavirin Achieves High Sustained Virologic Response Rates Regardless of Baseline Characteristics: Pooled Analyses of the SAPPHIRE-I and SAPPHIRE-II Studies

Session: Oral Abstract Session: Viral Infections: Clinical Trials and Pathogenesis
Friday, October 10, 2014: 2:00 PM
Room: The Pennsylvania Convention Center: 105-AB

Background: The 3 direct-acting antiviral (3D) regimen of ABT-450 (identified by AbbVie and Enanta) dosed with ritonavir (ABT-450/r), ombitasvir (formerly ABT-267), and dasabuvir (formerly ABT-333) with ribavirin (RBV) has achieved high rates of sustained virologic response 12 weeks post-treatment (SVR12) in HCV genotype 1-infected patients. The SVR12 rates based on pooled data from the SAPPHIRE-I and SAPPHIRE-II studies were assessed by baseline characteristics.

Methods: HCV genotype 1-infected patients who were treatment-naïve or with previous non-response to pegIFN/RBV were enrolled into SAPPHIRE-I or SAPPHIRE-II, respectively. Patients were randomized 3:1 to receive co-formulated ABT-450/r/ombitasvir (150 mg/100 mg/25 mg once daily) and dasabuvir (250 mg twice daily) with weight-based ribavirin (1000 – 1200 mg daily) or matching placebos during the 12-week double-blind period. Data from the 2 studies were pooled to assess overall SVR12 and by baseline factors including sex, age, body mass index (BMI), HCV RNA, fibrosis status, HCV subtype, and IL28B genotype.

Results: The overall SVR12 rate of 770 patients who received at least one dose of 3D + RBV was 96.2% (95% CI, 94.9 – 97.6). Similar SVR12 rates were achieved by treatment-naïve (96.2%, N = 473) and previously treated patients (96.3%, N = 297). SVR rates ranged 92.3 – 98.6% across all examined baseline subgroups (Figure). Rates of SVR12 were similarly high in historically difficult to cure populations including those with IL28B non-CC genotype, and patients with F3 baseline fibrosis stage. Only baseline BMI was statistically significantly associated with SVR12 rates (P < 0.05), though patients with baseline BMI ≥ 30 kg/m3 achieved an SVR12 rate of 92.3%.

Conclusion: Only baseline BMI ≥ 30 kg/m3 was significantly associated with a lower SVR12 rate (92.3%), however, was of limited clinical significance. Rates of SVR12 > 92% across all subgroups were observed in non-cirrhotic HCV genotype 1-infected patients previously untreated or experienced to pegIFN/RBV, including difficult to cure populations such as those with IL28B non-CC genotype, baseline HCV RNA >800,000 IU/mL, high BMI, and F3 baseline fibrosis stage.

 

Jordan J. Feld, MD, MPH1, Ola Weiland, MD2, Rui Tato Marinho, MD, PhD3, Heiner Wedemeyer, MD4, Ira M. Jacobson, MD5, Donald M. Jensen, MD6, Tarek Hassanein, MD7, Victor De Ledinghen, MD8, Moisés Diago, MD9, Lorenzo Magenta, MD10, Robert J. De Knegt, MD11, Junyuan J. Xiong, MS12, Eoin Coakley, MD12, Tolga Baykal, MD12, Fernando Tatsch, MD12 and Graham R. Foster, FCRP13, (1)Toronto Centre for Liver Disease, University of Toronto, Toronto, ON, Canada, (2)Karolinska University Hospital Huddinge, Karolinska Institutet, Stockholm, Sweden, (3)Centro Hospitalar Lisboa Norte and Medical School of Lisbon, Lisbon, Portugal, (4)Medizinische Hochschule Hannover, Hannover, Germany, (5)Weill Cornell Medical College, New York, NY, (6)Center for Liver Diseases, University of Chicago Medicine, Chicago, IL, (7)Southern California Liver Centers and Southern California Research Center, Coronado, CA, (8)Hopital Haut Leveque, Pessac, France, (9)Hospital Quirón de Valencia, Valencia, Spain, (10)Epatocentro Ticino, Lugano, Switzerland, (11)Erasmus MC, Rotterdam, Netherlands, (12)AbbVie Inc., North Chicago, IL, (13)Queen Marys University of London, London, United Kingdom

Disclosures:

J. J. Feld, AbbVie: Consultant, Grant Investigator and Scientific Advisor, Consulting fee, Research grant and Research support
Boehringer Ingelheim: Consultant, Grant Investigator and Scientific Advisor, Consulting fee, Research grant and Research support
Gilead: Consultant, Grant Investigator and Scientific Advisor, Consulting fee, Research grant and Research support
Roche: Grant Investigator, Research grant and Research support
Vertex: Consultant, Grant Investigator and Scientific Advisor, Consulting fee, Research grant and Research support
BMS: Consultant and Scientific Advisor, Consulting fee
Idenix: Consultant and Scientific Advisor, Consulting fee
Janssen: Consultant and Scientific Advisor, Consulting fee
Merck: Consultant and Scientific Advisor, Consulting fee

O. Weiland, AbbVie: Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium
Gilead: Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium
BMS: Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium
Medivir: Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium
Johnson & Johnson: Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium
Merck: Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium

R. T. Marinho, AbbVie: Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium
Gilead: Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium
BMS: Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium
Roche: Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium
Merck: Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium
Janssen: Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium

H. Wedemeyer, Abbott: Consultant, Grant Investigator and Speaker's Bureau, Consulting fee, Research support and Speaker honorarium
AbbVie: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium
Achillion: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium
BMS: Consultant, Grant Investigator and Speaker's Bureau, Consulting fee, Research support and Speaker honorarium
Boehringer Ingelheim: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium
Gilead: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium
GSK: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium
ITS: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium
Janssen: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium
Merck: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium
Novartis: Consultant, Grant Investigator and Speaker's Bureau, Consulting fee, Research support and Speaker honorarium
Roche: Consultant, Grant Investigator and Speaker's Bureau, Consulting fee, Research support and Speaker honorarium
Roche Diagnostics: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium
Siemens: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium
Transgene: Consultant and Speaker's Bureau, Consulting fee and Speaker honorarium
MSD: Grant Investigator, Research support

I. M. Jacobson, AbbVie: Consultant, Grant Investigator and Scientific Advisor, Consulting fee and Research support
Achillion: Consultant, Grant Investigator and Scientific Advisor, Consulting fee and Research support
BMS: Consultant, Grant Investigator, Scientific Advisor and Speaker's Bureau, Consulting fee, Research support and Speaker honorarium
Boehringer Ingelheim: Consultant, Grant Investigator and Scientific Advisor, Consulting fee and Research support
Roche: Consultant, Grant Investigator, Scientific Advisor and Speaker's Bureau, Consulting fee, Research support and Speaker honorarium
Gilead: Consultant, Grant Investigator, Scientific Advisor and Speaker's Bureau, Consulting fee, Research support and Speaker honorarium
Janssen: Consultant, Grant Investigator and Scientific Advisor, Consulting fee and Research support
Merck: Consultant, Grant Investigator and Scientific Advisor, Consulting fee and Research support
Novartis: Consultant, Grant Investigator and Scientific Advisor, Consulting fee and Research support
Vertex: Consultant, Grant Investigator, Scientific Advisor and Speaker's Bureau, Consulting fee, Research support and Speaker honorarium
Enanta: Consultant and Scientific Advisor, Consulting fee
Idenix: Consultant and Scientific Advisor, Consulting fee

D. M. Jensen, AbbVie: Grant Investigator, Research grant and Research support
Boehringer Ingelheim: Grant Investigator, Research grant and Research support
BMS: Grant Investigator, Research grant and Research support
Roche/Genentech: Grant Investigator, Research grant and Research support
Pharmasset/Gilead: Grant Investigator, Research grant and Research support
Tibotec/Janssen: Grant Investigator, Research grant and Research support

T. Hassanein, AbbVie: Grant Investigator and Scientific Advisor, Consulting fee and Research grant
Boehringer Ingelheim: Grant Investigator, Research grant
BMS: Grant Investigator, Scientific Advisor and Speaker's Bureau, Consulting fee, Research grant and Speaker honorarium
Eisai: Grant Investigator, Research grant
Gilead: Grant Investigator and Speaker's Bureau, Research grant and Speaker honorarium
Janssen: Grant Investigator, Research grant
Idenix: Grant Investigator, Research grant
Ikaria: Grant Investigator, Research grant
Mochida: Grant Investigator, Research grant
Roche: Grant Investigator, Research grant
Ocera: Grant Investigator, Research grant
Taigen: Grant Investigator, Research grant
Salix: Grant Investigator and Speaker's Bureau, Research grant and Speaker honorarium
Sundise: Grant Investigator, Research grant
Baxter: Speaker's Bureau, Speaker honorarium
Takeda: Grant Investigator, Research grant
Vertex: Grant Investigator, Research grant

V. De Ledinghen, AbbVie: Scientific Advisor, Consulting fee
BMS: Scientific Advisor, Consulting fee
Gilead: Scientific Advisor, Consulting fee
Merck: Scientific Advisor, Consulting fee
Janssen: Scientific Advisor, Consulting fee
Echosens: Scientific Advisor, Consulting fee

M. Diago, AbbVie: Research Contractor, Research support
Boehringer Ingelheim: Research Contractor, Research support
BMS: Research Contractor and Speaker's Bureau, Research support and Speaker honorarium
Gilead: Research Contractor and Speaker's Bureau, Research support and Speaker honorarium
Janssen: Research Contractor and Speaker's Bureau, Research support and Speaker honorarium
Roche: Research Contractor and Speaker's Bureau, Research support and Speaker honorarium
MSD: Research Contractor and Speaker's Bureau, Research support and Speaker honorarium
Novartis: Research Contractor, Research support
Vertex: Research Contractor, Research support

L. Magenta, AbbVie: Scientific Advisor, Consulting fee
MSD: Scientific Advisor, Consulting fee
Gilead: Scientific Advisor, Consulting fee
Janssen: Scientific Advisor, Consulting fee

R. J. De Knegt, Gilead: Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium
Janssen Cilag: Grant Investigator, Scientific Advisor and Speaker's Bureau, Consulting fee, Research support and Speaker honorarium
Norgine: Speaker's Bureau, Speaker honorarium
AbbVie: Scientific Advisor, Consulting fee
BMS: Grant Investigator and Scientific Advisor, Consulting fee and Research support
Merck: Scientific Advisor, Consulting fee
Roche: Grant Investigator and Scientific Advisor, Consulting fee and Research support
Medtronic: Grant Investigator, Research support

J. J. Xiong, AbbVie: Employee and Shareholder, Salary

E. Coakley, AbbVie: Employee and Shareholder, Salary

T. Baykal, AbbVie: Employee and Shareholder, Salary

F. Tatsch, AbbVie: Employee and Shareholder, Salary

G. R. Foster, AbbVie: Consultant, Grant Investigator and Scientific Advisor, Consulting fee, Research grant and Research support
BMS: Consultant, Grant Investigator and Scientific Advisor, Consulting fee, Research grant and Research support
Merck: Consultant, Grant Investigator and Scientific Advisor, Consulting fee, Research grant and Research support
Roche: Consultant, Grant Investigator and Scientific Advisor, Consulting fee, Research grant and Research support
Gilead: Consultant, Grant Investigator and Scientific Advisor, Consulting fee, Research grant and Research support
Novartis: Consultant, Grant Investigator and Scientific Advisor, Consulting fee, Research grant and Research support
Janssen: Consultant, Grant Investigator and Scientific Advisor, Consulting fee, Research grant and Research support
GSK: Consultant and Scientific Advisor, Consulting fee
Virco: Consultant and Scientific Advisor, Consulting fee
Vertex: Consultant and Scientific Advisor, Consulting fee

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