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744A AASLD ABSTRACTS HEPATOLOGY, October, 2015 Heiner Wedemeyer - Advisory Committees or Review Panels: Transgene, MSD, Roche, Gilead, Abbott, BMS, Falk, Abbvie, Novartis, GSK, Roche Diagnostics; Grant/Research Support: MSD, Novartis, Gilead, Roche, Abbott, Roche Diagnostics; Speaking and Teaching: BMS, MSD, Novartis, ITF, Abbvie, Gilead Xavier Forns - Consulting: Jansen, Abbvie; Grant/Research Support: Jansen, Gilead Pietro Andreone - Advisory Committees or Review Panels: Janssen-Cilag, Gilead, MSD/Schering-Plough, Abbvie; Speaking and Teaching: Gilead, BMS Massimo Colombo - Advisory Committees or Review Panels: BRISTOL-MEY- ERS-SQUIBB, SCHERING-PLOUGH, ROCHE, GILEAD, BRISTOL-MEYERS-SQUIBB, SCHERING-PLOUGH, ROCHE, GILEAD, Janssen Cilag, Achillion; Grant/ Research Support: BRISTOL-MEYERS-SQUIBB, ROCHE, GILEAD, BRISTOL-MEY- ERS-SQUIBB, ROCHE, GILEAD; Speaking and Teaching: Glaxo Smith-Kline, BRISTOL-MEYERS-SQUIBB, SCHERING-PLOUGH, ROCHE, NOVARTIS, GILEAD, VERTEX, Glaxo Smith-Kline, BRISTOL-MEYERS-SQUIBB, SCHERING-PLOUGH, ROCHE, NOVARTIS, GILEAD, VERTEX, Sanofi 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 Fred Poordad - Advisory Committees or Review Panels: Abbott/Abbvie, Achillion, BMS, Inhibitex, Boeheringer Ingelheim, Pfizer, Genentech, Idenix, Gilead, Merck, Vertex, Salix, Janssen, Novartis; Grant/Research Support: Abbvie, Anadys, Achillion, BMS, Boehringer Ingelheim, Genentech, Idenix, Gilead, Merck, Pharmassett, Vertex, Salix, Tibotec/Janssen, Novartis Christophe Hezode - Speaking and Teaching: Roche, BMS, MSD, Janssen, abbvie, Gilead Thomas Podsadecki - Employment: AbbVie; Stock Shareholder: AbbVie Wangang Xie - Employment: AbbVie Tami Pilot-Matias - Employment: AbbVie; Stock Shareholder: AbbVie Regis A. Vilchez - Employment: AbbVie Inc. John M. Vierling - Advisory Committees or Review Panels: Abbvie, Bristol-Meyers-Squibb, Gilead, Hyperion, Intercept, Janssen, Novartis, Merck, Sundise, HepQuant, Salix, Immuron, Exalenz, Chronic Liver Disease Foundation; Board Membership: Clinical Research Centers of America, LLC; Grant/Research Support: Abbvie, Bristol-Meyers-Squibb, Eisai, Gilead, Hyperion, Intercept, Janssen, Novartis, Merck, Sundise, Ocera, Mochida, Immuron, Exalenz, Conatus; Speaking and Teaching: GALA, Chronic Liver Disease Foundation, ViralEd, Chronic Liver Disease Foundation, Clinical Care Options in lifetime risks of developing advanced liver disease (i.e. CC, DCC or HCC) and an 80% reduction in risks of LrD, regardless of treatment history or cirrhosis status. The lifetime risks of liver morbidity and mortality are also substantially lower in the overall coinfected patients treated with 3D±R than those treated with SOF+PR or SOF+R. In the naïve non-cirrhotic coinfected patients, treatment with 3D±R offers comparable reductions in lifetime risks of liver morbidity and mortality compared to SOF+LDV. Conclusion Compared with former or other current standards of care for treating GT1 HCV and HIV coinfected patients in the US, 3D±R offers favorable or comparable reductions in lifetime risks of liver morbidity and mortality. Lifetime risks of liver morbidity and mortality in GT1 HCV and HIV coinfected patients * Clinical trial data not available Disclosures: Sammy Saab - Advisory Committees or Review Panels: BMS, Gilead, Merck, Janssen; Grant/Research Support: Gilead; Speaking and Teaching: BMS, Gilead, Merck, Janssen, Salix, Onyx, Bayer, Janssen; Stock Shareholder: Achillion, Johnson and Johnson, BMS, Gilead Suchin Virabhak - Consulting: AbbVie Scott J. Johnson - Consulting: AbbVie; Employment: Medicus Economics Hélène Parisé - Consulting: MedicusEconomics LLC, AbbVie ; Employment: Statlog Consulting Inc Yuri Sanchez - Employment: AbbVie; Stock Shareholder: AbbVie Timothy R. Juday - Employment: AbbVie; Stock Shareholder: AbbVie The following authors have nothing to disclose: Alice Wang 1087 Lifetime risks of liver morbidity and mortality in patients with chronic genotype (GT) 1 hepatitis C virus (HCV) and HIV coinfection treated with 3D±R (ombitasvir/ paritaprevir/ ritonavir, dasabuvir ± ribavirin) vs other standards of care in the US Sammy Saab 2 , Suchin Virabhak 3 , Scott J. Johnson 3 , Hélène Parisé 3 , Yuri Sanchez 1 , Alice Wang 1 , Timothy R. Juday 1 ; 1 HEOR, AbbVie, Mettawa, ID; 2 Pfleger Liver Institute, UCLA, Los Angeles, CA; 3 Medicus Economics Inc., Boston, MA Objective This study evaluated the lifetime risks of liver morbidity and mortality in patients with GT1 HCV and HIV coinfection treated with 3D±R for 12 or 24 weeks compared to other standards of care in the United States (US): sofosbuvir plus peg-interferon and ribavirin for 12 weeks (SOF+PR) and SOF+R for 24 weeks in the overall coinfected population, and sofosbuvir plus ledipasvir for 12 weeks (SOF+LDV) in the treatment-naïve non-cirrhotic population. Methods A Markov model based on the natural history of liver disease progression estimated the risks of liver-related morbidity and mortality over a lifetime horizon for a cohort of patients with GT1 HCV and HIV coinfection. Baseline population characteristics and efficacy data were obtained from published clinical trials. Lifetime risks of compensated cirrhosis (CC), decompensated cirrhosis (DCC), hepatocellular carcinoma (HCC) and liver-related death (LrD) were analyzed. Treatment strategies included ‘no treatment’ (NT), as well as regimens that have been studied in Phase II or III clinical trials of coinfected patients, and either recommended by the latest guidelines or approved by the Food and Drug Administration. Results Compared to untreated GT1 HCV and HIV coinfected patients, 3D±R offers at least a 59% reduction 1088 Effect of Chronic Kidney Disease on the Pharmacokinetics of Ombitasvir, Paritaprevir, Ritonavir and Dasabuvir in Subjects with HCV Genotype 1 Infection Diana L. Shuster, Rajeev Menon, Daniel E. Cohen, Amit Khatri; AbbVie, North Chicago, IL Background and Objective: The all-oral interferon-free, 3 direct acting antiviral (3-DAA) regimen of ombitasvir (OBV) (NS5A inhibitor) + paritaprevir (NS3/4A protease inhibitor identified by AbbVie and Enanta), coadministered with ritonavir, a pharmacokinetic enhancer (PTV/r), + dasabuvir (DSV) (NS5B non-nucleoside polymerase inhibitor) ± ribavirin (RBV) is being evaluated in HCV genotype (GT) 1-infected subjects with chronic kidney disease (CKD). No meaningful alterations in exposures were seen when the 3 DAAs were administered to HCV-uninfected subjects with renal impairment. The present analysis examines the effect of CKD Stage 4 and Stage 5 on the pharmacokinetics of OBV, PTV/r and DSV in HCV GT1-infected subjects. Methods: Pharmacokinetic data from a Phase 2 study (N=38) in subjects with normal or mild renal impairment (subjects “without kidney disease”) were combined with preliminary data from a Phase 3b study in subjects with CKD Stage 4 (N=5) or Stage 5 on hemodialysis (N=14). In both <strong>studies</strong> subjects received OBV/PTV/r 25/150/100 mg QD and DSV 250 mg BID ± RBV for 12 weeks. Pharmacokinetic parameters and steady-state exposures of the 3-DAA regimen were estimated using population pharmacokinetic models. Results: CKD was not a significant covariate in the population pharmacokinetic analyses, and the safety profile of the 3 DAAs was similar in subjects with or without CKD. PTV and DSV exposures were comparable (
HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 745A between subjects without kidney disease and CKD Stage 4. OBV and ritonavir exposures were ~80% and 200% higher, respectively, in CKD Stage 4 subjects in the limited number of subjects in this analyses. OBV and PTV exposures were comparable (7 log 10 IU/mL. Reasons for ineligibility for ACTG A5327 were treatment initiated >24 weeks after HCV diagnosis (n=6); peak ALT
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1312A AUTHOR INDEX HEPATOLOGY, Octo
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1366A CATEGORY INDEX HEPATOLOGY, Oc
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