Public Release: 

DCV, SOF, and RBV combination effective/tolerated in HCV with advanced cirrhosis, post-transplant recurrence

Results from ALLY-1 confirm combination addresses a high unmet therapeutic need for these patients

European Association for the Study of the Liver

April 25, 2015, Vienna , Austria: Phase 3 results presented today at The International Liver Congress™ 2015 show that a combination of daclatasvir (DCV), sofosbuvir (SOF) and ribavirin (RBV) for 12 weeks was effective and well tolerated amongst patients with hepatitis C virus (HCV) infection with advanced cirrhosis and post-transplant recurrence. Sustained virologic response rates at 12 weeks (SVR12) were >90% in patients with Child-Pugh class A or B cirrhosis but lower in Child-Pugh class C. SVR12 was achieved by 94% of liver transplant recipients with HCV recurrence.

ALLY-1 is an open-label study, including treatment-naive or -experienced adults with HCV infection of any genotype.

The most common adverse events (AEs) were headache, fatigue, anaemia, diarrhoea and nausea. There were no treatment-related serious AEs. One post-transplant patient discontinued all therapy after 31 days due to headache but achieved SVR12.

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About The International Liver Congress™

This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Specialists share research studies and findings, and discuss the hottest topics related to liver disease. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. 2015 is a very special year for EASL and the hepatology community as they will celebrate the 50th annual meeting. The International Liver Congress™ takes place from April 22-26, 2015, Vienna, Austria.

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Late Breakers: Hall D Presentation time: 17:45 - 18:00 Presenter: Fred Poordad (United States) Abstract LO8: DACLATASVIR, SOFOSBUVIR, AND RIBAVIRIN COMBINATION FOR HCV PATIENTS WITH ADVANCED CIRRHOSIS OR POSTTRANSPLANT RECURRENCE: PHASE 3 ALLY-1 STUDY

DACLATASVIR, SOFOSBUVIR, AND RIBAVIRIN COMBINATION FOR HCV PATIENTS WITH ADVANCED CIRRHOSIS OR POSTTRANSPLANT RECURRENCE: PHASE 3 ALLY-1 STUDY

Fred Poordad* 1, Eugene R. Schiff2, John M. Vierling3, Charles Landis4, Robert J. Fontana5, Rong Yang6, Fiona McPhee7, Eric Hughes6, Stephanie Noviello6, Eugene S. Swenson7 1Texas Liver Institute, University of Texas Health Science Center, San Antonio, TX, 2Schiff Center for Liver Diseases, University of Miami Miller School of Medicine, Miami, FL, 3Baylor College of Medicine, Houston, TX, 4University of Washington School of Medicine, Seattle, WA, 5University of Michigan Medical Center, Ann Arbor, MI, 6Bristol-Myers Squibb, Princeton, NJ, 7Bristol-Myers Squibb, Wallingford, CT, United States

Introduction: The pangenotypic combination of daclatasvir (DCV) and sofosbuvir (SOF) achieves high rates of SVR in patients with chronic HCV infection. DCV+SOF has favorable safety and drug interaction profiles and a high resistance barrier. These attributes support the ALLY-1 study of DCV+SOF with ribavirin (RBV) in patients with advanced cirrhosis or post-liver transplant HCV recurrence, who have a high unmet therapeutic need.

Material and Methods: This open-label study enrolled treatment-naive or experienced adults with HCV infection of any genotype (GT) in 2 cohorts: (1) advanced cirrhosis, (2) post-liver transplant recurrence. Patients received 12 weeks of treatment with once-daily DCV 60mg + once-daily SOF 400mg and RBV (initially 600mg/d, adjusted for hemoglobin and creatinine clearance). In the cirrhosis cohort, patients transplanted during treatment could receive 12 weeks of extended treatment immediately posttransplant, regardless of treatment duration before transplant. The primary endpoint was HCV RNA

Results: The cirrhosis (N=60) and posttransplant (N=53) cohorts were, respectively, 40% and 42% treatment-naive and 75% and 77% GT1. The Child-Pugh class in the cirrhosis cohort was 20% A, 53% B, and 27% C. MELD score ranged from 8 to 27. No posttransplant patients had cholestatic recurrence or hepatic decompensation. Overall, 83% of patients in the cirrhosis cohort achieved SVR12, with higher SVR12 rates in patients with Child-Pugh class A or B disease than in those with class C (Table). In the posttransplant cohort, 94% achieved SVR12. Twelve of the 13 patients without SVR12 relapsed posttreatment. SVR12 rates were comparable regardless of prior treatment experience or baseline demographic characteristics. Four cirrhotic patients received a liver transplant during treatment; 3 of 4 extended treatment posttransplant and all 4 achieved SVR12. The most common AEs (any grade) were headache, fatigue, anemia, diarrhea, and nausea. There were no treatment-related serious AEs. One posttransplant patient discontinued all therapy after 31 days due to headache but achieved SVR12.

Conclusions: DCV+SOF+RBV for 12 weeks was safe and well tolerated in both cohorts. SVR12 rates were >90% in patients with Child-Pugh class A or B cirrhosis but lower in Child-Pugh class C. SVR12 was achieved by 94% of liver transplant recipients with HCV.

Disclosure of Interest: F. Poordad: Grant: Conflict with: BMS, Gilead, Abbvie, Janssen, Salix, Idenix, Theravance, Achillion, Consultant: Conflict with: BMS, Gilead, Abbvie, Janssen, Salix, E. Schiff: Grant: Conflict with: Abbvie, BMS, Gilead, Merck, Orasure Technologies, Roche Molecular, Janssen Pharma, Discovery Life Sciences, Beckman Coulter, Siemens, MedMira, Conatus, Consultant: Conflict with: BMS, Gilead, Merck, Janssen Pharma, Salix, Pfizer, Arrowhead, Acorda, J. Vierling: Grant: Conflict with: BMS, Abbvie, Consultant: Conflict with: Abbvie, Gilead, Intercept, Janssen, Novartis, Roche, Merck, Sundise, C. Landis: Grant: Conflict with: Gilead, Abbvie, BMS, Janssen, R. Fontana: Grant: Conflict with: Gilead, Janssen, and BMS, Consultant: Conflict with: Chronic Liver Disease Foundation , R. Yang: Stockholder: Conflict with: BMS, Employee: Conflict with: BMS, F. McPhee: Employee: Conflict with: BMS, E. Hughes: Employee: Conflict with: BMS, S. Noviello: Employee: Conflict with: BMS, E. Swenson: Employee: Conflict with: BMS

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