Phase 3 Treatment-Naïve and Treatment-Experienced

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Presentation transcript:

Phase 3 Treatment-Naïve and Treatment-Experienced Daclatasvir + Sofosbuvir + Ribavirin in HCV with Advanced Cirrhosis or Post-Liver Transplant ALLY-1 Study Poordad F, et al. Hepatology. 2016;63:1493-505.

DCV + SOF + RBV in Advanced Cirrhosis and Post-Liver Transplant ALLY-1: Results ALLY-1: Features Design: Design: Multicenter, prospective, open-label, phase 3 study of daclatasvir plus sofosbuvir plus ribavirin in treatment-naïve and treatment- experienced patients with advanced cirrhosis or post-liver transplant HCV recurrence. Setting: Five centers in United States Entry Criteria - Treatment-naïve or treatment-experienced - Chronic HCV genotypes 1-6 - HCV RNA >10,000 IU/ml - Cirrhosis (compensated and decompensated) allowed - Post-liver transplant: received transplant ≥3 months prior to screening Outcome Measure: Primary = SVR12 Source: Poordad F, et al. Hepatology. 2016;63:1493-505.

Daclatasvir + Sofosbuvir + Ribavirin Daclatasvir + Sofosbuvir + DCV + SOF + RBV in Advanced Cirrhosis and Post-Liver Transplant ALLY-1: Results ALLY-1: Study Design 12 24 Week Advanced Cirrhosis N = 60 Daclatasvir + Sofosbuvir + Ribavirin SVR12 Post-Liver Transplant N = 53 Daclatasvir + Sofosbuvir + Ribavirin SVR12 Drug Dosing Daclatasvir: 60 mg once daily Sofosbuvir: 400 mg once daily Ribavirin: 600 mg daily, adjusted to 1000 mg/day based on hemoglobin levels and renal function Source: Poordad F, et al. Hepatology. 2016;63:1493-505.

Post-Liver Transplant DCV + SOF + RBV in Advanced Cirrhosis and Post-Liver Transplant ALLY-1: Patient Characteristics Characteristic Advanced Cirrhosis (n=60) Post-Liver Transplant (n=53) Male, n (%) 38 (63%) 38 (72%) Median age, years (range) 58 (19-75) 59 (22-82) Race White Black/African American Asian 57 (95%) 3 (5%) 0 (0%) 51 (96%) 1 (2%) HCV genotype 1a 1b 2 3 4 6 34 (57%) 11 (18%) 5 (8%) 6 (10%) 4 (7%) 31 (58%) 10 (19%) 11 (21%) Mean HCV RNA log10 (IU/mL) 6.01 6.61 Source: Poordad F, et al. Hepatology. 2016;63:1493-505.

ALLY-1: SVR12 Results for Advanced Cirrhosis Cohort by Genotype DCV + SOF + RBV in Advanced Cirrhosis and Post-Liver Transplant ALLY-1: Results for Advanced Cirrhosis Cohort ALLY-1: SVR12 Results for Advanced Cirrhosis Cohort by Genotype 50/60 26/34 11/11 4/5 5/6 4/4 0/0 Source: Poordad F, et al. Hepatology. 2016;63:1493-505.

DCV + SOF + RBV in Advanced Cirrhosis and Post-Liver Transplant ALLY-1: Results for Advanced Cirrhosis Cohort ALLY-1: SVR12 Results for Advanced Cirrhosis Cohort by Child-Pugh Class 50/60 11/12 30/32 9/16 Source: Poordad F, et al. Hepatology. 2016;63:1493-505.

ALLY-1: SVR12 Results for Post-Liver Transplant Cohort by Genotype DCV + SOF + RBV in Advanced Cirrhosis and Post-Liver Transplant ALLY-1: Results for Post-Liver Transplant Cohort ALLY-1: SVR12 Results for Post-Liver Transplant Cohort by Genotype 50/53 30/31 9/10 0/0 10/11 0/0 1/1 Source: Poordad F, et al. Hepatology. 2016;63:1493-505.

DCV + SOF + RBV in Advanced Cirrhosis and Post-Liver Transplant ALLY-1: Conclusion Conclusion: “The pan-genotypic combination of daclatasvir, sofosbuvir, and ribavirin was safe and well tolerated. High SVR rates across multiple HCV genotypes were achieved by patients with post-liver transplant recurrence or advanced cirrhosis.” Source: Poordad F, et al. Hepatology. 2016;63:1493-505.

This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online www.hepatitisc.uw.edu Hepatitis Web Study http://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.