Transcript PPTX
Phase 2 Treatment Naïve and Treatment Experienced Sofosbuvir + Ribavirin in HCV GT 4 Egyptian Ancestry Trial Ruane P, et al. 49th EASL. April 2014. Abstract P1243. Hepatitis web study Sofosbuvir and Ribavirin in HCV Genotype 4 Egyptian Ancestry Trial: Study Features Egyptian Ancestry Genotype 4 Trial: Features Design: Randomized, open-label, phase 2 study of sofosbuvir + ribavirin in treatment-naïve and treatment-experienced patients with HCV GT 4 Setting: single study center in United States Entry Criteria - HCV Genotype 4 - First generation Egyptian - Treatment naïve or treatment experienced - Age 18 or older - Not co-infected with HIV - Patients with compensated cirrhosis allowed Primary End-Points: Efficacy (SVR12) and safety Source: Ruane P, et al. 49th EASL. April 2014: Abstract P1243. Hepatitis web study Sofosbuvir and Ribavirin in HCV Genotype 4 Egyptian Ancestry Trial: Baseline Characteristics Chronic HCV GT4: Treatment with Sofosbuvir + Ribavirin Treatment Naive Baseline Characteristic Treatment Experienced 12-Week (n=14) 24-Week (n=14) 12-Week (n=17) 24-Week (n=15) 53 (26-69) 52 (27-75) 54 (32-72) 57 (38-68) 8 (57%) 5 (36%) 14 (82%) 14 (93%) 29.2 30.9 28.1 29.6 Cirrhosis, n % 3 (21%) 3 (21%) 4 (24%) 4 (27%) IL28B non-CC, n (%) 11 (79%) 8 (57%) 16 (94%) 15 (100%) Prior schistosomiasis, n (%) 8 (57%) 3 (21%) 6 (35%) 8 (53%) 5.7 5.9 6.2 6.1 Mean Age, y (range) Male, n % Mean BMI kg/m2 HCV RNA, mean baseline log10 IU/ml Source: Ruane P, et al. 49th EASL. April 2014: Abstract P1243. Hepatitis web study Sofosbuvir and Ribavirin in HCV Genotype 4 Egyptian Ancestry Trial: Design Week GT 4 Naïve or Experienced 0 12 Sofosbuvir + RBV (n = 32) 24 36 SVR12 Sofosbuvir + RBV (n = 28) SVR12 Drug Dosing Sofosbuvir: 400 mg once daily Weight-Based Ribavirin (in 2 divided doses): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg Source: Ruane P, et al. 49th EASL. April 2014: Abstract P1243. Hepatitis web study Sofosbuvir and Ribavirin in HCV Genotype 4 Egyptian Ancestry Trial: Results SVR 12 by Regimen Duration and Treatment Experience Patients with SVR 12 (%) 100 100 87 80 79 60 59 40 20 0 11/14 14/14 10/17 13/15 SOF + RBV x 12 weeks SOF + RBV x 24 weeks SOF + RBV x 12 weeks SOF + RBV x 24 weeks Treatment Naive Source: Ruane P, et al. 49th EASL. April 2014: Abstract P1243. Treatment Experienced Hepatitis web study 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. Hepatitis web study