No randomization N = 59 W12W24 Arm B : compensated cirrhosis N = 31 N = 29 Arm C : compensated cirrhosis Arm A : No cirrhosis AGATE-II Study: OBV/PTV/r + RBV in genotype 4 Egyptian patients without or with cirrhosis Randomization 1:1 Design Treatment regimens –Co-formulated ombitasvir (OBV)/paritaprevir (PTV)/rironavir (r) : 25/150/100 mg qd = 2 tablets –Weight-based RBV (bid dosing) Objective –SVR 12 (HCV RNA < LLOQ), with 2 sided 95% confidence interval, treatment-emergent adverse events years HCV genotype 4 Egyptian Naïve or pre-treated with PEG-IFN + RBV No cirrhosis (open-label) or compensated cirrhosis (randomisation) No HBV or HIV co-infection OPV/PTV/r + RBV AGATE-II Esmat G. AASLD 2015, Abs. 708
AGATE-II Study: OBV/PTV/r + RBV in genotype 4 Egyptian patients without or with cirrhosis No cirrhosis 12W N = 100 Cirrhosis 12W N = 31 Cirrhosis 24W N = 29 Mean age, years Female30%6%24% Mean BMI, kg/m Mean HCV RNA, log 10 IU/Ml6.0 Fibrosis stage (%) : F0-F1 / F2 / F3 / F468 / 11 / 19 / 20 / 0 / 3 / 970 / 0 / 0 /100 Treatment-naïve, % Treatment-experienced, % Null responder Partial responder Relapser Mean platelet count (x 10 9 /l) Mean albumin (g/l) 44.7 ± ± ± 5.3 History of diabetes, % Baseline characteristics AGATE-II Esmat G. AASLD 2015, Abs. 708
AGATE-II Study: OBV/PTV/r + RBV in genotype 4 Egyptian patients without or with cirrhosis AGATE-II Esmat G. AASLD 2015, Abs. 708 SVR rates by treatment arm SVR 12 by baseline fibrosis stage (12 week treatment arms) /9930/32 < F3= F4 Baseline fibrosis stage Arm A No-cirrhosis 12 weeks /10030/31 97 Arm B Cirrhosis 12 weeks Arm C Cirrhosis 24 weeks Data Pending – Study in Progress SVR 12 SVR 4 28/29 97 % %
AGATE-II Study: OBV/PTV/r + RBV in genotype 4 Egyptian patients without or with cirrhosis No cirrhosis W12 Cirrhosis W12 Cirrhosis W24 Non-response2/100 (2.0%)1/31 (3.2%)1/29 (3.4%) On-treatment virologic failure1 (1.0%) *1 (3.2%)1/29 Premature study drug discontinuation 1 (1.0%) withdrew consent 00 Missing SVR 12 data1/1000NA** Relapse by W12 post-treatment3/98 (3.1%) *0NA** Reasons for not achieving SVR 12 * Includes 1 patient with compensated cirrhosis miscategorized as non-cirrhotic and assigned in Arm A ** Study ongoing AGATE-II Esmat G. AASLD 2015, Abs. 708
AGATE-II Study: OBV/PTV/r + RBV in genotype 4 Egyptian patients without or with cirrhosis No cirrhosis W12 N = 100 Cirrhosis W12 N = 31 Cirrhosis W24 N = 29 Any treatment-emergent adverse event72 (72%)21 (68%)25 (86%) Adverse event leading to discontinuation000 Serious adverse event, %207 Severe adverse event, %207 Death, N100 Adverse events occurring in ≥ 10% in either group, % Headache Fatigue Pruritus Dyspepsia Upper abdominal pain ALT ≥ Grade 2 (> 3 x ULN)000 AST ≥ Grade 2 (> 3 x ULN)000 Total bilirubin grade 3 (> 3-10 x ULN), %2614 Hemogloblin 8-10 g/dl, N (%)7 (7)2 (6)4 (14) RBV dose reduction, N1047 Treatment-emergence adverse events AGATE-II Esmat G. AASLD 2015, Abs. 708
AGATE-II Study: OBV/PTV/r + RBV in genotype 4 Egyptian patients without or with cirrhosis Summary –High SVR rates were achieved in HCV genotype 4-infected Egyptian patients without cirrhosis or with compensated cirrhosis after 12 weeks of OBV/PTV/r + RBV weeks: SVR 12 was 94% and 97%, respectively –12 weeks treatment was well tolerated with no treatment discontinuations due to adverse events –Prolongation of therapy to 24 weeks does not provide additional benefit, with more serious adverse events and a higher frequency of hemoglobin decrease Esmat G. AASLD 2015, Abs. 708 AGATE-II