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Asselah T. AASLD 2015, Abs. 714 Randomisation 1:1 Open-label 18-65 years HCV genotype 4 HCV RNA ≥ 1,000 IU/ml Naïve or pre-treated with PEG-IFN + RBV (Part.

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Presentation on theme: "Asselah T. AASLD 2015, Abs. 714 Randomisation 1:1 Open-label 18-65 years HCV genotype 4 HCV RNA ≥ 1,000 IU/ml Naïve or pre-treated with PEG-IFN + RBV (Part."— Presentation transcript:

1 Asselah T. AASLD 2015, Abs. 714 Randomisation 1:1 Open-label 18-65 years HCV genotype 4 HCV RNA ≥ 1,000 IU/ml Naïve or pre-treated with PEG-IFN + RBV (Part I) Naïve or pre-treated with PEG-IFN + RBV or SOF + RBV + PEG-IFN (Part II) Compensated cirrhosis No HBV or HIV co-infection N = 59 W12W24 OPV/PTV/r + RBV Naïve or pretreated PEG-IFN + RBV W16 N = 61 N = 60 N = 10 Part II, exploratory No randomisation Part-I  Design  Objective –SVR 12 (HCVRNA < LLOQ), with 2 sided 97.5% confidence interval, treatment-emergent adverse events ; HCV N5B amplified and sequenced in all baseline samples  Treatment regimens –Co-formulated ombitasvir (OBV)/paritaprevir (PTV)/rironavir (r) : 25/150/100 mg qd = 2 tablets –Weight-based RBV (bid dosing) OPV/PTV/ + RBV (Naïve or pre-treated with PEG-IFN + RBV) OPV/PTV/r (Pre-treated with SOF + RBV ± PEG-IFN) AGATE-I AGATE-I Study – Part I: OBV/PTV/r + RBV in genotype 4 with cirrhosis

2 OBV/PTV/r + RBV 12W N = 60 OBV/PTV/r + RBV 16W N = 60 Mean age, years5857 Female23.3%36.7% Mean BMI, kg/m 2 28.128.3 Mean HCV RNA, log 10 IU/Ml6.26.0 GT4 subtype by phylogenetic analysis (%) 4a / 4c / 4d / 4e / 4f / 4h / 4k / 4l / 4n / 4o / 4p / 4 q / 4r / 4t 57.6 / 3.4 / 20.3 / 1.7 / 1.7 / 0 / 3.4 / 0 / 3.4 / 0 / 3.4 / 1.7 / 1.7 / 1.7 49.2 / 3.3 / 31.1 / 0 / 3.3. / 1.6 / 3.3. / 3.3 / 0 / 1.6 / 0 / 0 / 0 / 0 Treatment-naïve31 (51.7%)29 (48.3%) Treatment-experienced Null response Partial response Relapse 29 (48.3%) 17 5 7 31 (51.7%) 16 7 8 Mean platelet count (x 10 9 /l)159143 Mean albumin (g/l) 42 ± 3.742 ± 4.3 History of diabetes35%21.7% Baseline characteristics (AGATE-I, Part I) Asselah T. AASLD 2015, Abs. 714 AGATE-I AGATE-I Study – Part I: OBV/PTV/r + RBV in genotype 4 with cirrhosis

3 Asselah T. AASLD 2015, Abs. 714 AGATE-I Study – Part I: OBV/PTV/r + RBV in genotype 4 with cirrhosis AGATE-I SRV 12 rates by treatment arms Arm A 12 weeks 96 0 20 40 60 80 100 Arm B 16 weeks 100 52/54*49/49* % * All patients have not yet reached pst-treetment W12; SVR 4 : 97% and 100%, respectively

4 OBV/PTV/r + RBV 12W N = 54 OBV/PTV/r + RBV 16W N = 49 Non-response2 (3.7%)0 On-treatment virologic failure1 (1.9%) *0 Premature study drug discontinuation1 (1.9%) (at Day 1)0 Missing SVR 12 data0/540 Relapse by 12 weeks post-treatment0/520 Reasons for not achieving SVR 12 * GT4a, Fibroscan : 15.6 kPa NS3 : no baseline polymorphism ; no treatment-emergent NS3 RAVS NS5B : at baseline : P58L ; at VF : emergence of L28L/M and Y93Y/H + P58L Asselah T. AASLD 2015; Abs. 714 AGATE-I AGATE-I Study – Part I: OBV/PTV/r + RBV in genotype 4 with cirrhosis

5 OBV/PTV/r + RBV 12W N = 60 OBV/PTV/r + RBV 16W N = 60 Any treatment-emergent adverse event47 (78.3%)55 (91.7%) Adverse event leading to discontinuation00 Serious adverse event4 (6.7%) Severe adverse event2 (3.3%) Death00 Adverse events occurring in ≥ 10% in either group, % Asthenia Fatigue Headache Anemia Pruritus Nausea Dizziness Hemoglogin decreased Insomnia 18.3 16.7 23.3 15.0 8.3 10.0 5.0 8.3 31.7 23.3 18.3 23.3 13.3 15.0 13.3 10.0 ALT ≥ Grade 2 (> 3 x ULN) / AST ≥ Grade 2 (> 3 x ULN)3 (5.1%) / 1 (1.7%)0 / 0 Total bilirubin grade 3 (> 3-10 x ULN)5 (8.5%)3 (5.0%) Treatment-emergence adverse events (AGATE-I, Part I) Asselah T. AASLD 2015; Abs. 714 AGATE-I AGATE-I Study – Part I: OBV/PTV/r + RBV in genotype 4 with cirrhosis

6  Summary –High SVR rates were achieved in patients with HCV genotype 4 infection and compensated cirrhosis with OBV/PTV/r + RBV administered for 12 weeks or 16 weeks : SVR 12 was 96% and 100%, respectively –OBV/PTV/r + RBV was well tolerated with no discontinuations due to adverse events –All serious adverse events were deemed not related to study drugs Asselah T. AASLD 2015; Abs. 714 AGATE-I AGATE-I Study – Part I: OBV/PTV/r + RBV in genotype 4 with cirrhosis

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