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No cirrhosis or compensated cirrhosis * No HBV or HIV coinfection

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Presentation on theme: "No cirrhosis or compensated cirrhosis * No HBV or HIV coinfection"— Presentation transcript:

1 No cirrhosis or compensated cirrhosis * No HBV or HIV coinfection
SURVEYOR-II study – Part 2: ABT ABT-530 in genotypes 2 or 3 – Phase II Design Not randomised Open-label W8 W12 Genotype 2 No cirrhosis Naïve or experienced N = 54 ABT mg qd + ABT mg qd SVR12 18-70 years HCV genotype 2 or 3 Naïve or failure to PEG-IFN + RBV HCV RNA > IU/ml No cirrhosis or compensated cirrhosis * No HBV or HIV coinfection Naïve ABT mg qd + ABT mg qd SVR12 Genotype 3 No cirrhosis N = 29 N = 24 Not Randomised ABT mg qd + ABT mg qd SVR12 Experienced ongoing Genotype 3 Cirrhosis Naïve N = 24 ABT mg qd + ABT mg qd * Metavir > 3 or Ishak > 4, or Fibroscan ≥ 14.6 kPa, or FibroTest ≥ APRI > 2, and Child-Pugh ≤ 6 SVR12 N = 24 ABT mg qd + ABT mg qd + RBV 800 mg qd Randomised Open-label Objective SVR12 (HCV RNA < 25 IU/ml), by ITT Poordad F. EASL 2016, Abs. SAT-157, J Hepatol 2016; 64:S768 ; Muir AJ. EASL 2016, Abs. PS098, J Hepatol 2016; 64:S186 ; Kwo PY. EASL 2016, Abs. LB01, J Hepatol 2016; 64:S208 SURVEYOR-II – Part 2 1

2 Baseline characteristics, patients without cirrhosis
SURVEYOR-II study – Part 2: ABT ABT-530 in genotypes 2 or 3 – Phase II Baseline characteristics, patients without cirrhosis Genotype 2 Naïve or experienced N = 54 Genotype 3 Naïve N = 29 Median age, years 57 47 (mean) Female 39% 48% Race, white 94% 90% Median BMI, kg/m2 26 26 (mean) Median HCV RNA, log10 IU/ml 6.9 6.5 Genotype 2a / 2b / 2a-c / not subtyped, % 0 / 70 / 15 / 15 - Genotype 3a 86% Fibrosis stage (%) : F0-F1 / F2 / F3 71/ 18 / 12 69 / 7 / 24 IL28B CC 41% Treatment-naïve 87% 100% Poordad F. EASL 2016, Abs. SAT-157, J Hepatol 2016; 64:S768, Muir AJ. EASL 2016, Abs. PS098, J Hepatol 2016; 64:S186, Kwo PY. EASL 2016, Abs. LB01, J Hepatol 2016; 64:S208 SURVEYOR-II – Part 2 2

3 Baseline characteristics, patients with genotype 3 and cirrhosis
SURVEYOR-II study – Part 2: ABT ABT-530 in genotypes 2 or 3 – Phase II Baseline characteristics, patients with genotype 3 and cirrhosis ABT ABT-450 N = 24 ABT ABT RBV Median age, years 55 57 Female 46% 25* Race, white 96% 92% Median BMI, kg/m2 27 Median HCV RNA, log10 IU/ml 6.4 6.3 Genotype 3a 100% ALT, median IU/l 100 116 Platelets, median x 109/l 140 157 Albumin, median g/dl 4.1 4.2 Child-Pugh score = 6 21% 13% Poordad F. EASL 2016, Abs. SAT-157, J Hepatol 2016; 64:S768, Muir AJ. EASL 2016, Abs. PS098, J Hepatol 2016; 64:S186, Kwo PY. EASL 2016, Abs. LB01, J Hepatol 2016; 64:S208 SURVEYOR-II – Part 2 3

4 SVR12 (HCV RNA < 25 IU/ml)
SURVEYOR-II study – Part 2: ABT ABT-530 in genotypes 2 or 3 – Phase II SVR12 (HCV RNA < 25 IU/ml) 25 50 100 75 % 98 97 N 54 * 29 ** 24 ABT-493 + ABT RBV + ABT-530 Genotype 2, no cirrhosis, 8 weeks Genotype 3, no cirrhosis, 8 weeks Genotype 3, cirrhosis, 12 weeks 144 *, ** : SVR12 = 100% by ITTm, excluding non virologic failure * 1 patient was lost to follow-up after W6 with undetectable RNA at that visit ** 1 patient withdrew consent at W6 with undetectable RNA at that visit Poordad F. EASL 2016, Abs. SAT-157, J Hepatol 2016; 64:S768, Muir AJ. EASL 2016, Abs. PS098, J Hepatol 2016; 64:S186, Kwo PY. EASL 2016, Abs. LB01, J Hepatol 2016; 64:S208 SURVEYOR-II – Part 2 4

5 SURVEYOR-II study – Part 2: ABT-493 + ABT-530 in genotypes 2 or 3 – Phase II
Resistance analysis (population sequencing with 15% threshold) Baseline RAVs 58% of genotype 2 : NS3 only in 13%, NS5A only in 38%, NS3 + NS5A in 6% 46% of genotype 3 without cirrhosis, 38% of genotype 3 with cirrhosis No impact on SVR12 Poordad F. EASL 2016, Abs. SAT-157, J Hepatol 2016; 64:S768, Muir AJ. EASL 2016, Abs. PS098, J Hepatol 2016; 64:S186, Kwo PY. EASL 2016, Abs. LB01, J Hepatol 2016; 64:S208 SURVEYOR-II – Part 2 5

6 SURVEYOR-II study – Part 2: ABT-493 + ABT-530 in genotypes 2 or 3 – Phase II
Adverse events and laboratory abnormalities, % Genotype 2 N = 54 Genotype 3 No cirrhosis N = 29 Genotype 3 Cirrhosis ABT ABT-530 N = 24 ABT ABT RBV, N = 24 Any adverse event 61 76 88 83 Serious adverse event 2 (n = 1, cellulitis) 4 (n = 1, tibia fracture) 8 (n = 2, anemia, delusional disorder) Adverse event leading to study discontinuation Common adverse events Fatigue Headache Nausea Diarrhea 13 11 - 10 17 8 21 25 33 Laboratory abnormalities ALT > 3 x ULN AST > 3 x ULN Alk. phosphatase > 2.5 x ULN Total bilirubin > 1.5 x ULN Hemoglobin < 10 g/dl 0 0 0 3 0 29 4 Poordad F. EASL 2016, Abs. SAT-157, J Hepatol 2016; 64:S768, Muir AJ. EASL 2016, Abs. PS098, J Hepatol 2016; 64:S186, Kwo PY. EASL 2016, Abs. LB01, J Hepatol 2016; 64:S208 SURVEYOR-II – Part 2 6

7 SURVEYOR-II study – Part 2: ABT-493 + ABT-530 in genotypes 2 or 3 – Phase II
Summary High SVR rates were achieved in HCV genotype 2 and genotype 3-infected patients without cirrhosis after 8 weeks of ABT ABT-530 By ITTm, all patients achieved SVR12 No impact on efficacy of baseline NS3 and/or NS5A RAVs 100% SVR12 with 12 weeks once-daily ABT-493 and ABT in treatment-naïve genotype 3-infected patients with compensated cirrhosis regardless of RBV coadministration Adverse events were mostly mild in severity Poordad F. EASL 2016, Abs. SAT-157, J Hepatol 2016; 64:S768, Muir AJ. EASL 2016, Abs. PS098, J Hepatol 2016; 64:S186, Kwo PY. EASL 2016, Abs. LB01, J Hepatol 2016; 64:S208 SURVEYOR-II – Part 2 7

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