No randomisation Open-label 18-70 years HCV genotype 1 Naïve or null-response to PEG-IFN + RBV HCV RNA > 10,000 IU/ml No cirrhosis No HBV or HIV co-infection.

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Presentation transcript:

No randomisation Open-label years HCV genotype 1 Naïve or null-response to PEG-IFN + RBV HCV RNA > 10,000 IU/ml No cirrhosis No HBV or HIV co-infection  Design N = 39 W12 N = 40  Objective –SVR 12 (HCV RNA < LLOQ) Poordad F. AASLD 2015, Abs. 41 SURVEYOR-I - Part 1 SURVEYOR-I Study - Part 1: ABT ABT-530 in genotype 1 – Phase II SVR 12 ABT mg qd + ABT mg qd ABT mg qd + ABT mg qd

ABT mg + ABT mg N = 39 ABT mg + ABT mg N = 40 Mean age, years5352 Female54%42% Race, White90%85% Mean BMI, kg/m 2 28 Mean HCV RNA, log 10 IU/ml6.6 ± ± 0.6 Genotype 1a77%85% Fibrosis stage (%) : F0-F1 / F2 / F369 / 13 / 1855 / 13 / 32 IL28B CC18%22% Treatment-naïve Null-responder to PEG-IFN + RBV 64% 36% 63% 37% Baseline characteristics Poordad F. AASLD 2015, Abs. 41 SURVEYOR-I - Part 1 SURVEYOR-I Study - Part 1: ABT ABT-530 in genotype 1 – Phase II

SVR 12, ITT (%) 1 relapse on ABT ABT mg: white male, 55 years, genotype 1a, IL28B CC, F0-F1, treatment-naïve, no RAVs at baseline, emergent NS5A RAVs at relapse (Q30K + H58D) All patients (58%) with baseline NS3 and/or NS5A RAVs achieved SVR 12 Poordad F. AASLD 2015, Abs. 41 SURVEYOR-I - Part 1 SURVEYOR-I Study - Part 1: ABT ABT-530 in genotype 1 – Phase II  100% (29/29) treatment-experienced patients achieved SVR 12  98% (49/50) treatment-naïve patients achieved SVR %

ABT mg + ABT mg N = 39 ABT mg + ABT mg N = 40 Grade 3 adverse event 1 (decreased phosphoremia) 2 (elevated blood glucose) Serious adverse event01 Adverse event leading to study discontinuation00 Adverse events in > 10% of patients Fatigue Headache Nausea 13% 21% 21% 23%13% Laboratory abnormalities ALT > 3 x ULN AST > 3 x ULN Alkaline phosphatase > 2.5 x ULN Total bilirubin > 5 x ULN Hemoglobin 8-10 g/dl Adverse events and laboratory abnormalities Poordad F. AASLD 2015, Abs. 41 SURVEYOR-I - Part 1 SURVEYOR-I Study - Part 1: ABT ABT-530 in genotype 1 – Phase II

 Summary –High SVR rates were achieved in HCV genotype 1-infected patients without cirrhosis after 12 weeks of ABT ABT-530 All but one patient achieved SVR 12 1 relapse in a patient treated with the lowest ABT mg dose –Adverse events were mostly mild in severity –Selected doses for future studies: ABT mg qd + ABT mg qd Poordad F. AASLD 2015, Abs. 41 SURVEYOR-I - Part 1 SURVEYOR-I Study - Part 1: ABT ABT-530 in genotype 1 – Phase II