No randomisationOpen-label

18-70 yearsHCV genotype 1

Naïve or null-response to PEG-IFN + RBV

HCV RNA > 10,000 IU/mlNo cirrhosis

No HBV or HIV co-infection

Design

N = 39

W12

N = 40

Objective– SVR12 (HCV RNA < LLOQ)

Poordad F. AASLD 2015, Abs. 41SURVEYOR-I - Part 1

SURVEYOR-I Study - Part 1: ABT-493 + ABT-530 in genotype 1 – Phase II

SVR12

ABT-493 200 mg qd + ABT-530 120 mg qd

ABT-493 200 mg qd + ABT-530 40 mg qd

ABT-493 200 mg + ABT-530 40 mg

N = 39

ABT-493 200 mg + ABT-530 120 mg

N = 40Mean age, years 53 52Female 54% 42%Race, White 90% 85%Mean BMI, kg/m2 28 28Mean HCV RNA, log10 IU/ml 6.6 ± 0.6 6.7 ± 0.6Genotype 1a 77% 85%

Fibrosis stage (%) : F0-F1 / F2 / F3 69 / 13 / 18 55 / 13 / 32

IL28B CC 18% 22%

Treatment-naïveNull-responder to PEG-IFN + RBV

64%36%

63%37%

Baseline characteristics

Poordad F. AASLD 2015, Abs. 41SURVEYOR-I - Part 1

SURVEYOR-I Study - Part 1: ABT-493 + ABT-530 in genotype 1 – Phase II

SVR12, ITT (%)

1 relapse on ABT-493 + ABT-530 40 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 RAVsachieved SVR12

Poordad F. AASLD 2015, Abs. 41SURVEYOR-I - Part 1

SURVEYOR-I Study - Part 1: ABT-493 + ABT-530 in genotype 1 – Phase II

100% (29/29) treatment-experienced patients achieved SVR12

98% (49/50) treatment-naïve patients achieved SVR12

ABT-493 200 mg + ABT-530 40 mg

ABT-493 200 mg + ABT-530 120 mg

0

20

40

60

80

100

4039

97 100%

ABT-493 200 mg + ABT-530 40 mg

N = 39

ABT-493 200 mg + ABT-530 120 mg

N = 40

Grade 3 adverse event1

(decreased phosphoremia)

2(elevated blood

glucose)Serious adverse event 0 1Adverse event leading to study discontinuation 0 0Adverse events in > 10% of patients

FatigueHeadacheNausea

13%21%21%

23%13%13%

Laboratory abnormalitiesALT > 3 x ULNAST > 3 x ULNAlkaline phosphatase > 2.5 x ULNTotal bilirubin > 5 x ULNHemoglobin 8-10 g/dl

00000

00001

Adverse events and laboratory abnormalities

Poordad F. AASLD 2015, Abs. 41SURVEYOR-I - Part 1

SURVEYOR-I Study - Part 1: ABT-493 + 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-493 + ABT-530

• All but one patient achieved SVR12

• 1 relapse in a patient treated with the lowest ABT-530 40 mg dose– Adverse events were mostly mild in severity– Selected doses for future studies: ABT-493 300 mg qd

+ ABT-530 120 mg qd

Poordad F. AASLD 2015, Abs. 41SURVEYOR-I - Part 1

SURVEYOR-I Study - Part 1: ABT-493 + ABT-530 in genotype 1 – Phase II