1. SURVEYOR-I Study – Part 2: ABT-493 + ABT-530 in genotype 1, 4, 5, 6 – Phase II
Design
No randomisation
Open-label
W12 W8
18-70 years
HCV genotype 1
Naïve or null-response
to PEG-IFN + RBV
HCV RNA > IU/ml
No HBV or HIV coinfection
No cirrhosis
N = 34
ABT mg qd + ABT mg qd
SVR12
Compensated cirrhosis *
ABT mg qd + ABT mg qd
SVR12
N = 27
* Metavir F4 or Fibroscan > 14.6 kPa or FibroTest ≥ APRI > 2, and Child-Pugh ≤ 6
18-70 years
HCV genotype 4, 5 or 6
Naïve or null-response
to PEG-IFN + RBV
HCV RNA > IU/ml
No HBV or HIV coinfection
No cirrhosis
N = 34
ABT mg qd + ABT mg qd
SVR12
Objective
SVR12 (HCV RNA < 25 IU/ml), by ITT
Poordad F. EASL 2016, Abs. SAT-157, J Hepatol 2016; 64:S768 ; Gane E. EASL 2016, Abs SAT-135, J Hepatol 2016; 64:S757
SURVEYOR-I– Part 2 1

2. Baseline characteristics
SURVEYOR-I Study – Part 2: ABT ABT-530 in genotype 1, 4, 5, 6 – Phase II
Baseline characteristics
ABT mg + ABT mg
No cirrhosis, N = 34
ABT mg + ABT mg
Cirrhosis, N = 27
ABT mg
+ ABT mg
GT 4, 5, 6, N = 34
Median age, years 54 59 55
Female, % 44 26 47
Race : White , % 97 89
Median BMI, kg/m2 27 28
Genotype
1a = 24 ; 1b = 10
1a = 20 ; 1b = 7
4 = 22 ; 5 = 1 ; 6 = 11
Median HCV RNA, log10 IU/ml
6.5
6.7
6.3
Fibrosis stage (%) :
F0-F1 / F2 / F3 F4
71 / 18 / 12 4 96
73 / 12 / 15
IL28B CC, % 32 15 38
Treatment-naïve, % 85 78
Poordad F. EASL 2016, Abs. SAT-157, J Hepatol 2016; 64:S768 ; Gane E. EASL 2016, Abs SAT-135, J Hepatol 2016; 64:S757, Gane E. EASL 2016, Abs SAT-137, J Hepatol 2016; 64:S758
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3. SURVEYOR-I Study – Part 2: ABT-493 + ABT-530 in genotype 1, 4, 5, 6 – Phase II
SVR12, ITT
34*
27 ** 24 % 97 96
100
* SVR12, ITTm = 100%: 1 patient discontinued study drug at W4 due to advanced carcinoma. HCV RNA was undetectable at the time of discontinuation ; achieved SVR4 but died prior to W12 post treatment
** 1 relapse at post-treatment W4: 60-year-old, white, female, genotype 1a, Fibroscan 20.9 kPa, baseline HCV RNA 6.25 log10 IU/ml, history of iv drug abuse and depression, HCV RNA undetectable by W2
Poordad F. EASL 2016, Abs. SAT-157, J Hepatol 2016; 64:S768 ; Gane E. EASL 2016, Abs SAT-135, J Hepatol 2016; 64:S757, Gane E. EASL 2016, Abs SAT-137, J Hepatol 2016; 64:S758
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4. SURVEYOR-I Study – Part 2: ABT-493 + ABT-530 in genotype 1, 4, 5, 6 – Phase II
Resistance analysis (population sequencing with 15% threshold)
Genotype 1, no cirrhosis: baseline RAVs in 76%: NS3 only in 48%,NS5A only in 15%, NS3 + NS5A in 12%
Genotype 1, cirrhosis:
Baseline RAVs in 41%: NS3 only in 30%,NS5A only in 7%, NS3 + NS5A in 11%
In patient with relapse
At baseline: I170V in NS3 and L31M in NS5A
At relapse: emergence of Y93N in NS5A (195-fold increase in EC50 to ABT-530)
Genotype 4, 5, 6: 5/22 genotype 4 had baseline NS5A RAVs, and 7/11 genotype 6 patients had baseline RAVs (NS3 only in 2,NS5A only in 4, NS3 + NS5A in 1)
Poordad F. EASL 2016, Abs. SAT-157, J Hepatol 2016; 64:S768 ; Gane E. EASL 2016, Abs SAT-135, J Hepatol 2016; 64:S757, Gane E. EASL 2016, Abs SAT-137, J Hepatol 2016; 64:S758
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5. SURVEYOR-I Study – Part 2: ABT-493 + ABT-530 in genotype 1, 4, 5, 6 – Phase II
Adverse events and laboratory abnormalities, %
Genotype 1
GT 4, 5, 6
N = 34
No cirrhosis
Cirrhosis
N = 27
Any adverse event 68 52 71
Serious adverse event
3 (n = 1, adenocarcinoma)
4 (n = 1, pulmonary embolism)
Adverse event leading to discontinuation
3 (adenocarcinoma)
Adverse events in > 10% of patients
Fatigue
Headache
Diarrhea
18 13 - 11 12 24 15
Laboratory abnormalities
ALT > 3 x ULN
AST > 3 x ULN
Alkaline phosphatase > 2.5 x ULN
Total bilirubin > 1.5 x ULN
Hemoglobin < 10 g/dl
Poordad F. EASL 2016, Abs. SAT-157, J Hepatol 2016;64:S768 ; Gane E. EASL 2016, Abs SAT-135, J Hepatol 2016;64:S757, Gane E. EASL 2016, Abs SAT-137, J Hepatol 2016;64:S758
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6. SURVEYOR-I Study – Part 2: ABT-493 + ABT-530 in genotype 1, 4, 5, 6 – Phase II
Summary
High SVR rates were achieved in HCV genotype 1-infected patients with once daily combination of ABT ABT-530
By ITTm, all patients without cirrhosis achieved SVR12 after 8 weeks of treatment (97% by ITT)
In patients with compensated cirrhosis, SVR12 was 96% after 12 weeks of treatment
No impact on efficacy of baseline NS3 and/or NS5A RAVs
Only 1 of 11 patients with cirrhosis and baseline NS3 and NS5A RAVs experienced relapse
100% SVR12 was achieved in patients with HCV genotype 4, 5 or 6 following 12 weeks of ABT ABT-530
Adverse events were mostly mild in severity
No discontinuation for adverse event related to study drug
Poordad F. EASL 2016, Abs. SAT-157, J Hepatol 2016; 64:S768 ; Gane E. EASL 2016, Abs SAT-135, J Hepatol 2016; 64:S757, Gane E. EASL 2016, Abs SAT-137, J Hepatol 2016; 64:S758
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