1. Compensated cirrhosis No HBV or HIV co-infection
EXPEDITION-I Study: glecaprevir/pibrentasvir in genotype 1, 2, 4, 5 or 6 with compensated cirrhosis
Design
Open-label
W12
≥ 18 years
HCV genotype 1, 2, 4, 5, 6
HCV RNA ≥ 1000 IU/mL
Treatment-naïve or treatment-experienced with IFN or PEG-IFN + RBV or SOF + RBV ± PEG-IFN
Compensated cirrhosis
No HBV or HIV co-infection
N = 146
GLE/PIB
SVR12
GLE/PIB: 100/40 mg 3 tablets QD
Patients enrolled in Belgium, Canada, Germany, South Africa, Spain and the United States
Objective
Primary endpoint: SVR12 (HCV < 15 IU/mL)
EXPEDITION-I
Forns X. EASL 2017, Abs. GS-006 1

2. Baseline characteristics
EXPEDITION-I Study: glecaprevir/pibrentasvir in genotype 1, 2, 4, 5 or 6 with compensated cirrhosis
Baseline characteristics
GLE/PIB 12W
N = 146
Median age, years 60
Female, % 38
Race: White, % 82
Median BMI, kg/m2 29
Genotype: 1a / 1b / 2 / 4 / 5 / 6, %
33 / 27 / 23 / 11 / 1 / 5
Median HCV RNA, log10 IU/mL
6.1
Child-Pugh score at screening : 5 / 6, %
91 / 9
Treatment naïve, % 75
Treatment-experienced, %
IFN-based
SOF-based 25 69 31
Baseline RASs : None / NS3 only / NS5A only / NS3 + NS5A, %
57 / 2 / 40 / 2
EXPEDITION-I
Forns X. EASL 2017, Abs. GS-006 2

3. EXPEDITION-I Study: glecaprevir/pibrentasvir in genotype 1, 2, 4, 5 or 6 with compensated cirrhosis
SVR12 by ITT, % 99
100
100
100
100 99 90 31 16 2 7
146
One patient with genotype 1a relapsed at post-treatment week 8
- NS5A RASs: Y93N at baseline, Y93N, Q30R and H58D present at failure
- NS3 RASs: none
EXPEDITION-I
Forns X. EASL 2017, Abs. GS-006

4. Adverse events and laboratory abnormalities, N (%)
EXPEDITION-I Study: glecaprevir/pibrentasvir in genotype 1, 2, 4, 5 or 6 with compensated cirrhosis
Adverse events and laboratory abnormalities, N (%)
GLE/PIB 12W
N = 146
Any adverse event
101 (69%)
Serious adverse event
11 (8%)
Adverse event leading to discontinuation
Adverse events in > 10% of patients, %
Fatigue
Headache
Pruritus 19 14 10
Laboratory abnormalities
Hemoglobin < 8 g/dL
Platelet count x 109/L
AST grade ≥ 3 (> 5 x ULN)
ALT grade ≥ 3 (> 5 x ULN)
Total bilirubin grade ≥ 3 (> 3 x ULN)
1 (0.7%)
2 (1%)
No serious adverse event related to study drugs
Occurrence of hepatocellular carcinoma in 2 patients
One patient with a history of hemophilia died (post-treatment cerebral hemorrhage, not related to study drugs)
EXPEDITION-I
Forns X. EASL 2017, Abs. GS-006 4

5. EXPEDITION-I Study: glecaprevir/pibrentasvir in genotype 1, 2, 4, 5 or 6 with compensated cirrhosis
Summary
Glecaprevir/pibrentasvir for 12 weeks achieved a 99% SVR12 rate in patients with compensated cirrhosis and genotype 1, 2, 4, 5 or 6
Treatment was well-tolerated
EXPEDITION-I
Forns X. EASL 2017, Abs. GS-006 5