1. EXPEDITION-V Study: GLE/PIB in patients with renal impairment
Design
No randomisation
Open label W8
W12
W16
≥ 18 years, HCV genotype 1-6
HCV RNA > IU/mL
Treatment-naïve (TN) or treatment-experienced (TE) without DAA except SOF
With or without cirrhosis
Chronic kidney disease stage 3b, 4 or 5 *
No HBV or HIV co-infection
N = 84
GLE/PIB
N = 13
GLE/PIB
N = 4
GLE/PIB
8W: no cirrhosis, TN (GT 1 to 6) or TE (GT 1,2, 4,-6
12W: cirrhosis, TN (GT 1 to 6) or TE (GT 1,2, 4,-6)
16W: TE, GT3
* stage 3b: eGFR ≥ 30 to < 45 mL/min/1.73m² ;
stage 4: eGFR ≥ 15 to < 30 mL ;
stage 5: eGFR<15 mL or dialysis-dependent
GLE/PIB: 100/40 mg 3 tablets QD, administered regardless of timing of dialysis (hemo- or peritoneal)
Primary endpoint
SVR12 (HCV < LLOQ)
EXPEDITION-V
Persico N. EASL 2018, Abs. THU-363 1

2. EXPEDITION-V Study: GLE/PIB in patients with renal impairment
Baseline characteristics
GLE/PIB 8W
N = 84
GLE/PIB 12W
N = 13
GLE/PIB 16W
N = 4
Median age, years (range)
59 (32-84)
58 (49-87)
62 (54-70)
Male, N (%)
51 (61%)
7 (54%)
2 (50%)
Race: White, N (%)
62 (74%)
8 (62%)
4(100%)
Median BMI, kg/m2 (range)
24.9 ( )
28.7 ( )
24.3 ( )
Genotype: 1 / 2 / 3 / 4 / 5 / 6, %
54 / 31 / 11 / 4 / 0 / 0
69 / 8 / 15 / 8 / 0 / 0
0 / 0 / 100 / 0 / 0 / 0
Median HCV RNA, log10 IU/mL
5,9 ( )
5.6 ( )
6.6 ( )
Fibrosis F0-F1 / F2 / F3 / F4, %
73 / 6 / 19 / 1
0 / 0 / 0 / 100
100 / 0 / 0 / 0
Naïve/experienced, %
82 / 18
92 / 8
0 / 100
CKD stage 3b / 4 / 5, %
5 / 17 / 79
23 / 15 / 62
0 / 25 / 75
On dialysis, N (%)
66 (79%)
3 (75%)
EXPEDITION-V
Persico N. EASL 2018, Abs. THU-363 2

3. EXPEDITION-V Study: GLE/PIB in patients with renal impairment
Primary Endpoint (SVR12) 13 84 4
101 98
96 *
100 97
100 **
N = %
* 1 patient had missing data and 2 patients discontinued treatment
** 1 patient with NS5A Y93H RAS achieved SVR12
EXPEDITION-V
Persico N. EASL 2018, Abs. THU-363 3

4. EXPEDITION-V Study: GLE/PIB in patients with renal impairment
Adverse events and laboratory abnormalities, %
Overall
N = 101
Any adverse event 55
Grade ≥ 3 adverse event / serious adverse event
13 / 12 *
Adverse event leading to discontinuation 2
Adverse events in > 5% of patients
Pruritus
Hypertension
Generalized pruritus
Bronchitis
Diarrhea 22 12 10
Laboratory abnormalities
AST grade ≥ 3 (5 x ULN)
ALT grade ≥ 3 (5 x ULN)
Total bilirubin grade 3 (> 3 x ULN)
* No AE related to treatment
No death observed
EXPEDITION-V
Persico N. EASL 2018, Abs. THU-363 4

5. EXPEDITION-V Study: GLE/PIB in patients with renal impairment
Renal function
Of the 24 patients with CKD stage 3b or 4 and with available results, eGFR remained unchanged from screening to end of treatment and post-treatment week 4: 27.1 ± 9.2 vs 26.4 ± 9.8 vs 27.4 ± 11.6 mL/min/1.73m²
CKD stage remained unchanged in 22/24 patients with end of treatment results and declined in 2/24 from screening to end of treatment
EXPEDITION-V
Persico N. EASL 2018, Abs. THU-363 5

6. EXPEDITION-V Study: GLE/PIB in patients with renal impairment
Summary
GLE/PIB is highly efficacious in patients with chronic kidney disease stage 3b to 5 with the label recommended treatment durations based on genotype, cirrhosis status and prior treatment experience
Treatment was well-tolerated
Overall, renal function remained unchanged after treatment in pre-dialysis patients assessed
EXPEDITION-V
Persico N. EASL 2018, Abs. THU-363 6