1. MAGELLAN-3 Study: GLE/PIB + SOF + RBV in patients who failed GLE/PIB
Design
No randomisation
Open-label
W12
W16
≥ 18 years
HCV genotype 1-6
Experienced virologic failure with
GLE/PIB IFN in an AbbVie clinical study *
GLE/PIB treatment completed or discontinued ≥ 1 month prior to screening
No decompensated cirrhosis
HI co-infection allowed
No HBV co-infection
No cirrhosis,
GT1, 2, 4-6
No prior NS5A or PI
N = 2
GLE/PIB + SOF + RBV
Cirrhosis, or Genotype 3
or prior NS5A or PI
GLE/PIB + SOF + RBV
N = 21
* SURVEYOR-2, ENDURANCE-3, MAGELLAN-1, EXPEDITION-1
GLE/PIB: 100/40 mg 3 tablets QD
SOF: 400 mg QD
RBV: mg (BID regimen)
Primary endpoint
SVR12 (HCV < LLOQ)
MAGELLAN-3
Wyles D. EASL 2018, Abs. PS-040 1

2. MAGELLAN-3 Study: GLE/PIB + SOF + RBV in patients who failed GLE/PIB
Baseline characteristics
GLE/PIB + SOF + RBV 12 W
N = 2
GLE/PIB + SOF + RBV 16 W
N = 21
Median age, years (range)
56 (56-56)
56 (38-67)
Male, N (%)
1 (50%)
17 (81%)
Race: White, N (%)
2 (100%)
18 (86%)
Median BMI, kg/m2 (range)
35.1 ( )
26.2 ( )
Genotype: 1 / 1a / 2 / 3, N
0 / 0 / 2 / 0
7 / 6 / 0 / 14
Median HCV RNA, log10 IU/mL
6.6 ( )
6.3 ( )
Fibrosis F0-F2 / F3 / F4, N
2 / 0 / 0
14 / 0 / 7
Treatment naïve before GLE/PIB, N 15
NS5A inhib.-experienced before GLE/PIB, N 6
Baseline substitutions, N
NS3 alone
NS5A alone
Both NS3 and NS5A 2 16 5
MAGELLAN-3
Wyles D. EASL 2018, Abs. PS-040 2

3. MAGELLAN-3 Study: GLE/PIB + SOF + RBV in patients who failed GLE/PIB
Primary Endpoint (SVR12)
Treatment arm
Genotype 21 2 23
100
95 * 96 %
N = 2 7 14
100
86 * %
N =
* One relapse: genotype 1a, compensated cirrhosis, failed LDV/SOF prior to GLE/PIB
MAGELLAN-3
Wyles D. EASL 2018, Abs. PS-040 3

4. MAGELLAN-3 Study: GLE/PIB + SOF + RBV in patients who failed GLE/PIB
Adverse events and laboratory abnormalities, N (%)
N = 23
Any adverse event
19 (83%)
Serious adverse event
1 (4%)*
Adverse event leading to discontinuation
Adverse events in > 10% of patients, N (%)
Headache
Pruritus
Dizziness
Irritability
Fatigue
Insomnia
Upper respiratory tract infection
6 (26%)
5 (22%)
4 (17%)
3 (13%)
Laboratory abnormalities, N (%)
RBV dose reductions due to toxicity
ALT grade ≥ 3 (5 x ULN)
Total bilirubin grade 3 (> 3 x ULN)
1 (4%)
*Not related to study drugs, not leading to drug discontinuation
MAGELLAN-3
Wyles D. EASL 2018, Abs. PS-040 4

5. MAGELLAN-3 Study: GLE/PIB + SOF + RBV in patients who failed GLE/PIB
Summary
GLE/PIB + SOF + RBV resulted in 96% SVR12 in patients with previous GLE/PIB virologic failure
100% SVR12 in the 14 patients with genotype 3
Treatment was well-tolerated
MAGELLAN-3
Wyles D. EASL 2018, Abs. PS-040 5