1. No HBV or HIV co-infection
MAGELLAN-2 Study: glecaprevir/pibrentasvir in liver or kidney transplanted patients
Design
Open-label
≥ 18 years, BMI ≥ 18 kg/m²
HCV genotype 1-6
Treatment-naïve or treatment-experienced with IFN or PEG-IFN + RBV or SOF + RBV ± PEG-IFN
HCV RNA > IU/mL
Liver or kidney transplantation > 3 months with stable immunosuppression regimen
No cirrhosis
No HBV or HIV co-infection
W12
N = 100
GLE/PIB
SVR12
GLE/PIB: 100/40 mg 3 tablets QD
Patients enrolled in Australia, Canada, Italy, New Zealand, Puerto Rico, Spain, Taiwan, the United Kingdom and the United States
Objective
Primary endpoint: SVR12 (HCV < 15 IU/mL)
Non-inferiority to historical 94% SVR12 standard-of-care rate, achieved if > 86% (8% margin)
MAGELLAN-2
Reau N. EASL 2017, Abs. LBO-03 1

2. Baseline characteristics
MAGELLAN-2 Study: glecaprevir/pibrentasvir in liver or kidney transplanted patients
Baseline characteristics
GLE/PIB 12W, n = 100
Median age, years 60
Female, % 25
Race: White , % 78
Median BMI, kg/m2 26
Genotype: 1 / 2 / 3 / 4 / 5 / 6, %
57 / 13 / 24 / 4 / 0 / 2
Median HCV RNA, log10 IU/mL
6.5
Fibrosis F0-F1 / F2 / F3, %
80 / 6 / 14
Liver transplant / kidney transplant
80 / 20
Median months since transplant
55.6
Treatment-experienced, %
IFN-based / SOF-based
Treatment experienced pre-transplant / post-transplant 34
32 / 1
24 / 10
Immunosupression, %
Tacrolimus / Mycophenolic acid / Cyclosporine / Steroids / Evorolimus / Azathioprine / Sirolimus
68 / 30 / 13 /
24 / 8 / 6 / 7
MAGELLAN-2
Reau N. EASL 2017, Abs. LBO-03 2

3. MAGELLAN-2 Study: glecaprevir/pibrentasvir in liver or kidney transplanted patients
SVR12, % 99
100
Non-inferiority threshold
After exclusion of non-virologic failures
One relapse in genotype 3a
(post-treatment week 4)
One patient lost to follow-up 98
MAGELLAN-2
Reau N. EASL 2017, Abs. LBO-03

4. MAGELLAN-2 Study: glecaprevir/pibrentasvir in liver or kidney transplanted patients
Adverse events and laboratory abnormalities, N (%)
GLE/PIB 12W
N = 100
Any adverse event 85
Serious adverse event
8 *
Adverse event leading to discontinuation
1 (not related to study drugs)
Adverse events in > 10% of patients, %
Headache
Fatigue
Nausea
Pruritus
Diarrhea 22 12 10
Laboratory abnormalities
Creatinine clearance < 29 mL/min/1.73m²
AST grade ≥ 3 (> 5 x ULN)
ALT grade ≥ 3 (> 5 x ULN)
Total bilirubin ≥ grade 3 (> 3 x ULN) 2 1
* 2 related to study drugs : sinusitis (Day 2), abnormal hepatic function (post-treatment week 4)
One patient experienced mild liver transplant rejection, unrelated to study drugs
MAGELLAN-2
Reau N. EASL 2017, Abs. LBO-03 4

5. MAGELLAN-2 Study: glecaprevir/pibrentasvir in liver or kidney transplanted patients
Summary
Glecaprevir/pibrentasvir for 12 weeks achieved a 99% SVR12 rate in patients with liver or kidney transplant and genotype 1-6
This rate was not inferior to historical standard of care
Treatment was well-tolerated
MAGELLAN-2
Reau N. EASL 2017, Abs. LBO-03 5