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Phase 2. Treatment Naïve and Treatment Experienced. Ledipasvir + Sofosbuvir +/- Ribavirin in GT 1-3 ELECTRON 2. Source: Gane EJ, et al. 49 th EASL. 2014 : Abstract O6. Sofosbuvir-Ledipasvir +/- Ribavirin in GT 1 & 3 ELECTRON 2 Trial : Features. - PowerPoint PPT Presentation
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Hepatitisweb study
Hepatitisweb study
Ledipasvir + Sofosbuvir +/- Ribavirin in GT 1-3
ELECTRON 2
Phase 2
Treatment Naïve and Treatment Experienced
Source: Gane EJ, et al. 49th EASL. 2014: Abstract O6.
Hepatitisweb studySource: Gane EJ, et al. 49th EASL. 2014: Abstract O6.
Sofosbuvir-Ledipasvir +/- Ribavirin in GT 1 & 3ELECTRON 2 Trial: Features
ELECTRON 2 Trial
Design: Open-label, phase 2, using fixed-dose combination of ledipasvir-sofosbuvir +/- ribavirin in treatment-naïve and treatment-experienced genotype 1 and in treatment-naïve genotype 3
Setting: Hepatitis treatment centers in New Zealand
Entry Criteria - Chronic HCV (n=90)- Group 1: GT1, prior failure with sofosbuvir-based regimen (all relapse)- Group 2: GT1, decompensated cirrhosis (Child-Turcotte-Pugh class B)- Group 3: GT3, treatment naïve
Primary End-Point: SVR12
Hepatitisweb studySource: Gane EJ, et al. 49th EASL. 2014: Abstract O6.
Sofosbuvir-Ledipasvir +/- Ribavirin in GT 1 & 3ELECTRON 2: Study Design
LDV-SOF + RBV SVR12GT1
Prior Sofobuvir
n = 20
n = 19
GT1CTP Class B
n = 25LDV-SOF SVR12
n = 26 LDV-SOF + RBV SVR12
LDV-SOF SVR12
Week 0 2412
Abbreviations: LDV-SOF = ledipasvir-sofosbuvir; RBV = ribavirin
Drug DosingLedipasvir-sofosbuvir (90/400 mg): fixed dose combination; one pill once dailyRibavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg
GT3Treatment Naïve
Randomized
Hepatitisweb study
Sofosbuvir-Ledipasvir +/- Ribavirin in GT 1 & 3ELECTRON-2: Baseline Characteristics
GT 1Prior SOF
GT 1CPT Class B
GT 3Treatment Naïve
LDV-SOF + RBV n=19
LDV-SOF n=20
LDV-SOFn=25
LDV-SOF + RBV n=26
Mean age, years 55 56 43 48
Male, n (%) 13 (68) 17 (85) 13 (52) 11 (42)
White, n (%) 18 (95) 17 (85) 22 (88) 23 (88)
Mean BMI, kg/m2 27 31 27 28
Cirrhosis, n (%) 0 20 (100) 3 (12) 5 (19)
IL28B CC, n (%) 4 (21) 7 (35) 9 (36) 15 (58)
GT 1a, n (%) 17 (89) 18 (90) 0 0
GT 1b, n (%) 2 (11) 2 (10) 0 0
GT 3a, n (%) 0 0 25 (100) 26 (100)
Mean HCV RNA,log10 IU/mL 6.3 6.0 6.3 6.3
Source: Gane EJ, et al. 49th EASL. 2014: Abstract O6.
Hepatitisweb study
Sofosbuvir-Ledipasvir +/- Ribavirin in GT 1 & 3ELECTRON 2: Study Design
SVR 12, by GT and Treatment Regimen
Source: Gane EJ, et al. 49th EASL. 2014: Abstract O6.
0
20
40
60
80
100100
65 64
100
Pat
ien
ts w
ith
SV
R (
%)
19/19
SOF-Experienced Treatment Naive
13/20 16/25 26/26
CTP Class B
LDV-SOF = ledipasvir-sofosbuvir; RBV = ribavirin
Hepatitisweb study
Hepatitisweb study
This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects.
Hepatitis C Online
www.hepatitisc.uw.edu
Hepatitis Web Study
http://depts.washington.edu/hepstudy/
Funded by a grant from the Centers for Disease Control and Prevention.