Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin
Sofosbuvir and Ribavirin +/- Peginterferon in GT 1-3 ELECTRON Trial (Arms 1-8)
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Hepati tis web study Hepati tis web study Sofosbuvir and Ribavirin +/- Peginterferon in GT 1-3 ELECTRON Trial (Arms 1-8) Phase 2a Treatment Naïve and Treatment Experienced Gane EJ, et al. N Engl J Med. 2013;368:34-44.
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Phase 2a. Treatment Naïve and Treatment Experienced. Sofosbuvir and Ribavirin +/- Peginterferon in GT 1-3 ELECTRON Trial (Arms 1-8). Gane EJ, et al. N Engl J Med. 2013;368:34-44. . Sofosbuvir and Ribavirin +/- Peginterferon in GT 1-3 ELECTRON Trial (Arms 1-8 ): Features. - PowerPoint PPT Presentation
Transcript of Sofosbuvir and Ribavirin +/- Peginterferon in GT 1-3 ELECTRON Trial (Arms 1-8)
Hepatitisweb study
Hepatitisweb study
Sofosbuvir and Ribavirin +/- Peginterferon in GT 1-3ELECTRON Trial (Arms 1-8)
Phase 2a
Treatment Naïve and Treatment Experienced
Gane EJ, et al. N Engl J Med. 2013;368:34-44.
Hepatitisweb studySource: Gane EJ, et al. N Engl J Med. 2013;368:34-44.
Sofosbuvir and Ribavirin +/- Peginterferon in GT 1-3ELECTRON Trial (Arms 1-8): Features
ELECTRON Trial (Arms 1-8): Features Design: Randomized, double-blind, phase 2a trial comparing different
combinations of sofosbuvir and ribavirin with or without peginterferon Setting: 2 hepatitis C treatment centers in New Zealand Entry Criteria
- HCV RNA > 50,000 IU/mL- No cirrhosis
Study Arms- Arms 1-6: genotype 2,3 treatment naïve: SOF + RBV +/- PEG- Arm 7: GT 1; treatment experienced, prior null responder: SOF + RBV - Arm 8: GT 1; treatment naïve: SOF + RBV
Primary End-Point: SVR12
Hepatitisweb studySource: Gane EJ, et al. N Engl J Med. 2013;368:34-44.
Sofosbuvir and Ribavirin +/- Peginterferon in GT 1-3ELECTRON Trial (Arms 1-8): Design
SOF + RBV
N =14Drug DosingSofosbuvir (SOF): 400 mg once dailyRibavirin (RBV) weight-based and divided bid: 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kgPeginterferon alfa-2a (PEG): 180 µg once weekly
n = 9
n = 10
SOF + RBV + PEG (week 1-4)
n = 10 SOF + RBV + PEG (week 1-8)
n = 11 SOF + RBV + PEG
SOF
SOF + RBV + PEG
SOF + RBV
SOF + RBV SVR12
n = 10
n = 10
n = 10
n = 25
SVR12
SVR12
SVR12
SVR12
SVR12
SVR12
SVR12GT 1 Null
GT 2,3Naïve
GT 1 Naive
0 20 24Week 8 12
Hepatitisweb study
Sofosbuvir and Ribavirin +/- Peginterferon in GT 1-3ELECTRON Trial (Arms 1-8): Results
ELECTRON: SVR 12, by Treatment Regimen
Source: Gane EJ, et al. N Engl J Med. 2013;368:34-44.
SOF 12 wks _x000d_RBV
12 wks
SOF 12 wks _x000d_RBV
12 wks _x000d_PEG
wk 1-4
SOF 12 wks _x000d_RBV
12 wks _x000d_PEG
wk 1-8
SOF 12 wks _x000d_RBV
12 wks _x000d_PEG
12 wks
SOF 12 wks SOF 8 wks _x000d_RBV
8 wks_x000d_PEG 8 wks
SOF 12 wks _x000d_RBV
12 wks
SOF 12 wks _x000d_RBV
12 wks
0
20
40
60
80
100100 100 100 100
60
100
10
84
Patie
nts
with
SVR
(%)
10/10
Genotype 2 or 3 (all treatment naïve) Genotype 1Exp-Null Naive
9/9 10/10 11/11 6/10 10/10 21/25
1/10
Hepatitisweb studySource: Gane EJ, et al. N Engl J Med. 2013;368:34-44.
Sofosbuvir + RBV in Treatment-Experienced HCV GT 2 or 3ELECTRON Trial (Arms 1-8): Conclusions
Conclusions: “Sofosbuvir plus ribavirin for 12 weeks may be effective in previously untreated patients with HCV genotype 1, 2, or 3 infection.”
Hepatitisweb study
Hepatitisweb study
This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects.
Hepatitis C Onlinewww.hepatitisc.uw.edu
Hepatitis Web Studyhttp://depts.washington.edu/hepstudy/
Funded by a grant from the Centers for Disease Control and Prevention.
