Phase 2
Treatment Naïve and Treatment Experienced
Sofosbuvir + Ribavirin in HCV GT 4
Egyptian Ancestry Trial
Ruane P, et al. 49th EASL. April 2014. Abstract P1243.
Hepatitis
web study
Sofosbuvir and Ribavirin in HCV Genotype 4
Egyptian Ancestry Trial: Study Features
Egyptian Ancestry Genotype 4 Trial: Features
 Design: Randomized, open-label, phase 2 study of sofosbuvir + ribavirin in
treatment-naïve and treatment-experienced patients with HCV GT 4
 Setting: single study center in United States
 Entry Criteria
- HCV Genotype 4
- First generation Egyptian
- Treatment naïve or treatment experienced
- Age 18 or older
- Not co-infected with HIV
- Patients with compensated cirrhosis allowed
 Primary End-Points: Efficacy (SVR12) and safety
Source: Ruane P, et al. 49th EASL. April 2014: Abstract P1243.
Hepatitis
web study
Sofosbuvir and Ribavirin in HCV Genotype 4
Egyptian Ancestry Trial: Baseline Characteristics
Chronic HCV GT4: Treatment with Sofosbuvir + Ribavirin
Treatment Naive
Baseline Characteristic
Treatment Experienced
12-Week
(n=14)
24-Week
(n=14)
12-Week
(n=17)
24-Week
(n=15)
53 (26-69)
52 (27-75)
54 (32-72)
57 (38-68)
8 (57%)
5 (36%)
14 (82%)
14 (93%)
29.2
30.9
28.1
29.6
Cirrhosis, n %
3 (21%)
3 (21%)
4 (24%)
4 (27%)
IL28B non-CC, n (%)
11 (79%)
8 (57%)
16 (94%)
15 (100%)
Prior schistosomiasis, n (%)
8 (57%)
3 (21%)
6 (35%)
8 (53%)
5.7
5.9
6.2
6.1
Mean Age, y (range)
Male, n %
Mean BMI kg/m2
HCV RNA, mean baseline log10 IU/ml
Source: Ruane P, et al. 49th EASL. April 2014: Abstract P1243.
Hepatitis
web study
Sofosbuvir and Ribavirin in HCV Genotype 4
Egyptian Ancestry Trial: Design
Week
GT 4
Naïve
or
Experienced
0
12
Sofosbuvir + RBV
(n = 32)
24
36
SVR12
Sofosbuvir + RBV
(n = 28)
SVR12
Drug Dosing
Sofosbuvir: 400 mg once daily
Weight-Based Ribavirin (in 2 divided doses): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg
Source: Ruane P, et al. 49th EASL. April 2014: Abstract P1243.
Hepatitis
web study
Sofosbuvir and Ribavirin in HCV Genotype 4
Egyptian Ancestry Trial: Results
SVR 12 by Regimen Duration and Treatment Experience
Patients with SVR 12 (%)
100
100
87
80
79
60
59
40
20
0
11/14
14/14
10/17
13/15
SOF + RBV
x 12 weeks
SOF + RBV
x 24 weeks
SOF + RBV
x 12 weeks
SOF + RBV
x 24 weeks
Treatment Naive
Source: Ruane P, et al. 49th EASL. April 2014: Abstract P1243.
Treatment Experienced
Hepatitis
web 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.
Hepatitis
web study