Study C212
|
2011–2013
|
Multi-national
|
Yes
|
Single-arm
|
yes
|
85 %
|
Treatment-naïve patients + relapsers with EVR at week 4/12: 24 weeks
|
1000 mg / 1200 mg (w.a.)
|
N = 106
|
47 years
|
85 %
|
13 %
|
All other patients: 48 weeks
|
Chung 2004 [12]
|
2000–2002
|
US
|
Yes
|
RCT (not blinded)
|
no
|
82 %
|
Patients without response in week 24: 24 weeks
|
600 mg (week 1–4); 800 mg (week 5–8); 1000 mg (week >8)
|
N = 51
|
45 years
|
82 %
|
10 %
|
Patients with response in week 24: 48 weeks
|
Dahari 2010 [13]
|
n.r.
|
Brazil
|
No
|
Single-arm
|
n.r.
|
88 %
|
48 weeks
|
11 mg/kg body weight
|
N = 13
|
41 years
|
88 %
|
15 %
|
Fuster 2006 [14]
|
2001–2002
|
Spain
|
Yes
|
RCT (not blinded)
|
no
|
75 %
|
Patients with EVR in week 12: 48 weeks
|
800 mg
|
N = 51
|
39 years
|
75 %
|
39 %b
|
Patients without EVR in week 12: 48 weeks or 72 weeks (randomized)
|
Mandorfer 2014 [22]
|
n.r.
|
Austria
|
Yes
|
Single-arm
|
no
|
73 %
|
Patients with RVR in week 4: 48 weeks
|
1000 mg to 1200 mg for 12 weeks; 800 mg thereafter
|
N = 28
|
37 years
|
73 %
|
42 %
|
Patients without RVR in week 4: 72 weeks
|
Murphy 2011 [15]
|
2004–2007
|
US
|
No
|
RCT (not blinded)
|
n.r.
|
90 %
|
48 weeks
|
1000 mg / 1200 mg (w.a.)
|
N = 10
|
48 years
|
90 %
|
n.r.
|
Nunez 2007 [16]
|
2003–2006
|
Spain
|
Yes
|
Non-randomized study
|
no
|
78 %
|
Patients without EVR in week 12: 12 weeks
|
1000 mg / 1200 mg (w.a.)
|
N = 191
|
39 years
|
77 %
|
11 %
|
Patients with detectable HCV in week 24: 24 weeks
|
All other patients: 48 weeks (since August 2004: 72 weeks)
|
Rivero-Juarez 2014 [17]
|
n.r.
|
Spain
|
Yes
|
Non-randomized study
|
no
|
92 %
|
Treatment according to 2009 AASLD guidelines (48 weeks; patients with delayed virologic response: 72 weeks)
|
1000 mg / 1200 mg (w.a.)
|
N = 192
|
42 years
|
82 %
|
51 %c
|
Rodriguez-Torres 2012 [21]
|
2006–2009
|
US, Spain, Portugal
|
Yes
|
RCT (blinded)
|
no
|
89 %
|
48 weeksd
|
Treatment group 1: 800 mg
|
N = 135 (group 1)
|
45 years
|
80 %
|
12 %
|
Treatment group 2: 1000 mg / 1200 mg (w.a.)
|
N = 275 (group 2)
|
Torres-Cornejo 2014 [18]
|
2004–2011
|
Spain
|
No
|
Non-randomized study
|
no
|
85 %
|
48 weeks
|
1000 mg / 1200 mg (w.a.)
|
N = 135
|
41 years
|
85 %
|
39 %
|
Torriani 2004 [19]
|
2000–2003
|
Multi-national
|
Yes
|
RCT (blinded)
|
no
|
84 %
|
48 weeks
|
800 mg
|
N = 176
|
40 years
|
80 %
|
15 %
|
Tural 2008 [20]
|
2003–2005
|
Spain
|
Yes
|
Non-randomized study
|
n.r.
|
n.r.
|
48 weeks
|
1000 mg / 1200 mg (w.a.)
|
N = 55
|
40 years
|
67 %
|
n.r.
|