Kris V. Kowdley, Eric Lawitz, Fred Poordad, Daniel E

Kris V. Kowdley, Eric Lawitz, Fred Poordad, Daniel E

Kris V. Kowdley, Eric Lawitz, Fred Poordad, Daniel E. Cohen,
David Nelson, Stefan Zeuzem, Gregory T. Everson, Paul Kwo,
Graham R. Foster, Mark Sulkowski, Wangang Xie, Tami Pilot-Matias, George Liossis, Lois
Larsen, Amit Khatri, Thomas Podsadecki, Barry Bernstein
Abstract LB‐1
Treatment-naïve
N
Regimen/Duration
150/100
80
41
ABT-450 ABT-333 RBV
RBV
150/100
79
ABT-450 ABT-267
RBV
100/100,200/100
79
ABT-450 ABT-267 ABT-333
79
ABT-450 ABT-267 ABT-333 RBV
80
ABT-450 ABT-267 ABT-333 RBV
Wk 0
Null
Responder
ABT-450/r Dose (QD)
ABT-450 ABT-267 ABT-333
150/100
Wk 8
100/100,150/100
100/100,150/100
Wk 12
Wk 24
45
ABT-450 ABT-267
RBV
200/100
45
43
ABT-450 ABT-267 ABT-333 RBV
100/100,150/100
ABT-450 ABT-267 ABT-333 RBV
100/100,150/100
ABT-267 25mg QD; ABT-333 400mg BID; RBV weight-based 1000-1200 mg daily dose divided BIDAll patients to be followed through 48 weeks
post-treatment
Kowdley K, et al. 63rd AASLD; Boston, MA; November 9-13, 2012; Abst. LB-1.
Treatment-naïve Patients
Duration
8 wks
450/r
267
333
RBV
450/r
Regimen
333
RBV
RBV
Null Responders
12 wks
450/r
267
12 wks
450/r
267
333
450/r
267
333
RBV
450/r
267
RBV
450/r
267
333
RBV
80
41
79
79
79
45
45
Breakthroughs (N)
0
1
1
1
0
0
3
Relapses (N)
9
4
5
5
1
5
0
Lost to follow-up or
withdrawn consent prior
to SVR12
1
1
2
4
1
0
0
SVR12 rate (ITT)a, % (n/N)
87.5%
(70/80)
85.4%
(35/41)
89.9%
(71/79)
87.3%
(69/79)
97.5%
(77/79)
88.9%
(40/45)
93.3%
(42/45)
88.6%
(70/79)
87.5%
(35/40)
92.2%
(71/77)
92.0%
(69/75)
98.7%
(77/78)
88.9%
(40/45)
93.3%
(42/45)
Number dosed
SVR12 rate (Observed
data)b,
% (n/N)
aITT:
Intent-to-treat population, includes all patients who received at least one dose of study drug
data: Excludes patients with values missing for reasons other than virologic failure or discontinuation due to AEs
bObserved
Percentage of patients
achieving SVR12
Kowdley K, et al. 63rd AASLD; Boston, MA; November 9-13, 2012; Abst. LB-1.
96
100
90 86
80
70
60
50
96
40 84
30
20
10
56 24
0
100
82
100
100
88
100
98 100
88
100
79
85
83
100
81
96
96 100
100
89
ITT
Observed data
100
81
89
100
28 17 :N
29 12
52 27
52 25
54 25
26 18
1a 1b
1a 1b
1a 1b
1a 1b
1a 1b
1a 1b
1a 1b
ABT-450
ABT-267
ABT-333
RBV
ABT-450
ABT-450
ABT-267
ABT-450
ABT-267
ABT-333
ABT-450
ABT-267
ABT-333
RBV
ABT-450
ABT-267
ABT-450
ABT-267
ABT-333
RBV
8 weeks
ABT-333
RBV
RBV
12 weeks
Treatment-naϊve patients
Kowdley K, et al. 63rd AASLD; Boston, MA; November 9-13, 2012; Abst. LB-1.
RBV
12 weeks
Null Responders
Percentage of patients
achieving SVR12
100
90
80
70
60
50
40
30
20
10
0
100
96
85
86 85
100 97
86
100
100
89
87 88
93
IL28B CC
IL28B non-CC
22 56
14 27
ABT-450
ABT-267
ABT-333
RBV
8 weeks
ABT-450
ABT-333
RBV
21 58
ABT-450
ABT-267
23 56
22 57
ABT-450
ABT-267
ABT-333
RBV
12 weeks
Treatment-naϊve patients
Kowdley K, et al. 63rd AASLD; Boston, MA; November 9-13, 2012; Abst. LB-1.
ABT-450
ABT-267
ABT-333
RBV
1 44
ABT-450
ABT-267
RBV
2 43
:N
ABT-450
ABT-267
ABT-333
RBV
12 weeks
Null Responders