SOF RBV Randomisation 1 1 1 Openlabel BOSON Study SOF RBV PEGIFN for genotypes 2 and 3 18 years Chronic HCV infection Genotype 2 treatmentexperienced with cirrhosis ID: 611550
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Slide1
SOF + RBV
SOF + RBV
Randomisation*
1 : 1 : 1Open-label
BOSON Study: SOF + RBV + PEG-IFN for genotypes 2 and 3
≥ 18 years
Chronic HCV infection
Genotype 2, treatment-experienced with cirrhosisGenotype 3, naïve or experienced, with or without cirrhosisNo HBV or HIV co-infection
SOF + PEG-IFN + RBV
* Randomisation was stratified on genotype (2 or 3), prior therapy (yes or no) and cirrhosis (presence or absence)
N = 196
N = 199
N = 197
SVR12
SVR12
SOF 400 mg) : 1 pill QD RBV : 1000 or 1200 mg/day (bid dosing) according to body weight (< or ≥ 75 kg)PEG-IFNa-2a : 180 mg SC once weekly
ObjectiveSVR12 (HCV RNA < 15 IU/ml)
SVR12
BOSON
Foster GR.
Gastroenterology. 2015 Nov;149(6):1462-70
Design
W24
W16
W12Slide2
BOSON
Study: SOF + RBV + PEG-IFN for genotypes 2 and 3
SOF + RBV
16WN = 196
SOF + RBV
24W
N = 199
SOF + PEG-IFN + RBV12W
N = 197Mean age, years
51
49
50
Female
32%
35%
33%
Asian
14%
13%
13%
Genotype 3
92%
92%
92%
Cirrhosis
37%
37%
38%
IL28B CC genotype
38%
37%
40%HCV RNA log10 IU/ml, mean6.36.26.3Treatment-experienced54%53%52%
BOSON
Baseline characteristics
Foster GR.
Gastroenterology. 2015 Nov;149(6):1462-70Slide3
BOSON
Study: SOF + RBV + PEG-IFNfor genotypes 2 and 3
BOSONSVR12 (HCV RNA < 15 IU/ml), % (95% CI)
SOF + RBV 16W
SOF + RBV 24W
SOF +
PEG-IFN + RBV
12WGenotype 2Genotype 3All patients
In genotype 3, higher SVR
12 with SOF + PEG-IFN + RBV 12W compared to SOF + RBV for 16W or 24W, particularly in patients with cirrhosis and/or prior treatment
15
%
17
181
16
182
181
94/112
83/100
10/11
70
72
71
21
22
23
34
36
35
54
52
54Treatment NaïveTreatment ExperiencedTN no cirrhosisTN cirrhosisTE no cirrhosisTE cirrhosis%Genotype 3 by subgroupFoster GR. Gastroenterology. 2015 Nov;149(6):1462-70Slide4
BOSON
Study: SOF + RBV + PEG-IFN for genotypes 2 and 3BOSON
SVR12 in GT 3
SOF + RBV 16W
SOF + RBV 24W
SOF +
PEG-IFN + RBV
12W
40
60
100
80
80
n
99
124
20
0
87
95
51
79
88
77
88
95
64
80
91
SVR
12
(%)109126117123295744565158709183948994589070887987No CirrhosisCirrhosisTreatment HistoryNaïveExperienced
Foster GR. Gastroenterology. 2015 Nov;149(6):1462-70Slide5
BOSON
Study: SOF + RBV + PEG-IFN for genotypes 2 and 3Reasons for not achieving SVR
12Resistance analysis
BOSON
Deep sequencing
successful
on 78/88 patients with virologic failure
No S282T variantsSOF treatment-emergent variants L159F and V321A in 9/78 (21%)L159F at baseline and failure, N = 1, only at failure, N = 5V321A emerged at failure in 2 patientsPatients, n (%)
SOF + RBV
16W
N = 196
SOF + RBV
24W
N = 199
SOF + PEG-IFN + RBV
12WN = 197
SVR
12
141 (72)
170 (85)
183 (93)
On-treatment failure
0
3 (2)
0
Relapse
52/195 (27)
24/195 (12)
9/195 (5)
Other*
3 (2)
2 (1)5 (3)* Patients who discontinued before achieving HCV RNA < LLOQ or did not return for week 12 post-treatment visitFoster GR. Gastroenterology. 2015 Nov;149(6):1462-70Slide6
SOF + RBV
16W
N = 196
SOF + RBV
24W
N = 199
SOF +
PEG-IFN
+ RBV12W
N = 197
Grade 3–4
adverse event
11 (6)
7 (4)
15 (8)
Serious
adverse event
8 (4)
10 (5)
12 (6)
Treatment
discontinuation due
to
AE
3 (2)
2 (1)
1 (< 1)
Adverse event ≥ 15% in any arm
Fatigue
36%
41%
46%Headache31%36%36%Insomnia 24%28%25%Nausea16%17%25%
Rash
12%
14%
20%
Flu-like illness
4%
4%
19%
Decreased appetite
7%
8%
18%
Myalgia
6%
10%
17%
Dyspnea
exertional
11%
11%
15%
Pyrexia
3%
4%
15%
Hemoglobin < 10g/dl / 8.5
g/
dL
4% / 0
6% / 0
12% / 1%
BOSON
Study
: SOF + RBV
+
PEG-IFN
for
genotypes 2 and 3
BOSON
Adverse events,
N
(%)
Foster GR.
Gastroenterology. 2015 Nov;149(6):1462-70Slide7
BOSON
Study: SOF + RBV + PEG-IFN for genotypes 2 and 3Summary
Genotype 2 : treatment-experienced patients with cirrhosis achieved high SVR12 rates with all regimens Genotype 3 : higher SVR12 rates with SOF + PEG/RBV than with SOF + RBV for 16 or 24 weeks Genotype 3 treatment-experienced patients with cirrhosis achieved an SVR12 of 86% with SOF + PEG + RBV for 12 weeks SOF + RBV for 24 weeks achieved SVR12 rates > 80% in all other subgroups; results consistent with earlier phase III studies SOF + RBV for 16 or 24 weeks and SOF + PEG + RBV for 12 weeks were well tolerated with a low rate of treatment discontinuations due to adverse events
BOSONFoster GR. Gastroenterology. 2015 Nov;149(6):1462-70