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Phase 3. Treatment Experienced. Sofosbuvir in Genotype 2 or 3 FUSION Trial. *Note: Published in NEJM in tandem with POSITRON Trial (GT 2,3 Unable to receive PEG). Jacobson I, et al. N Engl J Med. 2013;368:1867-77. - PowerPoint PPT Presentation
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Hepatitisweb study
Hepatitisweb study
Sofosbuvir in Genotype 2 or 3 FUSION Trial
Phase 3
*Note: Published in NEJM in tandem with POSITRON Trial (GT 2,3 Unable to receive PEG)
Treatment Experienced
Jacobson I, et al. N Engl J Med. 2013;368:1867-77.
Hepatitisweb studySource: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.
Sofosbuvir + RBV in Treatment-Experienced HCV GT 2 or 3FUSION Trial: Features
FUSION Trial: Features Design: Randomized, controlled, blinded phase 3 trial comparing 12 and
16 weeks of sofosbuvir + ribavirin in treatment-experienced HCV GT 2 or 3 Setting: 67 sites in US, Canada, New Zealand, enrolled May-July 2012 Entry Criteria
- Treatment-experienced (failed prior interferon-based therapy) - HCV RNA ≥ 10,000 IU/ml
Patient Characteristics- N = 201 HCV-monoinfected patients- HCV genotype: 2 (34%); 3 (63%) - IL28B genotype: 70% non-CC- Prior treatment failure: 75% relapse; 25% nonresponse - Age and sex: mean age 54 (range 24-70); 70% male- Race: 87% white; 3% black- Liver disease: 34% had cirrhosis
Primary End-Point: SVR12
Hepatitisweb studySource: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.
N =98 Sofosbuvir + RBV16 weeks
Sofosbuvir + RBV12 weeks
N =103
Sofosbuvir + RBV in Treatment-Experienced HCV GT 2 or 3FUSION Trial: Design
Placebo
Drug DosingSofosbuvir: 400 mg once dailyWeight-Based Ribavirin (in 2 divided doses): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg
0 24Week 12 16 28
SVR12
SVR12
Hepatitisweb study
Sofosbuvir + RBV in Treatment-Experienced HCV GT 2 or 3FUSION Trial: Results
FUSION: HCV RNA <25 IU/ml by Study Timepoint
Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.
Week 4 End of Tx SVR120
20
40
60
80
10097 100
50
98 100
73
SOF + RBV (12 wk) SOF + RBV (16 wk)
Patie
nts
(%) w
ith H
CV
RN
A <
25
IU/m
l
SOF= Sofosbuvir; RBV = Ribavirin
97/100 93/95 100/100 95/95 50/100 69/95
Hepatitisweb study
Sofosbuvir + RBV in Treatment-Experienced HCV GT 2 or 3FUSION Trial: Results
FUSION: SVR12 by Genotype and Treatment Duration
Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.
GT 2 _x000d_(n=68) GT 3 _x000d_(n=127)0
20
40
60
80
100
86
30
94
62
SOF + RBV (12 wks) SOF + RBV (16 wks)
Patie
nts
(%) w
ith S
VR12
SOF = Sofosbuvir; RBV = Ribavirin
31/36 30/32 19/64 39/63
Hepatitisweb study
Sofosbuvir + RBV in Treatment-Experienced HCV GT 2 or 3FUSION Trial: Results
FUSION: SVR12 by Liver Disease
Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.
No Cirrhosis_x000d_(n=127) Cirrhosis_x000d_(n=68)0
20
40
60
80
100
61
31
76
66
SOF + RBV (12 wks) SOF + RBV (16 wks)
Patie
nts
(%) w
ith S
VR12
SOF = Sofosbuvir; RBV = Ribavirin
39/64 48/63 11/36 21/32
Hepatitisweb study
No Cirrhosis Cirrhosis0
20
40
60
80
100
37
19
63 61
SOF + RBV (12 wks) SOF + RBV (16 wks)
Sofosbuvir + RBV in Treatment-Experienced HCV GT 2 or 3FUSION Trial: Results
FUSION: SVR12 by Genotype, Cirrhosis, and Duration of Therapy
Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.
No Cirrhosis Cirrhosis 0
20
40
60
80
10096
60
100
78
SOF + RBV (12 wks) SOF + RBV (16 wks)
SOF = Sofosbuvir; RBV = Ribavirin
Genotype 2 Genotype 3
25/26 23/23 6/10 7/9 14/38 25/40 5/26 14/23
Hepatitisweb studySource: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.
Sofosbuvir + RBV in Treatment-Experienced HCV GT 2 or 3FUSION Trial: Conclusions
Conclusions: “Our findings suggest that 12 weeks of treatment with sofosbuvir and ribavirin can be an effective option for patients with HCV genotype 2 infection. However, for patients with genotype 3 infection,particularly those who have cirrhosis or who have not had a response to prior treatment with interferon, extending the duration of treatmentto 16 weeks may provide an additional benefit.”
*Note: This conclusion pertains to both the FUSION and POSITRON trials, which were published in tandem
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.
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