sofosbuvir in genotypes 2 or 3 valence trial
DESCRIPTION
Phase 3. Treatment Naïve and Treatment Experienced. Sofosbuvir in Genotypes 2 or 3 VALENCE Trial. Zeuzem S, et al. N Engl J Med. 2014 May 4. [ Epub ahead of print]. Sofosbuvir and Ribavirin for HCV GT 2 or 3 VALENCE Trial: Study Features. - PowerPoint PPT PresentationTRANSCRIPT
Hepatitisweb study
Hepatitisweb study
Sofosbuvir in Genotypes 2 or 3VALENCE Trial
Phase 3
Treatment Naïve and Treatment Experienced
Zeuzem S, et al. N Engl J Med. 2014;370:1993-2001
Hepatitisweb studySource: Zeuzem S, et al. N Engl J Med. 2014;370:1993-2001.
Sofosbuvir and Ribavirin for HCV GT 2 or 3VALENCE Trial: Study Features
VALENCE Trial: Features Design: Randomized, phase 3, using sofosbuvir + ribavirin in treatment
naive or experienced, chronic HCV GT 2 or 3 Setting: Europe Entry Criteria
- Chronic HCV Genotype 2 or 3- Treatment naïve or treatment experienced- Platelet ≥ 50,000
Patient Characteristics (range in different treatment arms)- N = 419 - Sex: male (55-62%)- Race: white (89-100%)- Cirrhosis: (14-23%)- IL28B Genotype: non-CC (64-74%)
End-Points: Primary = SVR12; Secondary = safety
Hepatitisweb studySource: Zeuzem S, et al. N Engl J Med. 2014;370:1993-2001.
Sofosbuvir and Ribavirin for HCV GT 2 or 3VALENCE: Treatment Arms
Sofosbuvir + RBV(n = 73)
Sofosbuvir + RBV(n = 250)
GT 2
GT 3
Drug DosingSofosbuvir 400 mg once dailyRibavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg
Original Study Protocol: Placebo versus 12 weeks treatment for GT 2 and 3. Amended Protocol: GT3 treatment extended from 12 to 24 weeks; Placebo arm offered alternative treatment
Note: 85 patients enrolled in placebo arm
0 24 36Week 12
SVR12
SVR12
Hepatitisweb study
Sofosbuvir and Ribavirin for HCV GT 2 or 3VALENCE: Results for Treatment Naïve and Experienced
VALENCE: SVR12 by Genotype
Source: Zeuzem S, et al. N Engl J Med. 2014;370:1993-2001.
Genotype 2 Genotype 3 0
20
40
60
80
100
9385
Patie
nt (%
) with
SVR
12
12-week Treatment 24-week Treatment
68/73 213/250
Hepatitisweb study
Sofosbuvir and Ribavirin for HCV GT 2 or 3VALENCE: Results
VALENCE: SVR12 by Genotype and Prior Treatment Experience
Source: Zeuzem S, et al. N Engl J Med. 2014;370:1993-2001.
Genotype 2 Genotype 30
20
40
60
80
100
9385
97 9490
79
All Treatment-Naïve Treatment-Experienced
Patie
nts
(%) w
ith S
VR12
68/73 213/25031/32 37/41 99/105 114/145
Hepatitisweb study
Sofosbuvir and Ribavirin for HCV GT 2 or 3VALENCE: Results for GT 2
VALENCE: GT 2 SVR12, by Treatment Experience & Liver Disease
Noncirrhotic Cirrhotic Noncirrhotic Cirrhotic0
20
40
60
80
10097 100
94
78
Patie
nts
(%) w
ith S
VR12
29/30 7/930/322/2
Treatment-Naive Treatment-Experienced
Source: Zeuzem S, et al. N Engl J Med. 2014;370:1993-2001.
Hepatitisweb study
Sofosbuvir and Ribavirin for HCV GT 2 or 3VALENCE: Results for GT 3
VALENCE: GT 3 SVR12, by Treatment Experience & Liver Disease
Source: Zeuzem S, et al. N Engl J Med. 2014;370:1993-2001.
Noncirrhotic Cirrhotic Noncirrhotic Cirrhotic0
20
40
60
80
10095 92
87
62
Patie
nts
(%) w
ith S
VR12
87/92 12/13 85/98 29/47
Treatment-Naive Treatment-Experienced
Hepatitisweb studySource: Zeuzem S, et al. N Engl J Med. 2014;370:1993-2001
Sofosbuvir and Ribavirin for HCV GT 2 or 3VALENCE: Conclusions
Conclusions: “Therapy with sofosbuvir–ribavirin for 12 weeks in patients with HCV genotype 2 infection and for 24 weeks in patients with HCV genotype 3 infection resulted in high rates of sustained virologic response.”
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.