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Hepatitisweb study
Hepatitisweb study
Sofosbuvir + Peginterferon + Ribavirin in Genotype 2 or 3
LONESTAR-2
Phase 2
Treatment Experienced
Lawitz E, et al. Hepatology. 2014 Oct 16. [Epub ahead of print].
Hepatitisweb studySource: Lawitz E, et al. Hepatology. 2014 Oct 16. [Epub ahead of print].
Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3LONESTAR-2 Trial: Features
LONESTAR-2 Trial: Features
Design: Open-label, single-arm, phase 2 trial of 12-week course of sofosbuvir + peginterferon + ribavirin in treatment-experienced patients with HCV GT 2 or 3
Setting: Texas Liver Institute
Entry Criteria - N = 47 patients with chronic hepatitis C- Previously failed treatment with peginterferon plus ribavirin- Excluded if coinfected with HIV or HBV- HCV genotype 2 (49%) or 3 (51%)- Compensated cirrhosis allowed
Regimen (All x 12 weeks)- Sofosbuvir: 400 mg once daily - Peginterferon alfa-2a: 180 µg once weekly- Ribavirin (weight based): 1000-1200 mg/day in 2 divided doses
Primary End-Point: SVR12
Hepatitisweb studySource: Lawitz E, et al. Hepatology. 2014 Oct 16. [Epub ahead of print].
Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3LONESTAR-2 Trial: Patient Demographics
Baseline Characteristic SOF + PEG + RBV x 12 weeks(n = 47)
Age, mean (range) 56 (39-72)
Male, n (%) 32 (68)
White, n (%) 45 (96)
Hispanic, n (%) 21 (45)
Mean Body Mass Index (BMI) kg/m2 (range) 31 (21-53)
IL28B CC, n (%) 17 (36)
HCV GT3 24 (51)
Mean baseline HCV RNA, log10 IU/ml (range) 6.2 (4.0-7.2)
Cirrhosis, % 26 (55)
Prior Relapse / virologic breakthrough 40 (85)
Hepatitisweb studySource: Lawitz E, et al. Hepatology. 2014 Oct 16. [Epub ahead of print].
Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3LONESTAR-2 Trial: Design
Sofosbuvir + Peginterferon + Ribavirin
N = 47
Drug DosingSofosbuvir: 400 mg once dailyPeginterferon alfa-2a: 180 µg once weeklyRibavirin (weight-based and in 2 divided doses): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg
GT 2 or 3
0 24Week 12
SVR12
Hepatitisweb study
Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3LONESTAR-2 Trial: Results
SVR12 in Treatment-Experienced by HCV Genotype
Source: Lawitz E, et al. Hepatology. 2014 Oct 16. [Epub ahead of print].
All GT 2 GT 30
20
40
60
80
100
8996
83
Pat
ien
ts w
ith
SV
R 1
2 (%
)
42/47 22/23 20/24
Hepatitisweb study
Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3LONESTAR-2 Trial: Results
SVR12 in Treatment-Experienced by HCV Genotype
Source: Lawitz E, et al. Hepatology. 2014 Oct 16. [Epub ahead of print].
All GT 2 GT 30
20
40
60
80
100
8996
83
Pat
ien
ts w
ith
SV
R 1
2 (%
)
42/47 22/23 20/24
Five Treatment Failures- 1 patient with GT2 lost to follow-up- 2 patients with GT3 with virologic relapse- 2 patients with GT3 lost to follow-up
Hepatitisweb study
Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3LONESTAR-2 Trial: Results
LONESTAR-2 Trial: SVR12 by Cirrhosis Status
Source: Lawitz E, et al. Hepatology. 2014 Oct 16. [Epub ahead of print].
Genotype 2 Genotype 30
20
40
60
80
100100
8393
83
No Cirrhosis Cirrhosis
Pat
ien
ts (
%)
wit
h S
VR
12
9/9 13/14 10/12 10/12
Hepatitisweb studySource: Lawitz E, et al. Hepatology. 2014 Oct 16. [Epub ahead of print].
Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3LONESTAR-2 Trial: Adverse Events
LONESTAR-2: Adverse Events in ≥ 15% of Patients
Preferred Term, n (%) SOF + PEG + RBV x 12 weeks (n = 47)
Any Adverse Event 45 (96)
Flu-like Symptoms 26 (55)
Fatigue 15 (32)
Anemia 14 (30)
Neutropenia 11 (23)
Nausea 8 (17)
Headache 7 (15)
Rash 7 (15)
Thrombocytopenia 7 (15)
Hepatitisweb studySource: Gane EJ, et al. N Engl J Med. 2013;368:34-44.
Sofosbuvir + PEG + RBV in Treatment-Experienced HCV GT 2 or 3LONESTAR-2 Trial: Conclusion
Conclusions: “In treatment-experienced patients with HCV genotypes 2 and 3, 12-week administration of sofosbuvir + peginterferon + ribavirin provided high SVR rates, irrespective of cirrhosis status. No safety concerns were identified.”
Hepatitisweb study
Hepatitisweb study
This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects.
Hepatitis C Online
www.hepatitisc.uw.edu
Hepatitis Web Study
http://depts.washington.edu/hepstudy/
Funded by a grant from the Centers for Disease Control and Prevention.