Sofosbuvir in HCV Genotype 2, 3 (PEG not an Option) POSITRON
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Hepati tis web study Hepati tis web study Sofosbuvir in HCV Genotype 2, 3 (PEG not an Option) POSITRON Phase 3 *Note: Published in tandem with FUSION Trial (GT 2,3 and prior failure with PEG) Interferon Intolerant, Unwilling, or Ineligible Jacobson I, et al. N Engl J Med. 2013;368:1867-77.
description
Phase 3. Interferon Intolerant, Unwilling, or Ineligible. Sofosbuvir in HCV Genotype 2, 3 (PEG not an Option) POSITRON. *Note: Published in tandem with FUSION Trial (GT 2,3 and prior failure with PEG). Jacobson I, et al. N Engl J Med. 2013;368:1867-77. - PowerPoint PPT Presentation
Transcript of Sofosbuvir in HCV Genotype 2, 3 (PEG not an Option) POSITRON
Hepatitisweb study
Hepatitisweb study
Sofosbuvir in HCV Genotype 2, 3 (PEG not an Option)
POSITRON
Phase 3
*Note: Published in tandem with FUSION Trial (GT 2,3 and prior failure with PEG)
Interferon Intolerant, Unwilling, or Ineligible
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 + Ribavirin for HCV GT 2 or 3 (PEG not an option)POSITRON Trial: Design
POSITRON: Study Features Design: Randomized, double-blind, placebo-controlled, phase 3 trial of
sofosbuvir + ribavirin versus placebo in patients with HCV GT 2 or 3 Setting: 63 sites in US, Canada, Australia, New Zealand, enrolled March-
May 2012 Entry Criteria
- Interferon intolerant with prior treatment, ineligible, or unwilling Patient Characteristics
- N = 278 HCV-monoinfected patients- HCV Genotype: 2 (51%), 3 (49%) - IL28B Genotype: 55% non-CC - Age and Sex: 52 (range 21-75); 54% male- Race: 91% white; 5% black- Liver disease: 16% had cirrhosis
Primary End-Point: SVR12
Hepatitisweb studySource: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.
N =71 Placebo12 weeks
Sofosbuvir + RBV12 weeks
N =207 SVR12
Sofosbuvir + Ribavirin for HCV GT 2 or 3 (PEG not an option)POSITRON Trial: Design
SVR12
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 12 24Week
Hepatitisweb studySource: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.
Sofosbuvir + Ribavirin for HCV GT 2 or 3 (PEG not an option)POSITRON Trial: Reasons for Interferon Ineligibility
Interferon Category Sofosbuvir + RBV(n=207)
Placebo(n=71)
Ineligible 43% 46%
Intolerant 8% 11%
Unwilling 49% 42%
Hepatitisweb studySource: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.
Sofosbuvir + Ribavirin for HCV GT 2 or 3 (PEG not an option)POSITRON Trial: Duration on Prior Interferon
Interferon Category Sofosbuvir + RBV(n=207)
Placebo(n=71)
None 82% 79%
≤ 12 weeks 10% 11%
> 12 weeks 8% 10%
Hepatitisweb study
Week 4 Week 12 (End of Tx) SVR120
20
40
60
80
10099 100
78
Patie
nts
(%) w
ith H
CV
RN
A <
25
IU/m
lSofosbuvir for HCV Infection GT 2,3 (PEG not an option)
POSITRON: Results with Sofosbuvir + Ribavirin
POSITRON: Patients with HCV RNA <25 IU/ml by Study Timepoint
Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.
Placebo arm: 0% for each timepointAbbreviations: SOF = sofosbuvir; RBV = ribavirin
202/204 202/202 161/207
Hepatitisweb study
Sofosbuvir + Ribavirin for HCV GT 2,3 (PEG not an option)POSITRON: Results with Sofosbuvir + Ribavirin
POSITRON: SVR12 by HCV Genotype
Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.
GT 2 GT 3 0
20
40
60
80
100
93
61
Patie
nts
(%) S
VR12
Placebo arm: 0% for each timepoint
101/109 60/98
Hepatitisweb study
Sofosbuvir + Ribavirin for HCV GT 2,3 (PEG not an option)POSITRON: Results with Sofosbuvir + Ribavirin
POSITRON: SVR12 by Liver Disease
Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.
Without cirrhosis Cirrhosis0
20
40
60
80
100
81
61
Patie
nts
(%) w
ith S
VR12
Placebo arm: 0% for each timepoint
142/176 19/31
Hepatitisweb study
Sofosbuvir + Ribavirin for HCV GT 2,3 (PEG not an option)POSITRON: Results with Sofosbuvir + Ribavirin
POSITRON: SVR12 by Liver Disease and Genotype
Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.
Genotype 2 Genotype 30
20
40
60
80
100
92
68
94
21
Without Cirrhosis With Cirrhosis
Patie
nts
(%) w
ith S
VR 1
2
16/1785/92 3/1457/84
Placebo arm: 0% for each timepoint
Hepatitisweb studySource: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.
Sofosbuvir + Ribavirin for HCV GT 2,3 (PEG not an option)POSITRON Trial: Conclusions
Conclusion*: “In patients with HCV genotype 2 or 3 infection for whom treatment with peginterferon and ribavirin was not an option, 12 [or 16] weeks of treatment with sofosbuvir and ribavirin was effective. Efficacy was increased among patients with HCV genotype 2 infection and those without cirrhosis.”
*Note: This conclusion pertains to both the POSITRON and FUSION 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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