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Hepatitisweb study
Hepatitisweb study
Sofosbuvir + Ribavirin in HCV Genotype 1
NIH SPARE
Phase 2
Treatment Naïve (unfavorable baseline treatment characteristics)
Osinusi A, et al. JAMA. 2013;310:804-11.
Hepatitisweb studySource: Osinusi A, et al. JAMA. 2013;310:804-11.
Sofosbuvir and Ribavirin for Treatment-Naïve HCV GT 1NIH SPARE Trial: Features
NIAID/NIH Trial: Features
Design - Randomized, open-label, 2-part, phase 2 study of sofosbuvir and ribavirin- Part 1: “proof of concept”- Part 2: low dose versus weight-based dose of ribavirin in GT-1
Setting: Single center: NIAID
Entry Criteria: HCV genotype 1; treatment-naïve
Patient Characteristics- N = 60 HCV-monoinfected patients- HCV Genotype: 1A (70%), 1B (30%) - IL28B Genotype: 81% non-CC - Age and Sex: median 54 (range 48-57); 62% male- Race: 83% black; 13% white- Liver disease: 23% had advanced fibrosis (F3-F4 by Knodell-HAI scoring)
Primary end-points: Efficacy (SVR24) and safety
Hepatitisweb studySource: Osinusi A, et al. JAMA. 2013;310:804-11.
Part 2N =50
Sofosbuvir + RBV (low-dose)24 weeks
Sofosbuvir + RBV (wt-based)24 weeks
Part 1N =10
Sofosbuvir and Ribavirin for Treatment-Naïve HCV GT 1NIH SPARE Trial: Design
SVR24
Sofosbuvir + RBV (wt-based)24 weeks
SVR24
N =25
N =25
Drug DosingSofosbuvir: 400 mg once dailyLow-dose Ribavirin (divided bid): 800 mg/dayWeight-based Ribavirin (divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg
SVR24
0 24 48Week
Hepatitisweb study
Sofosbuvir and Ribavirin for Treatment-Naïve HCV GT 1NIH SPARE Trial: Part 1 Results
NIH SPARE Part 1: HCV <12 IU/ml by Study Timepoint
Source: Osinusi A, et al. JAMA. 2013;310:804-11.
Week 4 Week 24 (End of Tx) SVR240
20
40
60
80
100
80
90 90
Pa
tie
nts
(%
) w
ith
HC
V R
NA
< 1
2
IU/m
l
All 10 patients in Part 1 received sofosbuvir plus weight-based ribavirin
8/10 9/10 9/10
Hepatitisweb study
Sofosbuvir and Ribavirin for Treatment-Naïve HCV GT 1NIH SPARE Trial: Part 2 Results
NIAID/NIH Part 2: HCV RNA <12 IU/ml by Study Timepoint
Source: Osinusi A, et al. JAMA. 2013;310:804-11.
Week 4 Week 24 (End of Tx) SVR240
20
40
60
80
100
9688
48
96 96
68
SOF + RBV (low dose) SOF + RBV (weight based)
Pa
tie
nts
(%
) w
ith
HC
V R
NA
< 1
2 IU
/ml
SOF = Sofosbuvir; RBV = Ribavirin
24/25 24/25 22/25 24/25 12/25 17/25
Hepatitisweb study
Sofosbuvir and Ribavirin for Treatment-Naïve HCV GT 1NIH SPARE Trial: Part 2 Results
NIH SPARE Part 2: SVR24 by Fibrosis Stage
Source: Osinusi A, et al. JAMA. 2013;310:804-11.
Early Stage (0-1*) Advanced (3-4*)0
20
40
60
80
100
56
29
74
50
SOF +RBV (Low Dose) SOF +RBV (Wt-Based)
Fibrosis Stage (Knodell Histology Activity Index Scoring System)
Pat
ien
ts (
%)
wit
h S
VR
24
SOF = Sofosbuvir; RBV = Ribavirin
3/62/714/1910/18
Hepatitisweb study
>800,000 IU/ml <800,000 IU/ml0
20
40
60
80
100
21
82
63
78
SOF +RBV (Low Dose) SOF +RBV (Wt-Based)
HCV RNA Level
Pat
ien
ts (
%)
wit
h S
VR
24Sofosbuvir and Ribavirin for Treatment-Naïve HCV GT 1
NIH SPARE Trial: Part 2 Results
NIH SPARE Part 2: SVR24 by Baseline HCV RNA Level
Source: Osinusi A, et al. JAMA. 2013;310:804-11.
SOF= Sofosbuvir; RBV = Ribavirin
7/99/1110/163/14
Hepatitisweb studySource: Osinusi A, et al. JAMA. 2013;310:804-11.
Sofosbuvir and Ribavirin for Treatment-Naïve HCV GT 1NIH SPARE Trial: Conclusions
Conclusion: “In conclusion, treatment with a 24-week regimen of
sofosbuvir and ribavirin resulted in an SVR rate of 68% in the weight-
based ribavirin regimen and 48% in the low-dose ribavirin regimen
among patients with chronic HCV and unfavorable traditional predictors
of treatment response who are representative of the demographics of the
US HCV epidemic.”
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.