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Phase 2. Treatment Naïve (unfavorable baseline treatment characteristics). Ledipasvir-sofosbuvir +/- 3 rd DAA in HCV Genotype 1 NIH SYNERGY. Kohli A, et al. 21 st CROI. 2014:Abstract 27LB. . Sofosbuvir-Ledipasvir +/- GS-9669 or GS-9451 in Naïve GT1 NIH SYNERGY Trial : Features. - PowerPoint PPT Presentation
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Hepatitisweb study
Hepatitisweb study
Ledipasvir-Sofosbuvir +/- 3rd DAA in HCV Genotype 1 NIH SYNERGY
Phase 2
Treatment Naïve (unfavorable baseline treatment characteristics)
Kohli A, et al. 21st CROI. 2014:Abstract 27LB.
Hepatitisweb studySource: Kohli A, et al. 21st CROI. 2014:Abstract 27LB.
Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1NIH SYNERGY Trial: Features
NIH SYNERGY Trial Design: Open-label, phase 2, using fixed dose ledipasvir-sofosbuvir alone
or in combination with either GS-9669 (non-nucleoside NS5B inhibitor) or GS-9451 (NS3/4A protease inhibitor) in treatment-naïve GT 1
Setting: single site, United States Entry Criteria
- Chronic HCV Genotype 1- Treatment naive- HCV RNA > 50,000 IU/mL
Patient Characteristics- N = 60 adult patients- Demographics: 72% male; 88% black- IL28B Genotype: 80% with non-CC- Liver Fibrosis: 70% Knodell HAI Fibrosis score 0-2
Primary End-Point: SVR12
Hepatitisweb studySource: Kohli A, et al. 21st CROI. 2014:Abstract 27LB.
Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1NIH SYNERGY Trial: Features
LDV-SOF + GS-9669
Treatment NaïveAll stages fibrosis
n = 20
n = 20
LDV-SOF + GS-9451n = 20
LDV-SOF
Treatment NaïveCirrhosis excluded
Treatment NaïveCirrhosis excluded
Abbreviations: LDV-SOF= ledipasvir-sofosbuvir
Drug DosingLedipasvir-sofosbuvir (90/400 mg): fixed dose combination; one pill once dailyGS-9669: 500 mg once dailyGS-9451: 80 mg once daily
Week 0 246 12 18
SVR12
SVR12
SVR12
Hepatitisweb studySource: Kohli A, et al. 21st CROI. 2014:Abstract 27LB.
Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1NIH SYNERGY Trial: Participants
Baseline Characteristic
LDV-SOF x 12 weeks
(n=20)
LDV-SOF + GS-9669 x 6 weeks
(n=20)
LDV-SOF + GS-9451 x 6 weeks
(n=20)
Age, mean 57 54 54
Male, % 70 65 80
Black, % 80 95 90
HCV genotype, % 1A 1B
5545
7030
8515
IL28B CT/TT, % 75 90 75
Advanced fibrosis, % Knodell score 3 Knodell score 4
2515
250
250
Hepatitisweb study
Ledipasvir-Sofosbuvir +/- [GS-9669 or GS-9451] in Naïve GT1NIH SYNERGY Trial: Features
NIH SYNERGY: SVR 12 by Treatment Regimen
Source: Kohli A, et al. 21st CROI. 2014:Abstract 27LB.
Ledipasvir-sofosbuvir Ledipasvir-sofosbuvir _x000d_+ GS-9669
Ledipasvir-sofosbuvir _x000d_+ GS-9451
0
20
40
60
80
100100
95100
Patie
nts
(%) w
ith H
CV
RN
A <
25
IU/m
l
20/20 19/20 20/20
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.