ledipasvir-sofosbuvir +/- 3 rd daa in hcv genotype 1 nih synergy

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Hepati tis web study Hepati tis web study Ledipasvir-Sofosbuvir +/- 3 rd DAA in HCV Genotype 1 NIH SYNERGY Phase 2 Treatment Naïve (unfavorable baseline treatment characteristics) Kohli A, et al. 21 st CROI. 2014:Abstract 27LB.

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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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Page 1: Ledipasvir-sofosbuvir +/- 3 rd DAA in HCV Genotype 1 NIH SYNERGY

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.

Page 2: Ledipasvir-sofosbuvir +/- 3 rd DAA in HCV Genotype 1 NIH SYNERGY

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

Page 3: Ledipasvir-sofosbuvir +/- 3 rd DAA in HCV Genotype 1 NIH SYNERGY

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

Page 4: Ledipasvir-sofosbuvir +/- 3 rd DAA in HCV Genotype 1 NIH SYNERGY

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

Page 5: Ledipasvir-sofosbuvir +/- 3 rd DAA in HCV Genotype 1 NIH SYNERGY

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

Page 6: Ledipasvir-sofosbuvir +/- 3 rd DAA in HCV Genotype 1 NIH SYNERGY

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.

http://www.hepatitisc.uw.edu/

http://depts.washington.edu/hepstudy/

http://depts.washington.edu/hepstudy/

http://depts.washington.edu/hepstudy/

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