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Phase 2b. Treatment Naïve . Sofosbuvir, Ribavirin, GS - 0938 QUANTUM. Lalezari JP, et al. EASL. 2013; Abstract 845. . Sofosbuvir, Ribavirin, & GS-0938 in Treatment Naïve QUANTUM Trial: Features. Source: Lalezari JP, et al. EASL. 2013; Abstract 845. .

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Sofosbuvir ribavirin gs 0938 quantum

Phase 2b

TreatmentNaïve

Sofosbuvir, Ribavirin, GS-0938QUANTUM

Lalezari JP, et al. EASL. 2013; Abstract 845.


Sofosbuvir ribavirin gs 0938 in treatment na ve quantum trial features
Sofosbuvir, Ribavirin, & GS-0938 in Treatment NaïveQUANTUM Trial: Features

Source: Lalezari JP, et al. EASL. 2013; Abstract 845.


Sofosbuvir ribavirin gs 0938 in treatment na ve quantum trial design
Sofosbuvir, Ribavirin, & GS-0938 in Treatment NaïveQUANTUM Trial: Design

0

12

24

36

Week

SVR12

n =28

GS-0938*

SVR12

n = 25

SOF + GS-0938*

SVR12

n = 25

SOF + RBV

SVR12

n = 25

SOF + RBV + GS-0938*

SVR12

n =27

GS-0938*

SVR12

n = 25

SOF + GS-0938*

SVR12

n = 25

SOF + RBV

SVR12

n = 29

SOF + RBV + GS-0938*

Randomized to available arm

n = 26

Placebo

Study Modification: all GS-0938 arms stopped; patients without SVR12 retreated with SOF + RBV x 24 weeks

N =14

Drug DosingSofosbuvir (SOF): 400 mg once dailyRibavirin (RBV) weight-based and divided bid: 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kgGS-0938: 300 mg once daily

Source: Lalezari JP, et al. EASL. 2013; Abstract 845.


Sofosbuvir ribavirin gs 0938 in treatment na ve quantum trial results
Sofosbuvir, Ribavirin, & GS-0938 in Treatment NaïveQUANTUM Trial: Results

QUANTUM: SVR12 Results for Completed Arms (all genotypes)

14/25

13/25

92/132

SOF = sofosbuvir; RBV = ribavirin

Source: Lalezari JP, et al. EASL. 2013; Abstract 845.


Sofosbuvir ribavirin gs 0938 in treatment na ve quantum trial results1
Sofosbuvir, Ribavirin, & GS-0938 in Treatment NaïveQUANTUM Trial: Results

QUANTUM: SVR12 Results for Patients with Genotype 1

10/19

9/19

69/105

SOF = sofosbuvir; RBV = ribavirin

Source: Lalezari JP, et al. EASL. 2013; Abstract 845.


Sofosbuvir ribavirin gs 0938 in treatment na ve quantum trial results2
Sofosbuvir, Ribavirin, & GS-0938 in Treatment NaïveQUANTUM Trial: Results

QUANTUM: SVR12 Results for Patients with Genotype 1

8/15

2/4

7/15

2/4

57/80

12/25

SOF = sofosbuvir; RBV = ribavirin

Source: Lalezari JP, et al. EASL. 2013; Abstract 845.


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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