Hepatitisweb study

Hepatitisweb study

Sofosbuvir + Ribavirin + Peginterferon in Genotypes 1-3PROTON

Phase 2

Treatment Naïve

Lawitz E, et al. Lancet Infect Dis. 2013;13:401-8.

Hepatitisweb studySource: Lawitz E, et al. Lancet Infect Dis. 2013;13:401-8.

Sofosbuvir + Ribavirin + Peginterferon in Genotypes 1-3PROTON Trial: Design

PROTON Trial: Features

Design: Randomized, two-cohort, phase 2 trial investigating effectiveness of sofosbuvir, ribavirin, and peginterferon in treatment-naïve GT 1-3

Setting: 22 hepatitis C treatment centers in the United States

Entry Criteria - Treatment-naïve- HCV RNA RNA ≥ 50,000 IU/mL- Absence of cirrhosis

Patient Characteristics- GT-1 = 121; GT 2= 15; GT 3 = 10

Study Arms- Cohort A: GT1; three arms and included 2 doses of sofosbuvir- Cphort B: GT 2 or 3

Primary End-Point: SVR24

Hepatitisweb studySource: Lawitz E, et al. Lancet Infect Dis. 2013;13:401-8.

Sofosbuvir + Peginterferon + Ribavirin in Genotypes 1-3PROTON Trial: Design

N =14Drug DosingSofosbuvir (SOF): 400 mg once daily, except as designated in arm that received 200 mg once dailyRibavirin (RBV) weight-based and divided bid: 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kgPeginterferferon alfa-2a (PEG): 180 µg once weekly

n = 48

SOF + PEG + RBVn = 25GT 2, 3

GT 1

SOF (200 mg) + PEG + RBV

+ RVRPEG + RBV

- RVR PEG + RBV

n = 47 SOF (400 mg) + PEG + RBV

+ RVRPEG + RBV

- RVR PEG + RBV

SOF + PEG + RBVn = 26

0 24 4812 72Week

Hepatitisweb study

Sofosbuvir + Ribavirin + Peginterferon in Genotypes 1-3PROTON Trial: Results, by Genotype

PROTON: SVR 24

Source: Lawitz E, et al. Lancet Infect Dis. 2013;13:401-8.

SOF 200 mg + PR SOF 400 mg + PR PR SOF 400 mg + PR0

20

40

60

80

100

90 91

58

92

Pat

ien

ts (

%)

wit

h S

VR

24

41/48 42/47 15/26 23/25

Genotype 1 Genotype 2 or 3

Hepatitisweb studySource: Lawitz E, et al. Lancet Infect Dis. 2013;13:401-8.

Sofosbuvir + Ribavirin + Peginterferon in Genotypes 1-3PROTON Trial: Conclusions

Interpretation: “Our findings lend support to the further assessment, in

phase 2 and 3 trials, of sofosbuvir 400 mg plus peginterferon and

ribavirin for 12 weeks in treatment-naive patients with HCV genotype-1.”

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.