sofosbuvir + peginterferon + ribavirin in genotypes 1,4,5,6 atomic

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Hepati tis web study Hepati tis web study Sofosbuvir + Peginterferon + Ribavirin in Genotypes 1,4,5,6 ATOMIC Phase 2 Treatment Naïve Kowdley K, et al. Lancet. 2013;381:2100-7.

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Phase 2. Treatment Naïve . Sofosbuvir + Peginterferon + Ribavirin in Genotypes 1,4,5,6 ATOMIC. Kowdley K, et al. Lancet. 2013;381:2100- 7 . Sofosbuvir + Peginterferon + Ribavirin in Genotypes 1,4,5,6 ATOMIC Trial : Study Overview. - PowerPoint PPT Presentation

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Page 1: Sofosbuvir + Peginterferon  + Ribavirin in  Genotypes  1,4,5,6 ATOMIC

Hepatitisweb study

Hepatitisweb study

Sofosbuvir + Peginterferon + Ribavirin in Genotypes 1,4,5,6ATOMIC

Phase 2

Treatment Naïve

Kowdley K, et al. Lancet. 2013;381:2100-7.

Page 2: Sofosbuvir + Peginterferon  + Ribavirin in  Genotypes  1,4,5,6 ATOMIC

Hepatitisweb studySource: Kowdley K, et al. Lancet. 2013;381:2100-7.

Sofosbuvir + Peginterferon + Ribavirin in Genotypes 1,4,5,6ATOMIC Trial: Study Overview

ATOMIC Trial: Features Design: Randomized, open-label, phase 2 trial investigating effectiveness

and required duration of sofosbuvir, peginterferon, and ribavirin in treatment-naïve patients with GT 1, 4, 5, or 6

Setting: 42 centers in United States and Puerto Rico

Entry Criteria - Chronic HCV infection with HCV genotype 1, 4, 5, or 6- Treatment-naïve- Age 18 or older- HCV RNA ≥ 50,000 IU/mL- Absence of cirrhosis- Absence of coinfection with HBV or HIV- BMI ≤ 18 kg/m2

Primary End-Point: SVR24

Page 3: Sofosbuvir + Peginterferon  + Ribavirin in  Genotypes  1,4,5,6 ATOMIC

Hepatitisweb studySource: Kowdley K, et al. Lancet. 2013;381:2100-7.

Sofosbuvir + Peginterferon + Ribavirin in Genotypes 1,4,5,6ATOMIC Trial: Design

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 kgPeginterferon alfa-2a (PEG): 180 µg once weekly

Cohort An = 52

GT 1

GT4

GT5

GT6

SOF + PEG + RBV

SOF + PEG + RBV

SOF + PEG + RBV SVR24

SVR24

SVR24

Cohort Bn = 125

Cohort Cn = 155

SOF SOF + RBV

0 12 48Week 24 36

Page 4: Sofosbuvir + Peginterferon  + Ribavirin in  Genotypes  1,4,5,6 ATOMIC

Hepatitisweb study

Sofosbuvir + Peginterferon + Ribavirin in Genotypes 1,4,5,6ATOMIC Trial: Results, by Cohort (Regimen)

ATOMIC: SVR 24 by Cohort (Regimen)

Source: Kowdley K, et al. Lancet. 2013;381:2100-7.

Cohort A Cohort B Cohort C0

20

40

60

80

100

89 89 87

Patie

nts

(%) w

ith S

VR24

46/52 97/109 135/155

Patients with Genotype 1, 4, or 6

Page 5: Sofosbuvir + Peginterferon  + Ribavirin in  Genotypes  1,4,5,6 ATOMIC

Hepatitisweb study

Sofosbuvir + Peginterferon + Ribavirin in Genotypes 1,4,5,6ATOMIC Trial: Results, by Cohort (Regimen)

ATOMIC: SVR 24 by Genotype

Source: Kowdley K, et al. Lancet. 2013;381:2100-7.

GT 1 GT 4 GT 60

20

40

60

80

100

8882

100

Patie

nts

(%) w

ith S

VR24

264/300 9/11 5/5

Notes: (1) No patients with Genotype 5 enrolled in study(2) All patients with Genotype 4 or 6 received 24 weeks of SOF + PEG + RBV(3) The 2 patients with Genotype 4 and failure resulted from lost to follow-up at end of treatment

Page 6: Sofosbuvir + Peginterferon  + Ribavirin in  Genotypes  1,4,5,6 ATOMIC

Hepatitisweb studySource: Kowdley K, et al. Lancet. 2013;381:2100-7.

Sofosbuvir + Peginterferon + Ribavirin in Genotypes 1,4,5,6ATOMIC Trial: Interpretation

Interpretation: “Our findings suggest that sofosbuvir is well tolerated and that there is no additional benefit of extending treatment beyond 12 weeks, but these finding will have to be substantiated in phase 3 trials. These results lend support to the further assessment of a 12 week sofosbuvir regimen in a broader population of patients with chronic HCV genotype-1 infection, including those with cirrhosis.”

Page 7: Sofosbuvir + Peginterferon  + Ribavirin in  Genotypes  1,4,5,6 ATOMIC

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.