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Chou R, Carson S, Chan BKS, et al. Drug Class Review: Pegylated Interferons for Chronic Hepatitis C Infection: Final Report [Internet]. Portland (OR): Oregon Health & Science University; 2007 May.

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Drug Class Review: Pegylated Interferons for Chronic Hepatitis C Infection: Final Report [Internet].

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Appendix D. Unpublished trials of pegylated interferons for chronic hepatitis C infection

Study, yearNComparisonInterventionsPopulationcharacteristics/NotesSVRWithdrawals due toAEs
Studies of peginterferon alfa-2b
Crespo, 2006121Peginterferon vs interferonA: Peginterferon alfa-2b 1.5μg/kg/week plus ribavirin 800 mg
B: Interferon alfa-2b 3 million units 3×/week plus ribavirin 800 mg (24 weeks for genotype 2 or 3, 48 weeks for genotype 1 or 4)
HIV co-infection, Treatment naïve33.9% genotype 1A vs B:
All patients: 33/60 (55%) vs16/61 (26%); p=0.002
Genotype 1 or 4: 18/39 (46%) vs 7/40 (18%); p=0.013
Genotype 2 or 3: 15/21 (71%) vs 9/21 (43%); p=0.12
A vs B:
10/60 (16.7%) vs14/61 (23.0%)
Jacobson4913Fixed vs weight- based ribavirin dosingA: Peginterferon alfa-2b 1.5μg/kg/week plus ribavirin 800 mg
B: Peginterferon alfa-2b 1.5μg/kg/week plus ribavirin 800–1400 mg (weight-based) (48 weeks for genotype 1, 24 or48 weeks for genotype 2 and 3)
Treatment naive62% genotype 1A vs B:
All patients: 853/2102 (41%) vs 939/2121 (44%); p=0.02
Genotype 1 377/1305 (29%) vs 448/1313 (34%); p=0.004
Genotype 2 or 3: 308/513(60%) vs 306/494 (62%) (NS)
357/2444 (14.6%) vs370/2469 (15.0%)
Studies of peginterferon alfa-2a
Bressler, 200540DoseA: Peginterferon alfa-2a 180μg/week plus ribavirin 1000–1200 mg × 48 weeks
B: Peginterferon alfa-2a 270μg/week plus ribavirin 1000–1200 mg × 48 weeks
Treatment naive BMI >30
Primary outcome was pharmacokinetic characteristics
A vs B:
14/20 (70%) vs 16/20 (79%)
Not reported
Conjeevaram, 2005401African American vs Caucasian patientsPeginterferon alfa-2a 180μg/week plus ribavirin 1000–1200 mg × 48 weeksGenotype 1African Americans vs Caucasians:
55/196 (28%) vs 107/20552%; p=0.0001
Not reported
Marcellin, 2003377Treatment duration and ribavirin doseA: Peginterferon alfa-2a 180μg/week plus ribavirin 800 mg ×24 weeks
B: Peginterferon alfa-2a 180μg/week plus ribavirin 1000–1200 mg × 24 weeks
C: Peginterferon alfa-2a 180μg/week plus ribavirin 800 mg ×48 weeks
D: Peginterferon alfa-2a 180μg/week plus ribavirin 1000–1200 mg × 48 weeks
Treatment naïve Compensated cirrhosisA vs B vs C vs D: (Overall results not reported)
Genotype 1: 26% vs 26% vs28% vs 37%
Genotype non-1: 71% vs75% vs 67% vs 73%
Not reported
Jensen, 2006950Dose and durationA: Peginterferon alfa-2a 360μg/week × 12 weeks followed by180 μg/week × 36 weeks plus ribavirin 1000–1200 mg
B: Peginterferon alfa-2a 360μg/week × 12 weeks followed by180 μg/week × 60 weeks plus ribavirin 1000–1200 mg
C: Peginterferon alfa-2a 180μg/week plus ribavirin 1000–1200 mg × 48 weeks
D: Peginterferon alfa-2a 180μg/week plus ribavirin 1000–1200 mg × 72 weeks
Patients who lacked virologic resonse after>12 weeks treatment with peginterferon alfa-2b plus ribavirinResults for SVR (72 weeks) not yet available.
Reports week 12 VR only: 62% for groups A and B vs45% for groups B and C; p<0.0001
Not reported
Shiffman, 20061469Treatment duration: 16 vs 24 weeksA: Peginterferon alfa-2a 180μg/week plus ribavirin 800 mg ×16 weeks
B: Peginterferon alfa-2a 180μg/week plus ribavirin 800 mg ×24 weeks
Genotype 2 or 3 Treatment naïveA vs B:
All patients: 483/732 (66%) vs 541/731 (74%); p<0.005
Genotype 2: 70% vs 86%; p<0.005
Genotype 3: 70% vs 76%(NS)
Not reported
Copyright © 2007, Oregon Health & Science University, Portland, Oregon.
Bookshelf ID: NBK10663

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