Three Regimens of PegIntron Plus Ribavirin in Previously Untreated Chronic Hepatitis C, Genotype 2 or 3 (Study P03548)

Summary

This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.5/R (24 weeks)\], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.0/R (24 weeks)\], using a 24 week treatment duration for both arms. Additionally, the study examined the efficacy of reduced treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks \[Arm PEG2b 1.5/R (16 weeks)\] .

Timeline

Start

2003-08

Primary completion

2008-04

Completion

2008-04

Outcome

Mixed primary results

registry p = 0.041; Risk Difference (RD) -0.02 (95% CI -0.10 to 1); z-test (non-inferiority margin=-0.1) NCT00302081 ↗

registry p = 0.495; Risk Difference (RD) -0.10 (95% CI -0.17 to 1); z-test (non-inferiority margin=-0.1) NCT00302081 ↗

paper groups B and C failed to show noninferiority relative to group A. PMID 21237227 ↗

Publications

• Manns M, Zeuzem S, Sood A, Lurie Y, Cornberg M, Klinker H, Buggisch P, Rossle M, Hinrichsen H, Merican I, Ilan Y, Mauss S, Abu-Mouch S, Horban A, Muller TH, Welsch C, Chen R, Faruqi R, Pedicone LD, Wedemeyer H. Reduced dose and duration of peginterferon alfa-2b and weight-based ribavirin in patients with genotype 2 and 3 chronic hepatitis C. J Hepatol. 2011 Sep;55(3):554-563. doi: 10.1016/j.jhep.2010.12.024. Epub 2011 Jan 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Peginterferon alfa-2b	Protein / enzyme biologic	1 ug/kg	—
Subject	Peginterferon alfa-2b	Protein / enzyme biologic	1.5 ug/kg	—
Subject	Ribavirin	Small molecule	800 mg	—
Subject	Ribavirin	Small molecule	1200 mg	—

Indications