REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy

Phase 4 Completed 948 enrolled Hoffmann-La Roche

RandomizedParallel-groupOpen-labelTreatment

Summary

This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

Timeline

Start: 2003-09
Primary completion: 2008-05
Completion: 2008-05

Outcome

Met primary endpoint

registry analysis (superiority or other test); Group A vs Group D; p = 0.0060; Odds Ratio (OR) 2.00 (95% CI 1.21 to 3.31); NCT00087646 ↗

paper a 72-week regimen of peginterferon alpha-2a (40 kDa) plus ribavirin improved SVR rates over a standard 48-week regimen PMID 23442834 ↗

Publications

Marcellin P, Craxi A, Brandao-Mello CE, Di Bisceglie AM, Andreone P, Freilich B, Rajender Reddy K, Olveira Martin A, Teuber G, Messinger D, Hooper G, Wat C, Tatsch F, Jensen DM. Predicting early and sustained virological responses in prior nonresponders to pegylated interferon alpha-2b plus ribavirin retreated with peginterferon alpha-2a plus ribavirin and the benefit-risk ratio of retreatment. J Clin Gastroenterol. 2013 Oct;47(9):786-93. doi: 10.1097/MCG.0b013e31827b9b45.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	Subcutaneous
Subject	Ribavirin	Small molecule	1000 mg	Oral
Subject	Ribavirin	Small molecule	1200 mg	Oral