Individually Adapted Therapy Duration for the Treatment of Chronic Hepatitis C Genotype 1 Infection

Phase 4 Completed 390 enrolled FGK Clinical Research GmbH University Hospital, Saarland · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Patients with chronic hepatitis C genotype 1 virus infection are usually treated with Interferon alfa plus Ribavirin over 48 weeks. For some patients this might be too long, for others too short. An individually adapted therapy length from 24 to 72 weeks will be determined in dependence of the initial virus load and the time to HCV RNA negativity. The primary objective is to compare the cumulative rate of the sustained viral response (SVR) of the patients with the individually adapted therapy duration to the SVR rates of a historic patient collective under the 48 week standard therapy.

Timeline

Start: 2006-07
Primary completion: 2010-01
Completion: 2010-01

Outcome

Met primary endpoint

paper Rates of sustained virologic response (SVR) were 55% among patients who received individualized treatment and 48% among those who received standard treatment PMID 21784046 ↗

paper (P < .0001 for noninferiority). PMID 21784046 ↗

Publications

Sarrazin C, Schwendy S, Moller B, Dikopoulos N, Buggisch P, Encke J, Teuber G, Goeser T, Thimme R, Klinker H, Boecher WO, Schulte-Frohlinde E, Prinzing R, Herrmann E, Zeuzem S, Berg T. Improved responses to pegylated interferon alfa-2b and ribavirin by individualizing treatment for 24-72 weeks. Gastroenterology. 2011 Nov;141(5):1656-64. doi: 10.1053/j.gastro.2011.07.019. Epub 2011 Jul 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Peginterferon alfa-2b	Protein / enzyme biologic	50 ug	Other
Subject	Peginterferon alfa-2b	Protein / enzyme biologic	80 ug	Other
Subject	Peginterferon alfa-2b	Protein / enzyme biologic	100 ug	Other
Subject	Peginterferon alfa-2b	Protein / enzyme biologic	120 ug	Other
Subject	Peginterferon alfa-2b	Protein / enzyme biologic	150 ug	Other
Subject	Ribavirin	Small molecule	200 mg	—