Farnesoid X receptor targeting for hepatitis C: study protocol for a proof-of-concept trial.

To test the modulation of farnesoid X receptor activity on the replication of hepatitis C virus in chronically infected patients. This is a proof-of-concept trial that was approved by the ex-French Agency for the Safety of Health Products (ex-Afssaps [currently ANSM]) and an ethics committee. It has started in January 2010. This one-arm, open-label study examines the safety and efficacy of the oral administration of guggulsterone. The main outcome measure will be the assessment of blood viral loads. We planned to enrol 15 genotype 1-infected patients that failed a first-line therapy. We think guggulsterone might be an effective therapeutic option for HCV genotype 1 patients who do not respond well to first-line therapy.