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

OBJECTIVE: To test the modulation of farnesoid X receptor activity on the replication of hepatitis C virus in chronically infected patients. METHODS: 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. RESULTS: We planned to enrol 15 genotype 1-infected patients that failed a first-line therapy. CONCLUSION: We think guggulsterone might be an effective therapeutic option for HCV genotype 1 patients who do not respond well to first-line therapy.