Role of FXR in Hepatitis C Virus Replication

Hospices Civils de Lyon15 enrolled

Overview

In vitro in the hepatitis C virus (HCV) replicon system, modulation of the biliary salts nuclear receptor FXR by either agonists or antagonists respectively increases or decreases the replication of HCV (J Hepatol, 2008, 48: 192-9). One antagonist of FXR is a vegetal sterol, guggulsterone, that is extracted from the Commiphora mukul tree and that has already been given safely to hyper cholesterolemic patients in a clinical trial (JAMA 2003, 290: 765-72). The aim of this trial is to test the effect of the FXR antagonist guggulsterone given orally, three times a day, on the viral load in 15 HCV genotype 1 chronically infected patients.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C

Interventions

guggulsterone, a natural FXR antagonist.OTHER

Gugulipid®, natural extract from Commiphora mukul tree, containing 2.5% guggulsterone

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male patients infected by HCV genotype 1, with anti-HCV antibodies, non responders to at least one first line of therapy * Viral load \> 1 x 105 UI/mL for more than 6 months and not treated for at least the last two months. * METAVIR score \< F4 Exclusion Criteria: * Alcohol intake \> 20 g/day * Immuno - suppressive therapy * Obesity BMI \> 30, diabetes * Dyslipidemia requiring specific therapy * Liver cirrhosis or carcinoma * HIV or HBV co-infections * Other liver diseases * Major organ failures * Therapy with cytochrome P450 metabolized drugs

Locations (1)

Department of hepatology, Hospices Civils de Lyon, Hôtel Dieu

Lyon, France

Outcomes

Primary Outcomes

Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone.

Time frame: One week

Secondary Outcomes

Modification of the fraction of the circulating viral forms associated with apolipoprotein B

Time frame: One week

Data from ClinicalTrials.gov

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