Efficacy of Vitamin D on Top of Pegylated Interferon and Ribavirin in Patients With Chronic Viral Hepatitis C Null-Responders

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Vitamin D deficiency is commonly found in patients with chronic hepatitis C. The investigators hypothesize that the correction of hypovitaminosis D before the initiation of anti-HCV combination therapy and the maintenance of an optimal vitamin D status during antiviral therapy could improve the antiviral efficacy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Treatments: Ergocalciferols; Interferons; Ribavirin; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Chronic Hepatitis C Genotype 1 or 4

• Hypovitaminosis D defined by a value <30 ng / ml

• Patient non responder to previous antiviral combination therapy of Pegylated Interferon and Ribavirin defined by a decrease in viral load <2 log at week 12 of the first course (Peg/RBV)

• Patient who received at least 80% of the optimal dose of Pegylated Interferon and Ribavirin according to current recommendations

• Patient for which the investigating physician decided to initiate treatment for hepatitis C combination therapy

Exclusion Criteria:

• Decompensated liver disease: Child-Pugh B> 8 or one of the following criteria:

bilirubin> 35 micromol/L, TP <50%, ascites, recurrent encephalopathy

• Positive serology for HBV and HIV

• Alcohol consumption exceeding 50 g/day

• Chronic intake of vitamin D

• Thrombocytopenia <50 000/mm ³, neutropenia <750/mm ³, hemoglobin <11 g/dL

• Pregnant women