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

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01226446

2010-021967-34

Details and patient eligibility

About

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

Full description

An open-label, prospective evaluation of the efficacy of vitamin D supplementation starting 1 month before and continuing for the duration of combination therapy with pegylated interferon alpha (2a or 2b) plus ribavirin in patients with chronic viral hepatitis C genotype 1 or 4, nonresponders to a first antiviral therapy.Vitamin D supplementation is started one month before antiviral therapy in order to introduce pegylated interferon plus ribavirin in patients with optimal vitamin D status

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Addition of Vitamin D to Peg-interferon plus Ribavirin

Experimental group

Treatment:

Drug: vitamin D