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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Multicenter Open and Prospective Trial Assessing the Efficacy of Vitamin D Supplementation in Addition to Pegylated Interferon Plus Ribavirin in Null-Responders Patients With Chronic Viral Hepatitis C Genotype 1 or 4

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: vitamin D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Addition of Vitamin D to Peg-interferon plus Ribavirin<br> | Drug: vitamin D<br>* Vitamin D on top of the standard treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negativity of HCV RNA below 12UI/mL after 12 weeks of antiviral combination therapy |  | at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HCV viral load after correction of vitamin D deficiency (delta log) |  | at day 0 | 
| Changes in HCV viral load (delta log) |  | at week 4 | 
| Changes in HCV viral load (delta log) |  | at week 12 | 
| Negativity of HCV RNA below 12 UI/ml |  | at week 24 | 
| Negativity of HCV RNA below 12 UI/ml |  | at week 72 |