Chronic Hepatitis C
Conditions
Brief 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
Detailed 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
Interventions
DRUGvitamin D
Vitamin D on top of the standard treatment
Sponsors
French National Agency for Research on AIDS and Viral Hepatitis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Negativity of HCV RNA below 12UI/mL after 12 weeks of antiviral combination therapy | at week 12 |
Secondary
| Measure | 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 |
| Negativity of HCV RNA below 12 UI/ml | at week 24 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPatrice Cacoub, MD
Pitié Salpétrière Hospital
Outcome results
None listed