Clinical trial NCT01226446: Efficacy of Vitamin D on Top of Pegylated Interferon and Ribavirin in Patients With Chronic Viral Hepatitis C Null-Responders
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2010-10-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Negativity of HCV RNA below 12UI/mL after 12 weeks of antiviral combination therapy
timeFrame: at week 12
Secondary outcomes:
measure: Changes in HCV viral load after correction of vitamin D deficiency (delta log)
timeFrame: at day 0
measure: Changes in HCV viral load (delta log)
timeFrame: at week 4
measure: Changes in HCV viral load (delta log)
timeFrame: at week 12
measure: Negativity of HCV RNA below 12 UI/ml
timeFrame: at week 24
measure: Negativity of HCV RNA below 12 UI/ml
timeFrame: at week 72
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
Study officials:
affiliation: Pitié Salpétrière Hospital
name: Patrice Cacoub, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Terrier B, Lapidus N, Pol S, Serfaty L, Ratziu V, Asselah T, Thibault V, Souberbielle JC, Carrat F, Cacoub P. Vitamin D in addition to peg-interferon-alpha/ribavirin in chronic hepatitis C virus infection: ANRS-HC25-VITAVIC study. World J Gastroenterol. 2015 May 14;21(18):5647-53. doi: 10.3748/wjg.v21.i18.5647.