Vitamin D in addition to peg-interferon-alpha/ribavirin in chronic hepatitis C virus infection: ANRS-HC25-VITAVIC study.

Abstract

AIM:

To investigate if correction of hypovitaminosis D before initiation of Peg-interferon-alpha/ribavirin (PegIFN/RBV) therapy could improve the efficacy of PegIFN/RBV in previously null-responder patients with chronic genotype 1 or 4 hepatitis C virus (HCV) infection.

METHODS:

Genotype 1 or 4 HCV-infected patients with null response to previous PegIFN/RBV treatment and with hypovitaminosis D (< 30 ng/mL) prospectively received cholecalciferol 100000 IU per week for 4 wk [from week -4 (W-4) to W0], followed by 100000 IU per month in combination with PegIFN/RBV for 12 mo (from W0 to W48). The primary outcome was the rate of early virological response defined by an HCV RNA < 12 IU/mL after 12 wk PegIFN/RBV treatment.

RESULTS:

A total of 32 patients were included, 19 (59%) and 13 (41%) patients were HCV genotype 1 and 4, respectively. The median baseline vitamin D level was 15 ng/mL (range: 7-28). In modified intention-to-treat analysis, 29 patients who received at least one dose of PegIFN/RBV were included in the analysis. All patients except one normalized their vitamin D serum levels. The rate of early virologic response was 0/29 (0%). The rate of HCV RNA < 12 IU/mL after 24 wk of PegIFN/RBV was 1/27 (4%). The safety profile was favorable.

CONCLUSION:

Addition of vitamin D to PegIFN/RBV does not improve the rate of early virologic response in previously null-responders with chronic genotype 1 or 4 HCV infection.

• Authors: Benjamin Terrier, Nathanael Lapidus, Stanislas Pol, Lawrence Serfaty, Vlad Ratziu, Tarik Asselah, Vincent Thibault, Jean-Claude Souberbielle, Fabrice Carrat, Patrice Cacoub
• Journal: World journal of gastroenterology (World J Gastroenterol) Vol. 21 Issue 18 Pg. 5647-53 (May 14 2015) ISSN: 2219-2840 [Electronic] United States
• PMID: 25987791 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)

Chemical References

• Antiviral Agents
• Biomarkers
• Interferon alpha-2
• Interferon-alpha
• RNA, Viral
• Recombinant Proteins
• Vitamins
• Cholecalciferol
• Polyethylene Glycols
• Ribavirin
• peginterferon alfa-2b
• Calcifediol
• peginterferon alfa-2a

Topics

• Adult
• Aged
• Antiviral Agents (adverse effects, therapeutic use)
• Biomarkers (blood)
• Calcifediol (blood)
• Cholecalciferol (adverse effects, therapeutic use)
• Drug Therapy, Combination
• Female
• France
• Genotype
• Hepacivirus (drug effects, genetics)
• Hepatitis C, Chronic (blood, diagnosis, drug therapy)
• Humans
• Intention to Treat Analysis
• Interferon alpha-2
• Interferon-alpha (adverse effects, therapeutic use)
• Male
• Middle Aged
• Polyethylene Glycols (adverse effects, therapeutic use)
• Prospective Studies
• RNA, Viral (blood)
• Recombinant Proteins (adverse effects, therapeutic use)
• Ribavirin (adverse effects, therapeutic use)
• Time Factors
• Treatment Outcome
• Viral Load
• Vitamin D Deficiency (blood, diagnosis, drug therapy)
• Vitamins (adverse effects, therapeutic use)