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Clinical Trial
. 2015 May 14;21(18):5647-53.
doi: 10.3748/wjg.v21.i18.5647.

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

Benjamin Terrier  1 , Nathanael Lapidus  1 , Stanislas Pol  1 , Lawrence Serfaty  1 , Vlad Ratziu  1 , Tarik Asselah  1 , Vincent Thibault  1 , Jean-Claude Souberbielle  1 , Fabrice Carrat  1 , Patrice Cacoub  1
Affiliations
Clinical Trial

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

Benjamin Terrier et al. World J Gastroenterol. .

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.

Trial registration: ClinicalTrials.gov NCT01226446.

Keywords: Chronic hepatitis; Hepatitis C virus; Pegylated interferon; Ribavirin; Vitamin D.

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Figures

Figure 1
Figure 1
Flow chart of the study.
Figure 2
Figure 2
Change in viral load (log10/mL) and 25-OH vitamin D (ng/mL) from W-4 to W12.
See this image and copyright information in PMC

References

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