Vitamin D in addition to peg-interferon-alpha/ribavirin in chronic hepatitis C virus infection: ANRS-HC25-VITAVIC study.
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.
['Terrier|Benjamin|B|', 'Lapidus|Nathanael|N|', 'Pol|Stanislas|S|', 'Serfaty|Lawrence|L|', 'Ratziu|Vlad|V|', 'Asselah|Tarik|T|', 'Thibault|Vincent|V|', 'Souberbielle|Jean-Claude|JC|', 'Carrat|Fabrice|F|', 'Cacoub|Patrice|P|']
D000328:Adult D000368:Aged D000998:Antiviral Agents D015415:Biomarkers D002112:Calcifediol D002762:Cholecalciferol D004359:Drug Therapy, Combination D005260:Female D005602:France D005838:Genotype D016174:Hepacivirus D019698:Hepatitis C, Chronic D006801:Humans D057194:Intention to Treat Analysis D000077190:Interferon alpha-2 D016898:Interferon-alpha D008297:Male D008875:Middle Aged D011092:Polyethylene Glycols D011446:Prospective Studies D012367:RNA, Viral D011994:Recombinant Proteins D012254:Ribavirin D013997:Time Factors D016896:Treatment Outcome D019562:Viral Load D014808:Vitamin D Deficiency D014815:Vitamins
Vitamin D Ribavirin Chronic hepatitis Hepatitis C virus Pegylated interferon