Randomized study comparing vitamin D3 and 1α‐Hydroxyvitamin D3 in combination with pegylated interferon/ribavirin therapy for chronic hepatitis C. Issue 9 (September 2015)

• Record Type: Journal Article
• Authors: Omori‐Mizuno, Yoshie; Nakayama, Nobuaki; Inao, Mie; Funyu, Junji; Asabe, Shinichi; Tomita, Kengo; Nishikawa, Kou; Hosoda, Yasuo; Tanaka, Masahiko; Hashimoto, Yoshiaki; Yakabi, Koji; Koshima, Yohei; Mochida, Satoshi
• Is Part Of: Journal of gastroenterology and hepatology. Volume 30:Issue 9(2015:Sep.)
• Page Start: 1384
• Page End: 1390
• Publication Date: 2015-09
• Subjects: Gastroenterology -- Periodicals; Digestive organs -- Diseases -- Periodicals; Liver -- Diseases -- Periodicals; Gastroenterology -- Periodicals; Liver Diseases -- Periodicals; 616.33
• DOI: 10.1111/jgh.12949
• Languages: English
• ISSNs: 0815-9319

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <sec id="jgh12949-sec-0001" sec-type="section"> <title>Background and Aim</title> <p>An intention‐to‐treat prospective randomized study was carried out to compare the potentiation of antiviral efficacies between cholecalciferol, non‐activated vitamin D3 supplement, and alfacalcidol, activated 1α‐Hydroxyvitamin D3 [1α (OH)‐vitamin D3].</p> </sec> <sec id="jgh12949-sec-0002" sec-type="section"> <title>Methods</title> <p>Chronic hepatitis patients with genotype 1b hepatitis C virus (HCV) infection showing serum HCV‐RNA levels greater than 5 Log IU/mL received oral administration of cholecalciferol (2000 IU/day) or alfacalcidol (0.5 μg/day) for 4 weeks, and then they were given pegylated interferon (Peg‐IFN)‐α2a plus ribavirin therapy in combination with either vitamin D3 for 48 or 72 weeks according to the response‐guided manner.</p> </sec> <sec id="jgh12949-sec-0003" sec-type="section"> <title>Results</title> <p>A total of 36 patients were evaluated. Serum 25‐hydroxyvitamin D3 [25(OH)‐D3] levels were increased only in patients in the cholecalciferol group during the lead‐in vitamin D administration, and the levels at 4 weeks were higher in these patients than in those in the alfacalcidol group (<italic>P</italic> < 0.001), while serum 1α, 25‐dihydroxyvitamin D3 [1α, 25(OH)<sub>2</sub>‐D3] levels were not different between both groups. Rapid virological response was obtained in six (33%) patients in the cholecalciferol group; the ratio was higher than that in the alfacalcidol group (one patient; 6%, <italic>P</italic> < 0.05). Serum HCV‐RNA level decline at 4 weeks of combined Peg‐IFN‐α2a plus ribavirin therapy compared with the baseline levels were greater in the cholecalciferol group (4.6 Log IU/mL) than in the alfacalcidol group (3.5 Log IU/mL) (<italic>P</italic> < 0.05), when four patients showing null response to the therapy was excluded. However, both complete early virological response and sustained viral response rates were not different between both groups.</p> </sec> <sec id="jgh12949-sec-0004" sec-type="section"> <title>Conclusion</title> <p>Cholecalciferol produced superior potentiation of the antiviral activity than alfacalcidol only during the initial periods of combined Peg‐IFN‐α2a plus ribavirin therapy through upregulation of serum 25(OH)‐D3 levels.</p> </sec> </abstract>