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Randomized Study Comparing Vitamin D3 and 1α-Hydroxyvitamin D3 in Combination With Pegylated interferon/ribavirin Therapy for Chronic Hepatitis C

Yoshie Omori-Mizuno, Nobuaki Nakayama, Mie Inao, Junji Funyu, Shinichi Asabe, Kengo Tomita, Kou Nishikawa, Yasuo Hosoda, Masahiko Tanaka, Yoshiaki Hashimoto, Koji Yakabi, Yohei Koshima, Satoshi Mochida

J Gastroenterol Hepatol. 2015 Sep;30(9):1384-90.

PMID: 25778685

Abstract:

Background and aim:
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].
Methods:
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.
Results:
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 (P < 0.001), while serum 1α,25-dihydroxyvitamin D3 [1α,25(OH)2 -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%, P < 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) (P < 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.
Conclusion:
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.

Chemicals Related in the Paper:

Catalog Number Product Name Structure CAS Number Price
AP41294568 1α-Hydroxyvitamin D3 1α-Hydroxyvitamin D3 41294-56-8 Price
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