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. 2013 Dec 23;13(12):e14872.
doi: 10.5812/hepatmon.14872. eCollection 2013.

Efficacy of Alfacalcidol on PEG-IFN/ Ribavirin Combination Therapy for Elderly Patients With Chronic Hepatitis C: A Pilot Study

Masanori Atsukawa  1 , Akihito Tsubota  2 , Noritomo Shimada  3 , Chisa Kondo  1 , Norio Itokawa  1 , Ai Nakagawa  1 , Satomi Hashimoto  1 , Takeshi Fukuda  1 , Yoko Matsushita  1 , Hideko Kidokoro  1 , Yoshiyuki Narahara  1 , Katsuhisa Nakatsuka  1 , Katsuhiko Iwakiri  1 , Chiaki Kawamoto  1 , Choitsu Sakamoto  1
Affiliations

Efficacy of Alfacalcidol on PEG-IFN/ Ribavirin Combination Therapy for Elderly Patients With Chronic Hepatitis C: A Pilot Study

Masanori Atsukawa et al. Hepat Mon. .

Abstract

Background: Serum vitamin D concentration is reported to show a decrease in older age. Patients with chronic hepatitis C (CHC) in Japan are older on average than those in Western countries. Moreover, the outcome of pegylated-interferon (PEG-IFN)/ ribavirin therapy combined with vitamin D in elderly patients is unclear.

Objectives: This pilot study explored the efficacy and safety of alfacalcidol as vitamin D source in PEG-IFN/ ribavirin combination therapy for elderly CHC patients infected with hepatitis C virus genotype 1b.

Patients and methods: Consecutive twenty CHC patients aged ≥ 65 years were enrolled in this pilot study. Fifteen patients met the inclusion criteria and received PEG-IFN/ ribavirin therapy combined with alfacalcidol. Four-week lead-in of oral alfacalcidol was conducted, and it was subsequently and concurrently administered in PEG-IFN/ ribavirin combination therapy (vitamin D group). Age, gender, and IL28B genotype-matched patients, who received PEG-IFN/ ribavirin alone, were saved as control group (n = 15) to compare the treatment outcome with the vitamin D group.

Results: Subjects consisted of 14 males and 16 females, with a median age of 70 years (65-78). The serum 25 (OH) D3 concentration in females (20 ng/ml, 11-37) was significantly lower than males (27 ng/mL, 13-49) (P = 0.004). Sustained virological response (SVR) rates were 33.3% (5/15) in the control group and 80.0% (12/15) in the vitamin D group, respectively (P = 0.025). While no significant difference was shown in the (SVR) rate between the two groups among males (P = 0.592), in females the SVR rate was significantly higher in the vitamin D group (87.5%, 7/8) than the control group (25.0%, 2/8) (P = 0.041). The relapse rates in the groups with and without alfacalcidol were 7.7% (1/13) and 61.5% (8/13), respectively (P = 0.011). Interestingly, in females, the relapse in the control group was shown in 5 of 7 (71.4%), whereas in the vitamin D group the relapse rate was decreased (1/8, 12.5%) (P = 0.041). No specific adverse events were observed in the vitamin D group.

Conclusions: PEG-IFN/ ribavirin combined with alfacalcidol may be effective and safe in elderly CHC patients. In particular, concomitant administration of alfacalcidol may lead to a reduced relapse rate, and consequently improving the SVR rate in elderly females.

Keywords: 1-hydroxycholecalciferol; Aged; Hepatitis C, Chronic; Ribavirin; Vitamin D.

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Figures

Figure 1.
Figure 1.. Treatment Protocol
Figure 2.
Figure 2.. Comparison of the Rate of SVR Between Control Group and Vitamin D Group
The results were analyzed by the Fisher’s exact test, adopting the bootstrap method (10,000 times).
Figure 3.
Figure 3.. Comparison of the Rate of Relapse Between Control Group and Vitamin D Group
The results were analyzed by the Fisher’s exact test, adopting the bootstrap method (10,000 times).
See this image and copyright information in PMC

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