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Paper Information

Journal:   HEPATITIS MONTHLY   DECEMBER 2013 , Volume 13 , Number 12; Page(s) 1 To 8.
 
Paper: 

EFFICACY OF ALFACALCIDOL ON PEG-IFN/ RIBAVIRIN COMBINATION THERAPY FOR ELDERLY PATIENTS WITH CHRONIC HEPATITIS C: A PILOT STUDY

 
 
Author(s):  ATSUKAWA MASANORI*, TSUBOTA AKIHITO, SHIMADA NORITOMO, ITOKAWA NORIO, NAKAGAWA AI, HASHIMOTO SATOMI, FUKUDA TAKESHI, MATSUSHITA YOKO, KIDOKORO HIDEKO, NARAHARA YOSHIYUKI, NAKATSUKA KATSUHISA, IWAKIRI KATSUHIKO, KAWAMOTO CHIAKI, SAKAMOTO CHOITSU
 
* DIVISION OF GASTROENTEROLOGY, DEPARTMENT OF INTERNAL MEDICINE, NIPPON MEDICAL SCHOOL CHIBA HOKUSOH HOSPITAL, 1715, KAMAKARI, INZAI, 270-1694, CHIBA, JAPAN
 
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
³ 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.

 
Keyword(s): 1-HYDROXYCHOLECALCIFEROL, VITAMIN D, RIBAVIRIN, AGED, HEPATITIS C, CHRONIC
 
References: 
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