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

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.