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Chronic haemodialysis is not associated with an increased risk of exposure to HEV, and the high prevalence of anti-HEV IgG in HD patients reported in uncontrolled studies is possibly due to the confounding effect of age and sex.

Background: Darbepoetin alfa is an erythropoiesis-stimulating glycoprotein with a -3-fold longer tl/2 and greater biological activity compared with recombinant human erythropoietin (rHuEPO).Objective: The objective of this study was to evaluate the efficacy and tolerability of long-term (24-week) darbepoetin alfa treatment in maintaining hemoglobin (Hb) concentrations in the target range of 10 to 13 g/dL in patients undergoing dialysis; the patients were switched from rHuEPO to a less-frequent dosing regimen of darbepoetin alfa without an increase in dose. Methods:In this Phase IIIb, open-label, multicenter study, patients with endstage renal disease (ESRD) undergoing dialysis who were receiving rHuEPO BIW or TIW at baseline were switched to darbepoetin alfa QW; patients receiving rHuEPO QW were switched to darbepoetin alfa Q2W. Administration of darbepoetin alfa was by the same route as previous rHuEPO administration (IV or SC). Patients received darbepoetin alfa for 24 weeks, including a 20-week drug titration period followed by a 4-week, stable-dose evaluation period. The mode, dose, and frequency of administration of darbepoetin alfa were compared with those of baseline rHuEPO. Tolerability assessment was based on spontaneous reporting and laboratory tests (hematology, vital sign measurement, iron status, and biochemistry). Results:The study comprised 173 patients who were divided into 2 groups by route of administration (IV group, n = 146; SC group, n = 27). Mean (SE) adjusted increases in Hb concentration from baseline to the evaluation period for patients receiving darbepoetin alfa QW were 0.94 (0.32) g/dL and 0.38 (0.30) g/dL for the IV or SC routes, respectively (P = 0.004 and NS, respectively). For patients receiving darbepoetin alfa Q2W, the mean (SE) adjusted increases in Hb concentration were 0.08 (0.53) g/dL and 0.48 (0.35) g/dL for the IV and SC routes, respectively (both, P = NS). No significant differences in IV/SC dose ratio were observed between the 2 routes of administration. In addition, no increases in darbepoetin alfa dose were observed. The most commonly reported adverse events were hypertension (8 patients [5%]) and vascular access thrombosis (4 [2%]). The incidence of treatment-related adverse events was 6 (3%). Conclusions: Darbepoetin alfa effectively maintained Hb concentrationswithin the target range without an increase in dose, even at a reduced dosing frequency. Overall, darbepoetin alfa was well tolerated. (Curr Ther Res Clin Exp. 2005;66:195-211)

Reports on the success of permanent vascular access in elderly HD patients vary considerably. We reviewed the records of 149 patients [62F and 87M] aged 20-89 years old (median 59) who were on hemodialysis for 6-242 (49 median) months, and had undergone 202 vascular access procedures (177 Cimmino-Brescia fistulae and 25 PTFE grafts). Patients were divided into two groups according to the age they started HD. Group A: 48 patients, over 60 years old (range 60-83; median 70) on HD for 43.5, (6-140) months. Group B: 101 patients, under 60 years old, range (15-59) median 46, on HD for 54 (6-242) months. There were no differences between the two groups in terms of gender, primary renal disease, (except polycystic kidney disease), Hct and EPO administration. The initial choice of vascular access, the complications and the technique survival were examined in both groups. Cimmino-Brescia fistulae were used as the first choice of vascular access in all patients except one in group B. PTFE-grafts were the second or third choice in 7/48 (group A) and 15/101 (group B) (p: NS). The only reason for technique failure was vascular thrombosis in both groups (11/48 group A and 31/101 group B p: NS). Other complications were: aneurysms (10/48 and 14/101, p: NS), infections (0/48 and 2/101 p: NS) and edema (0/48 and 6/101, p: NS). Five-year technique survival of the first AV fistula in the two groups was 35% and 45% respectively (log-rank test, p: NS). These findings suggest that: a) A.V. fistula is the first choice of vascular access in aged HD patients; b) There is no difference in vascular access complications across age groups; c) Survival of the first A.V. fistula is independent of age.