Adjuvanted recombinant HBV vaccine (HBV-AS04) is effective over extended follow-up in dialysis population. An open-label non randomized trial.

BACKGROUND: Patients on regular dialysis show a poor response to hepatitis B vaccine due to uremia. A recombinant HB vaccine (containing an improved adjuvant system AS04, HBV-AS04) has been licensed but the evidence on its efficacy and safety in dialysis population over the long term is extremely limited. AIM: We have measured antibody (anti-HBs) persistence for up to 72 months in a large cohort of patients on long-term dialysis (with susceptibility to HBV infection) who underwent vaccination with HBV-AS04 vaccine. METHODS: Patients were prospectively recruited to receive four 20-mcg doses of HBV-AS04 by intramuscular route (deltoid muscle). Two vaccine schedules were adopted: 0,1,2, and 3 month (n=217 patients) and 0,1,2, and 6 month (n=31 patients). Anti-HBs antibody concentrations were tested at 1,2,3, 4, 7 and 12 months and then every year up to 72 months. Multivariate analysis was made to find the baseline parameters that were associated with the immune response to HBV-AS04 vaccine. RESULTS: Two hundred and seventy-two patients were included and 248 completed the study. At completion of vaccine schedule, the frequency of responders (anti-HBs titers≥10mIU/mL) was 81.5% (202/248) (mean anti-HBs antibody titers, 384.9±391.9mIU/mL), according to per-protocol analysis. On the grounds of univariate analysis, age was lower in responder than non- responder patients to HBV AS04 even if no statistical significance was achieved (P=0.09). The sero-protection rate at month 72 was 77% (7/9) (anti-HBs antibody titers, 184.9±360.1mIU/mL, P=0.001). Multivariate analysis found a relationship between sero-response rate and age (P=0.04). No major side effects and no de novo HBV episodes were observed. CONCLUSIONS: Our open-label nonrandomized trial performed in a 'real-world' practice showed the persistence of anti-HBs antibody among responder patients over a very long follow-up. Studies with longer observation periods are under way.

Glomerular isolated microscopic hematuria: urinary features and long term follow-up of a selected cohort of patients.

BACKGROUND: Isolated microscopic hematuria is a condition characterized by the presence in the urine of an "abnormal" number of erythrocytes in the absence of proteinuria. Several studies have been published on this condition, but with heterogeneous inclusion criteria and variable outcomes at follow-up. In this retrospective study, we describe a selected and homogenous cohort of patients who presented with isolated microscopic hematuria of glomerular origin. METHODS: We included in the study patients with isolated microscopic hematuria of glomerular origin (> 1 erythrocyte/high power field at 400× and ≥ 40% dysmorphic erythrocytes and/or ≥ 5% acanthocytes and proteinuria ≤ 150 mg/24 h) with a follow-up of > 60 months from the first documentation of microscopic hematuria. RESULTS: Forty-two patients (M 12, F 30, age at presentation 14-68 years, eGFR < 60 ml/min/1.73 m2: 1 patient) were included. During a medium term follow-up, microscopic hematuria was persistent in 25 patients (59.5%), transiently absent in 17 (40.5%), always glomerular in 16 patients (38.1%), and occasionally non-glomerular in 26 (61.9%); proteinuria, observed in 16 patients (38.1%), was always transient and < 500 mg/24 h. At the end of a follow-up of 181.8 ± 97.9 (median 168) months, only 2 patients (4.8%) had eGFR < 60 ml/min/1.73 m2, one of whom had reduced eGFR already at presentation. CONCLUSIONS: This study on a small but selected and homogeneous cohort of patients with isolated microscopic hematuria of glomerular origin demonstrates that urinary features can transiently change over time and that the renal outcome is good.

Aristolochia clematitis, the herb responsible for aristolochic acid nephropathy, in an uncultivated piece of land of an Italian nephrologist.

BACKGROUND: Aristolochia clematitis (AC), a herbaceous plant that belongs to the family of Aristolochiaceae, is today considered as being responsible for Balkan endemic nephropathy (BEN). Very scarce information is available in the medical literature about the presence of AC outside Balkan area. This article reports on the finding of AC in Northwest Italy and the results of a questionnaire delivered to locals on their knowledge about AC. METHODS: AC was found in an uncultivated piece of land of a hilly area of Northwest Italy. It was identified by matching it with images available in the literature and Internet. The questionnaire, which was delivered with a set of 12 photographs and a bunch of true AC, contained 15 questions aimed at collecting information on the knowledge of the respondents about the existence, name, distribution and possible uses of AC. RESULTS: A total of 23 locals, mostly farmers, were interviewed. Among them, 22 (95.6%) had already seen AC, mostly in uncultivated areas; 4 (18%) had a name for it; 21 (95.4%) considered it as a weed and denied any personal use of it; 18 (81.8%) stated that breeding animals disliked AC and no one was aware that AC might damage kidneys. CONCLUSIONS: This study demonstrates that AC can be found outside the Balkan region and that people know it but today do not make any use of it. Other studies carried out by nephrologists in other geographic areas could expand our knowledge about AC outside the basin of BEN.