Randomized placebo-controlled phase II trial of high-dose melatonin mucoadhesive oral gel for the prevention and treatment of oral mucositis in patients with head and neck cancer undergoing radiation therapy concurrent with systemic treatment.

PURPOSE: The objective of this trial was to evaluate the safety and efficacy of melatonin oral gel mouthwashes in the prevention and treatment of oral mucositis (OM) in patients treated with concurrent radiation and systemic treatment for head and neck cancer. METHODS: Randomized, phase II, double-blind, placebo-controlled trial (1:1 ratio) of 3% melatonin oral gel mouthwashes vs. placebo, during IMRT (total dose ≥ 66 Gy) plus concurrent Q3W cisplatin or cetuximab. Primary endpoint: grade 3-4 OM or Severe Oral Mucositis (SOM) incidence by RTOG, NCI, and a composite RTOG-NCI scales. Secondary endpoints: SOM duration and grade 2-4 OM or Ulcerative Oral Mucositis (UOM) incidence and duration. RESULTS: Eighty-four patients were included in the study. Concurrent systemic treatments were cisplatin (n = 54; 64%) or cetuximab (n = 30; 36%). Compared with the placebo arm, RTOG-defined SOM incidence was numerically lower in the 3% melatonin oral gel arm (53 vs. 64%, P = 0.36). In patients treated with cisplatin, assessed by the RTOG-NCI composite scale, both SOM incidence (44 vs. 78%; P = 0.02) and median SOM duration (0 vs. 22 days; P = 0.022) were significantly reduced in the melatonin arm. Median UOM duration assessed by the RTOG-NCI scale was also significantly shorter in the melatonin arm (49 vs. 73 days; P = 0.014). Rate of adverse events and overall response rate were similar between the two arms. CONCLUSIONS: Treatment with melatonin oral gel showed a consistent trend to lower incidence and shorter SOM duration and shorter duration of UOM. These results warrant further investigation in phase III clinical trial.

HIV infection and frequency of micronucleus in human peripheral blood cells.

PURPOSE: People living with HIV have higher rates of malignancies than the general population in the era of active antiretroviral therapy (ART). Genotoxic effects of HIV infection and/or ART that can induce neoplastic development are not yet well known. A prospective cohort study to investigate DNA damage measured through the micronuclei (MN) frequency in HIV-patients has been performed. METHODS: Peripheral blood mononuclear cells (PBMC) were isolated from 52 HIV-patients treated with ART and 55 healthy controls. RESULTS: By the comparison of MN frequency, a significant difference between HIV-patients (15.5 ± 9.8) and controls (6.0 ± 3.6) (p < 0.001) has been revealed. In univariate linear regression analysis, HCV infection (r = 0.31; p < 0.001), HIV-RNA (r = 0.29; p < 0.03) and duration of infection (r = - 0.16; p < 0.25) were associated with MN frequency; while only viral load (VL) significantly correlates (r = 0.29; p < 0.05) in a multiple regression model. CONCLUSIONS: The association of VL with MN frequency supports a genotoxic effect of HIV infection.

Atherosclerosis is associated with a higher risk of hepatic steatosis in HIV-infected patients.

INTRODUCTION: Cardiovascular Diseases (CD) have emerged as a leading cause of morbidity and mortality in HIV population. Some studies have reported higher carotid Intima Media Thickness (c-IMT), a measure of subclinical atherosclerosis (AT), in this cohort of patients. METHODS: Here, we evaluate the role of Hepatic Steatosis (HS) as likely marker for AT in 128 HIV-infected patients without hepatitis C infection. c-IMT has been detected non-invasively by carotid ultrasonography to assess the progression of AT. HS has been evaluated using a process based on vibration-controlled transient elastography (Fibroscan) by a novel ultrasonic controlled attenuation parameter (CAP). The cut-off value for defining the presence of significant HS was CAP > 259 dBm-1. RESULTS: AT has been detected in 26 patients (20.3%), whereas steatosis of grade 2 (S2) in 31 (24.2%). The variables statistically related to AT were age, obesity, diabetes, hypertension and S2. In the multivariate analysis, AT was only associated (p < 0.001) with age and S2. The optimal cut-off value indicated by ROC curve for predicting AT was CAP > 250 dB/m-1. DISCUSSION: Our results highlight the presence of AT in HIVinfected persons and its association with fatty liver disease; therefore, HS assessment in HIV population results crucial to predict AT and CD.

Reduced risk of Efavirenz Discontinuation in Naïve Patients Starting First-Line Antiretroviral Therapy with Single Tablet versus dual Tablet Regimen.

OBJECTIVES: Despite not being approved in Europe as first-line therapy, the efavirenz (EFV)-containing single tablet regimen (STR) is frequently used in clinical practice in naïve patients but few data are available on this strategy. In our study, we aimed to assess the risk of EFV discontinuation in patients starting antiretroviral therapy with STR vs. nonSTR. METHODS: This was a multicentre study retrospectively enrolling naïve patients starting EFV+TDF+FTC. Patients were followed from the time of treatment initiation to the discontinuation of the EFV-containing regimen, comparing STR vs. nonSTR. Two different analyses were performed: (A) nonSTR patients censored at the last observation (switch to STR not considered as the end of observation); (B) nonSTR patients censored at the time of switch to STR. RESULTS: The study included 235 patients, of whom 74 (31.5%) directly started STR. Among patients starting nonSTR, 108 (67.1%) switched to STR after a median period of 6 months. Forty-four EFV discontinuations were observed (13 among STR vs. 31 among nonSTR patients). The overall estimated probability of discontinuation was 30% at 5 years, about half (14.8%) of these occurring during the first year. Analysis A did not show significant differences between STR and nonSTR regarding the probability of efavirenz discontinuation (19.9% vs. 24.7% at 5 years, P = 0.630). In contrast, Analysis B showed that the probability of EFV discontinuation was similar (8.3%) between STR and nonSTR patients up to 8 months. Thereafter, a significantly higher rate of discontinuation was observed in nonSTR patients (47.5% vs. 19.9% at 5 years, P = 0.034). CONCLUSIONS: Our data suggest that an early switch to STR during the first months of treatment could reduce the risk of EFV discontinuation.

Surveillance of human influenza A(H3N2) virus from 1999 to 2009 in southern Italy.

The aim of this study was to evaluate the presence of influenza virus co-infections in humans and changes in the genetic variability of A(H3N2) virus strains in southern Italy from 1999 to 2009. A partial sequence of the haemagglutinin (HA) gene by human influenza H3N2 strains identified in oropharyngeal swabs from patients with influenza-like illness was analysed by DNA sequencing and a phylogenetic analysis was performed. During the seasons 1999-2000, 2002-2003, 2004-2005 and 2008-2009, the influenza viruses circulating belonged to subtype H3N2. However, A(H1N1) subtype virus and B type were respectively prevalent during the 2000-2001, 2006-2007, 2007-2008 and 2001-2002, 2003-2004, 2005-2006 seasons. The HA sequences appeared to be closely related to the sequence of the influenza A vaccine strain. Only the 2002-2003 season was characterized by co-circulation of two viral lineages: A/New York/55/01(H3N2)-like virus of the previous season and A/Fujian/411/02(H3N2)-like virus, a new H3 variant. In this study, over the decade analysed, no significant change was seen in the sequences of the HA gene of H3 viruses isolated.

Comparison of cognitive performance in HIV or HCV mono-infected and HIV-HCV co-infected patients.

PURPOSE: Our aim was to explore the interplay between human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections in the expression of cognitive disorders. METHODS: We performed a multi-centre cross-sectional study, enrolling three groups of asymptomatic outpatients matched for age and education: (1) HIV mono-infected; (2) HCV mono-infected; (3) HIV-HCV co-infected. All subjects were subjected to the Zung depression scale and a comprehensive neuropsychological battery. RESULTS: A total of 50 patients for each group were enrolled. Patients in the three groups did not significantly differ in the main common demographic and clinical characteristics, except for a lower proportion of past injecting drug use (IDU) in group 1 (4 %) in comparison to groups 2 (38 %, p < 0.001) and 3 (78 %, p < 0.001), a longer duration of HIV infection in group 3 in comparison to group 1 (p < 0.001) and a longer duration of HCV infection in group 3 in comparison to group 2 (p = 0.028). Overall, 39.3 % of patients showed minor cognitive impairment, with a higher proportion in group 3 (54 %) when compared to groups 1 (28 %, p = 0.015) or 2 (36 %, p = 0.108). Patients in group 3 [odds ratio (OR) 3.35, p = 0.038 when compared to group 1] and those with higher depression scores (OR 1.05, p = 0.017) showed an increased risk of cognitive impairment after adjusting for education and past injection drug use. In particular, group 3 showed worse performance in psychomotor speed tasks when compared to group 1 (p = 0.033). CONCLUSIONS: A worse cognitive performance in HIV-HCV co-infected patients was observed, suggesting an additive role of the two viruses in the pathogenesis of cognitive disorders.

Cardiovascular risk factors and carotid intima-media thickness are associated with lower cognitive performance in HIV-infected patients.

OBJECTIVES: The aim of the study was to investigate the relationship between metabolic comorbidities, cardiovascular risk factors or common carotid intima-media thickness (cIMT) and cognitive performance in HIV-infected patients. METHODS: Asymptomatic HIV-infected subjects were consecutively enrolled during routine out-patient visits at two clinical centres. All patients underwent an extensive neuropsychological battery and assessment of metabolic comorbidities and cardiovascular risk factors. Moreover, cIMT was assessed by ultrasonography. Cognitive performance was evaluated by calculating a global cognitive impairment (GCI) score obtained by summing scores assigned to each test (0 if normal and 1 if pathological). RESULTS: A total of 245 patients (median age 46 years; 84.1% with HIV RNA < 50 copies/mL; median CD4 count 527 cells/µL) were enrolled in the study. Cardiovascular risk factors were highly prevalent in our population: the most frequent were dyslipidaemia (61.2%), cigarette smoking (54.3%) and hypertension (15.1%). cIMT was abnormal (≥ 0.9mm) in 31.8% of patients. Overall, the median GCI score was 2 [interquartile range (IQR) 1-4]; it was higher in patients with diabetes (P = 0.004), hypertension (P = 0.030) or cIMT ≥ 0.9 mm (P < 0.001). In multivariate analysis, it was confirmed that diabetes (P = 0.007) and cIMT ≥ 0.9 mm (P = 0.044) had an independent association with lower cognitive performance. In an analysis of patients on combination antiretroviral therapy (cART), abacavir use was independently associated with a better cognitive performance (P = 0.011), while no association was observed for other drugs or neuroeffectiveness score. CONCLUSIONS: Diabetes, cardiovascular risk factors and cIMT showed a strong association with lower cognitive performance, suggesting that metabolic comorbidities could play a relevant role in the pathogenesis of HIV-associated neurocognitive disorders in the recent cART era.

Interleukin-17 regulates visceral obesity in HIV-1-infected patients.

OBJECTIVE: The aim of the study was to evaluate the interleukin-17 (IL-17) plasma level in HIV-1-infected patients and its relation to central obesity. METHODS: Eighty-four HIV-1-infected patients [42 with visceral obesity (group A) and 42 without visceral obesity (group B)] and 46 HIV-negative subjects [23 with visceral obesity (group C) and 23 without visceral obesity (group D)] were enrolled in the study. Sonographic measurements of perirenal fat diameter/body mass index (PRFD/BMI) were used to assess visceral adipose tissue thickness. RESULTS: HIV-1-infected patients had higher plasma levels of IL-17 than HIV-negative subjects [837.8 ± 260 pg/mL (mean ± standard deviation) vs. 395.3 ± 138.6 pg/mL, respectively; P<0.001]. Furthermore, HIV-1-infected patients with a diagnosis of visceral obesity had lower levels of IL-17 than HIV-infected lean patients (756.9 ± 282.9 pg/mL vs. 918.7 ± 208.4 pg/mL, respectively; P<0.01). IL-17 (r= -0.21; P=0.03) and waist circumference (r=0.48; P<0.001) were significantly associated with visceral adipose tissue thickness. A negative correlation of IL-17 (r= -0.23; P<0.001) with PRFD/BMI was found. CONCLUSIONS: This study suggests a linear negative association between IL-17 and visceral adipose tissue thickness.

Seroepidemiology of human bocavirus in Apulia, Italy.

A serological survey was performed to determine the prevalence of antibodies against human bocavirus in an Apulian population. Anti-hBoV IgG antibodies were analysed in 1206 inhabitants (age range, 1month-84years) using a standardized ELISA test based on the use of recombinant hBoV VP2 virus-like particles. In total, 1075 (89.1%) of 1206 participants (mean age 32±24.8years) displayed anti-hBoV-IgG. The seroprevalence increased significantly (p<0.0001) in children from 2-4years (64.2%) to 5-9years (96.4%). A similar trend was observed in both male and female subjects. In conclusion, our results show that hBoV infection is common in this population, especially in children.

Human metapneumovirus and human bocavirus associated with respiratory infection in Apulian population.

We have studied the occurrence of hBoV, hMPV and InfA-B in an Apulian population with respiratory tract infections. During influenza season 2008-2009, 116 oropharingeal swabs were collected from patients affected by Influenza-Like Illness (ILI). The PCR products of hMPV M and HBoV NP-1 genes were sequenced. 78 out of 116 samples were positive for at least one respiratory virus; hBoV was detected in 53, hMPV in 22 and InfA-B in 41 out of 116 swabs. A high rate of hBoV infection in adult (18.9%) and elderly (26.4%) subjects was found. The co-infection rate was higher for hMPV (18/22 cases, 81.8%) compared to hBoV (26/53 cases, 49.1%), and InfA-B (25/41 cases, 61.0%). Co-infections were common in children. hBoV positive samples shared a high level of genetic similarity with the hBoV1 genotype, and hMPV positive samples clustered with A2 subgroup. Our results suggest that hBoV and hMPV play a role in ILI.

Ultrasonographic assessment of lipodystrophy in HIV-1-infected patients.

PURPOSE: We performed a cross-sectional study of physical changes in HIV-infected adults to evaluate the role of ultrasonography for the diagnosis of lipodystrophy. MATERIALS AND METHODS: Sixty HIV-infected patients were recruited from 1 June to 31 December 2006. A total of 34 patients were included in the lipodystrophy group and 26 in no lipodystrophy group. Thickness of subcutaneous fat was measured twice with a high-frequency (15 MHz) transducer by transverse scans at four skin-based reference points: the periumbilical region, the brachial region, the crural region and the malar region. Visceral fat thickness was determined with a low-frequency (3.75 MHz) transducer at two skin reference points: perirenal fat diameter and visceral abdominal fat. RESULTS: Compared with HIV-infected patients without lipodystrophy, those with lipoatrophy or mixed lipodystrophy had thinner facial, arm and leg fat, whereas patients with lipodystrophy showed thicker intra-abdominal fat. The median of the ratio between intra-abdominal fat and subcutaneous fat and between perirenal fat diameter and body mass index in the lipodystrophy group was higher than in the no lipodystrophy group. The measurements of brachial, malar and crural fat were significantly lower in patients with lipodystrophy. CONCLUSIONS: We consider the ratio between visceral adipose tissue and subcutaneous adipose tissue and the thickness of malar fat to be the most useful ultrasonographic parameters for the early diagnosis of lipodystrophy in HIV-infected patients on highly active antiretroviral therapy.

Detection of early liver fibrosis in patients with intestinal schistosomiasis: sonographic and histologic findings in Schistosoma mansoni infection.

BACKGROUND: Ultrasound (US) is a quite economical and noninvasive technique for morbidity assessment in intestinal schistosomiasis and it is widely used in order to detect organ-specific schistosomiasis-associated changes even if it may be invalidated by low reproducibility of measurements and high interobserver variance. Reports on histological assessment in patients with intestinal schistosomiasis mansoni are unusual because liver biopsy is not commonly feasible in endemic areas and it is not warranted for ethical reasons. This short report is a retrospective analysis of sonographic and histologic findings in patients with early liver pathology, in view of the pathogenesis and morbidity assessment of intestinal schistosomiasis, in a European hospital setting. PATIENTS AND METHODS: Seven immigrants from Madagascar with chronic diarrhea or Schistosoma mansoni egg detection in feces were admitted to our department. All of them were subjected to clinical, biochemical and ultrasound examination following current World Health Organization (WHO) guidelines. Each patient underwent percutaneous liver biopsy. RESULTS: Abdominal ultrasonography showed schistosomiasis image patterns or US signs of liver involvement only in one out of seven patients while histological findings showed dense discrete fibrous tissue formation in five out of seven patients. In three out of seven patients liver biopsy also showed inflammatory infiltration of eosinophils and macrophages with periportal granulomas with S. mansoni eggs. Considering the mean egg intensity of three stool specimens as the gold standard, US showed a sensitivity of 16% with a negative predictive value (NPV) of 16% and a specificity of 100% with a positive predictive value (PPV) of 100%. Liver biopsy showed a sensitivity of 83% with a NPV of 50% and a specificity of 100% with a PPV of 100%. CONCLUSION: In our small study, US seemed to underestimate hidden liver fibrosis in intestinal schistosomiasis. In some European clinical settings, histological evaluation by liver biopsy may be a useful tool to detect early liver pathology in schistosomiasis mansoni. These findings could provide additional information for studies from endemic areas where US is commonly used for morbidity assessment.

Routine ultrasound-guided liver biopsy versus echo-assisted procedure in viral chronic hepatitis.

PURPOSE: Ultrasound (US)-assisted liver biopsy is the most widespread practice for the staging of chronic hepatitis, but there are no data about a comparison with the US-guided procedure in terms of safety and diagnostic yield. The aim of this study was a retrospective analysis about 357 biopsies performed by using both these techniques. MATERIALS AND METHODS: We analysed 176 US-guided biopsies and and 181 US-assisted liver biopsies performed in the same unit in patients with chronic viral hepatitis. We recorded the number of passes, sample fragmentation and sample size, number of portal spaces and degree of fibrosis. Mortality and morbidity were also assessed. Differences between the two groups of needle biopsies were analysed statistically by the Welch test, with significance at p<0.05. RESULTS: Specimens obtained by US-guided liver biopsy were 27 mm long (range 25-28.9 mm) versus 13 mm mean value (range 12.2-13.9 mm, p<0.0001) of samples from US-assisted liver biopsies and contained 15.7 portal tracts (range 14.7-16.7) versus 11 mean value (range 10-11.9, p<0.0001) of specimens obtained by echo-assisted needle biopsy. Mortality and major complication rate was zero in our series. Both groups of liver biopsies were comparable with respects to number of passes and sample fragmentation. CONCLUSIONS: Both methods showed overlapping security. The diagnostic yield seems to be greater if liver biopsy is performed by the echo-guided technique.

When to start highly active antiretroviral therapy in chronically HIV-infected patients: evidence from the ICONA study.

OBJECTIVES: To compare the response to highly active antiretroviral therapy (HAART) in individuals starting HAART at different CD4 cell counts. DESIGN: The mean increase in CD4 cell count and rate of virological failure after commencing HAART were measured in antiretroviral-naive patients (1421) in a large, non-randomized multicentre, observational study in Italy (ICONA). Clinical endpoints were also evaluated in a subset of patients who started HAART with a very low CD4 cell count. RESULTS: After 96 weeks of therapy, the mean rise in CD4 cell count was 280, 281 and 186 x 10(6) cells/l in patients starting HAART with a CD4 cell count < 200, 201--350 and > 350 x 10(6) cells/l, respectively. Patients starting HAART with a CD4 cell count < 200 x 10(6) cells/l tended to have a higher risk of subsequent virological failure [relative hazard (RH), 1.15; 95% confidence interval (CI), 0.93--1.42] compared with patients starting with > 350 x 10(6) cells/l. There was no difference in risk between the 201--350 and the > 350 x 10(6) cells/l groups (RH, 1.0; 95% CI, 0.79--1.29). The incidence of new AIDS-defining diseases/death in patients who started HAART with a CD4 count < 50 was 0.03/person-year (95% CI, 0.10--0.33) during the time in which the patient's CD4 cell count had been raised to > 200 x 10(6) cells/l. CONCLUSIONS: There was no clear immunological or virological advantage in starting HAART at a CD4 cell count > 350 rather than at 200--350 x 10(6) cells/l. The increase in CD4 cells restored by HAART is meaningful in that they are associated with reduced risk of disease/death.

Dendritic cell number is related to IL-4 expression in the airways of atopic asthmatic subjects.

BACKGROUND: Airway dendritic cells are essential for stimulating naive T cells in response to inhaled antigen and for the development of allergic sensitization. IL-4 in vitro can distinguish dendritic cell lines from peripheral blood mononuclear cells. Our study had the following aims: 1) to compare the distribution of CD1a+ dendritic cells and IL-4+ cells, in the bronchial mucosa of asthmatics and controls 2) to determine the relationship between the numbers of CD1a+ dendritic cells and IL-4+ cells in the bronchial mucosa of asthmatics 3) to determine whether CD1a+ cells express the IL-4 receptor. METHODS: Twenty atopic asthmatic and eight normal subjects were studied. In each subject, bronchoscopy with bronchial biopsies was performed. CD1a, IL-4, and IL-4 receptor expressions were evaluated by immunohistochemistry. RESULTS: The number of CD1a+ and IL-4+ cells was significantly higher in asthmatics than controls. The number of CD1a+ cells was positively correlated to the number of IL-4 + cells. Bronchial biopsy serial section studies showed that CD1a+ cells express the receptor for IL-4. CONCLUSIONS: These results suggest that an increased amount of IL-4 may play a physiopathologic role in maintaining the dendritic cell pool in vivo. Therefore, because of possible IL-4 activity on antigen-presenting cells in T-cell immune responses to allergens, an important new role of IL-4 in asthma inflammation can be envisaged.

The increased number of very late activation antigen-4-positive cells correlates with eosinophils and severity of disease in the induced sputum of asthmatic patients.

BACKGROUND: Lymphocyte function associate-1 (LFA-1), macrophage antigen-1 (Mac-1), and very late activation antigen-4 (VLA-4) are involved in the infiltration of leukocytes into the tissues. Experimental models of allergic inflammation suggest that VLA-4 could determine the selective recruitment of eosinophils into the inflamed airways. OBJECTIVE: Our purpose was to evaluate the involvement of integrins in eosinophil recruitment in asthma. METHODS: We evaluated by immunocytochemistry the expression of VLA-4, LFA-1, and Mac-1 and their relationship with inflammatory cells and severity of disease in the induced sputum of 20 mild to moderate atopic asthmatic subjects and in 8 healthy subjects. RESULTS: The number of VLA-4+ cells is increased in asthmatic patients and VLA-4 is mainly localized on eosinophils. Furthermore, VLA-4+ cells are significantly related to eosinophils. In contrast, LFA-1 and Mac-1 cellular expressions do not differ between asthmatic and control subjects and are not related to any specific cell type. Eosinophils and VLA-4+ cells are significantly higher in moderately compared with mildly asthmatic patients (P <.01, P <.05) and with healthy control subjects (P <.0005, P <.001). Eosinophils and VLA-4+ cells are also higher in mildly asthmatic patients compared with control subjects (P <.001, P <.005). CONCLUSION: This is the first report demonstrating, by a noninvasive method in humans, that VLA-4+ cells are increased and correlate with the eosinophils in the induced sputum of atopic patients with mild to moderate asthma and that VLA-4 expression is related to the severity of disease.

Short-term treatment with a low dose of inhaled fluticasone propionate decreases the number of CD1a+ dendritic cells in asthmatic airways.

The activation of T-lymphocytes through the recognition of specific allergens is a crucial event in the development of allergic inflammation. Dendritic cells (DC) are potent accessory cells that play an important role in initiating bronchial immune responses by activation of T-lymphocytes. We investigated the distribution of CD1a+ DC in the bronchial biopsies from asthmatic patients, and evaluated the effects of a short course of low dose inhaled fluticasone propionate treatment. Twenty-three mild to moderate stable asthmatic patients and eight normal subjects were included in the study. Bronchoscopy with bronchial biopsies were performed in each subject. Eighteen of the 23 asthmatics underwent a second bronchoscopy after 6 weeks of low dose inhaled fluticasone propionate treatment (250 mcg bd) in a placebo-controlled double-blind study. Biopsies were embedded into glycolmethacrylate resin and analysed by immunohistochemistry methods using specific monoclonal antibodies against CD1a, which is a widely recognized marker for DC. In asthmatics, CD1a+ DC number was significantly higher in bronchial epithelium (P < 0.001) and in lamina propria (P < 0.001) when compared with normal controls. In addition, we observed that a short course of low dose inhaled fluticasone propionate treatment decreased the number of CD1a+ DC in both the bronchial epithelium (P < 0.05) and lamina propria (P < 0.01). The increased number of CD1a+ DC support the hypothesis that DC play an important role in the modulation of the immune response in chronic asthma. Short-term low dose fluticasone propionate treatment induces down-regulation of the CD1a+ DC number.

Efficacy of human leukocyte interferon-alpha treatment in elderly patients with hepatitis-C virus-related chronic liver disease.

Sixty-seven aged patients (mean age 69, age range 67-73 years) with hepatitis C virus (HCV)-related chronic liver disease were treated with human leukocyte interferon-alpha at a dose of 9 mU/week for 9 months and then followed up for other 6 months. At the end of treatment, 39 patients (58.2%) showed normalization of alanine aminotransferase (ALT) levels; however, 24 responders (61.5%) had a relapse of the disease in the following 6 months. Fifteen out of 39 responders (38.5%) had a sustained response. Of these, 9 (60%) showed clearance of HCV-RNA from serum. Similar rates were observed in a group of younger patients (mean age 48, age range 17-58 years) treated with the same schedule. In both groups, the most important predictor of response appeared to be the degree of fibrosis at liver histology, rather than the patients' age. These data suggest that interferon-alpha treatment may be as much useful in elderly patients as it may be in younger patients, provided that liver injury is not advanced too much.