Yeast Bloodstream Infections in the COVID-19 Patient: A Multicenter Italian Study (FiCoV Study).

Fungemia is a co-infection contributing to the worsening of the critically ill COVID-19 patient. The multicenter Italian observational study FiCoV aims to estimate the frequency of yeast bloodstream infections (BSIs), to describe the factors associated with yeast BSIs in COVID-19 patients hospitalized in 10 hospitals, and to analyze the antifungal susceptibility profiles of the yeasts isolated from blood cultures. The study included all hospitalized adult COVID-19 patients with a yeast BSI; anonymous data was collected from each patient and data about antifungal susceptibility was collected. Yeast BSI occurred in 1.06% of patients, from 0.14% to 3.39% among the 10 participating centers. Patients were mainly admitted to intensive or sub-intensive care units (68.6%), over 60 years of age (73%), with a mean and median time from the hospitalization to fungemia of 29 and 22 days, respectively. Regarding risk factors for fungemia, most patients received corticosteroid therapy during hospitalization (61.8%) and had a comorbidity (25.3% diabetes, 11.5% chronic respiratory disorder, 9.5% cancer, 6% haematological malignancies, 1.4% organ transplantation). Antifungal therapy was administered to 75.6% of patients, mostly echinocandins (64.5%). The fatality rate observed in COVID-19 patients with yeast BSI was significantly higher than that of COVID-19 patients without yeast BSI (45.5% versus 30.5%). Candida parapsilosis (49.8%) and C. albicans (35.2%) were the most fungal species isolated; 72% of C. parapsilosis strains were fluconazole-resistant (range 0-93.2% among the centers). The FiCoV study highlights a high prevalence of Candida BSIs in critically ill COVID-19 patients, especially hospitalized in an intensive care unit, a high fatality rate associated with the fungal co-infection, and the worrying spread of azole-resistant C. parapsilosis.

Adherence to Mediterranean Diet and Risk of Pancreatic Cancer: Systematic Review and Meta-Analysis.

Pancreatic cancer (PC) represents the 6th cause of cancer death. Although the aetiology of PC is not completely understood, numerous risk factors have been identified in association with this cancer, among them diet. However, little is known about the association between the Mediterranean Diet (MedDiet) and the risk of PC. For this reason, we conducted a systematic review with meta-analysis according to the PRISMA guidelines, searching on three databases (PubMed/MEDLINE, Scopus, and EMBASE). The protocol was registered in PROSPERO. Both fixed and random effect models were performed. The Effect size was reported as a hazard ratio (HR) with a 95% Confidence Interval (CI). A total of eight articles were included. The methodological quality of the included meta-analyses was high. Our results show that a higher adherence to the MedDiet is associated with a lower risk of PC [HR:0.82 (0.76-0.88) p < 0.001, based on 1,301,320 subjects]. The results were also confirmed in sensitivity and subgroups analyses (avoidance of potential overlapping effects, type of tools used to assess dietary intake and the diagnosis of PC, prevalence and incidence of PC risk, country where the studies took place, sex, and cancer site). Promoting a higher adherence to the MedDiet could be an effective approach to reduce the risk of PC.

Fungal diversity in lake and sea beaches of Italy: Relevance to human health.

Fungal diseases correlated to beach sand or water have not yet been demonstrated due to the lack of epidemiological studies. This study aims to illustrate the fungal population in beach sands of the two largest Italian lakes and in sands and waters of Mediterranean coasts of Southern Italy to contribute to the identification and assessment of causes of microbiological pollution that might impair bathers health. A great difference was observed between the two lakes, where the total of colony-forming units (CFU) ranged from 33.3 to 1049.9 CFU/g. For coastal sands, the total CFU ranged from 216.7 to 538.8 CFU/g, and for coastal waters the total ranged from 185 to 368.7 CFU/ml. The survey revealed the prevalence of opportunistic pathogenic moulds, mainly Aspergillus spp. (A. niger and A. fumigatus) and Penicillium spp., both in freshwater and costal bathing sites. Dermatophytes and yeasts were not detected in the freshwater sands while they were found at low load in coastal waters (3.3 CFU/ml) and sands (1.7 CFU/g). Differences were observed between urban and non-urban coastal beaches with regard to isolation of dermatophytes only from one urban beach. The present study reports a great diversity of fungi in sand and water of bathing beaches confirming that the Mediterranean region has a greater variety of fungal species.

Hepatitis B Vaccination: A Historical Overview with a Focus on the Italian Achievements.

Vaccination is the most effective way to control and prevent acute and chronic hepatitis B, including cirrhosis and HCC, on a global scale. According to WHO recommendations, 190 countries in the world have introduced hepatitis B vaccination into their national childhood immunization programs with an excellent profile of safety, immunogenicity, and effectiveness. Following vaccination, seroprotection rates are close to 100% in healthy children and over 95% in healthy adults. Persistence of anti-HBs is related to the antibody peak achieved after vaccination. The peak is higher the longer the antibody duration is. Loss of anti-HBs does not necessarily mean loss of immunity since most vaccinated individuals retain immune memory for HBsAg and rapidly develop strong anamnestic responses when boosted. Evidence indicates that the duration of protection can persist for at least 35 years after priming. Hence, booster doses of vaccines are currently not recommended to sustain long-term immunity in healthy vaccinated individuals. In Italy, vaccination against hepatitis B is met with success. In 2020, Italy became one of the first countries in Europe to be validated for achieving the WHO regional hepatitis B control targets.

[An update on the epidemiology of hepatitis A in Italy 2015-2019. Data from the surveillance of acute viral hepatitis SEIEVA]. / Aggiornamento sull'epidemiologia dell'epatite A in Italia negli ultimi cinque anni. Dati dalla sorveglianza SEIEVA 2015-2019.

BACKGROUND: hepatitis A is an infective disease whose global diffusion appears to be variable and strictly related to socioeconomic status, hygiene conditions, and access to potable water. During last twenty years, Italy registered a constant decrease of new cases with recurrent epidemic outbreaks. OBJECTIVES: to outline the hepatitis A epidemiological situation in Italy in the five-year period 2015-2019. DESIGN: descriptive study based on cases reported to the National Surveillance System for Acute Viral Hepatitis (SEIEVA). SETTING AND PARTICIPANTS: hepatitis A cases reported to SEIEVA from 2015 to 2019. MAIN OUTCOME MEASURES: hepatitis A incidence, percentages of cases exposed to known risk factors, distribution of cases by vaccination status. RESULTS: during the whole observational period, SEIEVA registered 4,929 type A hepatitis cases. The epidemic curve initially showed a trend with a low incidence level interrupted in August 2016 with the onset of a large epidemic, in the period between August 2016 and December 2017, involving 3,428 cases mostly adult men exposed to homosexual intercourses (MSM). Since January 2018, the trend of the cases has been decreasing even though its level is still higher than the pre-epidemic period. Based on the analysis of the epidemic curve, three periods characterized by different trends in the monthly number of notified cases were identified: January 2015-July 2016 (pre-epidemic period), August 2016-December 2017 (epidemic period), January 2018-December 2019 (post-epidemic period). In the last observation period, cases show different characteristics compared to the previous periods. They are mainly males under 18 years (p=0.026), subjects travelling to Morocco (8.9% vs 15.9%; p< 0.001) or being in contact with an infected person (p< 0.001). The multivariate analysis confirmed a significantly higher probability for cases notified in the post-epidemic period, compared to the pre-epidemic, to be secondary cases or to have traveled to Morocco. Compared to the pre-epidemic period and the epidemic period, there was a higher percentage of subjects who received a single dose of anti-hepatitis A vaccine (p=0.001). Taking into account only secondary cases reported in the third period, the percentage of cases with incomplete vaccination rises to 31%; in this group, a single dose of the vaccine was administered at a median of 11.5 days before the onset of symptoms. CONCLUSIONS: vaccination is of paramount importance for the prevention of hepatitis A in all risk groups, including adult males exposed to same-sex sexual intercourse and travelers to areas at high-medium endemic level, especially children, as the timeliness in the vaccination of contacts is fundamental and crucial for interrupting the chains of infection. The observed increase in secondary cases and the delay in the administration of doses lead to a reflection on the need for greater promotion of vaccination, but also highlight the critical issues in the organization of vaccination services, mainly in the areas that have reported the greatest number of cases.

Association between previous infection with SARS CoV-2 and the risk of self-reported symptoms after mRNA BNT162b2 vaccination: Data from 3,078 health care workers.

BACKGROUND: Health care workers (HCWs) are at high risk of contracting an infection by SARS CoV-2 and thus they are a priority for vaccination. We hereby aim to investigate whether the risk of severe and moderate systemic symptoms (MSS) after vaccination is higher in HCWs with a history of previous COVID-19. METHODS: An online questionnaire was offered to the cohort all HCWs undergoing anti-SARS CoV-2 mRNA BNT162b2 vaccination between January 4th and February 9th 2021 in two large tertiary hospitals (ASST Santi Paolo and Carlo) in Milan, Italy. Previous SARS-CoV-2 infection/COVID-19 was recorded. Local and systemic symptoms after each of the two doses were reported. MSS were those either interfering with daily activities or resulting in time off-work. Factors associated to MSS were identified by logistic regression. FINDINGS: 3,078 HCW were included. Previous SARS-CoV-2 infection/COVID-19 occurred in 396 subjects (12·9%). 59·6% suffered from ≥1 local or systemic symptom after the first and 73·4% after the second dose. MSS occurred in 6·3% of cases (14·4% with previous vs 5·1% with no COVID-19 p<0·001) and in 28·3% (24·5% in COVID-19 vs 28·3% no COVID, p = 0·074) after the first and second dose, respectively. Subjects already experiencing COVID-19 had an independent 3-fold higher risk of MSS after the first and a 30% lower risk after the second dose. No severe adverse events were reported. INTERPRETATION: Our data confirm in a real-world setting, the lack of severe adverse events and the short duration of reactogenicity in already infected HCWs. Possible differences in immune reactivity are drivers of MSS among this group of HCWs, as well as among females and younger individuals. FUNDING: None.

Are Epidemiological Estimates Able to Describe the Ability of Health Systems to Cope with COVID-19 Epidemic?

INTRODUCTION: The coronavirus disease 2019 (COVID-19) epidemic is an infectious disease which was declared a pandemic and hit countries worldwide from the beginning of the year 2020. Despite the emergency vigilance plans, health systems in all countries experienced a different ratio of lethality, amount of admissions to intensive care units and quarantine management of positive patients. The aim of this study is to investigate whether some epidemiological estimates could have been useful in understanding the capacity of the Italian Regional Health Services to manage the COVID-19 epidemic. METHODS: We have compared data between two different Italian regions in the Northern part of Italy (Lombardy and Veneto) and the national data to determine whether different health strategies might be significant in explaining dissimilar patterns of the COVID-19 epidemic in Italy. Data have been extracted from a public database and were available only in an aggregated form. RESULTS: The regions in question displayed two different health policies to face the COVID-19 epidemic: while Veneto's health service was largely territorially oriented, Lombardy's strategy was more hospital-centered. DISCUSSION: The key to facing epidemics like this one consists in identifying solutions outside of hospitals. This however requires there be well-trained general practitioners and enough healthcare personnel working outside hospitals.

[Epidemiology and surveillance of hepatitis E in Italy: data from the SEIEVA surveillance system 2007-2019]. / Epidemiologia e sorveglianza dell'epatite E in Italia: dati dalla sorveglianza SEIEVA 2007-2019.

BACKGROUND: hepatitis E is a disease spread all over the world, with endemic levels varying according to ecological and socioeconomic factors. In developing countries, large epidemics spread mainly through contaminated water; in developed countries, hepatitis E has always been considered a sporadic disease, closely associated to the travels to endemic areas, especially in Southeastern Asia. In the last years, this perception is significantly changing, because of an increasing number of autochthonous cases reported in many European countries. OBJECTIVES: to describe the epidemiological picture of hepatitis E in Italy from 2007 to 2019. DESIGN: descriptive study based on the cases reported to the special surveillance of acute viral hepatitis (SEIEVA); case-control analytical study for the analysis of risk factors associated with hepatitis E. SETTING AND PARTICIPANTS: hepatitis E cases reported to SEIEVA in the period 2007-2019. MAIN OUTCOME MEASURES: number of cases notified by year, percentages of cases exposed to known risk factors, odds ratios. RESULTS: from January 2007 to June 2019, 385 hepatitis E cases were notified to SEIEVA. The annual number increased from 12 in 2007 to 49 in 2018, the increasing trend continued in 2019, when 39 cases were observed in the first 6 months of the year. Northern and Central Regions reported most of the cases; only a few were diagnosed in Southern Regions. Based on SEIEVA data, the trend of hepatitis E notifications has increased according to the increasing propensity to the differentiated diagnosis, at least until 2018. However, only 46% of suspected cases are tested to detect the presence of anti-HEV IgM antibodies, during the observation period; the percentage of tested cases is significantly lower in the South than in Northern and Central Italy (p<0.001). The reported cases have a median age of 48 years (range: 5-87) and are mostly males (80%); 32% was observed in foreign citizens mainly from endemic areas of South Asia (Bangladesh, India, and Pakistan). In 72.5% of cases, the infection was contracted in Italy. The most frequent risk factor is the consumption of raw or undercooked pork meat, especially sausages (70% of cases), significantly associated with hepatitis E risk (OR 3.0; IC95% 1.4-6.1). Other important risk factors are wild boar sausages consumption (40% of cases, OR 4.6, not statistically significant), and travels to endemic areas during the six weeks before the disease (31% of cases, OR 3.2; IC95% 1.6-6.4). CONCLUSIONS: hepatitis E can now be considered as endemic even in industrialized countries. In Italy, from 2007 an increasing number of cases has been reported. However, the real impact of HEV infection is still underestimated due to the limited number of clinical centres which perform tests for the search of anti-HEV IgM antibodies in cases of acute hepatitis. An ad hoc surveillance has been activated in January 2019 in some Local Health Units/Regions and extended to a national level starting from January 2020. This initiative is necessary in order to better dimension the burden of the disease associated with HEV infection, to study its epidemiology, and to increase awareness of this infection among health professionals.

[Evidence-Based Psychological Treatments for Adults: A Selective Review]

Evidence-Based Psychological Treatments for Adults: A Selective Review. BACKGROUND: Psychological treatments have shown their efficacy, effectiveness, and efficiency in dealing with mental disorders. However, considering the scientific knowledge generated in recent years, in the Spanish context, there are no updating studies about empirically supported psychological treatments. The main goal was to carry out a selective review of the main empirically supported psychological treatments for mental disorders in adults. METHOD: Levels of evidence and degrees of recommendation were collected based on the criteria proposed by the Spanish National Health System (Clinical Practice Guidelines) for different psychological disorders. RESULTS: The results indicate that psychological treatments have empirical support for the approach to a wide range of psychological disorders. These levels of empirical evidence gathered range from low to high depending on the psychological disorder analysed. The review indicates the existence of certain fields of intervention that need further investigation. CONCLUSIONS: Based on this selective review, psychology professionals will be able to have rigorous, up-to-date information that allows them to make informed decisions when implementing empirically based psychotherapeutic procedures based on the characteristics of the people who require help.

Azole resistance in Aspergillus isolates by different types of patients and correlation with environment - An Italian prospective multicentre study (ARiA study).

BACKGROUND: A wide range of frequency of azole-resistance in A fumigatus in different patient populations worldwide was observed threatening to reduce therapeutic options. OBJECTIVES: Estimate the prevalence of azole-resistance, investigate the molecular mechanisms of resistance, compare the genotypes of resistant clinical isolates with those from the surrounding environment. METHODS: Aspergillus isolates were collected by seven Italian hospital microbiology laboratories. Strains were isolated from different clinical samples from unselected patients. The azole-resistance was evaluated using screening test and microdilution EUCAST method. The molecular mechanism of resistance was performed sequencing the cyp51A gene. Resistant isolates were genotyped by microsatellite analysis and their profiles compared with those of azole-resistant isolates from previous Italian studies. RESULTS: 425 Aspergillus isolates from 367 patients were analysed. The azole-resistance rates were 4.9% and 6.6% considering all Aspergillus spp. isolates and the A fumigatus sensu stricto, respectively. All resistant isolates except one were from a single hospital. Two rare azole-resistant species were identified: A thermomutatus and A lentulus. The predominant resistance mechanism was TR34 /L98H. No correlation between the clinical resistant strains and environmental isolates from patients' home/work/ward was observed. The analysis of the molecular correlation between the resistant clinical strains collected in the present study and those of environmental and clinical origin collected in previous Italian studies reveals a progressive diversification of azole-resistant genotypes starting from a founder azole-resistant genotype. CONCLUSIONS: This study confirms the trend of azole-resistance rate in Italy, showing a geographical difference. Data reinforce the importance of surveillance programmes to monitor the local epidemiological situation.

Thrombosis of the Iliac Vein Detected by 64Cu-Prostate-Specific Membrane Antigen (PSMA) PET/CT.

An 82-year-old man had a diagnosis of prostate cancer and underwent curative radiotherapy. During the oncological follow-up, the patient showed biochemical relapse and underwent whole-body Cu-prostate-specific membrane antigen PET/CT for restaging purpose. Cu-prostate-specific membrane antigen PET/CT showed a pathological uptake in left iliac venous axis, subsequently confirmed as venous thrombosis.

A Rare Case of Pituitary Melanoma Metastasis: A Dramatic and Prolonged Response to Dabrafenib-Trametinib Therapy.

Introduction: Pituitary metastases (PM) are rare events and to date only very few cases of melanoma PM have been described in literature up to now. Case Presentation: We describe the clinical history of a 33-year-old male patient who underwent surgical excision of an inter-scapular melanoma in 2008. The subsequent follow-up was negative for ~10 years. In September 2018, due to the onset of a severe headache, the patient underwent a brain magnetic resonance imaging, which showed an expansive mass in the saddle and suprasellar region with a maximum diameter of 17 mm. Pituitary function tests and visual field were normal. Worsening of the headache and the appearance of a left eye ptosis led the patient to surgical removal of the lesion in October 2018. The histological examination unexpectedly showed metastasis of the melanoma. Post-operative hormonal assessment showed secondary hypothyroidism and hypoadrenalism, which were both promptly treated, and a mild hypogonadism. Three months after surgery, a sellar MRI showed a persistent, increased pituitary mass (3 cm of diameter); fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) detected an increased radiopharmaceutical uptake in the sellar region. Due to the persistence of the disease and the evidence of a BRAF V600E mutation, in February 2019, the patient underwent a combined treatment with dabrafenib (a BRAF inhibitor) and trametinib (mitogen-activated extracellular signal-regulate kinase inhibitor). Sellar MRI performed 6 months later showed no evidence of mass in the sellar region. The patient was in a good clinical condition and did not complain of headaches or other symptoms; there were no significant side-effects from the anticancer therapy. After 13 months of treatment, the patient showed no recurrence of the disease on morphological imaging. Anticancer therapy was confirmed, replacement therapies with hydrocortisone and levothyroxine continued and the pituitary-gonadal axis was restored. Conclusion: This is a very interesting case, both for the rarity of the pituitary melanoma metastasis and for the singular therapeutic course carried out by the patient. This is the first case of a pituitary melanoma metastasis with BRAF mutation, successfully treated with the combination of dabrafenib and trametinib after incomplete surgical removal.

Heterogeneity of COVID-19 outbreak in Italy.

An outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) started in December 2019 in China and was declared a pandemic on 11.03.2020 by WHO. Italy is one of the most afflicted Country by this epidemic with 136,110 confirmed cases and 16,654 deaths on 9.4.2020 (at the same date, the Ministry of Health was reporting 143,626 cases).  During these few months the National Health Service have made a great effort to cope with the increasing request of intensive care beds and all the elective activities in hospital have been suspended. Data from the different Italian regions shows different patterns of positive and dead for this syndrome. Moreover, striking differences of the observed lethality of the infections among different areas were immediately evident from the epidemic reports. It will be of critical relevance to understand the expected evolution of the first lock-down phase, driving the exhaustion of the Covid-19 outbreak.(www.actabiomedica.it).

COVID-19: the end of lockdown what next?

The Corona Virus 19 (COVID 19) epidemic is an infectious disease which was declared as a pandemic and hit all the Countries, all over the world, from the beginning of the year 2020. In Italy the epidemic is particular serious with 169.325 confirmed cases and 21.551 deaths on 20.04.2020. To stop the contagion on March 8 and up to May 3, the Italian Government decided a lockdown for all the Country, the authors suggest how to manage the reopening and restarting of all the activities avoiding a restart of the epidemic.

Hepatitis A epidemic in men who have sex with men (MSM) in Milan, Italy.

BACKGROUND AND AIM OF THE WORK: Hepatitis A is an infectious disease characterized by fecal-oral transmission; however, a rise in sexually-transmitted cases has been observed, particularly among "men who have sex with men". In Europe, a Hepatitis A epidemic occurred among men who have sex with men between 2016 and 2018. The aim of this study is to describe this Hepatitis A epidemic in the city of Milan and to analyze the incidence of Sexually Transmitted Diseases co-infection among Hepatitis A cases. METHODS: Hepatitis A cases were traced and identified. Epidemiological data were collected and Hepatitis A vaccination was investigated. Cases were georeferenced, calculating incidence rates for each Milan Municipality. Viral genotypic analysis was carried out. RESULTS: 353 cases were reported in Milan. Incidence rates resulted significantly higher in males (RR 18.1 CI9 5% 11.5 - 28.4). 70 cases reported foreign travel. 172 cases reported "Men  who have Sex with Men" behaviour. Genotypic analysis revealed correlation with strains of the European "Men who have Sex with Men" epidemic. Georeferencing showed asymmetric case distribution. Only 12 cases reported Hepatitis A vaccination. The Relative Risk for syphilis infection among Hepatitis A cases was 133.9 (95% CI 81.7 - 219.7) and 29.7 (95%CI 9.5 - 92.7) for gonorrhea. CONCLUSIONS: Most genotyped cases (93.7%) correlated to the European Hepatitis A epidemic among Men who have Sex with Men. Georeferencing showed a greater incidence of Hepatitis A cases in areas characterized by the homosexual community. The higher incidence of Sexually Transmitted Diseases co-infection in Hepatitis A cases correlated to clusters responsible for the European Hepatitis A epidemic, suggests increased sexual promiscuity among Men who have Sex with Men. These data support the need for Hepatitis A vaccination programs and sensitization of Men who have Sex with Men to the adoption of safe sexual practices.

Epidemiological characteristics of cryptococcal meningoencephalitis associated with Cryptococcus neoformans var. grubii from HIV-infected patients in Madagascar: A cross-sectional study.

Cryptococcal meningoencephalitis (CM) remains the most prevalent invasive fungal infection worldwide. The main objective of this study was to describe the prevalence of CM and cryptococcal infection in HIV-infected patients in Madagascar. The secondary objectives were to assess the adjusted prevalence of CM according to clinical presentation and patient characteristics, to determine crude 90-day survival according to cryptococcal antigen (CrAg) status and CM, and to identify the genotypes of Cryptococcus clinical isolates. This cross-sectional study was carried out at two urban hospitals in Antananarivo (central highlands) and Toamasina (east coast) between November 2014 and December 2016. Consecutive HIV-infected adults presenting with CD4 cell counts ≤200/µl were enrolled. Lateral flow immunoassays of CrAg were performed on serum for all patients, and on cerebrospinal fluid for patients with CM symptoms. MALDI-ToF MS, ITS sequencing, and determinations of the molecular and mating types of the isolates were performed. Fluconazole is the only drug for CM treatment available in Madagascar. Patients were treated orally, with high doses (1200 mg/day) for 10-12 weeks and then with 200 mg/day. Minimum inhibitory concentrations were determined for amphotericin B, flucytosine, voriconazole and fluconazole in E-tests. Overall prevalence was 13.2% (95% CI 7.9-20.3) for cryptococcal infection and 10.9% (95% CI 6.1-17.5) for CM, among the 129 HIV-infected patients studied. The 90-day mortality rate was 58.8% (10/17) in CrAg-positive patients and 17.9% (20/112) in CrAg-negative patients (p<0.001). The 13 Cryptococcus strains obtained at baseline were all Cryptococcus neoformans var. grubii, genotypes VNI-αA (3 isolates), VNII-αA (4 isolates) or hybrid VNI/VNII-αAAα (6 isolates), suggesting high diversity. Two strains acquired fluconazole resistance after four and five months of exposure, respectively. The prevalence of cryptococcosis is high in Madagascar and this serious condition is life-threatening in HIV-infected patients. These findings will be used to raise the awareness of national authorities to strengthen the national HIV/AIDS control program.

Prevalence, incidence and residual risk of transfusion-transmitted hepatitis B virus infection in Italy from 2009 to 2018.

BACKGROUND: In Italy, the use of nucleic acid testing for hepatitis B virus (HBV) in donor screening has allowed the detection of infections in the window phase, as well as the presence of occult infections which could potentially be transmitted. The aim of this study was to analyse the trends of epidemiological data focused on HBV infection in blood donors and to estimate the residual risk of transmitting HBV from both the window phase and occult infection over a 10-year period in Italy. MATERIALS AND METHODS: Data were obtained from the Italian Haemovigilance System which includes the results of screening tests for transfusion transmissible infections. During the period of this survey (2009-2018), the molecular methods used for HBV screening were transcription-mediated amplification and polymerase chain reaction tests. Prevalence and incidence were calculated. The residual risk was estimated by applying the incidence-window period model for acute cases and a more recently reported model for estimating the risk due to occult infections. RESULTS: A total of 17,424,535 blood donors and 30,842,794 donations were tested for HBV. Altogether, 6,250 donors tested positive for HBV markers: 4,782 (175.6×105) were first time donors and 1,468 (10.0×105) were repeat donors. The prevalence of HBV markers in first time donors was 275.9×105 in 2009, declining to 143.6×105 in 2018. The incidence of new infections was 3.37×105 in 2009 and 2.17×105 in 2018. The overall residual risk for HBV amounted to 1 in 2,566,854 donations calculated as the sum of risks of both acute infections in the window period (1 in 5,835,306 donations) and occult infections (1 in 4,582,270 blood units). DISCUSSION: In Italy, the residual risk of transfusing a blood unit infected with HBV, both from window phase and occult infections, is currently very low, amounting to levels that can be considered tolerable.