Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial.

BACKGROUND: Baricitinib has shown efficacy in hospitalized patients with COVID-19, but no placebo-controlled trials have focused specifically on severe/critical COVID, including vaccinated participants. METHODS: Bari-SolidAct is a phase-3, multicentre, randomised, double-blind, placebo-controlled trial, enrolling participants from June 3, 2021 to March 7, 2022, stopped prematurely for external evidence. Patients with severe/critical COVID-19 were randomised to Baricitinib 4 mg once daily or placebo, added to standard of care. The primary endpoint was all-cause mortality within 60 days. Participants were remotely followed to day 90 for safety and patient related outcome measures. RESULTS: Two hundred ninety-nine patients were screened, 284 randomised, and 275 received study drug or placebo and were included in the modified intent-to-treat analyses (139 receiving baricitinib and 136 placebo). Median age was 60 (IQR 49-69) years, 77% were male and 35% had received at least one dose of SARS-CoV2 vaccine. There were 21 deaths at day 60 in each group, 15.1% in the baricitinib group and 15.4% in the placebo group (adjusted absolute difference and 95% CI - 0.1% [- 8·3 to 8·0]). In sensitivity analysis censoring observations after drug discontinuation or rescue therapy (tocilizumab/increased steroid dose), proportions of death were 5.8% versus 8.8% (- 3.2% [- 9.0 to 2.7]), respectively. There were 148 serious adverse events in 46 participants (33.1%) receiving baricitinib and 155 in 51 participants (37.5%) receiving placebo. In subgroup analyses, there was a potential interaction between vaccination status and treatment allocation on 60-day mortality. In a subsequent post hoc analysis there was a significant interaction between vaccination status and treatment allocation on the occurrence of serious adverse events, with more respiratory complications and severe infections in vaccinated participants treated with baricitinib. Vaccinated participants were on average 11 years older, with more comorbidities. CONCLUSION: This clinical trial was prematurely stopped for external evidence and therefore underpowered to conclude on a potential survival benefit of baricitinib in severe/critical COVID-19. We observed a possible safety signal in vaccinated participants, who were older with more comorbidities. Although based on a post-hoc analysis, these findings warrant further investigation in other trials and real-world studies. Trial registration Bari-SolidAct is registered at NCT04891133 (registered May 18, 2021) and EUClinicalTrials.eu ( 2022-500385-99-00 ).

Occurrence of cryptosporidium parvum IIaA17G1R1 in hospitalized hemato-oncological patients in Slovakia.

This study aimed to determine the presence of cryptosporidiosis in immunosuppressed patients hospitalized at the Clinic of Haematology and Oncohaematology in a form of routine screening. Samples were collected from November 2019 to February 2020, when the first wave of the Coronavirus pandemic occurred in Slovakia. A total of 36 samples were collected from patients hospitalized at the Clinic of Haematology and Oncohaematology, both from the open ward and the intensive care unit. For the diagnosis of cryptosporidiosis, a nested PCR targeting the gp60 gene and the SSU rRNA locus was used. From the 36 samples, Cryptosporidium parvum subtype IIaA17G1R1 was diagnosed in 9 patients (7 from the open ward and 2 from the intensive care unit), all hospitalized at the clinic at the same time, in February 2020. The occurrence of the same species and subtype, Cryptosporidium parvum IIaA17G1R1, in 9 patients hospitalized at the same time, both at the open ward and the intensive care unit may suggest a possible transmission occurred at the clinic.

Seroprevalence of hepatitis E among hospitalized patients in Slovakia: first report.

OBJECTIVE: Hepatitis E infection is one of the most frequent acute hepatitis in the world. Currently five human genotypes with different geographical distributions and distinct epidemiologic patterns are identified. In Slovakia, only rare cases of hepatitis E have been reported in recent years. Therefore, the aim of the study was to evaluate the prevalence of anti-HEV total antibodies and the main risk factors for HEV in the general population in Eastern Slovakia. METHODS: Detection of anti-HEV total antibodies samples was done by a commercial enzyme-linked immunosorbent assay (ELISA) kit. RESULTS: Of 175 hospitalized patients included in the study, 76 (43.5%) showed positivity for anti-HEV total antibodies. No statistically significant differences were found in anti-HEV positivity between men and women or in the groups of different living areas (town/village - urban/rural). CONCLUSION: Prevalence of anti-HEV total antibodies of hospitalised patients was high. The risk factor significantly associated with antibody positivity was eating raw meat. Other factors, such as sex, age, living area and contact with animals were not associated with antibody positivity.

Screening of opportunistic Encephalitozoon intestinalis and Enterocytozoon bieneusi in immunocompromised patients in Slovakia.

OBJECTIVE: In recent years new infectious diseases, i.e. emerging or re-emerging diseases, have been coming to the forefront. Currently, microsporidia, considered to be a major cause of emerging and opportunistic infections particularly in immunocompromised individuals, are also included in this group. Therefore, the aim of our study was to map the prevalence of Encephalitozoon intestinalis and Enterocytozoon bieneusi infection in a group of patients and to compare it with the occurrence of specific antigens in immunocompetent people. METHODS: Detection of spores of both pathogens in faecal samples was performed by an immunofluorescence test using species-specific monoclonal antibodies. RESULTS: Positivity to E. intestinalis in 91 examined immunosuppressed patients reached 33% (30/91), while only 4.3% (3/70) of the control group samples were found to be positive (relative risk 7.7, p < 0.001). In case of E. bieneusi 14.3% (13/91) of immunocompromised patients were positive, as were 5.7% (4/70) of people from the control group (relative risk 2.5, p = 0.095). CONCLUSION: In case of development of any opportunistic infection, the infection is detected and removed in most cases at an early stage. The incidence of clinically manifested microsporidiosis in patients with immunodeficiency is rare as they are under constant medical supervision. However, we must not forget about opportunistic infections, and in case of any non-specific symptoms it is necessary to exclude or confirm the diagnosis for immediate treatment.

Molecular characterization and first report of Cryptosporidium genotypes in human population in the Slovak Republic.

In our study, we examined 91 fecal samples from five different groups of people containing HIV patients, hemodialysis patients, kidney transplant recipients, immunocompetent humans without clinical signs, and humans with suspected cryptosporidiosis. The purpose of our study was to determine species and genotype composition of representatives of Cryptosporidium spp. using PCR analysis of small subunit ribosomal RNA gene and 60-kDa glycoprotein gene and examine their phylogenetic relationship. In HIV-positive/AIDS-infected group of patients and in hemodialysis patients, no presence of Cryptosporidium species was detected. In two kidney transplant recipients, we detected species/genotypes Cryptosporidium parvum IIaA13G1T1R1 (KT355488) and Cryptosporidium hominis IaA11G2R8 (KT355489) and in two immunocompetent patients with clinical symptoms, we identified Cryptosporidium muris and C. hominis IbA10G2T1 (KT355490). In the group of healthy immunocompetent individuals without clinical signs, we identified species/genotype C. hominis IbA11G2 (KT355491) in one sample.

Hepameta-- prevalence of hepatitis B/C and metabolic syndrome in population living in separated and segregated Roma settlements: a methodology for a cross-sectional population-based study using community-based approach.

BACKGROUND: Roma represent one of the largest and oldest minorities in Europe. Health of many of them, particularly those living in settlements, is heavily compromised by poor dwelling, low educational level, unemployment, and poverty rooted in generational poverty, segregation and discrimination. The cross-sectional population-based study using community based approach aimed to map the prevalence of viral hepatitis B/C and metabolic syndrome in the population living in separated and segregated Roma settlements and to compare it with the occurrence of the same health indicators in the majority population, considering selected risk and protective factors of these health indicators. METHODS: The sample consisted of 452 Roma (mean age = 34.7; 35.2% men) and 403 non-Roma (mean age = 33.5; 45.9% men) respondents. Data were collected in 2011 via questionnaire, anthropometric measures and analysed blood and urine samples. A methodology used in the study as well as in the following scientific papers is described in the Methods section (i.e. study design, procedures, samples, methods including questionnaire, anthropometric measurements, physical measurements, blood and urine measurements). CONCLUSIONS: There are regions of declining prosperity due to high unemployment, long-term problems with poverty and depleted resources. Populations living in these areas, i.e. in Central and Eastern Europe in Roma settlements, are at risk of poverty, social exclusion and other factors affecting health. Therefore, we should look for successful long-term strategies and tools (e.g. Roma mediators, terrain work) in order to improve the future prospects of these minorities.

Higher prevalence of nephropathy in young Roma females compared with non-Roma females.

OBJECTIVES: Ethnic differences in the prevalence of various chronic diseases, including end-stage renal disease, have been previously reported. Surprisingly, data focusing on the lower grade of chronic kidney disease (CKD) are scarce. Thus, the aim of this study was to explore differences in the prevalence of nephropathy between the Roma and non-Roma populations. METHODS: Data from the cross-sectional population based HepaMeta study conducted in Slovakia were used. Nephropathy was defined as: a known history of any kidney disease; or the presence of proteinuria/hematuria; or glomerular filtration rate (GFR) < 60 ml/min. The odds ratio for the prevalence of nephropathy was calculated using binary logistic regression. RESULTS: In an age-adjusted model, Roma females had OR of 1.56 for having nephropathy over non-Roma females (OR 1.56; 95% CI 1.01-2.42; p < 0.05). In addition, Roma females had a significantly lower GFR (mean difference 3.4 ml/min, t = -3.58, p < 0.001); all female patients with proteinuria were Roma. CONCLUSIONS: This cross-sectional study on the young general population found that Roma females have half-higher odds for nephropathy than non-Roma females. Therefore, to prevent risks we should focus on searching for ethnic, social and medical determinants of CKD. Interventions to decrease the incidence of CKD in the target population should also address ethnic inequalities as well as female gender.

The prevalence of Chlamydia trachomatis in the population living in Roma settlements: a comparison with the majority population.

BACKGROUND: We aimed to study the occurrence of Chlamydia trachomatis infection in the population living in Roma settlements and to compare the obtained results with the prevalence in the majority population. METHODS: We examined 340 people for the presence of bacterium C. trachomatis, 208 of them were Roma (66 men, 142 women) and 132 were from the majority population (75 men, 57 women). Respondents were aged 18-55 years (mean age = 33.44, STD = 9.57). The occurence of C. trachomatis was detected by direct proof of the pathogen by polymerase chain reaction (PCR). RESULTS: Of 340 respondents included in the study, 22 (6.5%) showed positivity for C. trachomatis infection, 15 of them were Roma (7.2%) and 7 non-Roma (5.3%). The highest positivity was detected in Roma women (8.5%), while positivity in both non-Roma women and men was 5.3%, and in Roma men 4.5%. We did not confirm any significant contribution of age, gender or ethnicity to the occurrence of C. trachomatis infection. CONCLUSIONS: Despite the increased number of people with risk factors in the Roma community, no significant difference in the occurrence of C. trachomatis infection was found. Neither age nor gender contributes to the probability of C. trachomatis infection. Nevertheless, there are other health consequences which might be more pronounced among the population living in Roma settlements due to barriers to the health care and their lower ability to benefit from health care services provided.

Socioeconomic characteristics of the population living in Roma settlements and their association with health and health-related behaviour.

BACKGROUND: The aim of this study was to compare socioeconomic characteristics of the Roma population living in Roma settlements with the majority population. Moreover, it was aimed to assess socioeconomic differences in health and health-related behaviour within the population living in Roma settlements. METHODS: Data from the cross-sectional HepaMeta study conducted in Slovakia in 2011 were used. The sample consisted of 452 Roma (mean age = 34.7; 35.2% men) and 403 non-Roma (mean age = 33.5; 45.9% men) respondents. Roma in selected settlements were recruited by local Roma community workers. Respondents from the major population were randomly selected from a list of patients from general practitioners. Data were collected via questionnaire, anthropometric measures and analysed blood samples. Differences in socioeconomic characteristics between the population living in Roma settlements and the majority population were tested using the chi-square test. The contribution of selected socioeconomic characteristics on health and health-related behaviour of the population living in Roma settlements was assessed by logistic regression models adjusted for age and gender. RESULTS: The population living in Roma settlements is characterised by significantly lower socioeconomic standards, and the living conditions are significantly worse compared with the majority. With few exceptions, the study did not confirm any significant association between socioeconomic indicators and health and health-related behaviour within the population living in Roma settlements. CONCLUSIONS: The deteriorating effect of living in Roma settlement on health and health-related behaviour seems to be immense regardless differences in socioeconomic characteristics or living condition within the settlement population.

Association between metabolic syndrome and hepatitis B virus infection in the Roma population in eastern Slovakia: a population-based study.

BACKGROUND: The simultaneous presence of chronic hepatitis B (CHB) and metabolic syndrome (MS) in the high-risk Roma community constitutes a high risk for liver cirrhosis and potentially hepatocellular carcinoma. This study aims to explore the relationship between MS and CHB. METHODS: Data from the cross-sectional HepaMeta Study conducted in Slovakia in 2011 among Roma living in rural communities were used. Participants were tested for the presence of MS, and lipid levels--total cholesterol, high density lipoproteins (HDL), low density lipoproteins (LDL), triglycerides (TG), apolipoprotein B100, and CHB HBsAg and anti-HBc IgG were also monitored. Viral load was measured in HBsAg-positive patients. RESULTS: A total of 452 patients were screened; MS was diagnosed in 29.6% of patients, and 12.5% had CHB. Anti-HBc IgG antibodies were present in 52.8% of patients. CHB patients had lower levels of total cholesterol (5.45 +/-1.21 vs. 4.71 +/- 1.23 mmol/l; p = 0.035), LDL cholesterol (median 2.2 mmol/l, interquartile range 0.88 mmol/l vs. 2.5 mmol/l, interquartile range 0.9 mmol/l; p = 0.01) and apolipoprotein B100 (median 0.66 mmol/l, interquartile range 0.26 mmol/l vs. 0.74 mmol/l, interquartile range 0.29 mmol/l; p = 0.025). Patients diagnosed with MS had a higher HBV DNA load than patients without MS (1,728.2 +/- 14.33 IU/ml vs. 12,779.1 +/- 20.9 IU/ml; p = 0.037). CHB patients with TC and apolipoprotein B100 within the reference range had a lower hepatitis B DNA (HBV DNA) load than patients with high or low values of TC or apolipoprotein B100. CONCLUSION: The prevalence of chronic hepatitis B and simultaneous presence of MS was high among Roma. HBsAg-positive patients had lower levels of total and LDL cholesterol along with decreased apolipoprotein B100. The viral load of chronic hepatitis B patients with MS was higher than in patients without MS.

Is Slovakia Almost a Hepatitis D Free Country?

BACKGROUND: It is assumed that the prevalence of hepatitis D in HBsAg-positive individuals reaches 4.5-13% in the world and on average about 3% in Europe. Data from several European countries, including Slovakia, are missing or are from an older period. METHODS: We analyzed all available data on hepatitis D from Slovakia, including reports from the Slovak Public Health Authority and the results of one prospective study, and three smaller surveys. The determination of anti-HDV IgG and IgM antibodies and/or HDV RNA was used to detect hepatitis D. RESULTS: In the years 2005-2022, no confirmed case of acute or chronic HDV infection was reported in Slovakia. The presented survey includes a total of 343 patients, of which 126 were asymptomatic HBsAg carriers, 33 acute hepatitis B, and 184 chronic hepatitis B cases. In a recent prospective study of 206 HBsAg-positive patients who were completely serologically and virologically examined for hepatitis B and D, only 1 anti-HDV IgG-positive and no anti-HDV IgM or HDV RNA-positive cases were detected. In other smaller surveys, two anti-HDV IgG-positive patients were found without the possibility of HDV RNA confirmation. In total, only 3 of 329 HBsAg-positive patients (0.91%) tested positive for anti-HDV IgG antibodies, and none of 220 tested positive for HDV RNA. CONCLUSION: The available data show that Slovakia is one of the countries with a very low prevalence of HDV infection, reaching less than 1% in HBsAg-positive patients. Routine testing for hepatitis D is lacking in Slovakia, and therefore it is necessary to implement testing of all HBsAg-positive individuals according to international recommendations.

Occurrence of Cryptosporidium spp. in red foxes and brown bear in the Slovak Republic.

Wild animals can be involved in epidemiology of many important diseases and often act as reservoirs of pathogens which cause disease in domestic animals and humans. This paper aims the role of red fox (Vulpes vulpes) and brown bear (Ursus arctos) in the circulation of coccidian parasites from the genus Cryptosporidium. Cryptosporidiosis is known as an important enteric pathogen, clinical symptoms in particular in immune-compromised individuals range from mild to severe diarrhoea and dehydration, which could be fatal. Fecal samples from 62 red foxes shot during September 2010 to February 2011 and 63 brown bears collected during June 2010 to March 2011 in central and eastern Slovakia were examined for the qualitative determination of Cryptosporidium spp. antigens in faeces by sandwich ELISA kit. Overall, 38.7% (24/62) of faecal samples of red foxes and 55.6% (35/63) of faecal samples of brown bear were positive. Our preliminary results emphasize prevalence of Cryptosporidium spp. amongst brown bears and red foxes in Slovakia and highlight the potential risk for transmission of cryptosporidiosis to humans using the countryside for professional or recreational purposes.

Molecular identification and genotyping of Microsporidia in selected hosts.

The work is described by microscopic analysis, the serological analysis (IFAT) and the molecular analysis of isolates from clinical samples (blood, faeces and urine) from ten domestic rabbits (Oryctolagus cuniculus), breed Malický, four New Zealand domestic rabbits, 11 sows of breed Slo0076akian Improved White and 15 clinically healthy laboratory BALB/c mice. The aim of the study was to validate the suitability of species-unspecific primer pairs 530F and 580R for genotype determination of the Microsporidia strain and species-specific primer pairs ECUNF and ECUNR, SINTF and SINTR and EBIER1 and EBIEF1 for the determination of E ncephalitozoon cuniculi, Encephalitozoon intestinalis and Enterocytozoon bieneusi species for diagnostic purposes. Sequences of animals were compared with those from the GenBank database. In rabbits, two murine genotypes II and four canine genotypes III were identified. Genotype II was identified in mice. The Encephalitozoon intestinalis identified in the sample from swine showed no genetic heterogeneity.

Seroprevalence of Bartonella henselae and Bartonella quintana Infection and Impact of Related Risk Factors in People from Eastern Slovakia.

The genus Bartonella is a rapidly expanding group of ubiquitous bacteria that occur mainly in different animal species, but some can also be transmitted to humans. Three species, B. henselae, B. bacilliformis, and B. quintana, are responsible for the majority of human cases. The severity of the clinical symptoms often depends on the immune status of the patient, but others factors such as the species of the pathogen, virulence factors, and bacterial load also can play an important role. As the information on the occurrence of bartonellosis in the human population in Slovakia is absent, the aim of our pilot study was to determine the seroprevalence against B. henselae and B. quintana in the population of people living in Eastern Slovakia, and to identify the impact of related risk factors. Of 536 people included in the study, 126 (23.5%) showed positivity for anti-B. henselae antibodies and 133 (24.8%) against B. quintana. A statistically higher prevalence was confirmed only in the case of B. quintana in women regardless of the risk group. In analyzing the risk factors, we found significant differences between B. henselae seropositive and seronegative groups only in uric acid levels and serum creatinine, both, however, clinically irrelevant. Significant, but clinically irrelevant differences were observed also in alanine aminotransferase (ALT) levels and creatinine in people seropositive to B. quintana.

Comparison of Two Diagnostic Methods for the Detection of Hepatitis B Virus Genotypes in the Slovak Republic.

The hepatitis B virus (HBV), belonging to the Hepadnaviridae family, is responsible for a global health concern still in the 21st century. The virus is divided into 10 genotypes, which differ in geographical distribution and in their effect on disease progression and transmission, susceptibility to mutations, and response to treatment. There are many methods for diagnostics of HBV and differentiating its genotypes. Various commercial kits based on real-time polymerase chain reaction (RT PCR) and hybridization available, as well as whole genome sequencing or the sequencing of only individual parts of the genomes. We compared a commercial kit AmpliSens HBV-genotype-FRT, based on RT PCR, with an adapted method of amplification of the surface genomic region combined with Sanger sequencing. In the examined samples we identified the A, B, C, D, and E genotypes. By PCR with Sanger sequencing, the genotypes were determined in all 103 samples, while by using the commercial kit we successfully genotyped only 95 samples, including combined genotypes, which we could not detect by sequencing.

Trichinellosis in Slovakia - epidemiological situation in humans and animals (2009-2018).

INTRODUCTION: Trichinella spp. are zoonotic parasitic nematodes with almost worldwide distribution. The infection can be transmitted through the foodborne route and can cause serious health problems in infected human patients. It is also an economically important issue due to the high financial cost connected with prevention of the disease. OBJECTIVE: The study aimed to discover trends in the epidemiological situation in people and animals in Slovakia in 2009-2018. MATERIAL AND METHODS: Data on human trichinellosis originated from the Public Health Authority of the Slovak Republic, and data on Trichinella infection in animals from the State Veterinary and Food Administration of the Slovak Republic. A seroepidemiological study on 655 voluntary respondents was performed. RESULTS: Altogether, 29 human cases were reported between 2009-2018, with a maximum of 13 cases in 2011. Males were affected more often (19 cases) than females (10 cases); the average age of patients was 45.1 years. Antibodies to Trichinellawere detected in two sera (0.3%): in a serum from one hunter and one veterinarian. In the monitored period, the average prevalence of Trichinella infection was 9.6% in 2,295 red foxes, and 0.04% in 165,643 wild boars. Three (1.7%) of 178 surveyed brown bears were positive. Within the compulsory monitoring of trichinellosis in domestic pigs, none from a total of 1,632,688 pigs were positive. The presence of three species, Trichinellabritovi, T. spiralis and T. pseudospiralis, was documented, with T. britovi representing 93.9% of identified isolates. CONCLUSIONS: The study indicates that the prevalence of Trichinella infection has not changed considerably with time in Slovakia, and the risk of human infection outbreaks is connected mainly with the consumption of wild boar meat.

Seroepidemiology of human toxocariasis in selected population groups in Slovakia: A cross-sectional study.

BACKGROUND: Human toxocariasis is a cosmopolitan helminthic zoonosis caused by roundworms of the genus Toxocara. The study aimed at a cross-sectional analysis of seropositivity to Toxocara spp. in selected groups of population in Slovakia and an estimate of the risk factors of infection. METHODS: For the detection of anti-Toxocara antibodies, an enzyme-linked immunosorbent assay (ELISA) based on an excretory-secretory (E/S) antigen of Toxocara canis was used. RESULTS: The overall seropositivity to Toxocara in 1489 evaluated sera was 3.7%. The seropositivity of Roma children/young people (40.3%) was significantly higher when compared with all other analysed groups. Among adult respondents, the positivity of farmers and hunters (5.5% and 5.1%, respectively) was significantly higher (p<0.001) than in the other analysed groups (veterinarians and veterinary assistants, soldiers, students of veterinary medicine, and students of other universities). Analysis of infection risk factors showed that living in a rural locality, everyday contact with soil, and everyday outdoor activities (12.7%, 8.8% and 8.3% positivity, respectively) can increase the risk of infection, but the observed differences were not significant. CONCLUSION: The results underline the importance of preventive measures and the need for improving of knowledge of toxocariasis among professionals, as well as the public.

What is the Role of the Horizontal Transmission of Hepatitis B Virus Infection in Young Adult and Middle-Aged Roma Population Living in the Settlements in East Slovakia?

Background: The aim of our work is to objectify the manner of transmission of HBV infection in young adult and middle-aged Roma people who live in the settlements. Methods: We used data from the cross-sectional study HepaMeta. We analyzed Roma people living in the settlements in East Slovakia, who have had HBsAg and anti HBc IgG antibodies examined. Results: We analyzed a cohort of 452 Roma participants with a mean of age 34.67 ± 9.14 years-159 (35.2%) were males. HBsAg positivity was diagnosed in 12.4% and the presence of anti HBc IgG antibodies was confirmed in 52% of participants. Prevalence of HBsAg positivity increases significantly with higher age, (p = 0.026), as well as the presence of anti HBc IgG antibodies (p < 0.0001). The prevalence of HBsAg positivity has doubled and anti HBc IgG positivity has tripled within two decades (<25 years vs. 35-45 years) in Roma settlements in East Slovakia. Conclusions: These findings allow us to express an opinion that horizontal transmission in adulthood may play an important role in the spreading of HBV infection.

Epidemiology and clinical course of primary biliary cholangitis in Eastern Slovakia.

OBJECTIVE: To determine both the incidence and the prevalence of primary biliary cholangitis (PBC) in Eastern Slovakia and to describe its clinical course and the response to ursodeoxycholic acid (UDCA). METHODS: We recorded data of patients with PBC, who were followed up in gastroenterology and hepatology centers in Eastern Slovakia during the period from June 30, 1999, through June 30, 2019. RESULTS: The annual incidence of PBC varied from 0.7 to 1.5 cases per 100,000 inhabitants between 2014 and 2018. PBC prevalence steadily increased from initial 10.2 cases per 100,000 inhabitants in 2014 to 14.9 cases per 100,000 inhabitants in June 2019. The mean age at the time of diagnosis was 56.3 ± 10.9 years. 95.7% of patients were females, and female/male gender ratio was 22.3:1. In June 2019, prevalence in the female population was 28 cases per 100,000 women. At the time of diagnosis, three-quarters of patients were symptomatic and 10% of patients had liver cirrhosis. The mean follow-up was 7.3 ± 5.2 years. Response to UDCA was observed in 72.1% of patients. Patients with higher baseline alkaline phosphatase (ALP) levels, liver cirrhosis at entry or at the end of follow-up and women younger than 45 years responded worse to UDCA. One-quarter of patients had liver cirrhosis at the end of follow-up. During follow-up, 1.6% of patients underwent liver transplantation and 5.5% of patients died. Five-year and 10-year liver-related mortalities were 2.7% and 4.3%, respectively. CONCLUSION: PBC prevalence in Eastern Slovakia is increasing, and most of the patients respond to therapy with UDCA.

The Roma Population Living in Segregated Settlements in Eastern Slovakia Has a Higher Prevalence of Metabolic Syndrome, Kidney Disease, Viral Hepatitis B and E, and Some Parasitic Diseases Compared to the Majority Population.

Background: The Roma population is one of the largest marginalized population groups in Europe. The aim of our work was to summarize the morbidity of lifestyle-related diseases and infectious diseases in the Roma population living in segregated settlements. Methods: We used data from the cross-sectional study HepaMeta, in which we examined 452 Roma subjects with an average age of 34.7 ± 9.1 years, 35.2% of which were men, and 403 non-Roma subjects with an average age of 33.5 ± 7.4 years, 45.9% of which were men. We collected data by means of a questionnaire, anthropometric measures, and we analyzed blood and urine samples. Results: Roma subjects had a higher incidence of metabolic syndrome (RR: 1.478 (1.159-1.885), p < 0.0001), obesity or waist circumference >94 cm in men/80 cm in women (RR: 1.287 (1.127-1.470), p < 0.0001), and HDL-C < 1.03 mmol/L in men or <1.29 in women (RR: 2.004 (1.730-2.321), p < 0.0001) than their non-Roma counterparts. Subjects of the Roma population were more frequently diagnosed with kidney disease (RR: 1.216 (1.096-1.349), p < 0.0001), HBsAg positivity (RR: 4.468 (2.373-8.415), p < 0.0001), anti HBc IgG positivity (RR: 3.13 (2.598-4.224), p < 0.0001), and anti HEV positivity (RR: 2.972 (1.226-7.287), p < 0.0001). Serological markers of Toxoplasma gondii infection and Toxocara spp. were observed much more frequently among Roma than non-Roma subjects (RR: 1.868 (1.520-2.296), p < 0.0001, for Toxoplasma gondii; and RR: 21.812 (8.097-58.761), p < 0.0001, for Toxocara spp.). Conclusions: Poor socio-economic conditions, an unhealthy lifestyle, and barriers precluding access to healthcare are factors that affect the Roma population in settlements and lead to an increased prevalence of metabolic syndrome and its components, kidney disease, viral hepatitis B and E, and some parasitic diseases.