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BackgroundThe World Health Organization European Action Plan 2020 targets for the elimination of viral hepatitis are that > 75% of eligible individuals with chronic hepatitis B (HBV) or hepatitis C (HCV) are treated, of whom > 90% achieve viral suppression.AimTo report the results from a pilot sentinel surveillance to monitor chronic HBV and HCV treatment uptake and outcomes in 2019.MethodsWe undertook retrospective enhanced data collection on patients with a confirmed chronic HBV or HCV infection presenting at one of seven clinics in three countries (Croatia, Romania and Spain) for the first time between 1 January 2019 and 30 June 2019. Clinical records were reviewed from date of first attendance to 31 December 2019 and data on sociodemographics, clinical history, laboratory results, treatment and treatment outcomes were collected. Treatment eligibility, uptake and case outcome were assessed.ResultsOf 229 individuals with chronic HBV infection, treatment status was reported for 203 (89%). Of the 80 individuals reported as eligible for treatment, 51% (41/80) were treated of whom 89% (33/37) had achieved viral suppression. Of 240 individuals with chronic HCV infection, treatment status was reported for 231 (96%). Of 231 eligible individuals, 77% (179/231) were treated, the majority of whom had received direct acting antivirals (99%, 174/176) and had achieved sustained virological response (98%, 165/169).ConclusionTreatment targets for global elimination were missed for HBV but not for HCV. A wider European implementation of sentinel surveillance with a representative sample of sites could help monitor progress towards achieving hepatitis control targets.

Background and Aims: Elimination of hepatitis C worldwide is more feasible if micro-elimination screening strategies are adopted. We aimed to screen hepatitis C virus (HCV) in specific high-risk populations in certain sub-regions of Romania and link them to antiviral treatment., Methods: A multicenter prospective study was conducted among the hospitalized or ambulatory adult patients from March 2019 to March 2020 in more than 20 medical institutions from 4 Romanian cities (Bucharest, Iasi, Timisoara, Cluj-Napoca). A rapid diagnostic test for HCV diagnosis was performed to all admitted patients and the positive ones were sent to gastroenterology departments for confirming the active infection, staging and treatment prescription., Results: In total, 25,141 subjects signed the informed consent and were consequently enrolled into the study. The prevalence of anti-HCV antibodies was 1.39% (95%CI: 1.25-1.54) and increased with the number of risk factors presented by one subject. There was a positive association between the presence of anti-HCV antibodies and female gender (p<0.001), rural area of residence (p<0.001), advanced age (p<0.001), as well as a negative association with the education level (p<0.001)., Conclusions: In a hospital-based screening micro-elimination program in Romania, HCV prevalence was lower than previously reported. This is a first step towards a cost-effective screening in a well-defined group of persons at risk and provides sufficient capacity to deliver access to HCV treatment and linkage to care in Romania.

Background and Aims: Ledipasvir/Sofosbuvir (LDV/SOF) with or without Ribavirin (RBV) has shown good results in terms of efficacy and safety in clinical trials in advanced liver cirrhosis, but real-life data are still needed in order to confirm this profile. We investigated the efficacy and safety of LDV/SOF in a large Romanian population with liver cirrhosis and genotype 1b hepatitis C virus (HCV)., Methods: We analyzed a multicentric retrospective cohort enrolling 349 patients with decompensated liver cirrhosis due to HCV who received LDV/SOF±RBV 12/24 weeks (301/48). Patients were included between 2017-2018, all with genotype 1b. Main inclusion criteria were liver cirrhosis and detectable HCV RNA. The cases were followed-up monthly during therapy and 12 weeks after the end of therapy., Results: The cohort included 60% females with a median age of 61, 16% interferon (IFN) pre-treated, 53% with comorbidities, 40/53/7 % with Child Pugh A/B/C, 4% with virus B co-infection and 8% with previously treated hepatocellular carcinoma. Mean initial MELD score was 11.92 (6.82÷ 24.5). Six patients were lost during follow-up. Sustained virologic response (SVR) in intention-to-treat was reported in 85.1%. Predictive factors of SVR in decompensated cirrhosis were female gender (p=0.01), advanced age (p<0.001), lower bilirubin levels (p=0.002) and lower CTP score (p=0.02). In patients with CTP score B or C low bilirubin levels (p=0.003), low INR (p<0.001), increased platelet count (p=0.04), low CTP score (p<0.001), lack of encephalopathy (p=0.02), serum albumin >3.5g/dl (p=0.002) predicted improvement of liver function. Serious adverse events were reported in 16/349 (4.6%), most of them due to severe liver decompensation (9/16)., Conclusions: LDV/SOF±RBV proved to be highly efficient in our difficult to treat population with 85.1% SVR.

Background and Aims: To combat hepatitis C virus (HCV) and achieve its elimination by 2030, the emphasis should be on public health policies. In this study, we investigated the dynamics of epidemiology of HCV in Romanian risk groups that are characterized by higher occurrence densities with the aid of The Let's End HepC (LEHC) project., Methods: The LEHC project addressed the modelling of HCV epidemiology, being applied in several countries, one of which is Romania. The model comprised an integrated solution of public health policies focused on the disease, using Adaptive Conjoint Analysis and Markov chains systems. This tool allowed the quantitative evaluation of public health policies' impact, for every year until 2030, in five population groups: people who inject drugs (PWID), prisoners, individuals who have received blood products, children at risk for vertical transmission, and the remnant population., Results: It appears that Romania was already making great efforts in the context of public policies, allowing the achievement of HCV elimination by 2028 if current policies were maintained. Through additional work and greater efforts in further implementing public policies, the LEHC model estimated the possibility of anticipating this outcome to 2026., Conclusion: The LEHC model estimated an anticipation of the HCV elimination year in Romania to be 2026 if the twenty-four health policies in the study are fully implemented and consistently maintained over the years.

Aims: The purpose of this study was to assess the changes in hepatic morphology evaluated by computed tomography (CT) examination in patients with hepatitis C virus (HCV)-related compensated cirrhosis who achieved sustained virologic response (SVR) after direct-acting antivirals (DAAs) treatment. Methods: CT examination was performed in 56 patients with HCV-related compensated cirrhosis before and within 6-18 months after the treatment with Ombitasvir/Paritaprevir/ritonavir + Dasabuvir. The liver CT changes were assessed by measuring liver volume, caudate-right lobe ratio (C/RL), hepatic vessels diameters, periportal widening space, and right posterior notch. Portal trunk, splenic and superior mesenteric vein diameters, as well as spleen volume were assessed as part of portal hypertension. Results: Right hepatic vein diameter was significantly wider after treatment (median: 8.12 mm; IQR: 4.20) than before treatment (median: 6.36 mm; IQR: 3.94) z = -3.894; p < 0.001. The liver volume was significantly higher prior to the treatment (median: 1786.77 mm 3 ; IQR: 879.23) than after treatment (median: 1716.44 mm 3 ; IQR: 840.50), z = -1.970; p = 0.049. Splenic volume was considerably higher before treatment (median: 564.79 mm 3 ; IQR: 342.54) than after (median: 474.45 mm 3 ; IQR: 330.00), z = -2.500; p = 0.012. The other parameters, such as C/RL, periportal space widening, and right hepatic notch showed no significant changes. Conclusions: SVR in patients with HCV-related compensated cirrhosis treated with DAAs is associated with some improvements of hepatic morphology detectable by CT, the most constant being the increase of right hepatic vein diameter.

Background & Aims: Literature data suggest that HCV genotype-1b is present in 93-99% of the Romanian patients infected with hepatitis C virus (HCV). We present the genotyping tests recently performed on patients with HCV and advanced fibrosis eligible for the Direct-Acting Antiviral (DAA) therapy, as well as the prevalence of these cases across Romania. Methods: The genotyping method was performed on 7,421 HCV patients with advanced fibrosis. The detection method was automatic real time PCR platform M2000 (Abbott). Every subject was introduced into a database including age, sex, county and address. Results: Genotype 1b was almost exclusively present: 7,392/7,421 (99.6%). Genotype 1b patients were 19.6% from Bucharest, 49% were males, with a median age of 60 years. Genotype non-1b was encountered in 29/7,421 subjects (0.4%), 62% were males, 69% from Bucharest and the median age was 52 years. Most of the subjects (75%) were in the 6th and 7th age decade. The prevalence of these cases varied significantly across Romanian counties: the highest was in Bucharest (61.3/105), Bihor (47/105), Iasi (46/105) and Constanţa (43/105), and the lowest in Ilfov (2.8/105), Harghita (3.7/105), Covasna (5.4/105) and Maramureş, Romania (8.8/105) (p<0.001). Conclusions: Genotype 1b is encountered in 99.6% of patients with chronic hepatitis C and advanced fibrosis from Romania. The presence of genotypes non-1b is more common in Bucharest, in males and at a younger age. There are significant differences regarding the distribution of these cases across Romania: the highest rates are in Bucharest, Bihor, Iasi and Constanta. [ABSTRACT FROM AUTHOR]

Background and Aims. Elimination of viral hepatitis represents a WHO objective that Romania undertook to fulfill it through the National Framework Plan for the control of viral hepatitis. Microelimination programs are recommended by WHO in order to reach the targets. Prisoners represent a population at risk for viral infection, considering multiple vulnerabilities: PWID, high-risk sexual behaviours and violence and the absence of screening upon incarceration. There are no standard protocols for HCV/HBV testing in Romanian prisons. A pilot study of HCV/HBV screening and linkage to care in prison setting was conducted using mobile medical teams in different prison facilities in three regions of Romania. Method. Multidisciplinary mobile teams were set up, coordinated by three University Hepatology Centers. A point-of-care anti-HCV and HBs-Ag tests and medical history were performed to prisoners and to staff. Only those positive for HBV/HCV rapid tests had blood collected for viremia and non-invasive tests and were selected for the hospital visit, for liver disease staging and treatment initiation. Results. For two years, multidisciplinary teams visited 18 detention centers in three regions of Romania - S-M, S-E, and N-E. Local awareness campaigns preceded every test visit. A number of 9950 persons deprived of liberty (PDL) and a number of 427 penitentiary staff were tested. The global prevalence of hepatitis B infection was 2.48 % and of hepatitis C infection was 9.9% with important diferences between centres and regions - 11,49% HCV infection vs 2,08% in the detention centres from the south part of the country and the N-E region, respectively. The greater part of tested were men (94%), with secondary education (51.7%) from urban areas (54.2%). 85.3% did not know they had hepatitis and had not been treated previously. Were highlighted 18.4% former PWID. 3.7% of PDL declared blood transfusions in the past, and a percentage of 28,2% declared previous surgical interventions. We specify these are interim data, the project being ongoing. Patients' medical records were processed and the eligible subjects started antiviral treatment after the hospital visit for complet diagnosis and staging. Conclusion. The prevalence of HCV and HBV in prisoners is significantly higher than in the general population. This ongoing project is a proof of concept that detection of incarcerated HCV/HBV positive patients and their linkage to care, in the prison environment in Romania, is feasible, prisons providing a rare opportunity for viral hepatitis microelimination. [ABSTRACT FROM AUTHOR]