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The article focuses on advancements in hepatitis D (HDV) management, emphasizing the challenges posed by this severe form of viral hepatitis and the recent introduction of new therapies like Bulevirtide (BLV) and Lonafarnib (LNF). It discusses the efficacy of these treatments, the need for personalized therapy approaches, and the global public health implications of improving HDV management to align with viral hepatitis elimination goals by 2030.

Background & Aims: The sofosbuvir (SOF) / velpatasvir (VEL) / voxilaprevir (VOX) combination has been evaluated in more than 800 patients enrolled in phase II and phase III studies, where it demonstrated excellent safety and efficacy, achieving overall sustained viral response (SVR) rates of more than 95%. We aimed to assess the efficacy and safety of SOF/VEL/VOX in a real-world study, including patients previously treated for genotype 1b hepatitis C virus (HCV) infection that did not obtain a sustained viral response with previous direct-acting antivirals (DAAs) therapy. Methods: In Romania, through a nationwide government-funded program in 2019-2020, 213 patients with chronic hepatitis C non-responders to previous DAAs therapy, received treatment with SOF/VEL/VOX 400/100/100 mg/day for 12 weeks. We performed a retrospective longitudinal study that included 143 individuals who were treated in Bucharest, Iași, Craiova and Constanța clinics, all with genotype 1b HCV infection. Efficacy was assessed by the percentage of patients achieving SVR 12 weeks post-treatment (SVR12). Serious adverse events (SAE) were registered. Results: Our cohort comprised 53% males with a median age of 60 years (27÷77); 47% were pre-treated with ombitasvir/paritaprevir/ritonavir+dasabuvir ± ribavirin, 40% with ledipasvir/SOF, 13% with elbasvir/grazoprevir. 42% of patients associated co-morbidities, 45% had compensated liver cirrhosis, 2% had treated hepatocellular carcinoma (HCC) and 1% had hepatitis B virus co-infection. SVR by intention to treat was reported in 139/143 (97.2%) and per protocol in 141/143 (98.6%). No predictive factors for SVR were identified. Rate of liver decompensation in patients with cirrhosis was 6% and was statistically associated in multivariate analysis with Child-Pugh score (p<0.01) and with severe steatosis (p=0.004). Occurrence of new HCC was reported in 3.6% of all patients with cirrhosis and was associated with poor liver function [higher Child-Pugh score (p=0.001) and low albumin levels (p=0.02)]. Serious adverse events related to therapy were reported in 1/143(0.7%). Conclusions: SOF/VEL/VOX was highly efficient in our population of patients with a 97.2% SVR. Liver decompensation occurred in 6% of cirrhotic patients at SVR, related to hepatic dysfunction. [ABSTRACT FROM AUTHOR]

Patient and liver graft survival rates have improved significantly in the last decades, leading to complications mainly related to long-term immunosuppression. Prevention of, screening for metabolic syndrome, cardiovascular disease, de novo diabetes mellitus, renal dysfunction, and malignancies and their management are mandatory due to important causes of morbidity and mortality in this patient population. Quality of life (QoL) and functional benefits are clearly better compared to preoperative status; however, post-liver transplantation (LT) complications may impair and alter QoL scores. Individualized immunosuppression managed by transplant physicians and collaboration with other non-transplant specialists for recognition and treatment of medical complications and comorbidities after LT is the key to enhanced QoL and life expectancy of this patient population. [ABSTRACT FROM AUTHOR]

A case study is presented on the prevalence of hepatitis B and C virus infections in the Roma population in Romania, highlighting higher infection rates in this group compared to the general population and the importance of screening. However, itraises concerns about the limited sample size and lack of a clear methodology in the study, questioning its representativeness for the broader Roma population.

Background & 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. [ABSTRACT FROM AUTHOR]

Background & Aims: Hepatitis C virus (HCV) infection is a common condition with endemic prevalence in some areas of the world. In Romania, the mean prevalence is about 3%. New treatments have become available on the market in recent years and new drugs are in the pipeline. A re-evaluation of HCV therapy was considered mandatory. The Romanian Society of Gastroenterology and Hepatology undertook this task for the practitioners of this country. Methodology: A group of recognized experts was created who screened the available literature and the major available guidelines. A list of items requiring attention was created and these were discussed and rated. Decisions were taken by consensus. Recommendations: We present here the second part of the Society's recommendations for chronic HCV infection treatment. An agreement between experts was reached regarding the therapy of the special categories of patients infected with HCV, complications and monitoring of the therapy, follow-up of the patients who reached sustained virologic response and re-treatment of the patients with therapy failure. Conclusions: This Position Paper represents a guide for the assessment and the therapy of HCV infection. The recommendations are in concordance with other guidelines but are applied to real-life conditions in Romania. [ABSTRACT FROM AUTHOR]

Background & Aims: Ombitasvir/Paritaprevir/ritonavir/Dasabuvir (OBV/PTV/r+DSV) is one of the elective direct-acting antivirals (DAAs) recommended by international guidelines and the only one covered by the National Insurance System in Romania until November 2016. Our aim was to present the first prospective Romanian cohort evaluating the effectiveness and safety in clinical practice of this 3DAA combination in patients with HCV genotype-1b Child A liver cirrhosis. Methods: 681 patients received OBV/PTV/r+DSV+RBV for 12 weeks and were assessed clinically and biologically at baseline, week 4, 8, 12 (end of treatment, EOT), and 12 weeks after therapy (sustained viral response, SVR). Results: Per protocol, EOT virological response was 99.8% and SVR12 rate was 99.4%. Adverse events were present in 36.4% of patients. Permanent discontinuation of 3DAA regimen due to side effects was reported in 11 patients (1.6%). In 47.6% (185/389) of patients, Transient Elastography values were >20kPa (defined as clinically significant portal hypertension, CSPH) at baseline. Independent variables associated with CSPH were: baseline cholesterol level (p=0.003), platelet count <120,000/mm? (p=0.02), MELD score (p=0.01). Liver stiffness measurement has significantly improved between baseline (26.6±12.7kPa) and SVR12 (21.6±11.8kPa) (p<0.0001). The same was true for APRI score (2.66±0.15 at baseline vs 0.85±0.02 at SVR12, p<0.0001) and FIB4 score (5.53±0.28 vs 3.24±0.08, p<0.0001), but not for Lok score (0.57±0.01 vs 0.63±0.01, p<0.0001). Conclusions: We report a high efficacy of the 3DAA regimen in a homogeneous compensated HCV genotype- 1b liver cirrhosis population, in a real-life setting. Noninvasive fibrosis scores significantly improved at SVR12. [ABSTRACT FROM AUTHOR]

Background & Aims: Hepatitis C Virus (HCV) infection is a common condition with endemic prevalence in some areas of the world. In Romania, the mean prevalence is about 3%. New treatments became available on the market in recent years and new drugs are in the pipeline. A re-evaluation of HCV therapy was considered mandatory. The Romanian Society of Gastroenterology and Hepatology undertook this task for the practitioners of this country. Methodology: A group of recognized experts was created who screened the available literature and the major available guidelines. A list of items requiring attention has been created. These items were discussed and rated. Decisions were taken by consensus. Recommendations: We present here the first of the two parts of our Society's recommendations for chronic HCV infection treatment. An agreement was reached regarding the diagnostic tools, the assessment of severity and the up-dated therapy schedules. Conclusions: This Position Paper represents a guide for the assessment and the therapy of HCV infection. The recommendations are in concordance with other guidelines but are applied to the real-life conditions in this country. [ABSTRACT FROM AUTHOR]

Background: Hepatitis delta virus (HDV) infection is associated with accelerated progression of fibrosis, early occurrence of hepatic decompensation and an increased risk for hepatocellular carcinoma. Epidemiological data on hepatitis delta virus (HDV) in Romania are still lacking. Aim: To assess the prevalence, virological, clinical and epidemiological features of HDV infection in Romanian patients. Methods: We conducted a multicenter study in 10 centers. Data on sociodemographic characteristics and potential risk factors were collected through a questionnaire. Virological markers of HBV and HDV infection, biochemical and clinical features of liver disease were evaluated. Results: The study population comprised 2,761 HBsAg(+) patients with a mean age of43.8±13.8years, out of whom 5.2% were HBeAg(+) and 55.7% were males. Liver cirrhosis was detected in 17.9% of patients, while 80.4% had chronic hepatitis. The prevalence of IgG anti-HDV(+) patients was 23.1%, out of whom 16.4% were HDV RNA positive. The highest prevalence of HDV infection was encountered in patients aged 50-59 years (28.9%) and patients aged >60 (24.8%) (p=0.0001). Seroprevalence of HDV was significantly higher in AgHBs(+) cirrhotics vs. noncirrhotics (43.4% vs 19.0%, p=0.0001). Risk factors for HDV infection were: occupational hazard, no HCV chronic infection, lack of anti-HBV vaccination, presence of blood transfusions, any previous surgery, frequent hospitalization or endoscopies, tattoos, body piercing, use of glass syringes, number of female sexual partners. Conclusions: HBsAg(+) population in Romania is characterized by a high prevalence of HBeAg(-) HBV infection as well as HDV co-infection. A cohort phenomenon for HDV prevalence is also observed similar to that of HCV/HBV monoinfections. [ABSTRACT FROM AUTHOR]

Background: A number of high quality randomized clinical trials examining the efficacy and safety of triple therapy in genotype-1 HCV-infected patients have been published. However, these trials included a small number of patients with advanced fibrosis, and selected a population different from that in real-world settings. Aim: To determine the efficacy of boceprevir, pegInterferon and ribavirin regimen in genotype-1 treatment-experienced HCV-infected patients with cirrhosis and bridging fibrosis in real-life setting. Method: 167 treatment-experienced patients (85.6% relapsers) out of which 33.5% had cirrhosis, with a mean age of 52.6 years, registered in the Romanian Name Patient Program Database were included into the study. Results: 16.7% of patients had a viral load >100 IU/mL. Undetectable HCV RNA was encountered in 77.3% of patients at week 12. Multiple logistic regression analysis revealed the following independent predictors, measured at week 8, for an HCV RNA =100 IU/mL at week 12 of triple therapy: alanine aminotransferase values (p=0.01), hemoglobin level (p=0.04) and <2log drop of viral load (p<0.0001). A stopping score at 8 weeks was created as the sum of these 3 parameters, with a total of 4 possible points. AUROC of this score was 0.84, with a sensitivity of 75% and a specificity of 86.2%. Conclusion: Triple therapy in this cohort of real-life genotype-1 HCV-infected patients with advanced fibrosis showed robust early virological response (EVR) rates. A week 8 model predicting lack of EVR was created, with good clinical utility that can be validated in prospective larger cohorts. [ABSTRACT FROM AUTHOR]

Aim: The aim of the present study was to characterize the dynamics of the Romanian waiting list (WL) for liver transplantation (LT) over two periods: 2004-2007 vs. 2008-2011. Methods: 1,085 patients listed for LT during the time period 2004-2011 were included in our analysis. Results: Death on the WL was significantly higher before 2008 (37% vs. 26.4%, p=0.0001) and risk of dying while on WL was 60% higher. Waiting time on the WL was 75% longer and time until LT was 102% longer before 2008 compared to the second time period (p=0.0001). After 2008, 62.3% of patients were listed for LT with Child Pugh class C compared to 22.1% before 2008 (p<0.0001). Conclusion: A significant reduction of mortality has been registered on the Romanian WL for LT after 2008, despite the increased severity of liver disease in patients listed for LT. [ABSTRACT FROM AUTHOR]

We present the case of a previously healthy 62 year old man who developed primary non-Hodgkin lymphoma of the liver. Biopsy confirmed that it was a diffuse large anaplastic T-cell lymphoma of an extremely rare type. The diagnosis of this type of lesions is suggested by the presence of a hepatic mass without lymphadenopathy, splenomegaly or bone marrow involvement associated with normal tumor markers (carcinoembryonic antigen, alpha-fetoprotein and CA 19-9 levels). Histological examination of tissue is essential to confirm the diagnosis. Treatment options are surgical resection and/or chemotherapy but the rate of response to treatment varies widely. Some patients can achieve prolonged remission. [ABSTRACT FROM AUTHOR]

Background: Antiviral therapy for chronic hepatitis D (delta) is not yet satisfactory, although it appears to be the only means to alter the progressive natural course of chronic hepatitis D virus (HDV) infection. Aim: To assess safety and efficacy, evaluated by virological, biochemical and histological end-of-treatment (EOT) and end-of-follow-up (EOF) response to Peg-Interferon α-2b 1.5μg/kg body weight weekly in a Romanian cohort of naïve patients with chronic hepatitis delta. Results: 49 Caucasian patients (55.1% men, 44.9% females) with a mean age of 37.95 years received study medication; per-protocol population consisted of 36 subjects. Virological EOT response was present in 33.3% and EOF response was maintained in 25% of patients. 50% of study population showed normalization of ALT level at EOT and 25% at EOF. A combined biochemical and virological response was observed in 19.4% of patients at EOT and in 16.7% at EOF. At baseline, the necroinflammation quantified by histological activity index (HAI) score was 9.72 and the mean fibrosis score was 2.03; there was a significant decrease of HAI score to 7.44 (p=0.01) at EOT, but not for fibrosis score (1.33, p=0.37). However, only 8.3% of patients at EOT and 19.4% at EOF had progressive histological disease. Conclusions: Treatment with Peg-Interferon α-2b succeeded in obtaining a negative HVD RNA in 25% of patients after 104 weeks of follow-up, although combined biochemical and virological response was present in only 16.7%. Necroinflammation decreased significantly in treated patients. Longer treatment periods with pegylated interferon or combination regimen peginterferon-nucleotide analogues should be tested in order to increase efficacy. [ABSTRACT FROM AUTHOR]

Introduction. Chronic HCV infection represents a public health problem in Romania, with a prevalence of 3.23-4.56%, and more than 5,000 patients on the waiting lists for antiviral therapy. Aim: To perform an evaluation of the severity of chronic HCV infection genotype 1b, and a quantification of patients with a low viral load, in order to quantify the number of patients who may be considered for shortened treatment duration. Material: Histological assessment and viral load were performed in 1,220 consecutive patients from the waiting list for antiviral therapy in 2009. The severity of chronic hepatitis was assessed by histological evaluation (the necrotic-inflammatory index - Metavir and the fibrosis score - Metavir). Viral load was measured by PCR and 400,000UI/ml and 600,000UI/ml were defined as thresholds for low versus high viral load We assessed the influence of age, sex, and viral load on necro-inflammatory activity and fibrosis. Results: The mean age of the patients included was 48 ±10.69 years and females predominated (58%). Many of them (60%) were in stage F3, with a high potential for disease progression in the next 10 years (necro-inflammatory activity was moderate to severe in over 90%). Almost half of the patients had low viral load, below 600,000 copies/ml. The viral load was significantly associated with the age (p< 0.001) and sex (p< 0.001) of the patients. Conclusion: Chronic HCV hepatitis in patients on the waiting lists for antiviral therapy in Romania has a high severity with important predictable consequences on the duration of life, complications and treatment costs. The strategy of shortening the duration of treatment would be beneficial for almost 50% of the patients. [ABSTRACT FROM AUTHOR]

Aims: This study was aimed at determining the seroprevalence of hepatitis C virus (HCV) infection in Romania and the possible risk factors and modality of HCV transmission. Methods: A nationwide cross-sectional survey among the adult population was conducted between 2006-2008 in Romania through a population multicenter stratified random cluster sampling. Serum samples from 13,460 subjects were tested with a 3rd generation ELISA and a standardized questionnaire concerning the socio-demographic characteristics and potential risk factors was used. Results: The prevalence rate of HCV infection in Romanian adult population was 3.23% with significant differences between the main geographical regions (Moldavia 4.25%, Wallachia & Dobrogea 3.35% and Transylvania & Banat 2.63%), as well as between different counties (maximum 7.19%, minimum 0.56%). Overall participation rate to the survey of the selected subjects was 74.69%. Risk factors for HCV infection were: blood/blood products transfusions (p=0.0001), previous surgery (elective and emergency, p=0.0001 and p=0.043, respectively), frequent hospitalizations (p=0.0001), injections at home (p=0.0001), accidents/trauma (p=0.0001), occupational hazard related to blood exposure (p=0.025), intravenous drug administration (p=0.002), a partner chronically infected with HCV/hepatitis B virus (HBV) (p=0.046), first sexual intercourse <18 years (p=0.019), familial exposure to HCV/HBV infection (p=0.001) or to chronic HBV/HCV liver disease (p=0.001), personal history of chronic HBV infection (p=0.001). HCV RNA positivity was detected in 91% of the anti HCV positive subjects. Conclusions: Overall HCV prevalence in Romania is 3.23%. Both nosocomial and non-nosocomial routes are implicated as risk factors for HCV infection. [ABSTRACT FROM AUTHOR]

Background: An overall prevalence rate of HCV infection in Romanian adult population was recently estimated to be 3.23%. The proportion of treated patients with chronic hepatitis C in our country has never been assessed. Aims: 1) to analyze the quality and quantity of antiviral therapy delivery; 2) to determine the proportion of patients being annually and ever treated with antiviral therapy in Romania and 3) to identify barriers against treatment of HCV infected-population in Romania. Results: The number of annually treated patients remained relatively stable between 2002 and 2007 (1,813 patients treated with pegylated interferon and ribavirin in 2002 and 2,446 in 2007). There was a doubled increase in reimbursed treatment in 2008 and 2009 (4,503 and respectively 4,701 treated patients) due to a special campaign organized to increase awareness and prevention of HCV transmission. The median time to therapy approval varies from county to county; overall it is 10.23 months. A total number of 25,318 patients with chronic C hepatitis were treated between 2002-2009, corresponding to a cumulative proportion of 4.1% of the prevalent cases of HCV infection treated in Romania until 1st January 2010. The main limiting factor of access to antiviral therapy for hepatitis C in Romania remains the lack of funds. Conclusions: This is the first analysis of the nationwide practice for treatment of hepatitis C in Romania. Increased public health efforts are required to improve access to antiviral therapy for hepatitis C in Romania. [ABSTRACT FROM AUTHOR]

Background: Small nodules (<3 cm) detected on ultrasound (US) in cirrhotics represent the most challenging category for noninvasive diagnosis of hepatocellular carcinoma (HCC). Aim: To evaluate real-time sonoelastography as a noninvasive tool for the diagnosis of small HCC nodules in cirrhotic patients. Methods: 42 cirrhotic patients with 58 nodules (1-3 cm) were evaluated with real-time elastography (Hitachi EUB-6500); the mean intensity of colors red, blue, green were measured using a semi-quantitative method. Analysis of histograms for each color of the sonoelastography images was performed for quantifying the elasticity of nodule tissue in comparison with the cirrhotic liver tissue. AUROC curves were constructed to define the best cut-off points to distinguish malignant features of the nodules. Univariate and multivariate logistic regression analysis was performed. Results: 595 sonoelastography images from 42 patients (25 men; 17 women) were analyzed. The mean age was 56.4±10.7 years and 69% patients were in Child-Pugh class A, 19% class B, 11% class C. For the mean intensity of green color AUROC=0.81, a cut-off value of <108.7 being diagnostic for HCC with a Sp=91.1%, Se=50%, PPV=92.1%, NPV=47.1%. Mean intensity of blue color proved to be an excellent diagnostic tool for HCC (AUROC=0.94); for a cut-off value>128.9, Sp=92.2%, Se=78.9%, PPV=95.4%, NPV=68%. Independent predictive factors of HCC for a small nodule in cirrhotic patients were: blue color>128.9 at sonoelastography and hypervascular appearance at Doppler US. Conclusions: US elastography is a promising method for the non-invasive diagnosis of early HCC. Blue color at elastography and hypervascular aspects are independent predictors of HCC. [ABSTRACT FROM AUTHOR]

Background: Hepatitis B Virus (HBV) remains a major global health challenge, with significant morbidity and mortality associated with chronic infections. Methods: This study examines the epidemiology, screening, and risk factors associated with HBV in Romania, focusing on a comprehensive national screening program, LIVE(RO)2, involving 320,000 individuals (majority of them considered vulnerable population). A questionnaire was used to collect information on the potential risk factors for HBV transmission. Results: The overall prevalence rate of HBV chronic infection among all the participants tested was 1.67% (confidence interval: 1.63–1.72%), with significant differences (p = 0.0001) between participants from the main geographical regions of residence (North-East 1.89%, South 1.38%, South-East 2.06%, and South-West 1.54%). Male persons aged 30–49 or 60–69 years old, from the rural and Eastern parts of Romania and non-Romanian ethnia, with a low level of education, unvaccinated, not married, unemployed, with family members with hepatitis, with personal histories of blood or blood product transfusion, surgical interventions, tattooing, hospitalizations, imprisonment, haemodialysis, unsafe sexual contacts, or with sexual transmitted infectious diseases were risk factors associated with HBsAg seropositivity. Conclusions: Our findings highlight significant demographic and epidemiological patterns of reduced HBV prevalence even in vulnerable persons, as well as modified risk factors and the impact of socio-economic factors. [ABSTRACT FROM AUTHOR]

Pegylated interferon-alpha in combination with ribavirin currently represents the therapeutic standard for the hepatitis C virus infection. Interferon based therapy may be responsible for many cutaneous side effects. We report a case of drug-induced Sweet's syndrome secondary to hepatitis C antiviral therapy. To our knowledge, this is the first reported case of Sweet's syndrome in association with pegylated interferon-alpha therapy. [ABSTRACT FROM AUTHOR]

The article presents a case study of a 66 year-old male patient who had a history of orthotopic liver transplantation for hepatitis C virus (HCV) liver cirrhosis. Topics discussed include the early detection of advanced pancreatic cancer in the patient, the abdominal computed tomography (CT) scan performed on the patient, and the recurrence of HCV in the patient.

Background & Aims: Hepatocellular carcinoma (HCC) is a significant public health issue, with an increasing incidence and prevalence and a high incidence-to-mortality ratio. The prognosis of HCC depends on two competing factors, tumor burden and underlying liver disease severity, encompassed in the Barcelona Clinic Liver Cancer (BCLC) classification. To assess HCC staging and the way staging affects eligibility for treatment at the time of the first diagnosis in Romania in the setting of opportunistic diagnosis, in the absence of a national HCC screening policy. Methods: Data regarding HCC staging, underlying liver disease, and eligibility for treatment at the time of diagnosis was analyzed using a prospectively maintained multicentric database, which included patients from the five largest tertiary care hepatology units in the country between June 2016 and February 2020. Results: A consecutive series of 477 patients was included. The distribution within BCLC classes was as follows: very early (0) 7.1%, early (A) 34.3%, intermediate (B) 19.4%, advanced (C) 14.2%, terminal (D) 24.7%. At the time of the diagnosis, 198 (41.5%) were eligible for a curative intent treatment, while 359 (75.2%) were eligible for a disease-modifying therapy. 228 patients (47.8%) had decompensated liver disease at the time of diagnosis, the most common decompensating event being ascites (78.1%). Conclusions: A large proportion of HCC cases are diagnosed at the time of a decompensating event, severely restricting the therapeutic potential. Proactive diagnostic strategies should be implemented to improve the rate of actionable diagnosis. [ABSTRACT FROM AUTHOR]

Introduction: Metabolic dysfunction-associated steatotic liver disease (MASLD) is an entity with a growing incidence but only a few pharmacological options. In Romania, the prevalence of MASLD has been increasing, while that of viral hepatitis has been decreasing. The purpose of this study is to compare two supplements for the treatment of MASLD. Methods: Between January 2020 and May 2022, 90 patients with MASLD were randomized to receive either silymarin 150 mg b.i.d (45 subjects) or essential phospholipids (EPLs) 825 mg b.i.d. (45 subjects) for six months. All study participants received recommendations for lifestyle and diet modifications. Assessment of the severity of steatosis and liver fibrosis was performed using FibroScan® with controlled attenuated parameter (CAP) at the beginning and end of treatment. Results: A total of 68 patients completed the trial. The two groups were statistically comparable in terms of clinical, biological and FibroScan® parameters. Aspartate transferase (AST) decreased from a median of 40 to 28 IU/L in the EPL arm (compared to 25→25.5 IU/L in the silymarin arm) (p-value=0.11) and alanine transaminase (ALT) decreased from 46 to 37.5 IU/L (compared to 31→30 IU/L) (p-value = 0.38). Plasma cholesterol levels also decreased significantly in the EPL group (218→189.5 mg/dL) compared to the silymarin arm (217→209 mg/dL) (p = 0.01). At the end of treatment, liver stiffness decreased by 0.7 KPa (6.9→6.2 KPa) in the EPL group but increased by 2.3 KPa (7.2→9.5 KPa) in the silymarin group (p = 0.1). The reduction in hepatic steatosis was comparable between the two groups: it decreased by 5% of the initial value. Conclusion: In our study, a six-month treatment with EPLs was superior to silymarin in MASLD patients because it succeeded in improving both laboratory parameters and liver fibrosis, as estimated by FibroScan®. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article on the diagnosis of clostridium difficile infection in gastroenterology in the previous issue.

A letter to the editor is presented in response to an article about the reactions of somatic mutation (V617F) in the Janus tyrosine kinase-2 (JAK2) gene of Budd-Chiari syndrome which appeared in the September 2009 issue.

The article discusses the prevalence and mildness of inflammatory bowel diseases (IBD) in South Eastern Europe. The authors had reported the low incidence and low prevalence of IBD in Romania. They compare the characteristic of IBD in Romania and Turkey and noted that most patients had ulcerative colitis and some had Crohn's disease.

Abstract: Background: Direct antiviral agents (DAA) showed very good results in terms of efficacy and safety in clinical trials, but real‐life data are still needed in order to confirm this profile. Material and methods: In Romania, through a nationwide government‐funded programme in 2015‐2016, approx.5800 patients with virus C cirrhosis received fully reimbursed DAA therapy with OBV/PTV/r+DSV+RBV for 12 weeks. We analysed a national prospective cohort enrolling the first 2070 patients, all with genotype 1b. The only key inclusion criteria was advanced fibrosis (Metavir stage F4) confirmed by Fibromax testing (or liver biopsy/Fibroscan). Efficacy was assessed by the percentage of patients achieving SVR 12 weeks post‐treatment (SVR12). Results: Forty patients stopped the treatment because of hepatic decompensation (1.9%), 21 stopped because of other adverse events and one was lost to follow‐up. This cohort was 51% females, mean age 60 years (25÷82), 67% pretreated, 70% associated NASH, 67% with severe necro‐inflammation (severity score 3‐Fibromax), 37% with comorbidities, 10.4% with Child Pugh A6, 0.5% B7. The median MELD score was 8.09 (6 ÷ 22). SVR by intention‐to‐treat was reported in 1999/2070(96.6%), 55/2070 failed to respond. Liver decompensation was statistically associated in multivariate analysis with platelets< 105/mm3(P = .03), increased total bilirubin (P < .001), prolonged INR (P = .02), and albumin<3.5 g/dL (P = .03). Conclusions: OBV/PTV/r+DSV+RBV proved to be highly efficient in our population of cirrhotics with a 96.6% SVR. Serious adverse events related to therapy were reported in 61/2070(2.9%), most of them liver decompensation (1.9%), related to hepatic dysfunction, and lower platelet count. [ABSTRACT FROM AUTHOR]

Aim: to compare the efficacy and safety of Adalimumab(ADA) and Infliximab(IFX), in a large Romanian population and to identify predictors of response. Methods We performed a national retrospective cohort study including 265 patients (136 ADA, 129 IFX) between 2008-2014. Binary logistic regression was performed with the statistical program Minitab. Results: Patients were half women, with a median age of 36, a median disease duration of 2.5 years, 80% received Azathioprine. Mean therapy duration was 20 months in ADA group and 36 months in IFX group. Complete response to Adalimumab respectively Infliximab was recorded in 77%vs.65%, secondary loss of response in 18%vs.28%, statistically comparable. We failed to identify predictors of response. In 79.2%of patients with secondary loss of response to ADA, the dose was escalated, 12.5% were switched to Infliximab. In 70%of patients that lost response to IFX, the dose was increased, 30% were switched to Adalimumab. Conclusions: Adalimumab and Infliximab have similar efficacy, with a complete response rate of~70%. In case of secondary loss of response to IFX, the best solution is to switch to ADA, with 83% response rate, while in case of secondary loss of response to ADA, increasing the dose leads to 84 % response rate. [ABSTRACT FROM AUTHOR]

Background. The influence of co-infection with hepatitis D and B viruses on the prognosis of patients with liver cirrhosis is not well established. It is generally considered that hepatic insufficiency in co-infected (HBV+HDV) patients is more severe and rapidly progressive, the evolution being aggravated by numerous complications. Aim. The aim of our study was to compare the long term evolution of patients with liver cirrhosis secondary to viral hepatitis B and D co-infection with that of cirrhotic patients with only hepatitis B virus infection. Methods. Patients were enrolled consecutively from cases admitted in our department during one year (2005) and diagnosed then for the first time with compensated cirrhosis secondary to VHB+VHD co-infection (first group) and VHB mono-infection (second group) respectively. We followed the patients from inclusion (at cirrhosis diagnosis) until death, liver transplantation or until the end of study period (31 December 2013). The occurrence of complications of cirrhosis (hepatocellular carcinoma, refractory ascites, hepatic encephalopathy, upper digestive bleeding, portal vein thrombosis, hepatorenal syndrome, spontaneous bacterial peritonitis) and the causes of death were noted. Survival curves were calculated using Kaplan Meier method and compared using the log-rank test. Results. We enrolled 75 patients with HVD+HBV cirrhosis and 75 patients with HBV cirrhosis. In HDV+HBV group 49.34% were men, with the mean age 43.86 +/-11.66 and in HBV group 66.67% were men with mean age 48.20 +/-11.82. At diagnosis mean MELD score was similar in both groups: 9.45 ± 1.99 for HDV+HBV and 8.14 ± 1.34 for HBV group. Patient mortality during follow-up was predicted (in univariate analysis) by: the presence of HBV and HDV coinfection, Child Pugh class C, MELD score and by the following complications of cirrhosis: hepatocellular carcinoma, refractory ascites, hepatic encephalopathy, upper digestive bleeding, jaundice, portal vein thrombosis, hepatorenal syndrome. Although patients with HDV+HBV related cirrhosis had a significantly lower survival compared to HBV related cirrhosis (p=0.01) in multivariate analysis the only independent predictors for patient death were: the presence of hepatocellular carcinoma, refractory ascites and presence of hepatic encephalopathy episodes. Liver transplantation was performed in 12 patients; 9 patients with HDV+HBV related cirrhosis and only 3 patients with HBV cirrhosis (p=0.13). Conclusion. The presence of HVD+HVB co-infection is not an independent risk factor for mortality [ABSTRACT FROM AUTHOR]

The article presents a response to a 2021 article by Pioppo et al. on patients with admissions for gastric antral vascular ectasia (GAVE) and the factors of portal hypertension and chronic kidney disease for their readmission. Topics discussed include the effectivity of endoscopic treatment for GAVE in reducing acute rebleeding and chronic blood loss, and the still undetermined timing of endoscopic treatment due to minimal GAVE cases. Also noted is the need for multicentric studies on timing.

Introduction. It is well known that portal vein thrombosis (PVT) can accelerate liver decompensation, reducing overall survival. In the literature, the topic whether PVT is a risk (1) factor for variceal bleeding or it influences the effectiveness of variceal band ligation (VBL) remains of great interest The aim of this study was to assess if VBL is a potential risk factor for PVT development. An observational and retrospective study was conducted in a single tertiary center from 2010 to 2021 and included data from 285 patients with liver cirrhosis. Results. Of the 285 patients, gender distribution described 47.32% female (n =135) and 52.8% male (n =150) with a mean age of 55 years (range =23-79). The average MELD score was 12.5 (range 7-27). Of the total number of patients, 48.8% (n=139) had previous VBL: 20% (n=57) underwent primary prophylactic VBL and 34.7% (n=99) underwent secondary prophylaxis. Thus, 285 VBL procedures had been performed and the average number of VBL session was 2 (range 1-10) The mean time follow up was 92.55 months (range 22-230. During the follow up period PVT was diagnosed in 41.4% of patients (n =118) of which 67.77% (n =80) had at least one previous session of VBL: 33% of patients (n =39) had performed primary prophylaxis and 34.74% (n =41) secondary. A logistic regression was conducted to assess if VBL (primary and/or secondary prophylaxis) are risk factors for PVT development. The model was significant for primary prophylaxis (p =0.002, OR 3.28, CI 1.53-7.02) resulting that the risk of PVT is increasing around 3 times after primary prophylactic VBL. Conclusion. Our study showed a certain predisposition for cirrhotic patients to develop PVT after VBL performed as primary prophylaxis thus raising the question: does VBL impact the occurrence of PVT in cirrhotic patients? Furthermore, to our knowledge, this is the first study in the literature that focuses on this topic. More studies should be performed to evaluate and describe the relationship between VBL and the risk of PVT. [ABSTRACT FROM AUTHOR]

The paper is concerned with the determination of blood permittivity and conductivity in Poiseuille and Couette simple shear flows. The experimental procedure, based on dielectric spectroscopy, evidences the sensitivity of blood electric properties to the applied frequency and local shear rate magnitude. The method evidences the possibility to correlate (for well‐defined flow geometry) magnitude of shear rate, and consequently the shear stress level, with spectra permittivity of blood. [ABSTRACT FROM AUTHOR]

Several biologic treatments are available in addition to intravenous also in subcutaneous form for treatment of chronic diseases. Benefits of the subcutaneous application of drugs include self-administration by the patient, shorter time of application process with less infusion related adverse events and consequently lower healthcare costs. With appropriate education and support patients are able to administer their treatments at home. This leads to improvement of quality of life, reduction of time needed to travel to the healthcare institution and consequently also reduces costs also for the patient. Over one million residents in the USA and 2.5 million in Europe are estimated to have inflammatory bowel disease (IBD), with substantial costs for health care. These estimates do not factor in the 'real' price of IBD, which can impede career aspirations, instil social stigma and impair quality of life in patients. The Virtual Community Meeting, which offered an exchange of experience and opinions from healthcare professionals who are active in treating IBD, and patients with this chronic disease, revealed in-depth arguments and answers to some essential questions: which patients prefer subcutaneous over intravenous dosing; which patients continue to favour intravenous infusions; what are the limitations regarding both applications; what is the patient's role in therapeutical decision-making and how does IBD affect the patient's work, finances and quality of life? The aim of this article is to discuss the differences between subcutaneous and intravenous dosing from the health-economic, scientific, and personal perspectives. The meeting offered strong confirmation that most of the patients and healthcare professionals prefer subcutaneous over intravenous drug administration but emphasise the management of risks associated with treatment compliance. Patient education provided by the IBD team in this regard is mandatory. Quality of life of patients is poorer during active disease, but the findings that it can improve over time, including as a result of home- or self-administration of biologics, may be encouraging for individuals with this chronic disease. [ABSTRACT FROM AUTHOR]

Background & Aims: Identifying the risk factors for extraintestinal manifestations (EIMs) in inflammatory bowel diseases (IBD) may optimize the therapeutic decision. We aimed to assess the prevalence of EIMs in IBD patients in Romania and to determine the risk factors. Methods: We analyzed 2,626 patients registered in the Romanian IBD Prospect National Registry. We performed a descriptive cross-sectional study to assess the point prevalence of EIMs, calculating global prevalence and analyzing the different types of EIMs and their respective frequencies were carried out. Demographic and clinical risk factors were researched as possible predictors for EIMs development, based on the results of the univariate and multivariate logistic regression analysis. Results: The overall point prevalence of EIMs was 16.3%. A significantly higher frequency of EIMs in Crohn's disease (CD) was noted in comparison to ulcerative colitis (UC) and IBD unclassified (IBDU) (23.2% vs 11.3% and 16.3%, respectively, p<0.001). The most frequent type of EIM was peripheral arthropathy (8.3%), significantly associated with CD (p<0.001). Univariate analysis highlighted the significant independent common predictive risk factors for EIMs, in both CD and UC patients: female gender, patient's urban area of origin, anemia, hypoalbuminemia, and high level of C-reactive protein (CRP), while significant independent IBD phenotype-related risk factors were ileocolonic location and concomitant involvement of upper gastrointestinal tract for CD, non-smoker status and both moderate and severe disease activity for UC (p<0.05). Multivariate analysis determined that female CD patients with moderate or severe disease activity, with other than isolated ileal disease, and female UC patients with moderate or severe extensive colitis are the most likely to develop EIMs. Conclusions: IBD patients are experiencing EIMs in a large proportion, with higher rates for CD. As EIMs negatively affect patient outcomes, foreseeing the risk by identifying independent and associated predictive factors could be a first step to optimal work-up and treatment [ABSTRACT FROM AUTHOR]

Background & Aims: The evidence regarding the use of anticoagulant (AC) agents in portal vein thrombosis (PVT) is increasing and, most patients undergo chronic treatment with low molecular weight heparin (LMWH) or vitamin K antagonists (VKA). Nevertheless, there are no clear data about who should receive antithrombotic therapy, when to initiate it, how long and what dose should be used for this set of patients. The aim of the study was to assess the outcome of patients with cirrhosis and portal vein thrombosis who received AC therapy, in terms of thrombus regression, bleeding events and survival rates. Methods: This observational and retrospective study included 107 cirrhotic patients diagnosed with PVT in a single tertiary center between 2010-2019. 54 received low molecular weight heparin or vitamin K antagonist (AC treatment group) and 53 were untreated. All patients were periodically follow-up to assess the evolution of PVT (regression, progression, stable thrombus) and potential occurrence of bleeding events. Results: The regression of portal vein thrombosis was significantly higher in the AC treatment group (OR=2.430; 95% CI=1.11-6.167; p=0.026), more than 50% of on-treatment patients experiencing regression of the thrombus. However, bleeding events were significantly more frequent in the AC treatment group (18.5% vs. 7.5%) and the risk of bleeding was associated with thrombocytes less than 50x103/mm3 (OR=8.266; 95%CI: 2.310-39.211; p=0.002). Survival was better in the AC treatment group (68.4% vs 48.7% at 5 years and 92.7% vs 77.8% at 1 year, p=0.038) and was lower in patients that experienced bleeding events (37.22% survival at 5 years, mean time survival 44 months, p=0.008). Conclusions: In our cohort of cirrhotic patients with PVT more than 50% of patients receiving AC therapy presented regression of the thrombus; most of them obtained partial recanalization. The bleeding complication rate was higher than expected, reaching 18%. The overall mortality was lower in the treated group. [ABSTRACT FROM AUTHOR]

Background and Aims: We assessed the clinical and economic impact of direct‐acting antiviral (DAA) therapy for hepatitis C virus (HCV) in England, Italy, Romania and Spain. Methods: An HCV progression Markov model was developed considering DAA eligibility and population data during the years 2015‐2019. The period of time to recover the investment in DAAs was calculated as the cost saved by avoiding estimated clinical events for 1000 standardized treated patients. A delayed treatment scenario because of coronavirus disease (COVID‐19) was also developed. Results: The estimated number of avoided hepatocellular carcinoma, decompensated cirrhosis and liver transplantations over a 20‐year time horizon was: 1,057 in England; 1,221 in Italy; 1,211 in Romania; and 1,103 in Spain for patients treated during 2015‐2016 and 640 in England; 626 in Italy; 739 in Romania; and 643 in Spain for patients treated during 2017‐2019. The cost‐savings ranged from € 45 to € 275 million. The investment needed to expand access to DAAs in 2015‐2019 is estimated to be recovered in 6.5 years in England; 5.4 years in Italy; 6.7 years in Romania; and 4.5 years in Spain. A delay in treatment because of COVID‐19 will increase liver mortality in all countries. Conclusion: Direct‐acting antivirals have significant clinical benefits and can bring substantial cost‐savings over the next 20 years, reaching a Break‐even point in a short period of time. When pursuing an exit strategy from strict lockdown measures for COVID‐19, providing DAAs should remain high on the list of priorities in order to maintain HCV elimination efforts. [ABSTRACT FROM AUTHOR]

Background & Aims: Inflammatory bowel diseases (IBD) patients management has been challenging during the ongoing coronavirus disease 2019 (COVID-19) pandemic, due to lockdowns, limitation of access to medical facilities and new recommendations regarding patient management. The implications of the COVID-19 pandemic on IBD patients' management were assessed in our Tertiary Gastroenterology Center in Bucharest, Romania. Methods: Medical records of IBD patients admitted between 15th of March and 15th of August 2020 were retrospectively reviewed and compared to a control cohort of consecutive IBD patients admitted to our unit during the corresponding period of 2019. Results: There was a highly significant shift towards one-day hospitalization during the referral period in 2020 for IBD cases (91% in 2020 vs 82.2% in 2019, p=0.0001). There was no statistically significant difference between the distribution of patient's gender, IBD phenotype or newly diagnosed IBD cases. A significantly lower proportion of admitted patients received 5-aminosalicylic acid (29% vs 41.2%, p=0.0001), whereas a substantially higher number of patients were prescribed biological therapy in 2020 in comparison to the corresponding 2019-time frame (79.5% vs 57.9%, p<0.0001). The distribution of the biological agent used was significantly different in 2019 in comparison to the 2020 period mainly due to the increase in vedolizumab prescription in 2020 (p<0.0001). During the study period in 2020, seven IBD patients (1.7%) were diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-Cov2) infection, all of them with mild symptoms without impact on the IBD course. Conclusions: The COVID-19 pandemic led to reorganizing medical care, limiting the hospital admissions in favor of severe IBD cases, favoring telemedicine for mild disease and optimization of treatment for moderate to severe IBD with an increased use of biologicals aimed to maximize the risk/benefit ratio. Incidence of SARS-Cov2 infection during the first wave of COVID-19 infection in our study group was 1.7% and did not adversely impact the IBD disease course. [ABSTRACT FROM AUTHOR]

Background and Aim. The number of patients with hepatocellular carcinoma (HCC) listed for liver transplant (LTx) has increased significantly and many of them are now receiving transarterial chemoembolization (TACE) to prevent disease progression. The aim of the study is to analyze the course of disease in patients with HCC who received TACE before LTx. Methods. Patients and tumor characteristics were compared between recipients who received TACE and those who did not. Kaplan-Meier method was used to compare patient survival. Results. Thirty-one patients treated with sequential TACE of a total of 63 patients with proven HCC that underwent LTx between 2013 and 2018 were included in the study. Altogether, 51 TACE procedures were accomplished (range 1-6). Twenty two patients (70.9%) received TACE with Lipiodol while the rest were treated with Debdox. Forty patients were within the Milano criteria and twelve patients (19.04%) had a complete response after TACE. Follow up duration was 72.3 months (62-114) and thirteen patients (20.6%) developed HCC recurrence after LTx. The recurrence free survival was 85.7 %, 69.6% and 58.9% at 1, 3 and 5 years, respectively. There was no significant difference in survival in patients that received TACE compared to those that did not (p=0.455). In the univariate analysis an AFP value greater than 100ng/mL, absence of tumor tissue at the time of LTx and a tumor within Milan criteria were found to be predictive factors for survival but only Milan criteria was significantly associated with survival in multivariate analysis (p=0.007; CI 95%: 0.1262 to 0.7266). Conclusion. TACE is an effective method for the therapy of the HCC before LTx in selected patients Milano criteria is the best predictive factor for survival in HCC patients undergoing liver transplant. [ABSTRACT FROM AUTHOR]

Background & Aims: Prevalence of malnutrition in inflammatory bowel diseases (IBD) varies between 16% and 75%. Data on the nutritional status at initial diagnosis of ulcerative colitis (UC) or Crohn's Disease (CD) are scarce. It is believed that more than 50% of IBD patients suffer significant weight loss prior to diagnosis. The aims of our study were to assess malnutrition in patients recently diagnosed with IBD and to determine its predictive factors. Methods: We retrospectively included 625 IBD patients registered in the Romanian "IBD Prospect" database between January 2006 and July 2017. All patients were diagnosed within 6 months prior to registration. We defined malnutrition as weight loss of more than 5% of the initial weight during the 3 months prior to registration. Results: There were 361 new cases of UC, 241 CD and 23 cases of unclassified IBD. There was a slight male predominance (M/F=1.2). Prevalence of overall malnutrition was 36.3%. It was significantly more frequent in CD than in UC patients (41.1% vs. 32.4%, p=0.031). In multivariate analysis, malnutrition in UC patients was associated with male gender (p=0.001), more severe disease (p<0.0001) and more extensive disease (p=0.027), while in CD it was associated with younger age (p=0.013) and more severe disease (p<0.0001). Conclusions: About 1 in 3 newly diagnosed IBD patients presents with malnutrition at the time of diagnosis. [ABSTRACT FROM AUTHOR]

Nonalcoholic liver disease (NAFLD) is a hot topic for gastroenterologists and hepatologists and clinical practitioners must be kept abreast with the rapid progress of knowledge in this field. The Romanian Society of Gastroenterology and Hepatology (RSGH) has elaborated this review dedicated to evidence-based data on pathogenesis, diagnosis and therapy of this condition. The term NAFLD includes two distinct conditions, with different histologic features and prognosis: nonalcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH), the second with the highest risk of evolution to cirrhosis and its complications, including hepatocellular carcinoma (HCC). Non-alcoholic fatty liver disease is considered the hepatic manifestation of the metabolic syndrome. Therefore, NAFLD is associated not only with an increase of liver-related mortality, but also of the overall mortality, especially cardiovascular and malignancies. Noninvasive techniques, such as biological tests and elastography can be used for the evaluation of NAFLD patients. Liver biopsy should be recommended in selected cases, for diagnostic, therapeutic and prognostic purposes. Patients with NAFLD would benefit from their lifestyle changes by progressive weight loss through exercise and low fat and sugar diet. Pharmacotherapy should be reserved for patients with NASH, particularly for those with significant fibrosis. Until now, there are no FDA approved therapies for NASH. [ABSTRACT FROM AUTHOR]

Background & Aims: Diverticular disease of the colon is a common clinical condition in developed countries, and is associated with significant (direct and indirect) economic burden. The aim of this Position Paper is to provide clinical guidance for appropriate definition, prevalence, risk factors, diagnosis, and treatment of colonic diverticular disease. Methods: A working group of recognized experts established by the Board of the Romanian Society of Gastroenterology and Hepatology (RSGH) screened the literature and the available guidelines on colonic diverticular disease. Statements were formulated based on literature evidence. These statements were discussed within the working group and decision for each of them was taken by consensus. Results: Thirty two statements were elaborated. The grade of recommendation, according to the level of evidence was established for each statement. Short comments with literature support accompany each statement. Conclusion: This Position Paper represents a practical guide for clinicians dealing with patients affected by colonic diverticular disease. [ABSTRACT FROM AUTHOR]

Background & Aims: To evaluate the predictive factors for recurrence of the disease and overall survival (OS) after achieving complete response (CR) in patients with hepatocellular carcinoma (HCC) treated with transarterial chemoembolization (TACE). Methods: From January 2013 to December 2017, 168 treatment-naïve patients diagnosed with HCC underwent TACE as a first-line therapy and the gathered data was retrospectively reviewed. We determined the predictive factors for complete response (CR), for recurrence after CR and for survival using the Cox proportional hazard model. Results: Median follow-up was 27.4 months (range 4-65 months). The mean patient age was 62.2±7.9 years. Eighty-three patients had an α-fetoprotein (AFP) level > 20ng/mL. The median maximal diameter of the tumors was 3.5 cm. Sixty-three patients (37.5%) achieved CR after TACE, and recurrence after CR was detected in 37 patients (58.7%). In multivariate analysis, tumor size (≤4.5 cm) and a single tumor were found to be predictive factors for CR, with hazard ratios (HRs) of 2.352 (p=0.022) and 3.964 (p<0.0001), respectively. After achieving CR the median time to recurrence was 12 months (range 6-24 months). Elevated serum AFP > 25 ng/mL and multiple tumors were demonstrated to have a significant relationship with recurrence after CR, with HRs of 1.650 (p=0.05) and 3.932 (p=0.038), respectively. Increased initial serum AFP > 22 ng/mL, tumor size > 4.5 cm, outside Milan criteria, not receiving a liver transplant and presence of portal vein thrombosis (PVT) were correlated with poor survival. Conclusions: In patients treated with TACE as an initial therapy, tumor size (≤4.5 cm) and single tumor were predictive factors for CR. Multiple nodules and an elevated serum AFP > 25 ng/mL were predictive factors for recurrence after CR. Outside Milan criteria tumors, elevated AFP levels and the presence of PVT were significantly correlated with decreased survival. [ABSTRACT FROM AUTHOR]

Background: Nowadays, interferon-free therapy using new direct-acting antivirals (DAA) has dramatically increased the cure rate across different HCV-infected patient populations, including groups traditionally viewed as difficult-to-treat (patients with co-infections, cirrhosis and liver transplant - LT recipients) with marked improvement in safety and tolerability. Aim: To present our experience with DAA therapy in LT recipients, as well as to compare pre- and posttreatment liver stiffness (LS) and noninvasive fibrosis scores. Methods: Our cohort consisted of 89 patients with genotype 1 (GT1) recurrent hepatitis C after LT. Seventy six patients received ombitasvir/paritaprevir/ritonavir+dasabuvir+ribavirin and 13 sofosbuvir/ ledipasvir±ribavirin. Fibroscan®, FIB4 and APRI scores were performed in all patients before and 12 weeks after DAA therapy. Results: We analyzed 45 (50.5%) males and 44 (49.5%) females with a mean age of 55±7.7 years. Median time since LT was 20.9 months. At baseline, 53 (59.6%) of patients had severe necroinflammation at Fibromax® advanced fibrosis (F3, F4) was encountered in 35 (39.4%) and grade 3 steatosis in 33 (37.1%) of LT recipients. End of therapy (EOT) virological response (VR) was 100%. Sustained virological response 12 weeks after therapy (SVR12) was 97.7% in the intention-to-treat analysis and 100% in per protocol analysis. There was a significant improvement in LS between antiviral therapy initiation and SVR12: 11.9±1.05kPa vs 8.8±0.6kPa (p<0.0001), as well as in APRI (2.7±0.3 vs 0.4±0.05, p<0.0001) and FIB4 (4.6±0.5 vs 2.5±0.2, p<0.0001) scores. Conclusion: In HCV positive recipients, DAA regimens are highly effective and safe. A significant decrease of LS by transient elastography and fibrosis non-invasive scores can be observed after successful therapy. [ABSTRACT FROM AUTHOR]

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]

Introduction. In the last decade, bariatric surgery has proven to be the only effective method for weight loss (WL) in patients with morbid obesity. Objective. To determine the factors that influence optimal WL after sleeve gastrectomy in patients with morbid obesity. Material and method. 72 patients with BMI >40 kg/m2 or BMI 35-39.9 kg/m2 with severe comorbidities were included in the study. The patients were evaluated clinical, biochemical, immunological, imaging and histological preoperative and postoperative (on average 8.7 months after the surgical intervention). WL were assessed by calculated the percentage of excess body mass index loss (%EBMIL) using the following formulas %EBMIL=(BMI1-BMI2) / (BMI1-25) x100; Optimal treatment response was considered a decrease in %EBMIL >50 Results. The patient had a mean age of 44.78±10.5 years, an average BMI and preoperative waist of 47.05 kg/m2 (between 33.3 and 70.1), respectively 130 cm (between 90 and 180cm). The results of our study showed a mean decrease in %EBMIL of 69.9 ± 27.6 (14.6-144.47), the value that shows an optimal response of postoperative weight loss. Using the univariate analysis we noted a negative correlation between % EBMIL and both the age and initial BMI of the patients (r=-0.438, p<0.01, r2=0.19). Patients with optimal WL have statistically significantly lower preoperative values of FG (U= 95.5, z=-2.25, p<0.05), TNFα (U=53, z=-2.5, p<0.05) and IL-6 (U=79, z=-2.3, p<0.05) compared to patients without clinical response (%EBMIL<50%). A negative correlation between %EBMIL and the presence of NASH was also found. Patients with preoperative NASH had a significantly lower %EBMIL than those with simple steatosis (U=56, z=-2.2, p<0.05). Conclusions. Sleeve gastrectomy was an effective bariatric surgery to treat obesity. Preoperative BMI, excess weight, age, TNF α, IL-6 and the presence of diabetes and steatohepatitis were predictive factors for optimal weight loss in patients with morbid obesity after sleeve gastrectomy. [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]