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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: 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/mm³ (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.

Background and 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.

Background and Aims: Nonalcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide. The aim of our study was to evaluate a population of diabetic patients regarding the severity of liver steatosis and liver fibrosis., Methods: The study included 392 type 2 diabetic patients prospectively randomized, evaluated in the same session by transabdominal ultrasound to assess steatosis and by liver elastography to assess fibrosis (Transient Elastography - TE, FibroScan, EchoSens). Steatosis severity was graded using a semi-quantitative scale (S0-no steatosis; S1-mild steatosis; S2-moderate steatosis; S3-severe steatosis). For differentiation between stages of liver fibrosis, the following cut-off values were used (Wong et al., 2010): F2-F3: 7-10.2kPa, F4>/=10.3 kPa., Results: Reliable elastographic measurements were obtained in 76% (298/392) patients. By using the proposed cut-off values, significant fibrosis (F2-F3) was found in 18.8% (56) patients with steatosis, while 13.8% (41) had cirrhosis (F4). Significant fibrosis (F2-F3) was found in 20.4% (20/98) of the patients with S1, in 18.6% (22/118) of those with S2 and in 31.8% (14/44) of those with S3, while cirrhosis (F4) was diagnosed in 7.1% (7/98) patients with S1, in 20.3% (24/118) of those with S2 and in 22.7% (10/44) of those with S3., Conclusions: Liver steatosis diagnosed by ultrasound is very frequently found in type 2 diabetes mellitus patients, more than half of them having moderate/severe steatosis. A significant liver stiffness increase was found in more than 30% of these patients. Liver stiffness assessment in type 2 diabetic patients should be performed systematically to identify those with significant liver fibrosis.

Aim: To present a large monocentric experience in the characterization of focal liver lesions (FLLs) using Contrast Enhanced Ultrasound (CEUS)., Method: A retrospective study was performed in the Gastroenterology and Hepatology Department, Timisoara, including 1100 patients with 1329 FLLs evaluated between September 2009 and January 2013. A CEUS examination was considered conclusive if the FLL respected the typical enhancement pattern as described in the EFSUMB Guidelines., Results: From the 1329 FLLs, CEUS was conclusive for a specific pathology in 1102 cases (82.9%). For the differentiation of benign/malignant lesions, CEUS reached a conclusive diagnosis in 1196 (90%) cases. The percentage of conclusive CEUS examinations was significantly higher in patients without chronic liver disease as compared with those with chronic hepatopathies: 87.3% vs. 74.4% (p<0.0001)., Conclusion: CEUS patterns of enhancement fell into clear cut specific diagnostic patterns in 83% of the FLLs discovered by US, and into clear cut benign versus malignant patterns in 90% of the cases. For this reason, we can strongly recommend CEUS as a first line imaging method to characterize FLLs found at US, at least in centers with a good experience in CEUS.

Background: Patients with HCV liver cirrhosis are a category difficult to treat. The aim of this study was to establish the sustained virological response (SVR) rates in HCV patients with liver cirrhosis treated with standard of care therapy (Pegylated Interferon and Ribavirin for 48 weeks in genotypes 1 and 4 and 24 weeks in genotypes 2 and 3)., Methods: Searching the PubMed, Medline, Lilacs, Scopus, Ovid and Medscape databases we identified all the articles published until February 2011 that included only HCV cirrhotic patients. These studies evaluated the SVR after standard of care treatment: Pegylated Interferon alpha 2a (doses ranging between 135-180 µg/week) or Pegylated Interferon alpha 2b (1 or 1.5 µg/kg/week) and Ribavirin (doses ranging between 800-1200 mg/day). We used the following key words: HCV, liver cirrhosis, sustained virological response (SVR)., Results: The overall SVR rate was 33.3% (95%CI-confidence interval=30.6-36.2%). SVR was significantly higher in patients with genotypes 2 and 3 (422 patients) as compared to those with genotypes 1 and 4 (692 patients): 55.4% (95%CI=50.7-60.1) versus 21.7% (95%CI=18.7-25), p < 0.0001., Conclusion: The overall SVR rate in cirrhotic patients treated with standard of care therapy is 33.3%, but lower in cases affected by genotypes 1 and 4 (21.6%) which makes them a priority regarding the development of more potent drugs for effective treatment.

Aim: Focal liver lesions (FLLs) are quite frequently discovered in daily practice at routine ultrasound. The aim of our study is to present a single centre experience concerning the use of contrast enhanced ultrasound (CEUS) in the characterization of FLL and to find when one can avoid using other expensive imaging modalities such as contrast enhanced CT or MRI., Method: We performed a prospective, single centre study during September 2009 - April 2010, and we evaluated 379 FLLs. A CEUS examination was considered conclusive if the FLL had a typical enhancement pattern according to the EFSUMB guidelines., Results: From the 379 cases with FLL, 198 (52.2%) were patients without known liver disease and 181 (47.8%) with known chronic liver disease (156 had cirrhosis, 25 chronic hepatitis); in 296/379 cases (78.1%) CEUS was conclusive. CEUS allowed the positive diagnosis of benign vs. malignant lesion in 261/294 (88.8%) de novo FLLs (CEUS performed for the first time), while in 33 (11.2%) cases it was inconclusive and could not differentiate between benign or malignant lesions. The CEUS results included 129 (49.4%) benign lesions and 132 (50.6%) malignant., Conclusion: CEUS was conclusive in approximately 80% of the FLLs and the benign or malignant character of a lesion was demonstrated in about 90% of cases. Thus, when faced with an uncharacteristic FLL on standard ultrasound examination, our local strategy is to perform CEUS as a first-line investigation, thus avoiding other expensive examinations.

Background and Aim: The current standard of care in chronic HCV genotype 1 hepatitis is the combination of pegylated interferon (PegIFN) with ribavirin for 48 weeks. The aim of our paper was to verify if there are significant differences regarding the sustained virologic response (SVR) in patients treated with PegIFN alfa-2a vs. those treated PegIFN alpha-2b, both in combination with ribavirin., Method: We performed a retrospective study on 507 patients with chronic viral C hepatitis treated with PegIFN alpha-2a 180 microg/kg/week or PegIFN alpha-2b 1.5 microg/kg/week plus ribavirin in the recommended doses according to weight, following the current treatment guidelines. We evaluated the SVR defined as PCR RNA-HCV undetectable 24 weeks after the end of treatment., Results: There were no differences regarding the baseline characteristics among the subgroups of patients treated with PegIFN alpha-2a or PegIFN alpha-2b concerning the pretreatment viral load (p=0.2445), the severity of fibrosis (p=0.2403), the mean age of the patients (p=0.9597) and the women/men ratio (p=0.2087). The SVR rates in patients treated with PegIFN alpha-2a were similar to those in patients treated with PegIFN alpha-2b: 208/338 (61.5%) vs. 94/169 (55.6%) (p=0.2129)., Conclusion: Sustained virologic response rates were similar in HCV genotype 1 patients treated with PegIFN alpha-2a and with Peg-IFN alpha-2b.

Unlabelled: The aim of this study was to evaluate if the sedation during colonoscopy is correctly performed in our patients, especially because it is usually performed by residents in anesthesiology., Methods: we retrospectively evaluated sedation in all the colonoscopies performed in our Endoscopy Department in 2007, by analyzing the sedation scheme that was used., Results: 974 colonoscopies were evaluated. The following sedation schemes were used in the majority of cases: midazolam+propofol+fentanyl-507 patients (52.1%) and diazepam+propofol+fentanyl-258 patients (26.5%). Propofol (in combination with one or more other agents) was used for sedation in 96.9% of cases. The mean doses of drugs were: propofol 125.2+/-67.7 mg, midazolam 2.29+/-0.84 mg (or diazepam 3.4+/-1.4 mg) and fentanyl 59+/-10 microg. The following complications were observed during sedation for colonoscopy: 6 patients (0.6%) developed hypoxemia, which was managed successfully with supplemental oxygen administration or flumazenil injection; 1 patient (0.1%) suffered a cardiac arrest that was successfully managed. There were no deaths or other complications., Conclusions: Propofol, combined with an opioid and a benzodiazepine, was used in approximately 97% of cases. The rate of significant oxygen desaturation was low (0.6%). No fatal complications occurred. The mean doses of propofol used were higher than those from published data, while the doses of midazolam and fentanyl were similar.

Aim: To assess the efficacy of Percutaneous Ethanol Injection Therapy (PEIT) for the treatment of hepatocarcinoma in a series of Romanian patients, and to compare it with previous studies., Material and Method: We retrospectively evaluated 88 patients with liver cirrhosis (LC) and hepatocellular carcinoma (HCC) treated by PEIT. Multiple sessions of PEIT were performed to treat a single nodule of 2-10 cm in diameter. The Child-Pugh classification was used for evaluating the severity of LC and the Okuda and Barcelona scores for HCC. The efficacy of PEIT was assessed by CT or MRI one month after the therapy. The patients' survival after PEIT was calculated starting from the first PEIT procedure until the moment of death or the end of study (2000-2005). We analyzed the main factors which influenced the survival of the treated patients., Results: The global survival was 38.07+/-3.97 months, longer in patients with Child-Pugh A class, than in Child-Pugh B class (Log Rank 0.04). Patients with HCC less than 3 cm in diameter survived significantly longer than patients with tumors larger than 5 cm (Log Rank 0.007). Also, survival was better in the Barcelona A stage than in the Barcelona B and C stages (Log Rank 0.002) and in patients with alpha-fetoprotein less than 200 ng/l (Log Rank 0.002)., Conclusion: The main factors which influenced the survival of patients treated by PEIT were: the size of the HCC, the Child-Pugh class, the Barcelona stage and the level of alpha-fetoprotein at the time of initiation of therapy.

Background: Patients with mild hepatitis C have a significant risk of disease progression at medium- and long-term follow-up and should be considered for antiviral therapy., Aim: To evaluate the rate of sustained viral response (SVR) and predictive factors of SVR in HCV genotype 1 patients with mild hepatitis C (fibrosis stage F0/F1) treated with combination antiviral therapy., Methods: 260 naïve patients were followed-up during 72 weeks in three referral hepatology centers between 2004 and 2006. Univariate and multivariate logistic regression analysis was conducted., Results: Early virological response was 88.1% and SVR was 74.2%. In the univariate analysis, SVR was associated with young age (p=0.001), very low (< or = 400,000 IU/mL) baseline viremia (p=0.03) and high aminotransferase levels (p=0.04) and was not associated with gender, body mass index, inflammatory activity, steatosis, ribavirin and peginterferon dose changes, premature cessation of therapy. Multivariate analysis identified the following independent predictors of SVR: age <50 years (p=0.0009), viral load < or = 400,000 IU/mL (p=0.03) and aminotransferase level >2 times normal value (p=0.02)., Conclusions: Genotype 1 HCV patients with mild hepatitis have a high rate of SVR, similar to genotype non-1. Young age, very low viremia and significant hepatocytolisis are independent predictors of SVR in patients with mild hepatitis.

Background and Aim: Chronic liver diseases are investigated through invasive (liver biopsy) or non-invasive (FibroScan or FibroTest) methods. Recently the non-invasive methods have become more and more popular. The aim of this paper is to evaluate the liver stiffness (LS) measured by transient elastography in individuals without known hepatic pathology ("normal" subjects) and to see if it is influenced by age., Material and Method: We examined a group of "normal" subjects by means of a FibroScan device (EchoSens, France). In each patient we performed 10 valid measurements and a median value was calculated by the device. The subjects were individuals without known hepatic pathology: healthy volunteers or patients from departments other than Gastroenterology in our hospital., Results: We evaluated 152 "normal" subjects (87 women and 65 men, mean age 45.3 + or - 17.6 years). The mean value of LS in "normal" subjects was 4.8 + or - 1.3 kPa, ranging from 2.3 to 8.8 kPa. The mean values of LS in age subgroups were: 18-29 years - 5 + or - 1.3 kPa; 30-39 years - 4.5 + or - 1.2kPa; 40-49 years - 5 = or - 1.1kPa; 50-59 years - 4.7 + or - 1.2kPa; 60-69 years - 5 + or - 1.3kPa; >70 years - 4.7 + or - 1.4kPa. There were no statistically significant differences between the mean values of LS in various age subgroups (p=0.5263)., Conclusions: The mean value of LS measured by transient elastography in "normal" subjects was lower than 5 kPa. Age does not modify the LS.

Unlabelled: The AIM of our study was to evaluate the results of transient elastography assessment of liver stiffness (LS) in various categories of patients., Material and Method: We performed transient elastography in 986 patients. We evaluated: the percentage of cases in which valid measurements could be obtained; the values of LS in 40 patients with no history of chronic liver disease ("normal" patients); 44 inactive HBsAg carriers; 173 patients with proven liver cirrhosis; and the correlation between liver biopsy results and LS in 93 patients with chronic HCV hepatitis., Results: We obtained valid measurements of LS in 94.6% of the 986 cases. Male gender, younger age and low BMI were positive predictive factors for obtaining valid measurements. The mean values of LS were: 5.2+/-1.3 kPa in "normal" patients, 5.8+/-2.6 kPa in inactive HBsAg carriers, 37.2+/-20.9 kPa in patients with liver cirrhosis. In patients with chronic HCV hepatitis, we found that the mean value of LS in those with METAVIR F>=2 was 8.5+/-4.2 kPa, higher than in those with F<2: 5.3+/-1.4 kPa (p=0.0017). In patients with F>=3, the mean value of LS was 11.1+/-4.3 kPa, significantly higher than in patients with F<3: 6.1+/-2.5 kPa (p<0.0001)., Conclusions: Liver stiffness, as a marker of fibrosis, can be evaluated by means of transient elastography in a great majority of patients. It is a useful method for the exclusion of significant liver fibrosis and for predicting liver cirrhosis. As compared to liver biopsy, transient elastography can discern significant fibrosis from no or mild fibrosis.

Unlabelled: The aim of our paper was to assess the quality of the liver fragment obtained by liver biopsy for staging chronic hepatitis., Material and Method: We analyzed retrospectively 250 echoassisted percutaneous liver biopsies (LB) concerning the length of the fragment and the mean number of portal spaces. We used Menghini modified needles 1.4 and 1.6 mm in diameter and the LBs were performed by the same senior hepatologist., Results: The indications for the LB were represented by: chronic hepatitis C in 69 % (172 cases), chronic hepatitis B in 17 % (43 cases), chronic hepatocytolysis in 10% (25 cases), primary billiary cirrhosis in 1.5% (4 cases), chronic B+C hepatitis in 3 cases, autoimmune chronic hepatitis in 2 cases and Wilson's disease in 1 case. From the 250 LBs, in 87% of cases (217 patients) the liver sample had 8-10 portal spaces ("good fragment") and in 69% of cases (173 patients) the liver sample had at least 11 portal spaces ("very good fragment"). In 13% of the cases (33 liver biopsies) the histological sample was suboptimal, less than 8 portal spaces. In 1.6% of the cases (4 biopsies), the liver sample was not adequate for the diagnosis (less than 4 portal spaces), so that we had to perform a second biopsy (in another session). In 88% cases (219 subjects), the length of the liver fragment obtained was longer than 2 cm and only in 12% of cases (31 patients) the fragment was smaller than 2 cm. The median length of the fragment obtained by LB in our department was 30.8 +/- 8.7 mm, and the mean number of portal spaces was 14.9 +/- 7.09., Conclusion: In experienced hands, percutaneous liver biopsy can obtain "good" histological material in the vast majority of cases.

Background and Aim: Increasing evidence to date highlights that individualized treatment regimens with pegylated interferon (PegIFN) and ribavirin represent a better approach for patients nowadays showing negative predictive factors for sustained virological response. The aims of this study were to assess the rate of early (EVR) and sustained virological response (SVR), tolerability and baseline predictive factors associated with EVR and SVR in patients with chronic hepatitis C treated with individualized weight-based dosing regimen for both PegIFN alpha-2b and ribavirin., Methods: The observational analysis included 234 consecutive patients with chronic hepatitis C genotype 1 treated with PegIFN alpha-2b and ribavirin on an out-patient basis between January 2003-March 2006., Results: The mean age of the study group was 49.5 years, and 35% were male patients; the group was slightly overweight (mean BMI=26.5 kg/sq.m). EVR was achieved in 84.6% (198/234 patients). The end-of-treatment and sustained biochemical responses were 76.3% and 66.1%, respectively. At the end of follow-up, an overall intent-to-treat SVR was achieved by 71 of 127 patients (in 55.9%). Lower baseline (< 1,000 000 IU/mL) HCV viral load was the only predictive factor associated with EVR (p=0.04); absent or mild fibrosis (F0-1) and a low histological activity (HAI < 8) were independently associated with SVR. Side effects resulted in PegIFN and ribavirin dose reductions in 9.4% and, respectively, 18.1%, but definitive discontinuation of therapy was necessary only in 8.7% of patients., Conclusion: PegIFN alpha-2b and ribavirin can be safe and successful when using a weight-based dosing regimen, leading to high response rates even in overweight patients.

Aim of the Study: To get data on the current practice of Gastroenterology in Romania., Material and Method: We obtained data regarding the number of gastroenterologists in Romania from the Centre of Statistics of the Ministry of Health and Family (CSMHF) and the National Centre of Training for Medical Personnel (NCTMP). We sent a questionnaire to all the Centers of Gastroenterology in Romania inquiring about the number of gastroenterologists and fellows, and about the gastroenterological procedures performed. We compared these data to that of 17 European countries., Results: The total number of gastroenterologists in Romania on January 1, 2005 was 175 (123 specialists and 52 senior consultants), and the total number of fellows in training was 133. Romania has a small number of gastroenterologists - 0.83/100,000 inhabitants, expected to reach approximately 1.4/100,000 inhabitants in 2010. Regarding the abilities in gastroenterological procedures, we obtained data from 98 gastroenterologists. They have good performances in diagnostic gastroscopy (97%), colonoscopy (81.6%), abdominal ultrasound (79.6%), but a poor performance in ERCP (10.2%). Less than half of the gastroenterologists (46.9%) perform proctologic procedures. Data regarding the training program of the Romanian fellows are disappointing: only 69.1% of them perform gastroscopy, 33.8% colonoscopy, 2.9% ERCP, 64.7% abdominal ultrasound and 14.7% proctology., Conclusions: The number of gastroenterologists in Romania seems low compared with most European countries. They do not acquire a uniform satisfactory mastering of gastroenterological procedures during their training program. This should be improved according to the guidelines of the European Diploma of Gastroenterology.

Background: Pegylated interferons (Peg-IFNs) represent, in association with Ribavirin, the first line of treatment in chronic C viral hepatitis. The AIM of our paper was to compare the efficacy of Peg-IFN alpha 2a (Pegasys) and Peg-IFN alpha 2b (PegIntron) in a group of patients from the Department of Gastroenterology in Timisoara., Material and Method: 116 patients with chronic C viral hepatitis were treated. The patients were randomized in chronological order (1:1), so that 58 patients were treated with Peg-IFN alpha 2a 180 microg/kg/week + Ribavirin (group 1) and 58 were treated with Peg-IFN alpha 2b 1.5 microg/kg/week + Ribavirin (group 2). Ribavirin was administered in the recommended doses, according to weight. The mean age was: group 1 -- 49.3 years, group 2 -- 50.9 years (p=0.37). Group 1 consisted of 37 women and 21 men and group 2 of 44 women 14 men (p=0.22). In group 1, 48 patients were naïve (N1), 7 were relapsers after previous treatment (RL1) and 3 non-responders to previous treatment (NR1). In group 2, 33 patients were naive (N2), 18 relapsers (RL2) and 7 non-responders (NR2). After 12 weeks of treatment we evaluated the early virological response (EVR), defined as a drop in the viral load with 2 logs compared to the baseline viremia., Results: The following EVR rates were found: in group 1 (Pegasys) - 82.2% (48/58); in group 2 (PegIntron) -- 67.2% (39/58) (p=0.08). There were also no significant statistical differences between the response rates in the subgroups: naïve patients [89.6% vs. 75.2%, p = 0.61], relapsers [57.1% vs. 66.6%, p = 0.67] and non responders [33.3% vs. 28.6%, p = 1]., Conclusion: Our head to head comparative study showed that there are no statistically significant differences in the EVR between the patients treated with Peg-IFN alpha 2a and Peg-IFN alpha 2b.