Endoscopist-Level and Procedure-Level Factors Associated With Increased Adenoma Detection With the Use of a Computer-Aided Detection Device.

INTRODUCTION: To investigate the impact of procedure-related and endoscopist-related factors on the effectiveness of a computer-aided detection (CADe) device in adenomas per colonoscopy (APC) detection. METHODS: The SKOUT clinical trial was conducted at 5 US sites. We present prespecified analyses of procedure-related and endoscopist-related factors, and association with APC across treatment and control cohorts. RESULTS: There were numeric increases in APC between SKOUT vs standard colonoscopy in community-based endoscopists, withdrawal time of ≥8 minutes, for endoscopists with >20 years of experience, and endoscopists with baseline adenoma detection rate <45%. DISCUSSION: The application of CADe devices in clinical practice should be carefully evaluated. Larger studies should explore differences in endoscopist-related factors for CADe.

Inhibition of the Inflammasome Signaling Cascade Reduces Alcohol Consumption in Female But Not Male Mice.

BACKGROUND: Alcohol use disorder is a significant societal and medical burden that is associated with both organ pathology and addiction. Excessive alcohol use results in neuroinflammation characterized by activation of the inflammasome, a multiprotein complex, and IL-1ß increase in the brain. Recent studies suggest that inflammation could contribute to alcohol addiction. Here, we targeted components of the NOD-like receptor family pyrin domain containing 3 (NLRP3) inflammasome cascade, which senses and responds to immunologic stimuli, to determine whether NLRP3 inhibition modulates alcohol consumption. METHODS: C57BL/6J male and female mice were provided a 2-bottle choice of alcohol at increasing concentrations (3, 6, 9, and 12%, 4 days each) or water, and some were treated with daily injections of an NLRP3 inhibitor (MCC950), a caspase-1 inhibitor (VX765), IL-1 receptor antagonist (IL-1ra; anakinra), or vehicle injection. RESULTS: Treatment with VX765, MCC950, and IL-1ra significantly reduced alcohol consumption and preference in female mice (p < 0.05). Treatment with MCC950 and IL-1ra reduced alcohol consumption, while IL-1ra reduced alcohol preference in male mice (p < 0.05). VX765 did not affect alcohol consumption or preference in male mice. CONCLUSIONS: These findings highlight gender differences in alcohol preference and demonstrate that inhibition of different steps in inflammasome signaling can reduce alcohol consumption in females. Inhibition of NLRP3 inflammasome activation and the inflammasome-IL-1ß cascade opens novel insights into the development of new therapies to address alcohol use disorder in an era of targeted and precision medicine.

Evaluation of Early Atherosclerosis Markers in Patients with Inflammatory Bowel Disease.

BACKGROUND The aim of this study was to investigate relationships between early atherosclerosis and inflammatory bowel disease (IBD) using laboratory, functional, and morphological markers of atherosclerosis. MATERIAL AND METHODS In the present prospective single-center study, 96 patients with IBD (58 patients with ulcerative colitis and 36 patients with Crohn's disease) and 65 healthy control subjects were included. The demographic data of each patient and control subject were recorded. The patients with IBD and healthy controls were compared in terms of the carotid intima-media thickness (CIMT), the values of flow-mediated dilatation (FMD) and nitroglycerine-mediated dilatation (NMD), and the levels of von Willebrand factor antigen (VWF-Ag), D-dimer, and lipoprotein (a). RESULTS There were no significant differences between the IBD patients and controls in terms of age, sex, BMI, systolic and diastolic BPs, serum levels of total cholesterol, low-density lipoprotein, or triglycerides. IBD patients had significantly higher levels of VWF-Ag (156.6±58.9 vs. 104.2±43.3, P<0.001) and D-dimer (337.2±710.8 vs. 175.9±110.9, P<0.001) as compared to the controls. No significant differences were determined between the 2 groups in terms of FMD and NMD values. Although statistically not significant, the CIMT values were higher in the IBD patients than in the controls (0.517±0.141 mm vs. 0.467±0.099 mm, P=0.073). In the correlation analysis, the CIMT was found to be correlated negatively with FMD and positively with high sensitive C-reactive protein, VWF-Ag, and D-dimer. CONCLUSIONS These findings suggest that VWF-Ag and D-dimer can be beneficial early atherosclerosis markers in IBD patients.

Significance of serum and ascitic fluid C-reactive protein in differential diagnosis of benign and malignant ascites.

BACKGROUND: The values of C-reactive protein (CRP) can prove useful in determining disease progress. Because of synthesis by the liver, production of CRP in response to inflammation may be attenuated in patients with liver dysfunction. This may result in differences interpreting CRP levels in patient with portal and non-portal hypertension ascites. AIM: The aim of the present study is to assess discriminant value of serum and ascitic fluid CRP, which is easily accessible and inexpensive laboratory marker of inflammation, concentrations for diagnosis of underlying cause of ascites. METHODS: This prospective study was conducted at Diskapi Yildirim Beyazit Educational and Research Hospital Department of Gastroenterology. Patients with ascites were further divided into two subgroups based on underlying cause of ascites: Group 1, patient with ascites due to portal hypertensive etiology (high-gradient ascites); Group 2, patient with ascites due to non-portal hypertensive etiology (low-gradient ascites). RESULTS: A total of 91 patients fulfilling the criteria for a diagnosis of ascites were enrolled in the study. Of these patients, 50 had proven (Group 1) ascites due to portal hypertensive etiology (high-gradient ascites) and 41 had clinical (Group 2) ascites due to non-portal hypertensive etiology (low-gradient ascites). Mean baseline serum and ascites levels of CRP were significantly higher in Group 2 compared to those in Group 1 (p = 0.021, p = <0.0001, respectively). CONCLUSIONS: Increased levels of serum and ascitic fluid CRP were associated with malignant ascites.

Mean platelet volume could be possible biomarker in early diagnosis and monitoring of gastric cancer.

Gastric cancer is the fourth most frequent cancer and the second cause of cancer-related deaths worldwide. The early diagnosis of gastric cancer is fundamental in decreasing the mortality rates. It has been shown that MPV level is a sign of inflammation in hepatocellular carcinoma and pancreatic adenocarcinoma. The aim of this study is to examine whether MPV would be a useful inflammatory marker for differentiating gastric cancer patients from healthy controls. Thirty-one gastric cancer patients and 31 age-sexes matched healthy subjects included into the study. Patients with hypertension, hematological and renal disease, heart failure, chronic infection, hepatic disorder and other cancer were excluded from the study. MPV level was significantly higher in pre-operative gastric cancer patients compared to healthy subjects (8.31 fL vs. 7.85; p: 0.007). ROC analysis suggested 8.25 fL as the cut-off value for MPV (AUC: 0.717, sensitivity: 61%, specificity: 81%). Surgical tumor resection resulted in a significant decrease in MPV level (8.31 fL vs. 7.55 fL; p: 0.001). No significant difference was found in MPV level between the post-operative group and control subjects. We did not find statistically significant difference between MPV and TNM stages. In conclusion, changes in MPV values may be used as an easily available biomarker for monitoring the healthy patients for GC risk and may prompt physicians to make an early diagnosis of GC.

M30 does not predict the severity of hepatosteatosis, whereas adiponectin level declined with increase of ALT and the severity of hepatic steatosis.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is an emerging problem all over the world. Because NAFLD and polycystic ovary syndrome (PCOS) are both closely related with insulin resistance, it would be necessary to determine the rate of presence of NAFLD in PCOS patients. So, this study aimed to investigate the utility of M30 in PCOS patients for the diagnosis of hepatic injury. METHODS: Eighty patients with PCOS were included in the study. Ultrasonographic examination for the presence of hepatic steatosis, M30 serum level for determining the severity of ongoing apoptotic cell death in liver, and BARD index for defining the hepatic injury were performed during the study. 25-OH vitamin D and adiponectin level in sera were studied using ELISA (Enzyme-Linked ImmunoSorbent Assay). RESULTS: M30 and vitamin D levels did not change significantly with the severity of hepatic steatosis. On the other hand, M30 levels showed a positive correlation with ALT and AST levels, and M30 level suddenly increased with the presence of hepatic steatosis from 159.7 to 170 U/l, however stabilized with the increasing severity of hepatic setatosis. Adiponectin levels decreased with the increasing severity of hepatic steatosis and significantly varied between ALT greater than 40 U/l and less than 40 U/l. CONCLUSIONS: M30 level in serum increased with the appearance of hepatic steatosis and had a positive correlation with a noninvasive hepatic injury test, BARD (BMI, aspartate aminotransferase [AST]/alanine aminotransferase [ALT] ratio [AAR], diabetes mellitus [DM]) index. Adiponectin level decreased with the increasing ALT level and severity of hepatic steatosis.

Long-term efficacy and safety of lamivudine, entecavir, and tenofovir for treatment of hepatitis B virus-related cirrhosis.

BACKGROUND & AIMS: Data are limited on the efficacy and safety of tenofovir and entecavir when given for more than 1 year to patients with hepatitis B-related cirrhosis. We investigated the long-term safety and efficacy of these antiviral drugs in patients with chronic hepatitis B virus (HBV) infection, with compensated or decompensated cirrhosis, and compared results with those from lamivudine. METHODS: We performed a retrospective analysis of data from 227 adult patients with chronic HBV infection who were diagnosed with cirrhosis, beginning in 2005, at 18 centers throughout Turkey. There were 104 patients who had decompensated cirrhosis, and 197 patients were treatment naive before. Seventy-two patients received tenofovir (followed up for 21.4 ± 9.7 mo), 77 patients received entecavir (followed up for 24.0 ± 13.3 mo), and 74 patients received lamivudine (followed up for 36.5 ± 24.1 mo). We collected data on patient demographics and baseline characteristics. Laboratory test results, clinical outcomes, and drug-related adverse events were compared among groups. RESULTS: Levels of HBV DNA less than 400 copies/mL were achieved in 91.5%, 92.5%, and 77% of patients receiving tenofovir, entecavir, or lamivudine, respectively. Levels of alanine aminotransferase normalized in 86.8%, 92.1%, and 71.8% of patients who received tenofovir, entecavir, and lamivudine, respectively. Child-Turcotte-Pugh scores increased among 8.5% of patients who received tenofovir, 15.6% who received entecavir, and 27.4% who received lamivudine. Frequencies of complications from cirrhosis, including hepatic encephalopathy, variceal bleeding, hepatocellular carcinoma, and mortality, were similar among groups. Lamivudine had to be changed to another drug for 32.4% of the patients. CONCLUSIONS: Tenofovir and entecavir are effective and safe for long-term use in patients with compensated or decompensated cirrhosis from HBV infection.

Lamivudine treatment failure risks in chronic hepatitis B patients with low viral load.

AIM: To analyze the risk factors of lamivudine treatment failure (LTF) for the long-term use in patients with low viral load (LVL). MATERIAL AND METHODS: In this multicenter study, 548 antiviral naïve noncirrhotic adult patients with LVL (for HBeAg+ patients HBV DNA <10 9 copies/ml and for HBeAg­patients HBV DNA <10 7 copies/ml) were enrolled. As a control group, 46 lamivudine-initiated patients with high viral load (HVL) were included. Primary outcome was switching to or adding on another antiviral drug as a consequence of primary nonresponse, partial response, viral breakthrough or adverse events. Secondary outcomes included LTF rates at 1, 2, 3, 4 and 5 years and LTF-related viral and host factors. RESULTS: Among 594 patients, 294 had to change lamivudine at the follow-up. Primary nonresponse, partial response, viral breakthrough or adverse events frequencies were 6.8, 1.6, 64.5 and 0.1%, respectively. Five-year LTF rates were 61.3 and 84.2% in patients with LVL and HVL, respectively. Among patients with LVL, patients with <100,000 copies/ml and ≥ 100,000 copies/ ml had 54.8 and 67.3% LTF rates at the end of the 5th year, respectively. Logistic regression analysis of risk factors showed HBeAg+, hepatic activity index, HBV DNA, virological response at 6 months and duration of follow-up were independent predictors for LTF (p values were 0.001, 0.008, 0.003, 0.020 and 0.003, respectively). CONCLUSION: Similar to patients with HVL, first-line lamivudine therapy is not efficient for long-term use in patients with LVL. LTF risk is so high even in the absence of worse predictive factors.

Adding pineapple juice to a polyethylene glycol-based bowel cleansing regime improved the quality of colon cleaning.

BACKGROUND/AIMS: An unsuccessful colonoscopy procedure is often related to inadequate bowel cleansing. It is difficult for patients to finish the whole 4 liters of polyethylene glycol-electrolyte lavage (PEG-EL) because of its salty taste and the large quantity. Pineapple juice has been shown to be an effective agent in the dissolution of undigested food in the stomach. This study assessed the effectiveness of both 2 and 4 liters of PEG-EL in precolonoscopic bowel cleansing and the quality of colonoscopic cleaning by adding 1 liter of pineapple juice to a reduced-volume PEG-based regime. METHODS: The patients were chosen from those undergoing a colonoscopic procedure. A total of 126 patients were randomized into 3 groups receiving 3 different PEG-EL (Golytely®) regimes, i.e. 4 liters of PEG-EL (group 1, n = 44), 2 liters of PEG-EL (group 2, n = 39) or 2 liters of PEG-EL with 1 liter of pineapple juice (Dimes® 100%; group 3, n = 43). RESULTS: Both the 4- and 2-liter PEG-EL regimes resulted in similar bowel cleansing scores in all parts of the colonic segments. However, adding 1 liter of pineapple juice to the reduced-volume PEG-EL regime improved the quality of the cleansing on the right side of the colon and in the transverse colon. Adequate bowel cleansing was achieved in 68.1% of the patients in group 1, 63.9% in group 2 and 80% in group 3 (the lowest score in one of the segments). On the other hand, the tolerability of the regimes was similar in all 3 groups (p = 0.509). CONCLUSIONS: Reduced PEG-EL (2 rather than 4 liters) may be sufficient for precolonoscopic bowel cleansing in the Turkish population. Administration of pineapple juice in the reduced-dose preparation regime may improve the quality of the bowel cleaning.

Clinical trial: transcutaneous interferential electrical stimulation in individuals with irritable bowel syndrome - a prospective double-blind randomized study.

BACKGROUND: The exact etiology of irritable bowel syndrome (IBS) remains unclear. Curative treatment is not available and current treatment modalities are mainly directed against the predominant symptoms. There are a few studies reporting the beneficial effects of transcutaneous electrical stimulation in patients with chronic constipation, gastroparesis, and functional dyspepsia. AIM: To investigate whether transcutaneous electrical stimulation is an effective procedure in IBS patients. METHODS: IBS patients were randomly placed in vacuum interferential current (IFC) and placebo groups. Both treatments consisted of 12 sessions administered over 4 weeks. Symptoms due to IBS were documented via questionnaires, including the IBS Global Assessment of Improvement Scale, numeric rating scales, visual analogue scale, and IBS Quality of Life Scale at the beginning of, end of, and 1 month after the treatment. RESULTS: Patients in the therapy (29 cases) and placebo (29 cases) groups were homogeneous with respect to demographic data and gastrointestinal system symptoms. When compared to the beginning scores, severity of abdominal discomfort, bloating, and abdominal distension and rumbling improved significantly in either interference or placebo groups at both the end of treatment and 1 month after treatment. In the IFC group, severity of symptoms continued to decrease significantly at 1 month after treatment when compared to scores at just the end of treatment, whereas in the placebo group severity of these symptoms did not change significantly on numeric severity scales. Also, the visual analogue scale of the first month after treatment continued to decrease significantly when compared to the level at the end of treatment in the IFC group. Total quality score increased significantly in the IFC group. CONCLUSIONS: Vacuum IFC therapy can significantly improve symptoms and quality of life in patients with IBS. It may represent a novel treatment modality for drug-refractory IBS patients.

Is there an association between the measurement of qualitative HBsAg and virologic response in chronic HBV infection?

BACKGROUND: In the follow up of chronic hepatitis B infection (HBV), a significant correlation between quantitative HBsAg titer measurement and HBV DNA level, and moreover with intrahepatic covalently closed circular DNA was already shown. However, besides their impact on long-term follow up, they are really expensive methods, and not available widespread. We aimed to investigate the utility of qualitative measurement of HBsAg titer in prediction of virologic response at the end of the first year of anti-viral treatment in chronic HBV infection. MATERIAL AND METHODS: A total of 70 patients receiving anti-viral therapies for chronic HBV infection were included into the study. The patients were evaluated according to Hbe Ag status and response to treatment. The determinations used in the study (biochemical, virologic responses, primary non-response) were accepted as it was described in AASLD. RESULTS: Qualitative HBsAg titer increased significantly in both HBeAg positive and negative patients (p values 0.002 and < 0.000). Increasing of HBsAg titer in first three months is more dramatic in responder group, however the difference was disappeared at the sixth and twelve moths on follow up. Similarly, a fast increasing in anti-HBe titer in HBeAg negative chronic HBV patients was related with higher response at the end of first year therapy. However, the changings at the 12th month of anti-viral treatment were similar in both responder and non-responder groups. CONCLUSION: In conclusion, the fast increase in qualitative measurement of HBsAg titer seemed to be a predictor of higher anti-viral medication success in chronic HBV patients. However, this meaningful increasing was disappeared on the follow up, particularly after the six months examination.

Amantadine in non-responder patients with chronic hepatitis C: a randomized prospective study.

BACKGROUND/AIMS: The management of non-responders (NR) represents the most challenging of all aspects in the care of patients with chronic hepatitis C (CHC). The purpose of the study was to evaluate the efficacy of amantadine. METHODOLOGY: Fourty- three patients with CHC who did not respond to prior combination therapy [IFNα-2a plus ribavirin for 48 weeks] were enrolled into the study. The first group (n=21) was administered pegylated IFN-α2a (180 mcg/week) plus ribavirin (1000-1200 mg/day) and amantadine (200mg/day) for 48 weeks. After discontinuation of therapy, patients were followed-up for an additional 24 weeks. The second group (n=22) received only amantadine (200mg/day) daily for at least 24 weeks (mean 96 weeks) and starting from the 24th week, HCV-RNA was assessed every 12 weeks without discontinuation of therapy. RESULTS: Mean ALT levels before treatment were 115.30 units in the first and 107.73 units in the second group whereas they were 48.38 and 54.76 units, respectively, after the treatment (p<0.001 for both). Sustained viral response rate for the first group at the 72nd week was 52.3% (11/21) (p<0.025). Among patients receiving amantadine, 1 patient became HCV-RNA negative at the 24th and 3 patients at the 48th week (response rate at week 48 was 18.2%), 1 patient at the second year and 1 patient at the fourth year of the treatment (p=0.031). CONCLUSIONS: Amantadine has a potential anti-inflammatory activity that can be a safe alternative for NR-CHC subjects to combination therapy.

Inflammation and Gastric Cancer.

Gastric cancer remains a major killer globally, although its incidence has declined over the past century. It is the fifth most common cancer and the third most common reason for cancer-related deaths worldwide. Gastric cancer is the outcome of a complex interaction between environmental, host genetic, and microbial factors. There is significant evidence supporting the association between chronic inflammation and the onset of cancer. This association is particularly robust for gastrointestinal cancers in which microbial pathogens are responsible for the chronic inflammation that can be a triggering factor for the onset of those cancers. Helicobacter pylori is the most prominent example since it is the most widespread infection, affecting nearly half of the world's population. It is well-known to be responsible for inducing chronic gastric inflammation progressing to atrophy, metaplasia, dysplasia, and eventually, gastric cancer. This review provides an overview of the association of the factors playing a role in chronic inflammation; the bacterial characteristics which are responsible for the colonization, persistence in the stomach, and triggering of inflammation; the microbiome involved in the chronic inflammation process; and the host factors that have a role in determining whether gastritis progresses to gastric cancer. Understanding these interconnections may improve our ability to prevent gastric cancer development and enhance our understanding of existing cases.

Pancreatic Cystic Neoplasms.

Early detection of high-risk pancreatic cystic lesions enables potentially curative surgical resection, and early detection of lesions without worrisome features may lead to appropriate surveillance. Regrettably, differentiating premalignant and malignant cysts from nonmalignant ones remains challenging. However, emerging additional diagnostic tools, including the needle biopsy with microforceps and needle-based confocal laser endomicroscopy, are of exciting potential along with cyst fluid analysis".

Mean platelet volume as a fibrosis marker in patients with chronic hepatitis B.

INTRODUCTION: Many noninvasive tests have been studied for the diagnosis and determining the liver fibrosis score (LFS). In this study, we aimed to research the correlation of mean platelet volume (MPV) and stage of liver fibrosis in patients with chronic hepatitis B (CHB). PATIENTS AND METHODS: Fifty-nine patients with CHB were enrolled retrospectively into the study. Age-sex matched 25 healthy subjects were used as control group. The following data were obtained from computerized patient registry database: HBV-DNA level, hepatitis B e-antigen seropositivity, liver enzymes and function tests, white blood cell count, platelet count, hemoglobin, histological activity index, LFS, and MPV. Patients were divided into two groups: patients without significant fibrosis (F0, F1, or F2) (Group 1) and patients with advanced fibrosis (F3, F4) (Group 2). RESULTS: A statistically significant increase in MPV was seen in patients with CHB compared with healthy controls (8.49±0.84 fl vs.7.65±0.42 fl, P<0.001). Receiver operating characteristic curve analysis suggested that the optimum MPV level cut-off points for CHB was 8.0 fl, with sensitivity, specificity, PPV, and NPV of 68, 76, 86, and 50%, respectively. MPV levels were significantly higher in Group 2 (8.91±0.94 fl, P: 0.009) compared with Group 1 (8.32±0.74 fl). ROC curve analysis suggested that the optimum MPV level cut-off points for Group 2 was 8.45 fl, with sensitivity, specificity, positive and negative predictive value of 77, 59, 45, and 85%, respectively. Multivariable logistic regression model, which consisted of HAI, ALT, HBV-DNA, platelet count, and MPV, was performed. We showed that MPV was independently associated with advanced fibrosis (P: 0.031). CONCLUSION: We suggest that MPV might help in the assessment of fibrosis in CHB. It should not be considered a stand-alone test for this use owing to nonspecificity with other diseases.

Gamma-glutamyltranspeptidase in predicting sustained virological response in individuals with chronic hepatitis C.

BACKGROUND/AIMS: Serum gamma-glutamyltranspeptidase (GGT) levels often increase in chronic hepatitis C. We aimed to identify whether GGT levels can predict sustained virological response (SVR) in patients with chronic hepatitis C and to investigate other potential predictive factors associated with SVR in patients with chronic hepatitis C treated with pegylated interferon and ribavirin at a single center. METHODOLOGY: We evaluated 112 consecutive patients with histologically proven chronic hepatitis C who were treated with pegylated interferon and ribavirin. As potential predictors of SVR to combination therapy, we analyzed age, gender, body mass index, pretreatment GGT and alanine transaminase levels, diabetes mellitus, receiving of anti-viral therapy before beginning combination therapy, viral load, and liver histology by use of a multivariate logistic regression model. RESULTS: SVR to combination therapy was seen in 57.2% of the patients. Variables associated with lower rates of sustained response were liver steatosis (p=0.026), diabetes mellitus (p=0.027), receiving anti-viral therapy before beginning combination therapy (p=0.016), higher GGT levels before therapy (>50IU/mL, p<0.001), and advanced fibrosis stage (p=0.017). On logistic regression analysis, the only independent predictor of SVR was the GGT level before therapy (p=0.003). CONCLUSIONS: Low serum levels of GGT before treatment are associated with higher rates of SVR in patients with chronic hepatitis C treated with pegylated interferon and ribavirin.

Pegylated interferon alfa-2B for chronic delta hepatitis: 12 versus 24 months.

BACKGROUND/AIMS: The aim of this study was to evaluate the efficacy of pegylated interferon (PEG-IFN) alfa-2b for short (one year) and long (two years) terms of treatment for chronic hepatitis D. METHODOLOGY: Eighteen patients with chronic hepatitis D were administered PEG-IFN alfa-2b 1.5µg/kg twice weekly for 1 month, after which they were randomly assigned (2:1) to receive PEG-IFN alfa-2b 1.5µg/kg/wk for an additional 23 months (n=11; group 1) or 11 months (n=7; group 2). All patients were followed-up for 6 months after completing therapy. RESULTS: In group 1, there was no significant difference between HDV-RNA and ALT levels at follow-up compared with baseline (p=0.219 and p=0.624, respectively). However, in group 2, HDVRNA levels, but not ALT levels, were significantly lower at the end of follow-up (EOF) than at baseline (p=0.016 and p=0.237, respectively). Three patients, all in group 2, had undetectable hepatitis B surface antigen (HBsAg) at the end of followup (EOF). However, there was no patient who had undetectable HBsAg in group I (p=0.043). There were statistical differences for all 18 patients in terms of baseline levels of HDV-RNA compared to end of treatment (EOT) (p=0.021) and EOF (p=0.003). CONCLUSIONS: Extending therapy from 12 to 24 months conferred no additional advantage in terms of HDV-RNA suppression and ALT normalisation.