Update on Imaging-based Noninvasive Methods for Assessing Hepatic Steatosis in Nonalcoholic Fatty Liver Disease.

Nonalcoholic fatty liver disease (NAFLD), among the most common chronic liver diseases worldwide, affects approximately 25% of the global population. Its incidence is increasing owing to various risk factors, including genetic variation, metabolic health, dietary habits, and microbiota. Hepatic steatosis is a critical histological characteristic of NAFLD. Evaluating liver fat content is vital for identifying and following up with patients at risk of developing NAFLD. NAFLD includes simple liver steatosis and more severe forms such as inflammation, nonalcoholic steatohepatitis, fibrosis, and cirrhosis. The early assessment of fatty liver is important for reversing liver disease progression. Metabolic (dysfunction)-associated fatty liver disease recently replaced NAFLD as the most common hepatic disease worldwide. This article reviews the current state of noninvasive imaging, especially ultrasound, for liver fat quantification.

Impact of the COVID-19 pandemic on inflammatory bowel disease care in Taiwan: A multicenter study.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic had a great impact on healthcare system and patients. This study aimed to evaluate the effect of the COVID-19 pandemic on the perceptions of patients with inflammatory bowel disease (IBD). METHODS: This prospective multicenter study was conducted between July 2021 and December 2021. Patients with IBD answered a structured questionnaire, and their degree of anxiety was assessed using a visual analogue scale (VAS) before and after reading educational materials. RESULTS: A total of 225 (47.67%) patients with Crohn's disease, 244 (51.69%) with ulcerative colitis and 3 (0.64%) with indeterminate colitis were enrolled. Common concerns were adverse events from vaccination (20.34%), and higher risks of developing severe COVID-19 (19.28%) and COVID-19 infection (16.31%) than the general population. Medications deemed by the patients to increase the risk of COVID-19 were immunomodulators (16.10%), anti-tumor necrosis factor-α antagonists (9.96%), and corticosteroids (9.32%). Thirty-five (7.42%) patients self-discontinued IBD medication, of whom 12 (34.28%) had worse symptoms. Older age (>50 years) (OR 1.10, 95% CI 1.01-1.19, p = 0.03), IBD-related complications (OR 1.16, 95% CI 1.04-1.28, p = 0.01), education status below senior high school (OR 1.22, 95% CI 1.08-1.37, p = 0.001), and residing in north-central Taiwan (OR 1.21, 95% CI 1.10-1.34, p < 0.001) were associated with more anxiety. None of the enrolled patients contracted COVID-19. The anxiety VAS score (mean ± SD) improved after reading the educational materials (3.84 ± 2.33 vs. 2.81 ± 1.96, p < 0.001). CONCLUSION: The medical behavior of IBD patients was influenced by the COVID-19 pandemic, and their anxiety could be mitigated after education.

Intestinal Ultrasound in Inflammatory Bowel Disease: A Novel and Increasingly Important Tool.

New and efficacious medical therapies have become available that have greatly enhanced clinicians' ability to manage inflammatory bowel diseases (IBDs). IBD activity should be assessed regularly in scheduled examinations as the part of a treat-to-target strategy for IBD care. The gold-standard approach to investigating IBD is colonoscopy, but this is an invasive procedure. Intestinal ultrasound (IUS) has played a crucial role in recent years regarding the assessment of IBD activity because it is noninvasive, safe, reproducible, and inexpensive. IUS findings could inform changes in therapeutic interventions for IBDs; this would necessitate fewer endoscopies and enable faster decision-making processes. Furthermore, patients are accepting and tolerant of IUS examinations. This review outlines the current evidence and gives indication regarding the use of IUS in the management of IBDs.

Ledipasvir/Sofosbuvir for Patients Coinfected With Chronic Hepatitis C and Hepatitis B in Taiwan: Follow-up at 108 Weeks Posttreatment.

BACKGROUND: For patients coinfected with hepatitis C virus (HCV) and hepatitis B virus (HBV), HCV treatment with direct-acting antivirals can lead to HBV reactivation. We evaluated HBV reactivation during ledipasvir/sofosbuvir treatment and 108-week follow-up. METHODS: In Taiwan, 111 patients with HCV genotype 1 or 2 and HBV received ledipasvir/sofosbuvir (90mg/400mg) once daily for 12 weeks. HBV virologic reactivation was defined as postbaseline increase in HBV DNA from either less than the lower limit of quantification (LLOQ, 20 IU/mL) to equal to or more than LLOQ or equal to or more than LLOQ to >1 log10 IU/mL. HBV clinical reactivation was HBV virologic reactivation with alanine aminotransferase (ALT) >2× upper limit of normal. Factors associated with development of HBV virologic or clinical reactivation were evaluated with logistic regression analysis. RESULTS: All patients (100%, 111/111) maintained HCV suppression through 108 weeks after treatment. HBV virologic reactivation occurred in 73% of patients (81/111). Clinical reactivation occurred in 9% (10/111). The majority of HBV virologic reactivations (86%, 70/81) occurred by follow-up week 12, whereas clinical reactivation was generally more delayed. Eight (7%, 8/111) initiated HBV therapy. In regression analyses, baseline HBV DNA and hepatitis B surface antigen (HBsAg) levels were associated with HBV virologic reactivation and baseline ALT and HBV DNA, and HBsAg levels were associated with HBV clinical reactivation. CONCLUSION: Among HCV/HBV coinfected patients treated with direct-acting antivirals for HCV, HBV virologic reactivation occurred in a majority of patients during treatment and follow-up. In most patients, HBV virologic reactivation was asymptomatic; only a small proportion initiated HBV treatment. Notably, clinical reactivation may still occur >3 months after end of therapy. CLINICAL TRIALS REGISTRATION: NCT02613871.

Endoscopic management of strictures in patients with Crohn's disease - A multi-center experience in Taiwan.

BACKGROUND/PURPOSE: Inflammatory bowel disease (IBD) is a chronic gastrointestinal (GI) disorder that causes relapsing inflammation and severe mucosal damage in the intestine. Crohn's disease (CD)-related stricturing complications are a major cause of surgery, disability, and reduced quality of life. Endoscopic balloon dilation (EBD) has been shown to reliably delay or prevent surgery in patients with stricturing CD. However, cases of EBD performed for stricture in CD in Taiwan are rare. In this study, we want to evaluate the experiences regarding EBD for stricturing CD in Taiwan. METHODS: We conducted a retrospective analysis of 9 medical centers in Taiwan. Patients with CD-related strictures who were treated with EBD were included and analyzed. RESULTS: In nine medical centers, a total of 26 CD patients (19 male, 7 female, mean disease duration 75.4 ± 65.2 months) underwent 42 EBD procedures during the study period. Among the subjects, an 83.3% (35/42) EBD success rate was seen, but 26.9% (7/26) patients underwent surgery after ineffective EBD. In the surgery group, the the small bowel strictures was high compared with the non-surgery group (p = 0.01). There were no significant differences in disease phenotype, disease duration or history of fistulizing disease. In the surgery group, immunosuppressant use was high, and 5-aminosalicylic acid (5-ASA) use was low compared with the non-surgery group. After EBD, the physicians tended to change the drugs, especially increasing the use of biologic agents. CONCLUSION: EBD is a safe and effective procedure for CD-related stricture, with a 83.3% success rate in Taiwan.

Fecal Microbiota Transplantation Prevents Intestinal Injury, Upregulation of Toll-Like Receptors, and 5-Fluorouracil/Oxaliplatin-Induced Toxicity in Colorectal Cancer.

FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin), a 5-fluorouracil (5-FU)-based chemotherapy regimen, is one of most common therapeutic regimens for colorectal cancer. However, intestinal mucositis is a common adverse effect for which no effective preventive strategies exist. Moreover, the efficacy and the safety of fecal microbiota transplants (FMT) in cancer patients treated with anti-neoplastic agents are still scant. We investigated the effect of FMT on FOLFOX-induced mucosal injury. BALB/c mice implanted with syngeneic CT26 colorectal adenocarcinoma cells were orally administered FMT daily during and two days after five-day injection of FOLFOX regimen for seven days. Administration of FOLFOX significantly induced marked levels of diarrhea and intestinal injury. FMT reduced the severity of diarrhea and intestinal mucositis. Additionally, the number of goblet cells and zonula occludens-1 decreased, while apoptotic and NF-κB-positive cells increased following FOLFOX treatment. The expression of toll-like receptors (TLRs), MyD88, and serum IL-6 were upregulated following FOLFOX treatment. These responses were attenuated following FMT. The disrupted fecal gut microbiota composition was also restored by FMT after FOLFOX treatment. Importantly, FMT did not cause bacteremia and safely alleviated FOLFOX-induced intestinal mucositis in colorectal cancer-bearing mice. The putative mechanism may involve the gut microbiota TLR-MyD88-NF-κB signaling pathway in mice with implanted colorectal carcinoma cells.

Decreased Colorectal Adenoma Risk After Helicobacter pylori Eradication: A Retrospective Cohort Study.

BACKGROUND: Helicobacter pylori infection is associated with colorectal adenoma and confers a 1.3- to 2.26-fold increased risk. We evaluated the association between H. pylori and the progression of colorectal adenoma. METHODS: This retrospective cohort study included 615 adults with no history of colorectal adenoma or cancer at baseline who participated in a repeated, regular health screening examination, which included a bidirectional gastrointestinal endoscopy, between July 2006 and June 2015. A gastric biopsy specimen from each subject was tested for H. pylori. RESULTS: During follow-up, the incidence rates of colorectal adenoma progression in participants with persistent H. pylori infections (persistent group) and those whose infections had previously been successfully eradicated (eradication group) were 160.52 and 51.60 per 1000 person-years, respectively (P = .0003). After adjustment for confounding factors, the persistent group exhibited a higher risk of colorectal adenoma than the eradication group (hazard ratio = 3.04, 95% CI 1.899, 5.864). The colorectal adenoma ratio of patients uninfected with H. pylori was similar to that of the eradication group (23.93% vs 20.12%, P = .328). CONCLUSIONS: Persistent H. pylori infection was associated significantly with the independent development of colorectal adenoma. H. pylori infection may have a pathophysiological role in colorectal adenoma development and, after successful eradication of H. pylori, the colorectal adenoma ratio might decrease.

Efficacy of Ledipasvir and Sofosbuvir Treatment of HCV Infection in Patients Coinfected With HBV.

BACKGROUND & AIMS: There have been reports of reactivation of hepatitis B virus (HBV) infection during treatment of hepatitis C virus (HCV) infection with direct-acting antiviral agents. We performed a prospective study of risks and outcomes of HCV infection treatment with ledipasvir and sofosbuvir in patients with HBV infection. METHODS: We performed a phase 3b, multicenter, open-label study in Taiwan of 111 patients with HCV infection (61% HCV genotype 1, 39% HCV genotype 2 infection; 62% women, 16% with compensated cirrhosis) along with HBV infection. All but 1 were positive for the hepatitis B surface antigen (HBsAg); 1 patient who was HBsAg-positive at screening was found to be HBsAg-negative at baseline. Overall, 33% of participants had received prior treatment for HCV and 5% had previously been treated for HBV; no patient was on HBV therapy at the start of the study. All patients received a fixed-dose combination of 90 mg of the HCV NS5A inhibitor ledipasvir with 400 mg of the NS5B nucleotide analogue inhibitor sofosbuvir, once daily for 12 weeks. The primary endpoint was sustained virologic response 12 weeks after the end of therapy. RESULTS: All 111 patients (100%) achieved a sustained virologic response. Of the 37 patients with baseline HBV DNA below 20 IU/mL, 31 (84%) had at least 1 episode of quantifiable HBV DNA through posttreatment week 12. Of the 74 patients with baseline HBV DNA levels of 20 IU/mL or more, 39 (53%) had increases of HBV DNA greater than 1 log10 IU/mL through posttreatment week 12. Overall, 5 patients had increased levels of HBV DNA concomitant with a level of alanine aminotransferase >2 times the upper limit of normal through posttreatment week 12. Of these, 3 patients started HBV treatment. In addition, 1 patient with HBV reactivation since week 8 and concomitant alanine aminotransferase elevation >2 times upper limit of normal at posttreatment week 48 started treatment at posttreatment week 53. This patient had clinical signs and symptoms associated with HBV reactivation. The most common adverse events were headache, upper respiratory infection, and fatigue. CONCLUSIONS: In a prospective study, the combination of ledipasvir and sofosbuvir for 12 weeks produced a sustained virologic response in 100% of patients with HCV infection who were coinfected with HBV. Most patients had an increase in level of HBV DNA not associated with signs or symptoms. ClinicalTrials.gov no: NCT02613871.

Trends and risk factors of mortality analysis in patients with inflammatory bowel disease: a Taiwanese nationwide population-based study.

BACKGROUND: Inflammatory bowel disease (IBD) was emerging as a worldwide epidemic disease, and the advanced therapy changed the clinical course and possibly the outcomes. Our previous study reported a higher mortality rate from (IBD) in Taiwan than in Western countries. We proposed to analyze the trend and risk factors of mortality in order to improve the care quality of IBD patients. METHODS: This retrospective study was conducted to analyze data for January 2001 to December 2015 from a registered database, compiled by the Taiwan's National Health Insurance. RESULTS: Between 2001 and 2015, a total of 3806 IBD patients [Crohn's disease (CD): 919; ulcerative colitis (UC): 2887] were registered as having catastrophic illness, and 8.2% of these patients died during follow-up. The standardized mortality ratios (SMRs) of CD and UC were 3.72 (95% CI 3.02-4.55) and 1.44 (95% CI 1.26-1.65), respectively, from 2001 to 2015, respectively. A comparison of the periods of 2011-2015 and 2001-2005 revealed a decrease in the mortality rates from both UC and CD. Multivariate Cox proportional hazards analysis identified elderly individuals; sepsis and pneumonia were the risk factors for IBD mortality. The specific risk factors of mortality were liver cancer for UC and surgeries for CD. CONCLUSION: For further decreasing IBD-related mortality in Taiwan, we need to pay special attention toward elderly individuals, infection control, cancer screening and improvement in perioperative care.

Small bowel tumors: A digestive endoscopy society of Taiwan (DEST) multicenter enteroscopy-based epidemiologic study.

BACKGROUND/PURPOSE: Small bowel (SB) accounts for the majority of gastrointestinal tract but its tumors are rare and always overlooked. In this study, we aimed to evaluate the epidemiology of SB tumors. METHODS: This multicenter retrospective study utilized endoscopy database from 2006/11 to 2016/07. Baseline demographic characteristics, clinical, radiologic and endoscopic findings were collected. RESULTS: Totally 103 (34 benign, 69 malignant lesions) patients with SB tumors in 1070 enteroscopic examinations were enrolled. There were male preponderance (56.3% males, 43.7% females), both in benign (52.9%, 49.1%) and malignant (58.0%, 42.0%) lesions, except for subtype gastrointestinal stromal tumors (GISTs) (31.6%, 68.4%). The age (mean ± SD) at diagnosis in malignant SB tumors (62.2 ± 15.6) was older than those with benign tumors (50.7 ± 21.4) (p < 0.01). Bleeding (43.7%), abdominal pain (40.8%) and ileus (10.7%) were the most common clinical presentations. Hamartoma (32.4%) and adenoma (14.7%) were the most common benign histology. Four major malignant histological subtypes were lymphomas (29.0%), GISTs (27.5%), adenocarcinomas (26.1%) and metastatic cancers (14.5%). SB adenocarcinoma patients (>60-year-old, 77.8%) were older than lymphomas (60%) and GISTs (50%). Proximally location rates of lymphomas, GISTs, adenocarcinomas were 25.0% (5/20), 84.2% (16/19), and 88.9% (16/18), respectively. CONCLUSION: This endoscopy-based study revealed the most common histology of benign SB tumors were hamartoma and adenoma, and malignant ones were lymphomas, GISTs, adenocarcinomas and metastatic cancers. Most of them were male gender, except for GISTs, and with proximal location, except for lymphomas. Further large-scale investigation efforts are warranted to elucidate the epidemiology of SB tumors.

Comparison of telbivudine and entecavir on the change of off- treatment eGFR after 3 years of treatment in non-cirrhotic chronic hepatitis B patients.

BACKGROUND: The change of estimated glomerular filtration rate (eGFR) with off-treatment nucleos(t)ide analogues (NA) in chronic hepatitis B patients (CHB) is unclear. This study is aimed to evaluate the off-treatment eGFR after 3 years of therapy with telbivudine (LdT) or entecavir (ETV) and to assess predictive factors for eGFR improvement. METHODS: From January 2009 to December 2011, we identified NA-naïve patients who were at least 20 years of age diagnosed with compensated CHB. All patients received a 3-year NA treatment and 1 year off-treatment follow-up; the initial selection of patients for LdT or ETV treatment was at the physicians' discretion. An increase of more than 10% in eGFR from the baseline was identified as an improvement. The change of chronic kidney disease stages were recorded and compared with baseline at year 3 and year 4, respectively. RESULTS: This study included two groups consisting of 46 patients each (each with3 years of treatment with LdT or ETV). In LdT-treated patients, the mean eGFR increased from 94.3 ± 28.3 to 104.0 ± 31.2 mL/min/1.73 m2 in year 3 (p = 0.01) and from 104.0 ± 31.2 to 104.0 ± 28.8 mL/min/1.73 m2 in year 4 (p = 0.99). However, in ETV-treated patients, the mean eGFR decreased from 93.1 ± 26.1 to 85.5 ± 25.1 mL/min/1.73 m2 in year 3 (p = 0.0009) and from 85.5 ± 25.1 to 87.7 ± 24.8 mL/min/1.73 m2 in year 4 (p = 0.2). After a multivariate analysis, the predictors for the off-treatment eGFR improvement were the LdT treatment (odds ratio [OR], 3.97 (1.37-11.5), p = 0.01) and pre-treated eGFR (OR, 0.98 (0.95-1.00), p = 0.04). CONCLUSIONS: At year 4, 48.8 and 21.3% patients had an improved eGFR from baseline in LdT and ETV patients, respectively. Telbivudine may have a protective renal effect that can last for one year after treatment in non-cirrhotic CHB patients without a virological breakthrough.

A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection.

BACKGROUND & AIMS: In Taiwan, patients with chronic hepatitis C virus (HCV) infection are currently treated with pegylated interferon-alpha plus ribavirin, but interferon-based regimens can be poorly tolerated, especially by those with advanced liver disease and the elderly. Sofosbuvir, an oral nucleotide analogue inhibitor of HCV NS5B polymerase, is approved in Europe, the USA and Japan for treating chronic HCV infection. This phase 3b study examined the efficacy and safety of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 HCV infection ± compensated cirrhosis. METHODS: In this multicentre, open-label, phase 3b (NCT02021643) study, 87 patients (n = 43, treatment-naive; n = 44, treatment-experienced) received 12 weeks of treatment with sofosbuvir plus weight-based ribavirin. The primary efficacy endpoint was the proportion of patients with sustained virological response 12 weeks after treatment discontinuation (SVR12). Safety and pharmacokinetic data were also collected. RESULTS: All 87 patients (100%; 95% confidence interval, 92-100%) achieved SVR12, including the 13 patients with compensated cirrhosis. The most common treatment-emergent adverse events (AEs) were insomnia (16%, 14/87) and upper respiratory tract infection (16%, 14/87). No grade 3 or grade 4 AE was reported. There was one serious AE (biliary colic), which was deemed unrelated to study treatment. Laboratory abnormalities other than ribavirin-related reductions in haemoglobin were uncommon. CONCLUSIONS: The results from this phase 3b study demonstrate that 12 weeks of treatment with the interferon-free regimen sofosbuvir plus ribavirin is effective and well tolerated in both treatment-naive and treatment-experienced Taiwanese patients with chronic genotype 2 HCV infection.

Four-year entecavir therapy reduces hepatocellular carcinoma, cirrhotic events and mortality in chronic hepatitis B patients.

BACKGROUND & AIMS: Oral antiviral therapy may reduce the disease progression of chronic hepatitis B (CHB) patients. We aimed to further investigate the efficacy of long-term entecavir therapy in reduction of the risk of hepatocellular carcinoma (HCC), cirrhotic events and mortality in a large group of CHB-related cirrhosis patients. METHODS: The C-TEAM (Cirrhosis-Taiwanese EntecAvir Multicenter) study was a nationwide, multicenter, retrospective-prospective cohort study in Taiwan. We enrolled treatment-naïve patients with CHB-related cirrhosis and baseline HBV-DNA≥2000 IU/mL receiving long-term entecavir therapy and compared the development of HCC, cirrhotic events and mortality with that of a historical untreated cohort. RESULTS: In total, 1315 entecavir-treated and 503 untreated patients with cirrhosis were enrolled, with median treatment and follow-up durations of 4 and 6 years respectively. Compared with the untreated cohort, entecavir therapy was associated with a 60% HCC risk reduction [hazard ratio (HR): 0.40, 95% confidence interval (CI): 0.28-0.57]. Additionally, an older age, the male gender, HBeAg positivity, alpha-fetoprotein (AFP)≥7 ng/mL before therapy were independent predictors of HCC development. Further analysis showed that entecavir therapy significantly reduced risks of variceal bleeding, spontaneous bacterial peritonitis, and liver-related and all-cause mortality. These findings were confirmed by propensity score-matched cohorts in sensitivity analysis. In patients under entecavir therapy, an older age, the male gender, HBeAg positivity, AFP level ≥7 ng/mL before therapy, and 1-year virological response were predictive of HCC development. CONCLUSIONS: Four-year entecavir therapy significantly reduces the risk of HCC, cirrhotic events and mortality in patients with CHB-related cirrhosis.

A novel artificial tissue simulator for endoscopic submucosal resection training - a pilot study.

BACKGROUND: We developed a novel artificial simulator for endoscopic submucosal dissection (ESD) as a bridge between instructional videos and animal tissue training and aimed to evaluate the feasibility of using an artificial tissue model in ESD training. METHODS: Eight gastroenterology fellows from one medical center were enrolled in this ESD training program. Before and after the simulator training, attendees indicated on a 5-point scale the degree of difficulty in performing the following procedures: lesion marking, mucosal pre-cutting, circumferential incision, submucosal dissection, and hemostasis. After the simulator training, the participants completed a questionnaire regarding their opinions on the degree of realism and the feasibility of using this model for training. RESULTS: After watching an instructional video, attendees felt that the most difficult techniques were submucosal dissection and hemostasis. After using the artificial tissue simulator model, the attendees felt more confident in performing performing lesion marking (p = 0.026) and submucosal dissection (p = 0.037). However, they still felt that hemostasis was the most difficult techniques to master. Overall, the attendees thought the simulator was realistic in simulated lesion marking and its use was feasible for simulated lesion marking and submucosal dissection. CONCLUSION: Our pilot study shows the feasibility of using a novel artificial tissue in performing ESD and we believe that the artificial tissue simulator acts well as a bridge between instructional videos and animal model training. The model is reusable and inexpensive, and could disseminate the techniques of the ESD more easily and quickly.

Ledipasvir/sofosbuvir fixed-dose combination tablet in Taiwanese patients with chronic genotype 1 hepatitis C virus.

BACKGROUND AND AIM: Pegylated-interferon-alpha plus ribavirin is the current standard-of-care regimen for treating chronic hepatitis C virus (HCV) infection in Taiwan; however, interferon-based regimens can be poorly tolerated. The interferon-free, two-drug, fixed-dose combination tablet ledipasvir/sofosbuvir is approved in Europe, the USA, and Japan for treating chronic genotype 1 HCV infection. Little is known about its efficacy/safety in Taiwanese patients. METHODS: In this multicenter, open-label, phase 3b (NCT02021656) study, 85 Taiwanese patients (n = 42, treatment-naïve; n = 43, treatment-experienced) with chronic genotype 1 HCV infection (±compensated cirrhosis) received 12 weeks of ledipasvir/sofosbuvir fixed-dose combination tablet. The primary efficacy end point was the proportion of patients with sustained virologic response 12 weeks after treatment discontinuation (SVR12). Safety and pharmacokinetic data were collected. RESULTS: The overall SVR12 rate was 98% (83/85), with 100% (42/42) and 95% (41/43) of treatment-naïve and treatment-experienced patients, respectively, achieving SVR12. There were no on-treatment virologic failures. One patient relapsed after treatment discontinuation; one patient withdrew consent on day 2. The most common treatment-emergent adverse event (AE) was headache (14%, 12/85). There was one grade 3 AE (small cell lung cancer unrelated to ledipasvir/sofosbuvir), no grade 4 AEs, and four grade 3-4 laboratory abnormalities. Only the patient with small cell lung cancer prematurely discontinued treatment. Two patients reported three serious AEs; none was considered related to ledipasvir/sofosbuvir. CONCLUSIONS: Data from this phase 3b study suggest that 12 weeks of once-daily treatment with the interferon-free, ribavirin-free regimen ledipasvir/sofosbuvir is effective and well-tolerated in Taiwanese patients with chronic genotype 1 HCV infection, irrespective of treatment history.

Hepatitis C treatment outcome in relation to alcohol consumption and racial differences in southeastern Taiwan.

BACKGROUND/PURPOSE: Alcohol use may have negative impacts on hepatitis C virus (HCV) treatment due to low adherence, and racial differences can influence HCV sustained virological response (SVR) rate between East Asian and European ancestry. The objective of this study is to confirm the influence of alcohol consumption and racial differences on HCV treatment outcome in aboriginal and nonaboriginal people of southeastern Taiwan. METHODS: In this retrospective cohort study, a total of 195 patients were treated with peginterferon-alpha once weekly plus ribavirin for 24 weeks. The efficacy analysis was performed based on the SVR rate for patients who received at least one dose of the study medication or who completed treatment. The endpoints were denoted by virological response rate including the influences of alcohol use, HCV genotype, serum level of HCV virological load, and racial differences. RESULTS: No differences were observed in the baseline clinical characteristics between drinkers and nondrinkers, but a significant difference was noted in the body mass index between aboriginal and nonaboriginal populations (28.3 vs. 25.8; p < 0.01). With respect to the SVR rate, no difference was found between drinkers and nondrinkers, and between aboriginal and nonaboriginal people. The treatment efficacy of SVR in the whole group was significantly different between patients with HCV genotype 1 and nongenotype 1 (73.5% vs. 91.2%; p < 0.01). An analysis of the SVR rate in the aboriginal group showed no significant difference between patients with genotype 1 and nongenotype 1 (80.0% vs. 91.3%; p = 0.31). CONCLUSION: In southeastern Taiwan, alcohol consumption did not influence the HCV treatment outcome, and the SVR rates were similar between patients with HCV genotype 1 and nongenotype 1 infections in the aboriginal group.

Clinical presentations of patients from different age cohorts with biliary tract stone diseases.

BACKGROUND AND AIM: The role of clinical symptoms, transabdominal ultrasound scan (USS), and liver function tests (LFTs) in evaluating common bile duct (CBD) stones in patients suspected to have pancreatobiliary disease has been studied. However, it is unclear whether these predictive models are useful in different age cohorts. The aim of this study is to investigate the clinical presentations from different age cohorts with and without CBD stones. METHODS: Four hundred and forty-three patients with pancreatobiliary diseases were divided into cohorts according to decades as follows: young (Y, 18-64 years old, n = 143), young-old (YO, 65-74 years old, n = 168), old-old (OO, 75-84 years old, n = 97), and very old (VO, ≥ 85 years old, n = 35). The clinical symptoms, LFTs, and USS findings were demonstrated and compared among patients. RESULTS: Y- and YO-group patients were more likely to develop symptoms such as biliary colic in the presence of CBD stones. The proportion of abnormal serum aspartate aminotransferase and alanine aminotransferase were significantly greater in Y-, YO-, and OO-group patients with than in those without CBD stones. Sensitivity of USS for CBD stones in Y: 0.15; YO: 0.45; OO: 0.57; and VO: 0.68. Accuracy of USS for detected CBD stone in Y: 48%; YO: 62.5%; OO: 70.1%; and VO: 71.4%. CONCLUSION: Combined evaluation of clinical symptoms, biochemical and USS findings may help predict the presence of CBD stones. In Y, YO, and OO patients with CBD stones, the incidences of abnormal LFTs were higher. The sensitivity and accuracy of USS in detecting CBD stones were increased according to age.

Peginterferon alpha-2b plus ribavirin for chronic hepatitis C virus mixed genotype infection.

BACKGROUND AND AIM: The treatment efficacy of peginterferon plus ribavirin for patients with HCV genotype 1 is inferior to that in patients with HCV genotype 2, but the efficacy among patients with mixed HCV genotype 1 + 2 is less clear. We compared the treatment outcome of peginterferon alpha-2b plus ribavirin among naïve chronic hepatitis C patients in Taiwan with HCV genotype 1 and 2, and mixed genotype 1 + 2. MATERIAL AND METHODS: In this retrospective cohort study, 150 patients were treated with peginterferon alpha-2b once weekly, plus ribavirin, for 24 weeks. The endpoint was sustained virological response after receiving at least one dose of the study medication. RESULTS: There were no differences in clinical characteristics among the 3 groups. There were significant differences in rapid virological response rate between patients with genotype 1 and genotype 2 (64.7 vs. 85.5%, respectively; p < 0.05) and a sustained virological response rate (55.9 vs. 83.6%, respectively; p = 0.001). The rapid virological response rate differed between the genotype 1 and mixed genotype 1 + 2 groups (64.7 vs. 85.2%, respectively; p < 0.05), but the sustained virological response rate was similar (55.9 vs. 74.1%; p = 0.101). CONCLUSIONS: Using peginterferon alpha-2b plus ribavirin for 24 weeks to treat patients with HCV genotype 1 + 2 achieved a 74.1% sustained virological response rate; the treatment efficacy was not inferior to patients with HCV genotype 1, but the percentage of liver cirrhosis in mixed genotype 1 + 2 group was higher to 22%, it is worth to be appropriately valued and studied.

Socioeconomic status, personal habits, and prevalence of Helicobacter pylori infection in the inhabitants of Lanyu.

BACKGROUND/PURPOSE: Lanyu Island is a closed environment inhabited by the Yami people, Taiwan's smallest and most primitive tribe. This study assessed the prevalence and risk factors of Helicobacter pylori infection among Lanyu Island residents. METHODS: A cross-sectional study was conducted among the inhabitants of Lanyu Island, using the (13)C urea breath test to determine the prevalence of H. pylori. All study participants completed a form requesting demographic data and anthropometric measurements and a questionnaire evaluating socioeconomic characteristics and personal habits. Multiple logistic regression analyses were used to identify independent factors of H. pylori infections, and a two-sided p < 0.05 was considered significant. RESULTS: Among 796 participants, the mean age was 45 ± 13.2 years, with a range of 12-89 years. The overall prevalence of H. pylori infection was 72.1%, and there was no significant difference between genders. The H. pylori-infected group contained higher proportions of Yami people, married individuals, as well as higher rates of alcohol consumption and betel chewing, but lower family incomes and education levels. Multiple logistic models found that Yami ethnicity [odds ratio (OR) = 2.567, 95% confidence interval (CI): 1.344-4.905], alcohol consumption (OR = 1.641, 95% CI: 1.151-2.341), and marital status (OR = 1.779, 95% CI: 1.043-3.032] were associated with H. pylori infection. CONCLUSION: This cross-sectional study identified a high prevalence of H. pylori infection on Lanyu Island. When investigating H. pylori infection status in a closed environment, such as Lanyu Island, it is important to consider all factors relating to the host population, including environment and lifestyle.

Interaction of Colorectal Neoplasm Risk Factors and Association with Metabolic Health Status Focusing on Normal Waist-to-Hip Ratio in Adults.

BACKGROUND: We aimed to evaluate the interaction between colorectal adenoma risks among asymptomatic individuals in terms of metabolic health status and obesity, and examine the normal waist-to-hip ratio (WHR) in adults with colorectal adenoma risk. METHODS: A cross-sectional, retrospective study was conducted at MacKay Memorial Hospital involving 16,996 participants who underwent bidirectional gastrointestinal endoscopy between 2013 and 2023. The study recorded important clinicopathological characteristics, including age, body mass index and WHR, Framingham Risk Score (FRS), blood glucose level, and Helicobacter pylori (H. pylori) infection status. RESULTS: Multivariate logistic regression analysis demonstrated that elevated hemoglobin A1C (HbA1c), increased FRS, positive H. pylori infection, and WHR ≥ 0.9 are independent risk factors for colorectal adenoma. In examining the interaction between FRS and WHR using multivariate logistic regression to evaluate adenoma risk, the OR for the interaction term was 0.95, indicating a decline in adenoma risk when considering the interaction between these two factors. Incorporating HbA1c into the analysis, evaluating the interaction between FRS and WHR still demonstrated a statistically significant impact on adenoma risk (OR 0.96, p < 0.001). Participants with WHR < 0.9, elevated FRS, positive H. pylori infection, and increased HbA1c levels were associated with a higher risk of colorectal adenoma formation. Remarkably, the increased risk of adenoma due to rising HbA1c levels was statistically significant only for those with a WHR < 0.9. CONCLUSIONS: An increase in FRS and HbA1c or a positive H. pylori infection still warrants vigilance for colorectal adenoma risk when WHR is 0.9. These factors interacted with each other and were found to have a minimal decline in adenoma risk when considering the interaction between WHR and FRS.