Impact of Sofosbuvir-Based Direct-Acting Antivirals on Renal Function in Chronic Hepatitis C Patients With Impaired Renal Function: A Large Cohort Study From the Nationwide HCV Registry Program (TACR).

BACKGROUND & AIMS: Sofosbuvir is approved for chronic hepatitis C (CHC) patients with severe chronic kidney disease (CKD). The impact of sofosbuvir-based therapy on renal function augmentation on a real-world nationwide basis is elusive. METHODS: The 12,995 CHC patients treated with sofosbuvir-based (n = 6802) or non-sofosbuvir-based (n = 6193) regimens were retrieved from the Taiwan nationwide real-world HCV Registry Program. Serial estimated glomerular filtration rate (eGFR) levels were measured at baseline, end of treatment (EOT), and end of follow-up (EOF) (3 months after EOT). RESULTS: The eGFR decreased from baseline (91.4 mL/min/1.73 m2) to EOT (88.4 mL/min/1.73 m2; P < .001) and substantially recovered at EOF (88.8 mL/min/1.73 m2) but did not return to pretreatment levels (P < .001). Notably, a significant decrease in eGFR was observed only in patients with baseline eGFR ≥90 mL/min/1.73 m2 (from 112.9 to 106.4 mL/min/1.73 m2; P < .001). In contrast, eGFR increased progressively in patients whose baseline eGFR was <90 mL/min/1.73 m2 (from 70.0 to 71.5 mL/min/1.73 m2; P < .001), and this increase was generalized across different stages of CKD. The trend of eGFR amelioration was consistent irrespective of sofosbuvir usage. Multivariate adjusted analysis demonstrated that baseline eGFR >90 mL/min/1.73 m2 was the only factor independently associated with significant slope coefficient differences of eGFR (-1.98 mL/min/1.73 m2; 95% confidence interval, -2.24 to -1.72; P < .001). The use of sofosbuvir was not an independent factor associated with eGFR change. CONCLUSIONS: Both sofosbuvir and non-sofosbuvir-based regimens restored renal function in CHC patients with CKD, especially in those with significant renal function impairment.

Efficacy and safety of gastric peroral endoscopic myotomy (G-POEM) for refractory gastroparesis: 3-year follow up results.

BACKGROUND/PURPOSE: Gastroparesis is a common but easily overlooked disease. Gastric peroral endoscopic myotomy (G-POEM) is one of the third-space endoscopy techniques to treat gastroparesis. In this study, we aimed to evaluate the efficacy and safety of G-POEM for patients with refractory gastroparesis. METHODS: Between December 2017 and 2020, we consecutively enrolled patients with gastroparesis who failed after the administration of several kinds of medication and repeated admission for nutritional support. All patients underwent gastric emptying scintigraphy and answered a questionnaire on Gastroparesis Cardinal Symptom Index (GCSI). Demographic data, endoscopic procedure, and post procedural outcome were analyzed. RESULTS: A total of 11 (9 women and 2 men) patients with refractory gastroparesis (nine with diabetes mellitus, one systemic lupus erythematosus, and one idiopathic) were enrolled. The mean (±standard deviation (SD)) procedure time was 61.82 (±18.99) min with technical and clinical success rates of 100% and 81.82%, respectively. A statistically significant improvement was observed in the clinical severity (mean GCSI score 36.00 vs. 14.73, p < 0.0001) and gastric emptying time (mean T1/2 341.92 vs. 65.92 min, p = 0.016) after G-POEM. Hospital stay was 7.18 (±4.49) days without mortality. Complications included 4 (36.36%) patients with self-limited postprocedural abdominal pain and 3 (27.27%) patients with intra-procedural pneumoperitoneum. During the mean follow-up period of 554.36 days, one (9.09%) patient had relapsed clinical symptoms after 6 months. CONCLUSION: G-POEM is an efficient and safe pylorus-directed endoscopic therapy for refractory gastroparesis with promising results.

Ledipasvir/sofosbuvir for HCV genotype 1, 2, 4-6 infection: Real-world evidence from a nationwide registry in Taiwan.

BACKGROUND/PURPOSE: The Taiwan Association for the Study of the Liver (TASL) HCV Registry (TACR) is a nationwide registry of chronic hepatitis C patients in Taiwan. This study evaluated antiviral effectiveness of ledipasvir (LDV)/sofosbuvir (SOF) in patients in the TACR. METHODS: Patients enrolled in TACR from 2017-2020 treated with LDV/SOF were eligible. The primary outcome was the proportion of patients with sustained virologic response 12 weeks after end of treatment (SVR12). RESULTS: 5644 LDV/SOF ± ribavirin-treated patients were included (mean age: 61.4 years; 54.4% female). Dominant viral genotypes were GT1 (50.8%) and GT2 (39.3%). 1529 (27.1%) patients had liver cirrhosis, including 201 (3.6%) with liver decompensation; 686 (12.2%) had chronic kidney disease. SVR12 was achieved in 98.6% of the overall population and in 98.2% and 98.7% of patients with and without cirrhosis, respectively. SVR12 rates in patients with compensated cirrhosis treated with LDV/SOF without RBV were >98%, regardless of prior treatment experience. SVR12 was 98.6%, 98.4%, 100%, 100%, and 98.7% among those with GT1, GT2, GT4, GT5, and GT6 infections, respectively. Although patient numbers were relatively small, SVR12 rates of 100% were reported in patients infected with HCV GT2, GT5, and GT6 with decompensated cirrhosis and 98% in patients with severely compromised renal function. LDV/SOF adherence ≤60% (P < 0.001) was the most important factor associated with treatment failure. Incidence of adverse events was 15.8%, with fatigue being the most common. CONCLUSION: LDV/SOF is effective and well tolerated in routine clinical practice in Taiwan. Cure rates were high across patient populations.

Factors associated with treatment failure of direct-acting antivirals for chronic hepatitis C: A real-world nationwide hepatitis C virus registry programme in Taiwan.

BACKGROUND/AIMS: Direct-acting antivirals (DAAs) are highly effective in treating chronic hepatitis C virus (HCV)-infected patients. The real-world treatment outcome in Taiwanese patients on a nationwide basis is elusive. METHODS: The Taiwan HCV Registry (TACR) programme is a nationwide registry platform including 48 study sites, which is organized and supervised by the Taiwan Association for the Study of the Liver. The primary endpoint was sustained virological response (SVR12, undetectable HCV RNA 12 weeks after end-of-treatment). RESULTS: A total of 13 951 registered patients with SVR12 data available were analysed (mean age, 63.0 years; female, 55.9%; HCV genotype-1 [GT1], 57.9%; cirrhosis, 38.4%; preexisting hepatocellular carcinoma [HCC], 10.6%; and hepatitis B virus coinfection, 7.7%). The overall SVR12 rate was 98.3%, with 98.7%, 98.0%, 98.4% and 97.4% in treatment-naïve noncirrhotic, treatment-naïve cirrhotic, treatment-experienced noncirrhotic and treatment-experienced cirrhotic patients, respectively. The SVR12 rate was > 95% across all subgroups except treatment-experienced cirrhotic patients who received sofosbuvir/ribavirin (88.7%), treatment-naïve noncirrhotic patients (94.8%) and treatment-experienced cirrhotic (94.8%) patients who received daclatasvir/asunaprevir. The most important factor associated with treatment failure was DAA adherence < 60% ( adjusted odds ratio [aOR]/95% confidence interval [CI]: 117.1/52.4-261.3, P < .001), followed by GT3/GT2 (aOR/CI: 5.78/2.25-14.9, P = .0003 and aOR/CI: 1.55/1.05-2.29, P = .03, compared with GT1), active hepatocellular carcinoma (aOR/CI: 4.29/2.57-7.16, P < .001), the use of sofosbuvir/ribavirin (aOR/CI: 2.51/1.67-3.77, P < .001) and daclatasvir/asunaprevir (aOR/CI: 3.29/1.94-5.58, P < .001), decompensated liver cirrhosis (aOR/CI: 2.50/1.20-5.22, P = .02) and high HCV viral loads (aOR/CI: 2.16/1.57-2.97, P < .001). CONCLUSIONS: DAAs are highly effective in treating Taiwanese HCV patients in the real-world setting. Maintaining DAA adherence and selecting highly efficacious regimens are keys to ensure treatment success.

Peroral endoscopic tumor resection (POET) with preserved mucosa technique for management of upper gastrointestinal tract subepithelial tumors.

BACKGROUND: Third space endoscopy technique facilitates therapeutic endoscopy in subepithelial space. This study aimed to investigate peroral endoscopic tumor resection (POET) with preserved mucosa technique for upper gastrointestinal tract subepithelial tumors (UGI-SETs) removal. METHODS: Between February 2011 and December 2019, consecutive patients with SETs of esophagus and stomach who underwent POET for enlarging size during follow-up, malignant endoscopic ultrasound features or by patient's request were enrolled. Demographic, endoscopic and pathological data were analyzed retrospectively. RESULTS: Totally 18 esophageal (mean ± SD age, 55.23 ± 4.15 year-old, 38.89% female) and 30 gastric (52.65 ± 2.43 year-old, 53.33% female) SETs in 47 patients (one with both esophageal and gastric lesions) were resected. The mean (± SD) endoscopic/pathological tumor size, procedure time, en-bloc/complete resection rate, and hospital stays of esophageal and gastric SET patients were 12.36 (± 7.89)/11.86 (± 5.67) and 12.57 (± 6.25)/12.35 (± 5.73) mm, 14.86 (± 6.15) and 38.21 (± 15.29) minutes, 88.89%/94.44% and 86.77%/93.30%, and 4.14 (± 0.21) and 4.17 (± 0.20) days, respectively. The overall complication rate was 18.75%, including 6 self-limited fever and 3 pneumoperitoneum relieved by needle puncture. There was no mortality or recurrence reported with mean follow-up period of 23.74 (± 4.12) months. CONCLUSIONS: POET is a safe and efficient third space endoscopic resection technique for removal of UGI-SETs less than 20 mm. Long term data are warranted to validate these results.

Identification of risk factors for neoplastic colonic polyps in young adults with bloody stool in comparison with those without symptom.

BACKGROUND AND AIMS: The incidence and disease burden of colorectal cancer (CRC) in young adults were increasing. However, there was a dearth of advice on how to identify young population at risk for neoplastic colonic polyps (NCPs) and CRC. We aimed to identify risk factors for NCPs and CRC in young adults presenting with bloody stool. METHODS: A total of 1496 subjects younger than 40 years old who underwent colonoscopy due to bloody stool from 2005 to 2014 were enrolled in this retrospective study as the study group, and 1481 age-matched and gender-matched asymptomatic subjects who underwent colonoscopy for health checkup from 2011 to 2016 were enrolled as the control group at a tertiary center hospital. RESULTS: Multivariate analysis results showed that increasing age (odds ratio [OR] = 1.11, 95% confidence interval [CI]: 1.07-1.15, P < 0.001), higher body mass index (BMI) (OR = 1.07, 95%CI: 1.03-1.12, P = 0.001), diabetes mellitus (OR = 2.80, 95%CI: 1.06-7.42, P = 0.038), and positive family history of CRC (OR = 13.28, 95%CI: 5.70-30.97, P < 0.001) were identified as independent risk factors for NCPs in study group. The best cut-off values by receiver operating characteristic curve for age and BMI were 32 years old and 24.8 kg/m2 , respectively. More risk factors were associated with the higher risk for NCPs (OR = 2.17 every increasing one risk factor, P < 0.001). In the control group, no independent risk factors were identified. CONCLUSIONS: Adults aged ≤ 40 years with bloody stool who had increasing age (> 32 years old), higher BMI (> 24.8 kg/m2 ), diabetes mellitus, and positive family history of CRC had a higher detection rate of NCPs and CRC.

Real-world practice and Expectation of Asia-Pacific physicians and patients in Helicobacter Pylori eradication (REAP-HP Survey).

OBJECTIVE: The aims of the study were: 1, to survey the most popular anti-H. pylori regimens in Asia-Pacific region and the real-world effectiveness of these regimens; and 2, to investigate the expectation gaps of eradication rate between physicians and patients. DESIGN: A questionnaire was distributed to Asia-Pacific physicians who attended the Asia-Pacific Digestive Week 2015 meeting. Reported eradication rates from the literatures were compared with real-world rates of surveyed popular regimens within the region. In addition, a questionnaire was distributed to H. pylori-infected patients in three regions of Taiwan. RESULTS: A total of 691 physicians and 539 patients participated in the survey. The top five most commonly used regimens were 7-day clarithromycin-based standard triple therapy (50.4%), 14-day clarithromycin-based standard triple therapy (31.0%), 10-day sequential therapy (6.1%), 14-day bismuth quadruple therapy (3.9%), and 14-day hybrid therapy (3.6%). All countries except for China had a significant gap between the expectation of physicians on anti-H. pylori therapy and the real-world eradication rate of most commonly adopted regimens (all P value <.05). The expectation on minimal eradication rate among patients was higher than that of physicians (91.4% vs 86.5%, P<.001). CONCLUSIONS: It is time for physicians in Asia-Pacific countries to adopt newer and more efficacious anti-H. pylori regimens to meet the Kyoto consensus recommendation and their patients' expectations.

Differences of microbiota in small bowel and faeces between irritable bowel syndrome patients and healthy subjects.

OBJECTIVE: Several studies suggested that colonic microbiota have impacts on irritable bowel syndrome (IBS) patients. However, the knowledge about the association of small intestine (SI) microbiota with IBS is limited. We aimed to investigate the gut microbiota composition of SI and stool in IBS patients. MATERIALS AND METHODS: Biopsies of jejunum mucosa by balloon-assisted enteroscopy and faecal samples from 28 IBS patients and 19 healthy controls were analysed by next-generation sequencing method. RESULTS: The three major phyla in SI microbiota of case/control groups were Proteobacteria (32.8/47.7%), Bacteroidetes (25.2/15.3%), and Firmicutes (19.8/11.2%), and those of stool were Bacteroidetes (41.3/45.8%), Firmicutes (40.7/38.2%), and Proteobacteria (15.4/7.1%). Analysis based on the family level, IBS patients had a higher proportion of Veillonellaceae (mean proportion 6.49% versus 2.68%, p = 0.046) in stool than controls. Prevotellaceae was more abundant in IBS patients than in control group (14.27% versus 6.13%, p = 0.023), while Mycobacteriaceae (0.06% versus 0.17%, p = 0.024) and Neisseriaceae (6.40% versus 8.94%, p = 0.038) was less abundant in IBS patients' jejunal mucosa than those in controls. This less abundant jejunal Neisseriaceae was associated with more severe IBS (p = 0.03). The ratio of Firmicutes to Bacteroidetes in the stool of IBS-diarrhoea type patients was approximately three-fold higher, and the ratio of Firmicutes to Actinobacter in SI of IBS-mixed type patients was about nine-fold higher than healthy subjects. CONCLUSION: Higher abundance of colonic Veillonellaceae and SI Prevotellaceae, and lower amount of oral cavity normal flora in proximal SI were found in IBS patients. We may manipulate these bacteria in IBS patients in future studies (ClinicalTrial.gov Number NCT01679730).

Stress ulcer prophylaxis in patients being weaned from the ventilator in a respiratory care center: A randomized control trial.

BACKGROUND/PURPOSE: No data has been available on prophylaxis for stress ulcer development during the process of weaning patients off mechanical ventilators. We conducted a randomized study to evaluate the efficacy of stress ulcer prophylaxis with lansoprazole OD in patients being weaned from mechanical ventilators. METHODS: A total of 120 patients were randomly allocated into two groups using blocked randomization, with 60 patients in each group. Group A was the treatment group, receiving lansoprazole OD 30 mg from a nasogastric tube for 14 days, while Group B, the control group, received no proton pump inhibitors or other medications for treating peptic ulcers. The primary end point of our study was apparent upper gastrointestinal bleeding within 2 weeks of enrollment. RESULTS: Apparent upper gastrointestinal bleeding occurred in zero patients and five patients in Groups A and B, respectively (Group A: 0% vs. Group B: 8.3%, p = 0.057). There was no significant difference between the two groups in ventilator-associated pneumonia (Group A: 6.7% vs. Group B: 10.0%, p = 0.509) and 30-day survival rates (Group A: 96.7% vs. Group B: 100%, p = 0.496). CONCLUSION: Stress ulcer prophylaxis with lansoprazole in patients being weaned from mechanical ventilators led to a lower but not statistically significant incidence of apparent upper gastrointestinal bleeding. There was no significant increase of incidence of ventilator-associated pneumonia in the prophylaxis group. Further larger scale studies are needed to clarify the benefit of stress ulcer prophylaxis in such patients.

Similar rebleeding rate in 3-day and 7-day intravenous ceftriaxone prophylaxis for patients with acute variceal bleeding.

BACKGROUND/PURPOSE: Although prophylactic antibiotics have been recommended for cirrhotic patients with upper gastrointestinal bleeding, the duration of its use remains an inconclusive issue. We designed this study to investigate the duration of antibiotic prophylaxis for cirrhotic patients with acute esophageal variceal bleeding. METHODS: We enrolled those patients suffering from acute esophageal variceal bleeding and receiving band ligation. They were randomly allocated to two groups to receive prophylactic antibiotics; Group I: receiving intravenous ceftriaxone 500 mg every 12 hours for 3 days, and Group II: same regimen for 7 days. We used rebleeding rate within 14 days as the primary end point and also evaluated the survival rate within 28 days and the amount of transfusion during admission. RESULTS: There were 38 patients in Group I and 33 patients in Group II that completed the study course for analysis. Overall, there was no significant difference in the baseline characteristics between these two groups. There were three patients both in Group I and Group II who developed rebleeding within 14 days (8% vs. 9%, p > 0.99). There was also no difference between Group I and Group II in transfusion amount (2.71 ± 2.84 units vs. 3.18 ± 4.07, p = 0.839) and survival rate in 28 days (100 vs. 97%, p = 0.465). CONCLUSION: Our small scale study demonstrated that there was no difference in the rebleeding rate between 3-day and 7-day ceftriaxone prophylaxis for cirrhotic patients with acute esophageal variceal bleeding. There was also no difference in 28 day survival rate between these two groups.

Increasing biopsy number and sampling from gastric body improve the sensitivity of rapid urease test in patients with peptic ulcer bleeding.

BACKGROUND: Previous studies demonstrated that the sensitivity of rapid urease test (RUT) for diagnosis of Helicobacter pylori infection decreased during peptic ulcer bleeding. AIM: We designed this study and tried to find a better method to improve the detection rate of H. pylori infection at the same session of endoscopic diagnosis of peptic ulcer bleeding. METHODS: We prospectively enrolled 116 patients with peptic ulcer bleeding. These patients received intravenous proton pump inhibitor and then received upper gastrointestinal endoscopy within 24 h after arrival. We took one piece of biopsy from gastric antrum (Group 1), four pieces from gastric antrum (Group 2), and one piece from the gastric body (Group 3) for three separate RUTs, respectively. (13)C-urease breath test was used as gold standard for diagnosis of H. pylori infection. RESULTS: There were 74 patients (64 %) with positive (13)C-urease breath test. Among these 74 patients, 45 patients had positive RUT (sensitivity: 61 %) in Group 1; 55 patients had positive RUT (sensitivity: 74 %) in Group 2; 54 patients had positive RUT (sensitivity: 73 %) in Group 3. There were significant differences between Group 1 and Group 2 (p = 0.02) and between Group 1 and Group 3 (p = 0.022). CONCLUSIONS: The sensitivity of RUT was 61 % during peptic ulcer bleeding. The sensitivity of RUT can be increased significantly by increased biopsy number from gastric antrum or biopsy from gastric body.

Magnifying Endoscopy With Narrow Band Imaging for Graft Failure and Disease Recurrence in Patients With Crohn Disease After Intestinal Transplantation: 2 Case Reports.

Crohn disease (CD) is one of the most common causes of short bowel syndrome and intestinal failure. Intestinal transplantation (IT) is sometimes needed for patients with CD who develop intestinal failure after multiple intestinal resections resulting from CD-related complications, such as uncontrollable bleeding and penetrating diseases. However, there have been few case reports concerning the endoscopic surveillance of patients with CD after IT. In this article, we present 2 patients with CD who underwent IT because of short bowel syndrome with intestinal failure. We administered posttransplantation immunosuppressants and conducted regular follow-up magnifying endoscopy with narrow-band imaging (ME-NBI). Both cases demonstrated favorable outcomes after surveillance with ME-NBI. In this report, we outline our post-IT follow-up strategies applying the VENCH scoring system, which is based on endoscopic features using ME-NBI to predict graft rejection. Our approach could effectively distinguish between acute cellular rejection and non-rejection, particularly disease recurrence of underlying CD. This study was approved by the institutional review board of Far Eastern Memorial Hospital (FEMH-105023-F). The patients provided written informed consent for publication.

Artificial intelligence predicts direct-acting antivirals failure among hepatitis C virus patients: A nationwide hepatitis C virus registry program.

BACKGROUND/AIMS: Despite the high efficacy of direct-acting antivirals (DAAs), approximately 1-3% of hepatitis C virus (HCV) patients fail to achieve a sustained virological response. We conducted a nationwide study to investigate risk factors associated with DAA treatment failure. Machine-learning algorithms have been applied to discriminate subjects who may fail to respond to DAA therapy. METHODS: We analyzed the Taiwan HCV Registry Program database to explore predictors of DAA failure in HCV patients. Fifty-five host and virological features were assessed using multivariate logistic regression, decision tree, random forest, eXtreme Gradient Boosting (XGBoost), and artificial neural network. The primary outcome was undetectable HCV RNA at 12 weeks after the end of treatment. RESULTS: The training (n=23,955) and validation (n=10,346) datasets had similar baseline demographics, with an overall DAA failure rate of 1.6% (n=538). Multivariate logistic regression analysis revealed that liver cirrhosis, hepatocellular carcinoma, poor DAA adherence, and higher hemoglobin A1c were significantly associated with virological failure. XGBoost outperformed the other algorithms and logistic regression models, with an area under the receiver operating characteristic curve of 1.000 in the training dataset and 0.803 in the validation dataset. The top five predictors of treatment failure were HCV RNA, body mass index, α-fetoprotein, platelets, and FIB-4 index. The accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the XGBoost model (cutoff value=0.5) were 99.5%, 69.7%, 99.9%, 97.4%, and 99.5%, respectively, for the entire dataset. CONCLUSION: Machine learning algorithms effectively provide risk stratification for DAA failure and additional information on the factors associated with DAA failure.

An algorithm for simplified hepatitis C virus treatment with non-specialist care based on nation-wide data from Taiwan.

BACKGROUND: Both European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (AASLD-IDSA) guidelines recommend simplified hepatitis C virus (HCV) treatment with pan-genotypic sofosbuvir/velpatasvir or glecaprevir/pibrentasvir for eligible patients. This observational study used real-world data to assess these regimens' safety in eligible patients and develop an algorithm to identify patients suitable for simplified treatment by non-specialists. METHODS: 7,677 HCV-infected patients from Taiwan Hepatitis C Registry (TACR) who received at least one dose of sofosbuvir/velpatasvir or glecaprevir/pibrentasvir, and fulfilled the EASL/AASLD-IDSA criteria for simplified treatment were analyzed. Multivariate analysis was conducted on patient characteristics and safety data. RESULTS: Overall, 92.8% (7,128/7,677) of patients achieved sustained virological response and only 1.9% (146/7,677) experienced Grades 2-4 laboratory abnormalities in key liver function parameters (alanine aminotransferase, aspartate aminotransferase, and total bilirubin), with only 18 patients (0.23%) experiencing Grades 3-4 abnormalities. Age > 70 years old, presence of hepatocellular carcinoma, total bilirubin > 1.2 mg/dL, estimated glomerular filtration rate < 60 mL/min/1.73 m2, and Fibrosis-4 > 3.25 were associated with higher risks of Grades 2-4 abnormalities. Patients with any of these had an odds of 4.53 times than that of those without in developing Grades 2-4 abnormalities (p < 0.01). CONCLUSIONS: Real-world data from Taiwan confirmed that simplified HCV treatment for eligible patients with pan-genotypic regimens is effective and well tolerated. The TACR algorithm, developed based on this study's results, can further identify patients who can be safely managed by non-specialist care.

Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan.

INTRODUCTION: Eight-week glecaprevir/pibrentasvir (GLE/PIB) is indicated for treatment-naïve (TN) patients with chronic hepatitis C (CHC), with or without compensated cirrhosis. Given that the Taiwanese government is committed to eliminating hepatitis C virus (HCV) by 2025, this study aimed to measure real-world evidence for TN patients using 8-week GLE/PIB in the Taiwan HCV Registry (TACR). METHODS: The data of patients with CHC treated with 8-week GLE/PIB were retrieved from TACR, a nationwide registry program organized by the Taiwan Association for the Study of the Liver (TASL). Treatment efficacy, defined as a sustained virologic response at posttreatment week 12 (SVR12), was assessed in the modified intention-to-treat (mITT) population, which excluded patients who were lost to follow-up or lacked SVR12 data. The safety profile of the ITT population was assessed. RESULTS: A total of 7246 (6897 without cirrhosis; 349 with cirrhosis) patients received at least one dose of GLE/PIB (ITT), 7204 of whom had SVR12 data available (mITT). The overall SVR12 rate was 98.9% (7122/7204) among all patients, 98.9% (6780/6856) and 98.3% (342/348) among patients without and with cirrhosis, respectively. For the selected subgroups, which included patients with genotype 3 infection, diabetes, chronic kidney disease, people who injected drugs, and those with human immunodeficiency virus coinfection, the SVR12 rates were 95.1% (272/286), 98.9% (1084/1096), 99.0% (1171/1183), 97.4% (566/581), and 96.1% (248/258), respectively. Overall, 14.1% (1021/7246) of the patients experienced adverse events (AEs). Twenty-two patients (0.3%) experienced serious AEs, and 15 events (0.2%) resulted in permanent drug discontinuation. Only one event was considered treatment drug related. CONCLUSION: Eight-week GLE/PIB therapy was effective and well tolerated in all TN patients, regardless of cirrhosis status.

Risk factors for second primary neoplasia of esophagus in newly diagnosed head and neck cancer patients: a case-control study.

BACKGROUND: The prevalence of esophageal neoplasia in head and neck (H&N) cancer patients is not low; however, routine esophageal surveillance is not included in staging of newly-diagnosed H&N cancers. We aimed to investigate the risk factors for synchronous esophageal neoplasia and the impact of endoscopy on management of H&N cancer patients. METHODS: A total of 129 newly diagnosed H&N cancer patients who underwent endoscopy with white-light imaging, narrow-band imaging (NBI) with magnifying endoscopy (ME), and chromoendoscopy with 1.5% Lugol's solution, before definite treatment were enrolled prospectively. RESULTS: 60 esophageal lesions were biopsied from 53 (41.1%) patients, including 11 low-grade, 14 high-grade intraepithelial neoplasia and 12 invasive carcinoma in 30 (23.3%) patients. Alcohol consumption [odds ratio (OR) 5.90, 95% confidence interval (CI) 1.23-26.44], advanced stage (stage III and IV) of index H&N cancers (OR 2.98, 95% CI 1.11-7.99), and lower body mass index (BMI) (every 1-kg/m2 increment with OR 0.87, 95% CI 0.76-0.99) were independent risk factors for synchronous esophageal neoplasia. NBI with ME was the ideal screening tool (sensitivity, specificity, and accuracy of 97.3%, 94.1%, and 96.3%, respectively, for detection of dysplastic and cancerous esophageal lesions). The treatment strategy was modified after endoscopy in 20 (15.5%) patients. The number needed to screen was 6.45 (95% CI 4.60-10.90). CONCLUSIONS: NBI-ME surveillance of esophagus should be done in newly-diagnosed H&N cancer patients, especially those with alcohol drinking, lower BMI, and advanced stage of primary tumor.

Cardiac events after using clarithromycin for anti-Helicobacter pylori therapy in patients with coronary artery disease.

Clarithromycin is an antibiotic commonly used to treat Helicobacter pylori infections. The US Food and Drug Administration (FDA) advises caution before prescribing clarithromycin to patients with cardiac diseases. This study aimed to evaluate cardiac events after anti-H pylori treatment in patients with coronary artery disease. A retrospective 5-year study was conducted on outpatients who received anti-H pylori therapy. Among the 7855 patients receiving therapy, 228 patients (2.9%) underwent angiography with coronary artery disease before therapy, and 193 patients received clarithromycin. Clarithromycin users seemed not to be at risk for cardiac events as compared with non-clarithromycin users at 3 months (4.7% vs 2.9%, P = .63) and 1 year (10.9% vs 5.7%, P = .35). Neither life-threatening dysrhythmia nor cardiac death was noted. The risk factors for cardiac events within 3 months after therapy were smoker (OR:5.38, 95% CI:1.39-20.78), and events within 1 year were smoker (OR:3.8, 95% CI:1.41-10.22), and diabetes mellitus (OR:5.68, 95% CI:1.9-16.98). Among patients with coronary artery disease who received anti-H pylori therapy, short-term cardiac events did not increase in clarithromycin users but should be considered in diabetic and smoking patients.

Effectiveness and safety of 8-week glecaprevir/pibrentasvir in HCV treatment-naïve patients with compensated cirrhosis: real-world experience from Taiwan nationwide HCV registry.

BACKGROUND: Large-scale real-world data of the 8-week glecaprevir/pibrentasvir (GLE/PIB) therapy for treatment-naïve patients of chronic hepatitis C virus (HCV) infection with compensated cirrhosis is scarce. METHODS: The TASL HCV Registry (TACR) is an ongoing nationwide registry program that aims to set up a database and biobank of patients with chronic HCV infection in Taiwan. In this study, data were analyzed as of 31 October 2021 for treatment-naïve HCV patients with compensated cirrhosis receiving 8-week GLE/PIB therapy. Effectiveness reported as sustained virologic response at off-therapy week 12 (SVR12) and safety profiles were assessed. Patient characteristics potentially related to SVR12 were also evaluated. RESULTS: Of the 301 patients enrolled, 275 had available SVR12 data. The SVR12 rate was 98.2% (270/275) in the modified intention-to-treat (mITT) population and 89.7% (270/301) in the ITT population. For those mITT patients with genotype 3, FibroScan > 20 kPa, platelet < 150,000/µl, and FibroScan > 20 kPa and platelet < 150,000/µl, the SVR12 rates were 100% (6/6), 100% (12/12), 98.0% (144/147), 100% (7/7), respectively. Overall, 24.9% (75/301) patients experienced adverse events (AEs). The most frequent AEs (> 5%) included fatigue (9.0%) and pruritus (7.0%). Seven (2.3%) patients experienced serious AEs and two (0.7%) resulted in permanent drug discontinuation. None of them were considered as GLE/PIB-related. CONCLUSIONS: In this large-scale real-world Taiwanese cohort, 8-week GLE/PIB therapy was efficacious and well tolerated for treatment-naïve compensated cirrhosis patients. SVR12 rates were similarly high as in the clinical trials, including those with characteristics of advanced liver disease.