A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease.

Background/Aims: Efficacy of proton pump inhibitors is limited in patients with nonerosive reflux disease (NERD). The aim of this study was to comparatively evaluate the efficacy and safety of esomeprazole with sodium bicarbonate and esomeprazole alone. Methods: This was a multicenter, randomized, double-blind, active-controlled, noninferiority comparative study. A total of 379 patients with NERD were randomly allocated to receive either EsoduoⓇ (esomeprazole 20 mg with sodium bicarbonate 800 mg) or NexiumⓇ (esomeprazole 20 mg) once daily for 4 weeks from January 2019 to December 2019. The patients had a history of heartburn for at least 2 days in the week before randomization as well as in the last 3 months and no esophageal mucosal breaks on endoscopy. The primary endpoint was a complete cure of heartburn at week 4. The secondary and exploratory endpoints as well as the safety profiles were compared in the groups at weeks 2 and 4. Results: A total of 355 patients completed the study (180 in the EsoduoⓇ group and 175 in the NexiumⓇ group). The proportions of patients without heartburn in the entire 4th week of treatment were not different between the two groups (33.33% in the EsoduoⓇ group and 35% in the NexiumⓇ group, p=0.737). There were no significant differences in most of the secondary and exploratory endpoints as well as the safety profiles. Conclusions: EsoduoⓇ is as effective and safe as NexiumⓇ for managing typical symptoms in patients with NERD (ClinicalTrial.gov identifier: NCT03928470).

Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis.

BACKGROUND: Fexuprazan, a novel potassium-competitive acid blocker, reversibly suppresses the K+/H+-ATPase enzyme in proton pumps within gastric parietal cells. Fexuprazan's suppression of gastric acid was maintained in healthy individuals for 24 h in a dose-dependent manner. AIM: To compare fexuprazan to esomeprazole and establish its efficacy and safety in patients with erosive esophagitis (EE). METHODS: Korean adult patients with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg or esomeprazole 40 mg once daily for eight weeks. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy at week 8. The secondary endpoints included the healing rate of EE at week 4, symptom response, and quality of life assessment. Safety profiles and serum gastrin levels were compared between the groups. RESULTS: Of the 263 randomized, 218 completed the study per protocol (fexuprazan 40 mg, n = 107; esomeprazole 40 mg, n = 111). Fexuprazan was non-inferior to esomeprazole regarding the healing rate at week 8 [99.1% (106/107) vs 99.1% (110/111)]. There were no between-group differences in the EE healing rate at week 4 [90.3% (93/103) vs 88.5% (92/104)], symptom responses, and quality of life assessments. Additionally, serum gastrin levels at weeks 4 and 8 and drug-related side effects did not significantly differ between the groups. CONCLUSION: Fexuprazan 40 mg is non-inferior to esomeprazole 40 mg in EE healing at week 8. We suggest that fexuprazan is an alternative promising treatment option to PPIs for patients with EE.

Rates and Risk Factors for Interval Gastric Cancers at Screening Gastroscopy.

BACKGROUNDS/AIMS: Interval gastric cancers (GCs) can be encountered during screening gastroscopy. This study investigated the rate of interval GCs and their risk factors. MATERIALS AND METHODS: We retrospectively investigated subjects who underwent screening gastroscopy from 2005 to 2017 in a university hospital and were diagnosed with GC. Subjects were grouped based on their endoscopic images and descriptive results into interval GC and initially diagnosed GC groups. Interval GCs were defined when endoscopic results within the previous 3 years were negative for GC. The clinico-pathological characteristics of the groups and risk factors for interval GCs were evaluated. RESULTS: Of 54 724 subjects who underwent screening gastroscopy, 234 were diagnosed with GC, of which 43 were interval GCs. The rate of interval GCs was 18.4% (43/234, mean age 61.6 years). Interval GCs were smaller than initially diagnosed GCs (1.6 vs 1.9 cm, P = .011). They were located in the low-to-mid-body in 44.2%, antrum in 48.8%, and high body and cardia in 7%. Their observation time was shorter (248.74 vs 410.64 sec, P = .032). In multivariate analysis, they were associated with short observation time (odds ratio [OR] 0.99, 95% CI 0.994-0.998, P < .001) and location in the low-to-mid-body (OR 2.12, 95% CI 1.071-4.181, P = .031), although differentiation, ulcerated type, metaplasia, Helicobacter pylori infection, and endoscopists' experience were not associated with interval GCs. CONCLUSIONS: The rate of interval GCs was significant during screening gastroscopy. They might be reduced by increasing observation time, focusing on smaller lesions, and observing the low-to-mid-body of the stomach more carefully.

Prevalence and clinical characteristics of antibiotics associated drug induced liver injury.

BACKGROUND: The use of antibiotics increases recently. Accordingly, the incidence of antibiotics associated with drug induced liver injury (DILI) also increases. The purpose of this study is to evaluate the proportion and the clinical characteristics of antibiotic associated with DILI. METHODS: This study is a retrospective study of analyzed adult patients who were referred to the department of hepatology for the elevation of liver function tests and the frequency of elevated liver enzyme of patients with prescribed antibiotics during the same period at outpatient setting as a validation set. RESULTS: Antibiotics associated with DILI (64.0%) are the most common reason agent among consulting to hepatology department. Rheumatoid arthritis related drugs (11.0%), health supplements (5.0%), herbal medicines (4.0%), anti-viral drugs, anti-inflammatory analgesics/acetaminophen and lipid-lowering agents (3.0%) were next common causative drug for DILI in inpatients setting (training set). The frequency of antibiotics associated with DILI was high in order of flomoxef, cetrazole, ceftriaxone, vancomycin, piperacillin/tazobactam and amoxicillin/clavulanate. In the same period, 32% of the patients who prescribed flomoxef showed elevated liver enzyme levels above the upper normal limit. The prevalence of flomoxef induced DILI (>3 folds of ALT) was 13% and liver enzyme levels were five times higher than upper normal limits in 5% of flomoxef groups. Hypertension or diabetes was the risk factor of flomoxef associated with DILI. CONCLUSIONS: The Prevalence of antibiotics associated with DILI was 2-14%. Co-morbidity with diabetes and hypertension was the risk factor of flomoxef associated with DILI.

Diagnostic Performance of Serum Asialo α1-Acid Glycoprotein Levels to Predict Liver Cirrhosis.

Background/Aims: To date, studies on various noninvasive techniques have been suggested to evaluate the degree of liver fibrosis. We aimed to investigate the diagnostic performance of serum asialo α1-acid glycoprotein (AsAGP) in the diagnosis of liver cirrhosis compared with chronic hepatitis for clinically useful result. Methods: We conducted a case-control study of 96 patients with chronic liver disease. Chronic hepatitis was defined as the presence of chronic liver disease on ultrasonography, with a liver stiffness of less than 5.0 kPa as shown on magnetic resonance elastography (MRE). Liver cirrhosis was defined as liver stiffness of more than 5.0 kPa on MRE. The serum AsAGP concentration was compared between the two groups. Results: Serum AsAGP levels were significantly higher in patients with cirrhosis than in those with chronic hepatitis (1.83 µg/mL vs 1.42 µg/mL, p<0.001). Additionally, when comparing patients in each cirrhotic group (Child-Pugh grades A, B, and C) to those with chronic hepatitis, AsAGP levels were significantly higher in all the cirrhotic groups (p<0.05, p<0.01, p<0.001, respectively). The sensitivity and specificity of AsAGP for detecting cirrhosis were 79.2% and 64.6%, respectively, and the area under the curve value was 0.733. The best diagnostic cutoff to predict cirrhosis was 1.4 µg/mL. AsAGP and bilirubin were found to be independent risk factors for the prediction of cirrhosis in the logistic regression analysis. Conclusions: Serum AsAGP showed an acceptable diagnostic performance in predicting liver cirrhosis.

Efficacy and Safety of DWJ1252 Compared With Gasmotin in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study.

BACKGROUND/AIMS: Prokinetics such as mosapride citrate CR (conventional-release; Gasmotin) are commonly used in functional dyspepsia (FD). This study aims to evaluate the efficacy and safety of once-a-day mosapride citrate SR (DWJ1252), a sustained-release formulation of mosapride citrate, compared with mosapride citrate CR 3 times a day, in patients with FD. METHODS: In this multicenter, randomized, double-blind, active-controlled, non-inferiority study, 119 patients with FD (by the Rome III criteria, 60 for mosapride citrate SR and 59 for mosapride citrate CR) were randomly allocated to mosapride citrate SR once daily or mosapride citrate CR thrice daily for 4 weeks in 16 medical institutions. Primary end point was the change in gastrointestinal symptom (GIS) score from baseline, assessed by GIS questionnaires on 5-point Likert scale after 4-week treatment. Secondary end points and safety profiles were also analyzed. RESULTS: The study included 51 and 49 subjects in the mosapride citrate SR and mosapride citrate CR groups, respectively. GIS scores at week 4 were significantly reduced in both groups (mean ± SD: -10.04 ± 4.45 and -10.86 ± 5.53 in the mosapride citrate SR and mosapride citrate CR groups, respectively; P < 0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, -1.17, 2.81; P = 0.643). Changes in GIS at weeks 2 and 4 and quality of life at week 4, and the improvement rates of global assessments at weeks 2 and 4, did not differ between the groups. Adverse events were similar in the 2 groups, and there were no serious adverse events. CONCLUSION: In patients with FD, mosapride citrate SR once daily is as effective as mosapride citrate CR thrice daily, with a similar safety profile.

Correlation between Three-Dimensional Volume and Malignant Potential of Gastrointestinal Stromal Tumors (GISTs).

BACKGROUND AND PURPOSE: Gastrointestinal stromal tumors (GISTs) are rare diseases of the gastrointestinal tract but they are the most common gastrointestinal tumors of mesenchymal origin. Since most GISTs have malignant potential, their probability of malignant progression must be evaluated. This study was conducted to examine the correlation between three-dimensional GIST volume measured by CT and malignant potential. MATERIALS AND METHODS: A retrospective study was performed on 70 patients diagnosed with GIST after surgical resection in Hanyang University Seoul Hospital from 2012 to 2017. Linear regression analysis was used to establish which between the length of the long axis of GISTs, originally considered a predictor of malignancy, and their volume was a more accurate predictor of malignancy. Tumor dimensions were measured by CT. RESULTS: Data were analyzed using the chi-square test or Student's t-test and logistic regression. Of the GISTs, 53 (75.71%) were in the stomach, 3 (4.29%) in the small intestine, and 14 (20.0%) in the large intestine. The mean age of the malignant GIST group was significantly higher than that of the benign GIST group (p = 0.032), their tumor long axes were significantly greater (p = 0.073), their tumor volumes were significantly larger (p = 0.001), and the frequency of tumor necrosis was higher (p = 0.001). In multivariate analysis, malignant GIST was associated with location in organs other than the stomach (OR 7.846, 95% CI 1.293-47.624, p = 0.025), longer axis (OR 1.037, 95% CI 1.011-1.065, p = 0.006), larger volume (OR 1.003, 95% CI 1.000-1.006, p = 0.029), and necrosis (OR 12.222, 95% CI 1.945-76.794, p = 0.008). The mean age of the recurrent GIST group was higher than that of the non-recurrent group (p = 0.045), their tumor long axes were significantly longer (p = 0.005), and their volumes were greater, but this last difference was not significant (p = 0.072). CONCLUSIONS: Tumor volume can be considered an additional risk factor in assessing the malignant potential of GISTs and tends to increase in recurrent GISTs.

Effect on Bleeding Prevention of an Intravenous Proton Pump Inhibitor During the Fasting Period After Endoscopic Submucosal Dissection: a Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: No consensus has been achieved on optimal perioperative strategies for patients undergoing endoscopic submucosal dissection (ESD). The aim of this study was to investigate the effects of an intravenous (IV) proton pump inhibitor (PPI) given during the fasting period after ESD on delayed bleeding following ESD. METHODS: This study was designed as a prospective, randomized, double-blind, placebo-controlled trial in a single center. A total of 235 patients who underwent ESD for adenoma and early gastric cancer between March 2016 and September 2018 were randomized into a PPI group and placebo group. Patients were administrated intravenous pantoprazole 40 mg daily (PPI group) or placebo (placebo group) during the fasting period 48 h after ESD (from the day of ESD to the following day, 48 h). After oral feeding (48 h after ESD), oral PPI was given to both groups for 8 weeks. RESULTS: Among 235 patients in the intention-to-treat (ITT) and 195 in the per-protocol (PP) analysis, there was no significant difference between the PPI and control groups in major bleeding (PPI vs. placebo; 3.3% vs. 1.7%, p = 0.27) or minor bleeding (PPI vs. placebo; 7.6% vs. 4.3%, p = 0.41) after ESD. There was no significant difference in age (p = 0.28), histology (p = 0.75), tumor size (p = 0.48), or procedure time (p = 0.49) between the two groups. The only independent risk factor for major delayed bleeding was the combined use of aspirin and antiplatelet agent (OR; 12.25, 95% CI; 1.06-141.19, p = 0.04). CONCLUSIONS: Administration of routine IV PPI during the fasting period 48 h after ESD does not reduce delayed post-ESD bleeding.

Risk Factors and Clinical Outcomes of Non-Curative Resection in Patients with Early Gastric Cancer Treated with Endoscopic Submucosal Dissection: A Retrospective Multicenter Study in Korea.

BACKGROUND/AIMS: The purpose of this study was to investigate the risk factors and long-term clinical outcomes of non-curative resection (NCR) in a large-scale patient population. METHODS: We retrospectively analyzed the clinical data of 3,094 patients who underwent endoscopic submucosal dissection (ESD) of early gastric cancer from March 2005 to March 2018 at 13 institutions in Korea. We analyzed the risk factors for NCR and the survival between patients with curative resection and those with NCR with no additional treatment. RESULTS: The NCR rate was 21.4% (661/3,094). In multivariate regression analysis, the risk factors affecting NCR with ESD were old age, undifferentiated tumor, tumor location in the upper body, tumor size ≥2 cm, and presence of an ulcer. In Cox proportional hazard regression analysis, tumor size ≥2 cm, submucosal invasion, positive horizontal margin, and lymphovascular invasion were risk factors for local recurrence. In Kaplan-Meier analysis, there was no statistically significant difference in the overall survival between the two groups (log-rank p=0.788). However, disease-specific survival was significantly lower in the NCR group (log-rank p=0.038). CONCLUSION: Clinicians should be aware of the risk factors for NCR and local recurrence after ESD for early gastric cancer, and should consider providing additional treatment after NCR.

Efficacy and Safety of AlbisD Compared With Omeprazole 20 mg in Patients With Non-erosive Reflux Disease: A Randomized, Open-label, Active-controlled, Pilot Study.

BACKGROUND/AIMS: Proton pump inhibitors (PPIs) are frequently used to treat non-erosive reflux disease (NERD), but their effect is limited. It is not known whether a potential alternative, AlbisD, containing ranitidine hydrochloride, sucralfate hydrate, and tripotassium dicitrato bismuthate, is effective and safe in treating NERD. The aim of the study is to evaluate the efficacy and safety of AlbisD compared with omperazole in patients with NERD. METHODS: This was a multicenter, randomized, open-label, parallel-group, non-inferiority comparative study. A total of 126 patients with NERD were randomly allocated to either AlbisD twice daily or omeprazole 20 mg once daily for 4 weeks from February 2016 to August 2016. The study patients had histories of heartburn or regurgitation of moderate severity (> score 2) and a frequency of at least 2 episodes per week, and had no mucosal breaks of the esophagus on endoscopy. The primary efficacy variable was complete cure of heartburn at week 4. Secondary efficacy variables evaluating symptoms of heartburn and acid reflux as well as safety profiles were compared in the 2 groups at week 2 and 4 after treatment. RESULTS: A total of 113 patients completed the study (57 and 56 in AlbisD and omeprazole groups, respectively). The proportion of patients with complete cure of heartburn at week 4 was not significantly different between the AlbisD and omeprazole groups (35.1% vs 32.1% respectively, P = 0.740). There were no significant differences between the 2 groups in the any secondary variables including proportions of days without heartburn or acid reflux over 4 weeks (including daytime and nighttime). Adverse events were similarly reported in the 2 groups (7 [12.3%] vs 6 [10.7%]), and there were no serious adverse events. CONCLUSIONS: The efficacy and safety of AlibsD in treating NERD patients are not inferior to those of omeprazole. Therefore, AlbisD can be an alternative to PPIs for NERD.

Low-Dose Propranolol as Secondary Prophylaxis for Varix Bleeding Decreases Mortality and Rebleeding Rate in Patients with Tense Ascites.

BACKGROUND AND AIM: The risk and benefit of non-selective propranolol in patients with tense ascites are controversial. This study aimed to investigate the effect of propranolol as secondary prophylaxis on varix rebleeding and overall mortality in patients with tense ascites. METHODS: This study used a database of the Health Insurance Review and Assessment Service (HIRAS), which provides health insurance to 97.2% of the total population in Korea. A total of 80,071 patients first variceal bleeding as the first decompensated complication enrolled from 2007 to 2014. RESULTS: There were 2274 patients with large-volume ascites prescribed propranolol as secondary prophylaxis after first varix bleeding. The average prescription dose of propranolol as secondary prophylaxis was 74 mg/day in patients with large-volume ascites. The mean duration of rebleeding was 22.8 months. Result of analysis showed that low-dose propranolol (40-120 mg/day) compared to inadequate propranolol dose (<40 mg/day) as secondary prophylaxis decreased overall mortality and varix rebleeding in patients with tense ascites. CONCLUSIONS: Low-dose propranolol (40-120 mg/day) as secondary prophylaxis for variceal re-bleeding decreased overall mortality and varix rebleeding recurrence in patients with tense ascites.

Lifestyle predictors of obese and non-obese patients with nonalcoholic fatty liver disease: A cross-sectional study.

BACKGROUND & AIMS: Most people with nonalcoholic fatty liver disease (NAFLD) are obese, and they usually eat more while being less physically active as compared to healthy individuals. However, little is known about the lifestyle patterns of non-obese or obese patients with NAFLD. The aim of this study was to investigate nutrition components and behavioral differences between non-obese and obese patients with NAFLD. METHODS: This is a cross-sectional study comprising of 209 patients. Nutritional components and physical activity status were compared in obese and non-obese subjects with NAFLD against healthy controls. Dietary intake was assessed using the 5-day food diary. Physical activity was measured using the protocol of Korea Health and Nutrition Examination Survey. Total and regional body composition analysis was conducted using anthropometry and tetrapolar multi-frequency bio-impedance. Visceral adipose tissue, total abdominal adipose tissue, abdominal subcutaneous adipose tissue as well as liver fat were measured using abdomen tomography. RESULTS: Non-obese subjects with NAFLD had higher levels of ALT, AST, GGT, triglyceride, fasting glucose; higher carbohydrate energy ratio; higher visceral fat area, subcutaneous area, body muscle mass, fat free mass and body fat compared to subjects without NAFLD. Subjects with obesity and NAFLD had higher ALT, AST, visceral fat, fasting glucose and HOMA-IR (homeostatic model assessment-insulin resistance), and less moderate-level physical activity compared to those with obesity who do not have NAFLD. Obese subjects with NAFLD also had higher blood pressure, visceral fat area, subcutaneous fat area, body fat, body fat percent and GGT compared to non-obese subjects with NAFLD. In multivariate analysis, carbohydrate energy ratio and physical activity less than moderate-level (<2 h/week) were predictors of NAFLD in non-obese subjects independent of the visceral fat, body muscle index, total energy intake, age and sex. Physical activity less than moderate-level was a predictor of NAFLD in obese subjects with NAFLD, independent of the HOMA-IR, visceral fat, total energy intake, fat energy percent, age and sex. CONCLUSIONS: Percentage of carbohydrate intake percent and physical activity, less than moderate-level were independent predictors of NAFLD in non-obese subjects. Meanwhile, physical activity, less than moderate-level, was an independent predictor in obese subjects.

Estimating of hepatic fat amount using MRI proton density fat fraction in a real practice setting.

The recently developed magnetic resonance imaging (MRI) proton density fat fraction (PDFF) allows measurement of the fat in all segments of hepatic tissue. However, it is time consuming and inconvenient to measure each segment repeatedly. Moreover, volume of each segment also should be adjusted with arithmetic mean of the selected segments when total amount of liver fat is estimated. Therefore, we try to develop a clinically-relevant and applicable method of estimating hepatic fat in PDFF image.A total of 164 adults were enrolled. We addressed the measurement frequency and segment selection to determine the optimal method of measuring intrahepatic fat. Total hepatic fat was estimated by the weighted mean of each segment reflecting their respective segmental volumes. We designed 2 models. In Model 1, we determined the segment order by which the mean was closest to the whole weighted mean. In Model 2, we determined the segment order by which the arithmetic mean of the selected segments was closest to the whole weighted mean.Fat fraction (FF) was most important risk factor of hepatic heterogeneity in multivariable analysis (ß = 0.534, P < .001). In severe fatty liver (FF > 22.1%), intrahepatic fat variability was 2.47% (1.16-6.26%). The arithmetic mean total intrahepatic FF was 12.66%. But the weighted mean that applied to each segmental volume was 12.90%. In Model 1, arithmetic mean of segments 4 and 5 was closest to the total estimated hepatic fat amount. However, when we added segment 8, the mean of segments 4, 5, and 8 was significantly different from the estimated total hepatic fat amount (P = .0021). In Model 2, arithmetic mean of segments 4 and 5 was closest to the total estimated hepatic fat amount. There was a significant reduction in variability between segment 4 and segments 4 and 5 (P < .0001).Averaging the mean hepatic FF of segments 4 and 5 was the most reasonable method for estimating total intrahepatic fat in practice.

Patients' Preferences for Primary Colorectal Cancer Screening: A Survey of the National Colorectal Cancer Screening Program in Korea.

BACKGROUND/AIMS: The adoption of colonoscopy as a primary colorectal cancer (CRC) screening technique has been argued for in Korea, without evidence of patient preferences. This study aimed to investigate patients' preferences for the primary CRC screening test for the National Cancer Screening Program (NCSP). METHODS: Between June and August 2016, 414 individuals aged ≥50 years who participated in the NCSP were prospectively invited to complete a questionnaire regarding their preferences for the primary CRC screening test and the reasons for their selection. RESULTS: Among the 396 respondents who completed the questionnaire, 124 individuals (31.3%) preferred the fecal immunochemical test (FIT), whereas 272 individuals (68.7%) preferred colonoscopy. Elderly participants preferred the FIT (p<0.001), whereas participants with a higher education level (p=0.030), a higher income level (p=0.009), or individuals with a family member (p=0.028) or acquaintance (p=0.013) with a history of CRC preferred colonoscopy. Only 12.9% of participants had a bad experience with a previous FIT; however, 39.3% of participants had a bad experience with a previous colonoscopy. CONCLUSIONS: Colonoscopy was preferred to FIT in a 2.2:1 ratio as the primary CRC screening test for the NCSP. Patients' preference for colonoscopy should be considered for the NCSP in Korea.

Fatal lactic acidosis in hepatitis B virus-associated decompensated cirrhosis treated with tenofovir: A case report.

RATIONALE: Recently tenofovir disoproxil fumarate (TDF) has been widely used as a first-line therapy for chronic hepatitis B (CHB) infection. Although TDF demonstrates successful viral suppression, the possibility of renal failure and lactic acidosis has been proposed with TDF administration, especially in human immunodeficiency virus co-infected patients. However, TDF induced lactic acidosis has never been reported in CHB mono-infected patients. PATIENT CONCERNS: A 59-year-old man received TDF for hepatitis B associated with cirrhosis. After ten days of TDF administration, nausea, vomiting and abdominal pain developed. High anion gap acidosis with elevated lactate level (pH 7.341, pCO2 29.7 mmHg, HCO3- 15.6mmHg, lactate 3.2mmol/L, anion gap 15.4 mEq/L) was developed. DIAGNOSIS: With no infection, normal diagnostic paracentesis, and urinalysis together with high anion gap and increased blood lactate levels suggested lactic acidosis. INTERVENTIONS: TDF was stopped, and haemodialysis was performed to control lactic acidosis. OUTCOMES: Although stopping TDF instantly and treating lactic acidosis using hemodialysis, the patient died. LESSONS: Although, Fatal lactic acidosis is very rare in TDF patient, however, decompensated cirrhotic patients should be closely observed to keep the possibility of lactic acidosis in mind.