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Background/Aims: Besifovir dipivoxil maleate (BSV) and tenofovir alafenamide fumarate (TAF) have been recently approved in Korea as the initial antiviral agents for chronic hepatitis B (CHB). However, the real-world outcome data for these drugs remain limited. Therefore, we conducted a noninferiority analysis using real-world data to compare the clinical outcomes of the two nucleotide analogs in treatment-naïve patients with CHB. Methods: We retrospectively investigated a cohort of patients with CHB who received BSV or TAF as first-line antiviral agents. The endpoints were virological response (VR) and liver-related clinical outcomes. Results: A total of 537 patients, consisting of 202 and 335 patients administered BSV and TAF, respectively, were followed up for 42 months. No significant difference was observed between the VRs of the patients from the two groups. The rates of biochemical response, virologic breakthrough, and incidence rates of hepatocellular carcinoma did not differ between the groups. However, the hepatitis B e antigen seroclearance rate was higher and the renal function declined less in the BSV group. Multivariable analysis indicated older age, alcohol abuse, cirrhosis and ascites, and lower serum HBV DNA level to be independently associated with increased hepatocellular carcinoma risk. The 1:1 propensity score-matched analysis with 400 patients showed VR rates of 85.0% and 88.7% in the BSV and TAF group patients, respectively, at 2 years. The absolute value of the 95% confidence interval for the difference (–0.04 to 0.12) satisfied the a priori limit of a noninferiority of 0.15. Conclusions: BSV is noninferior to TAF in terms of VR, and their clinical outcomes are comparable to CHB. [ABSTRACT FROM AUTHOR]

Abstract: Background: The standard triple Helicobacter pylori regimen now shows unacceptably low treatment success in Korea. Administration of the concomitant therapy for 10 days, which has a high cure rate, is recommended as an alternative first‐line treatment in areas of high clarithromycin resistance including Korea. Recently, modified bismuth‐containing quadruple therapy with amoxicillin (PAM‐B therapy) showed excellent results, regardless of dual clarithromycin and metronidazole resistance. This study compared the concomitant therapy with PAM‐B therapy as a first‐line treatment for H. pylori infection. Method: Subjects infected with H. pylori and naïve to treatment were performed a head‐to‐head comparison between 10‐day concomitant therapy [rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily] and 14‐day PAM‐B therapy [rabeprazole 20 mg, amoxicillin 1 g, metronidazole 750 mg, and tripotassium dicitrato bismuthate 600 mg (elemental bismuth 240 mg) twice daily]. Six weeks after treatment, H. pylori eradication was assessed. Results: Two hundred and seventy subjects were randomized. Both regimens achieved high cure rates: 83.0% (112/135) and 88.1% (119/135) by the intention‐to‐treat analysis and 95.5% (106/111) and 96.6% (114/118) by the per‐protocol analysis, respectively. The intention‐to‐treat and per‐protocol analyses revealed no statistically significant difference in the eradication rate (P = .299 and P = .743, respectively). Rates of adverse events were similar between groups (25.2% vs 23.0%, P ‐value: .776) Adverse events, which resulted in poor compliance, occurred in six patients of each group, but there were no serious complications. Conclusions: PAM‐B therapy is as effective as concomitant therapy for eradicating H. pylori with comparative safety. PAM‐B therapy is regarded as a promising alternative to standard triple therapy for a first‐line eradication in Korea. [ABSTRACT FROM AUTHOR]

Background & Aims The aim of this study was to reveal nationwide seroprevalence of HCV infection in South Korea by a large-scale survey. Methods From January to December 2009, a total of 291 314 adults underwent health check-up in 29 centres nationwide. The data concerning anti- HCV antibody and biochemical tests were obtained from all participants. Among subjects with positive anti- HCV, such data as HCV RNA, genotypes and treatment detail were additionally analysed. Results Using an estimated 2009 population of Korea, the age, sex and area-adjusted anti- HCV positive rate was 0.78%. Anti- HCV prevalence in female patients (0.83%) was higher than that in male patients (0.75%). Gradual increase in anti- HCV positivity was observed, from 0.34% in those aged 20-29 years to 2.31% in those >70 years. The age- and sex-adjusted anti- HCV prevalence varied in different areas, being higher in Busan and Jeonnam (1.53-2.07%), mid-level in Seoul and surrounding districts (0.50-0.61%) and lower in Jeju (0.23%). The comparative analysis of laboratory variables between anti- HCV (+) and anti- HCV (−) group revealed significantly higher levels of alanine aminotransferase and lower levels of serum lipids in anti- HCV (+) group. Among 1 718 anti- HCV positive subjects, serum HCV RNA was measured only in 478 people, of whom 268 (56.1%) patients had detectable HCV RNA in serum. Among 50 patients for whom assessment of response to antiviral therapy was feasible, overall sustained virological response was achieved in 84% of patients. Conclusion The prevalence of HCV infection is low in South Korea. Studies to analyse risk factors are warranted to reduce HCV infection. [ABSTRACT FROM AUTHOR]

Background and Aims: Currently, it is difficult to predict the reversibility of renal function and to discriminate renal parenchymal injury in cirrhotic patients with acute kidney injury (AKI). The aim of this study is to evaluate whether urine N-acetyl-β-d-Glucosaminidase (NAG) can predict the survival and response to terlipressin in cirrhotic patients with AKI. Methods: Two hundred sixty-two cirrhotic consecutive patients who developed AKI were prospectively enrolled from 11 tertiary medical centers in Korea between 2016 to 2019. AKI was defined as an increase in serum Cr (SCr) of 0.3 mg/dL or a 50% increase in baseline SCr. Patients diagnosed with hepatorenal syndrome (HRS-AKI) were treated with terlipressin plus albumin. Results: The patients were 58.8 ± 12.9 years old on average and were predominantly male (72.5%). The mean MELD score was 25.3 ± 9.1. When classified according to the AKI phenotype, there were 119 pre-renal, 52 acute tubular necrosis, 18 miscellaneous, and 73 HRS-AKI patients. However, the urine NAG was not effective at discriminating AKI phenotypes, except for HRS-AKI. The baseline urine NAG increased as the baseline AKI stage increased (p < 0.001). In addition, within the same AKI stage, the urine NAG values were significantly lower in the AKI-resolved group than in the unresolved group. The urine NAG level was significantly lower in living patients compared with those who died or who underwent a liver transplant within 3 months (p = 0.005). In the multivariate analysis, the increased urine NAG was a significant risk factor for the 3-month transplant-free survival (TFS) rate, especially in patients with Child–Pugh class ≤ B or MELD < 24. The urine NAG did not predict the response to terlipressin treatment in patients with HRS. Conclusions: Urine NAG is strongly associated with the severity of AKI in patients with liver cirrhosis and is useful for predicting the 3-month TFS. [ABSTRACT FROM AUTHOR]

Background/Aims Recently, we reported that modified bismuth quadruple therapy in which tetracycline was replaced by amoxicillin (PAM-B therapy) showed excellent clinical results in Korea. Further prospective longitudinal analysis with larger number was performed in our hospital. The aim of this study was to evaluate the effectiveness of a first line 14-day PAM-B therapy and investigate the optimal rescue treatment for the first-line treatment failure. Methods A prospective observational study of Helicobacter pylori eradication was conducted in a single institute. A total of 324 treatment-naïve patients with active H. pylori infections, who were positive for H. pylori between April 2016 and January 2019, were included for analysis. All enrolled patients were treated with 14-day PAM-B therapy (rabeprazole 20 mg, amoxicillin 1 g, metronidazole 750 mg, and tripotassium dicitrato bismuthate 600 mg (elemental bismuth 240 mg twice daily). Six weeks after treatment, H. pylori eradication was assessed. Results Among the 324 participants, 30 patients were lost to follow-up and nine patients consumed less than 80% of prescribed medication. So, the overall eradication rates by intention- to-treat (ITT) and per-protocol (PP) analyses were 83.0% (269/324) and 94.4% (269/285). All 298 patients who received a dose and for whom an outcome measure is available, 19 patients including three patients of low compliance were failed to eradicate H. pylori with PAM-B therapy (modified ITT= 93.6% [279/298]). In 16 patients of treatment failure despite of good compliance, 11 patients were agreed to treat with 2nd line treatment with conventional bismuth-containing quadruple therapy. Among them, eradication rate was 88.9% (8/9) except two follow-up loss patients. Conclusions PAM-B therapy was highly effective as a first line therapy for H. pylori eradication. Conventional bismuth quadruple therapy is thought to be sufficient as a rescue therapy. [ABSTRACT FROM AUTHOR]

Recurrent episodes of liver injury may either waste hepatic reserve or induce tolerance to further injury. We aimed to investigate whether the previous acute decompensation (AD) in liver cirrhosis (LC) affects the long-term transplant-free survival of patients with alcoholic hepatitis (AH). The survival data of 894 alcoholic LC cohort who had been admitted with acute deterioration in 21 academic hospitals in Korea were prospectively followed up. Enrolled patients were divided into three groups: Group 1, without AH; group 2, with nonsevere AH; and group 3, with severe AH. Although the baseline liver function was not different between the groups with or without previous AD, it was a significant predictor of poor long-term outcomes. The presence of previous AD negatively affected long-term overall survival (HR 1.62, 95% C.I. 1.20–2.18, p = 0.002) in groups 1 and 2 as a whole, independent of the Model for End-stage Liver Disease score. The three-month conditional survival was significantly worse in group 3 for up to 12 months in the presence of previous AD (p < 0.05). We concluded that not only the severity of AH, but also the prior AD is an important predictor of long-term outcomes in alcoholic LC patients with acute deterioration. [ABSTRACT FROM AUTHOR]