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Background: Patients with decompensated cirrhosis are well known to experience morbidity and mortality. Aim: We assessed clinical characteristics, health‐care utilization, and economic burden according to the type, number, and combination of decompensation‐related complications. Methods: We used recent nationally representative sample data from 2016 to 2018, covering approximately 13% of hospitalized patients in South Korea annually. Decompensation‐related complications included ascites, hepatic encephalopathy (HE), gastroesophageal variceal (GEV) bleeding, and hepatorenal syndrome (HRS). Results: Among 14 601 patients with decompensated cirrhosis, 11 201 (76.7%) experienced ≥ 1 decompensation‐related complications, and approximately three‐quarters underwent hospitalization. The most prevalent decompensation‐related complications were ascites (54.8%), GEV bleeding (33.2%), HE (27.4%), and HRS (3.6%). Patients with GEV bleeding exhibited the highest hospitalization rate (95.7%), and patients with HE or HRS underwent hospitalization for 4 weeks/year due to decompensated cirrhosis. Hospitalization costs were 1.9 times higher in patients with HRS than in those with ascites alone ($9022 vs $4673; P < 0.01). Once patients developed decompensation‐related complications, 41.3% had ≥ 2 types of decompensation‐related complications. As the number of decompensation‐related complications increased from 0 to ≥ 3, health‐care utilization and economic burden significantly increased in a stepwise manner; patients with ascites, GEV bleeding, and HE visited medical institutions 2.2 times more (11 vs 5/year; P < 0.01) and incurred 6.4 times greater medical expenditure ($11 060 vs $1728/year; P < 0.01) than those with ascites only. Conclusion: A substantial proportion of patients had multiple decompensation‐related complications and socioeconomic burdens for decompensated cirrhosis considering admission rate, hospital stay, and costs increased markedly, depending on the number of decompensation‐related complications. [ABSTRACT FROM AUTHOR]

Introduction: Long-term complications of chronic hepatitis B (CHB) viral infection, such as cirrhosis, hepatocellular carcinoma (HCC), and liver failure, cause a large disease burden. This study aimed to describe the epidemiology, clinical outcomes, and treatment patterns of CHB infection and co-infection with hepatitis D virus (HDV) in South Korea. Methods: The retrospective, observational study used existing data from the Health Insurance Review and Assessment Service (HIRA) database. Confirmed cases of (CHB) and HBV/HDV co-infection were identified between 2013 and 2019. Hepatitis C virus co-infections and acute HBV infections were excluded. Incident cases diagnosed between 2015 and 2018 with no prior disease history up to 2 years were included. Patient characteristics, clinical outcomes, economic burden, and healthcare-resource utilization were described. Results: The estimated 7-year prevalence of CHB and HBV/HDV co-infection were 0.9% and 0.0024%, respectively. The prevalence was higher among 45–54 years old (CHB: 1.6%, HBV/HDV: 0.0049%) and males (1.1%, 0.0035%). The 5-year cumulative incidences of compensated cirrhosis, decompensated cirrhosis, HCC, and liver transplantation were 13.3%, 7.1%, 8.4%, and 0.7%, respectively. Hyperlipidemia (40.6%), hypertension (23.5%), and peptic ulcer (23.7%) were the more prevalent comorbidities. Among CHB patients, 48.1% received ≥ 1 prescribed anti-HBV drug including interferon or nucleos(t)ide analogues and 64.4% had ≥ 1 hospitalization compared to 80.4% and 79.4% HBV/HDV patients. Estimated total healthcare costs for CHB and HBV/HDV were US$786 million and $62 million, respectively. Conclusions: These findings provide insights to the epidemiology, clinical burden, treatment patterns, and healthcare costs of CHB and HBV/HDV co-infection in South Korea. [ABSTRACT FROM AUTHOR]

Background/Aim: In the era of direct‐acting antivirals (DAA), active screening for hidden hepatitis C virus (HCV) infection is important for HCV elimination. This study estimated the cost‐effectiveness and health‐related outcomes of HCV screening and DAA treatment of a targeted population in Korea, where anti‐HCV prevalence was 0.6% in 2015. Methods: A Markov model simulating the natural history of HCV infection was used to examine the cost‐effectiveness of two strategies: no screening vs screening and DAA treatment. Screening was performed by integration of the anti‐HCV test into the National Health Examination Program. From a healthcare system's perspective, the cost‐utility and the impact on HCV‐related health events of one‐time anti‐HCV screening and DAA treatment in Korean population aged 40‐65 years was analysed with a lifetime horizon. Results: The HCV screening and DAA treatment strategy increased quality‐adjusted life years (QALY) by 0.0015 at a cost of $11.27 resulting in an incremental cost‐effectiveness ratio (ICER) of $7435 per QALY gained compared with no screening. The probability of the screening strategy to be cost‐effective was 98.8% at a willingness‐to‐pay of $27 205. Deterministic sensitivity analyses revealed the ICERs were from $4602 to $12 588 and sensitive to screening costs, discount rates and treatment acceptability. Moreover, it can prevent 32 HCV‐related deaths, 19 hepatocellular carcinomas and 15 decompensated cirrhosis per 100 000 screened persons. Conclusions: A one‐time HCV screening and DAA treatment of a Korean population aged 40‐65 years would be highly cost‐effective, and significantly reduce the HCV‐related morbidity and mortality compared with no screening. [ABSTRACT FROM AUTHOR]

Summary: Background: Antiviral treatment in patients with chronic hepatitis B (CHB) may decrease the risk of hepatocellular carcinoma (HCC) and death. However, only 2.2% of CHB patients receive antiviral treatment globally. The complexity and strictness of the current clinical practice guidelines may limit expanding the treatment coverage for CHB. Aims: To examine the impact of expanding treatment criteria on future disease burden in Korea, a hepatitis B virus (HBV) endemic country with high diagnostic rates. Materials: Dynamic country‐level data were used to estimate the HCC incidence, overall mortality and economic impact of three incremental scenarios compared to the base case in Korea through 2035. Results: In 2020, 1,409,000 CHB cases were estimated, with the majority born before 1995. All scenarios assumed treating 70% of eligible individuals. The first scenario removed viral load restrictions in cirrhotic patients, which would avert 13,000 cases of HCC and save 11,800 lives. The second scenario, lowering the alanine aminotransferase (ALT) level restriction to the upper limit of the normal in non‐cirrhotic patients, would avert 26,700 cases of HCC and save 23,300 lives. The last scenario removed the restriction by ALT and HBeAg in treating non‐cirrhotic individuals with a viral load of ≥2000 IU/ml, which would avert 43,300 cases of HCC and save 37,000 lives. All scenarios were highly cost‐effective. Conclusions: Simplifying and expanding treatment eligibility for CHB would save many lives and be highly cost‐effective when combined with high diagnostic rates. These dynamic country‐level data may provide new insights for their global application. [ABSTRACT FROM AUTHOR]

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]

Simple Summary: This study investigated the mortality rates and causes of death in patients with chronic hepatitis B (CHB) according to cirrhosis. Over a 10-year follow-up period of 223,424 patients (cohort 1) with CHB, the overall mortality was 1.54 per 100 person-years. The mortality associated with HCC was the highest (0.65 per 100 person-years), followed by mortality related to extrahepatic malignancies (0.26 per 100 person-years), and cardio/cerebrovascular diseases (0.18 per 100 person-years). In the non-cirrhotic CHB (87.4%), 70% (11,198/15,996) of patients died due to non-liver related causes, and mortality due to extrahepatic malignancies had the highest rate (0.23 per 100 person-years). Considering that mortality related to HCC decreased and mortality related to extrahepatic malignancies increased in the antiviral era of CHB, it will be important to develop customized strategies for aging CHB cohort to reduce mortality. (1) Background: Accurate statistics on the causes of death in patients with chronic hepatitis B (CHB) are lacking. We investigated mortality rates and causes of death over time. (2) Methods: Data on patients newly diagnosed with CHB from 2007 to 2010 (cohort 1, n = 223,424) and 2012 to 2015 (cohort 2, n = 177,966) were retrieved from the Korean National Health Insurance Service. Mortality data were obtained from Statistics Korea. The causes of death were classified as liver-related (hepatic decompensation or hepatocellular carcinoma [HCC]) or extrahepatic (cardiovascular-related, cerebrovascular-related, or extrahepatic malignancy-related). (3) Results: Over a 10-year follow-up period of 223,424 patients (cohort 1) with CHB, the overall mortality was 1.54 per 100 person-years. The mortality associated with HCC was the highest (0.65 per 100 person-years), followed by mortality related to extrahepatic malignancies (0.26 per 100 person-years), and cardio/cerebrovascular diseases (0.18 per 100 person-years). In the non-cirrhotic CHB (87.4%), 70% (11,198/15,996) of patients died due to non-liver-related causes over ten years. The 10-year overall mortality was 0.86 per 100 person-years. Among these, mortality due to extrahepatic malignancies had the highest rate (0.23 per 100 person-years), followed by mortality related to HCC (0.20 per 100 person-years), and cardio/cerebrovascular diseases (0.16 per 100 person-years). The 5-year mortality associated with extrahepatic malignancies increased from 0.36 per 100 person-years (cohort 1) to 0.40 per 100 person-years (cohort 2). (4) Conclusions: Mortality related to HCC decreased, whereas mortality related to extrahepatic malignancies increased in the antiviral era. Extrahepatic malignancies were the leading cause of death among patients with CHB without cirrhosis. [ABSTRACT FROM AUTHOR]

Background As a rare disease, only a few population-based epidemiology studies of primary biliary cirrhosis ( PBC) have been reported. Aims To elucidate the nationwide prevalence, incidence, complications, fatality and direct medical costs of PBC in South Korea. Methods The nationwide Health Insurance Review and Assessment Service claims data and Rare Intractable Disease registration data on PBC, identified with the International Classification of Diseases ( ICD) 10 code of K74.3, were obtained from 2009 to 2013. Age- and gender-specific prevalence and incidence rates of PBC were calculated, and data on complications, comorbidities, prescribed drugs, therapeutic procedures and direct medical costs were analysed. Results A total of 2824 patients over 20 years old with PBC were identified in 2009-2013 (female-to-male ratio 6.2, median age 57 years old). The average age- and sex-adjusted incidence from 2011 to 2013 was 8.57 per million per year, and the average age- and sex-adjusted prevalence from 2009 to 2013 was 47.50 per million population. About 10% of patients presented with complications such as ascites (10.3%), variceal bleeding (5.8%) and/or hepatocellular carcinoma ( HCC) (1.3%). Liver transplantation was undertaken in 71 patients (2.5%) for 5 years. Case fatality was 2.2% and the transplantation-free survival was 95.4% for 5 years. Conclusions This is the first report on the nationwide epidemiology of primary biliary cirrhosis in South Korea, demonstrating lower incidence and prevalence rates than those of Western countries, but a considerable disease burden, representing at least 10% were complicated with decompensated cirrhosis or hepatocellular carcinoma requiring liver transplantation. [ABSTRACT FROM AUTHOR]

• The hepatocellular carcinoma risk was not statistically different between the ETV and TDF groups. • The death or liver transplant risk was not statistically different between the 2 groups. • These results were consistently reproduced after adjusting for confounding variables. It is currently unclear which antiviral agent, entecavir (ETV) or tenofovir disoproxil fumarate (TDF), is superior for improving prognosis in patients with chronic hepatitis B (CHB). Here, we assessed the ability of these 2 antivirals to prevent liver-disease progression in treatment-naïve patients with CHB. From 2012 to 2014, treatment-naïve patients with CHB who received ETV or TDF as a first-line antiviral agent were recruited from 4 academic teaching hospitals. Patients with decompensated cirrhosis or hepatocellular carcinoma (HCC) at enrollment were excluded. Cumulative probabilities of HCC and death or orthotopic liver transplant (OLT) were assessed. In total, 2,897 patients (1,484 and 1,413 in the ETV and TDF groups, respectively) were recruited. The annual HCC incidence was not statistically different between the ETV and TDF groups (1.92 vs. 1.69 per 100 person-years [PY], respectively; adjusted hazard ratio [HR] 0.975 [ p = 0.852] by multivariate analysis). Propensity score (PS)-matched and inverse probability of treatment weighting (ITPW) analyses yielded similar patterns of results (HR 1.021 [ p = 0.884] and 0.998 [ p = 0.988], respectively). The annual incidence of death or OLT was not statistically different between the ETV and TDF groups (0.52 vs. 0.53 per 100 PY, respectively; adjusted HR 1.202 [ p = 0.451]). PS-matched and ITPW analyses yielded similar patterns of results (HR 1.248 [ p = 0.385] and 1.239 [ p = 0.360], respectively). These findings were consistently reproduced in patients with compensated cirrhosis (all p >0.05). The overall prognosis in terms of HCC and death or OLT was not statistically different between the ETV and TDF groups. Further studies are needed to validate our results. It is currently unclear which antiviral agent, entecavir or tenofovir disoproxil fumarate, is superior for improving prognosis in patients with chronic hepatitis B virus infection. In this analysis we found that there was no difference in terms of overall prognosis, including risk of hepatocellular carcinoma, death, or the need for a liver transplant, in patients receiving either antiviral. [ABSTRACT FROM AUTHOR]

Above all, as indicated, we compared the risk of HCC development between 2 groups among a study population, including patients with decompensated cirrhosis, to find that a similar outcome between 2 treatment groups was consistently maintained (p = 0.289). As mentioned, since we also excluded patients with decompensated cirrhosis at enrollment, the range of prothrombin time-international normalization ratio (PT-INR) was very narrow in our study population and we did not have to consider the effect of ascites or Child-Pugh score. 1 Y. Yu, J. Zhang, B. Zhang, J. Gao, Comment on the article 'A multi-center study of entecavir vs. tenofovir on prognosis of treatment-naïve chronic hepatitis B in the Republic of Korea'. [Extracted from the article]

Background: Alcoholic liver disease (ALD) is still increasing and leads to acute liver injury but also liver cirrhosis and subsequent complications such as liver failure or hepatocellular carcinoma (HCC). As most patients fail to achieve alcohol abstinence, it is essential to identify alternative treatment options in order to improve the outcome of ALD patients. Methods: Evaluating two large cohorts of patients with ALD from the USA and Korea with a total of 12,006 patients, we investigated the effect on survival of aspirin, metformin, metoprolol, dopamine, and dobutamine drugs in patients with ALD between 2000 and 2020. Patient data were obtained through the "The Observational Health Data Sciences and Informatics consortium," an open-source, multi-stakeholder, and interdisciplinary collaborative effort. Results: The use of aspirin (p = 0.000, p = 0.000), metoprolol (p = 0.002, p = 0.000), and metformin (p = 0.000, p = 0.000) confers a survival benefit for both AUSOM- and NY-treated cohorts. Need of catecholamines dobutamine (p = 0.000, p = 0.000) and dopamine (p = 0.000, p = 0.000) was strongly indicative of poor survival. β-Blocker treatment with metoprolol (p = 0.128, p = 0.196) or carvedilol (p = 0.520, p = 0.679) was not shown to be protective in any of the female subgroups. Conclusion: Overall, our data fill a large gap in long-term, real-world data on patients with ALD, confirming an impact of metformin, acetylsalicylic acid, and β-blockers on ALD patient's survival. However, gender and ethnic background lead to diverse efficacy in those patients. [ABSTRACT FROM AUTHOR]

Aim and Objectives: Direct-acting antiviral (DAA) therapy can cure chronic hepatitis C (CHC), and daclatasvir (DCV)/asunaprevir (ASV) was the first interferon-free DAA therapy introduced in Korea. Patients who achieve sustained virologic response (SVR) after DAA treatment are expected to have good prognoses. Therefore, in this study, we aimed to investigate the prognosis of these patients. Materials and Methods: This multicenter prospective observational study included patients with CHC who achieved SVR after DCV/ASV treatment. The primary endpoint was hepatocellular carcinoma (HCC) occurrence, which was reviewed annually. Results: We included 302 patients (median follow-up duration: 38 [16.5–60.0] months; median age: 58 [49–67] years) in the study. Cirrhosis was observed in 103 patients (34.1%), and the median Child–Pugh score was 5.0. HCC occurred in 16 patients (5.3%) within six years post-SVR; these patients were older and had higher cirrhosis prevalence, alpha-fetoprotein levels, and fibrosis-4 index scores than did those without HCC development. Cox proportional hazards analysis revealed that age > 71 years (p = 0.005) and cirrhosis (p = 0.035) were significant risk factors for HCC occurrence. Conclusions: Although the prognoses of patients who achieved SVR with DCV/ASV therapy were generally good, the risk for HCC was present, especially in older patients and in those with cirrhosis. Hence, early treatment at younger ages and regular follow-up surveillance after achieving SVR are warranted. [ABSTRACT FROM AUTHOR]

Simple Summary: It is still controversial whether tenofovir disoproxil fumarate (TDF) has a lower risk of hepatocellular carcinoma (HCC) development than entecavir (ETV) in patients with chronic hepatitis B (CHB). Furthermore, other antiviral treatment-related outcomes need to be evaluated between the two antivirals to provide essential information for clinical practice. Using a multicenter cohort of 4210 CHB patients, we demonstrated that ETV and TDF are comparable in terms of HCC development as well as mortality, incidence of liver-related outcome, extrahepatic malignancy or new decompensation events, and seroconversion rates. Patients treated with TDF experienced more side effects than those treated with ETV. The results of this study can be applied to the development of a personalized antiviral treatment strategy for CHB patients. Tenofovir disoproxil fumarate (TDF) is reportedly superior or at least comparable to entecavir (ETV) in preventing hepatocellular carcinoma (HCC) among chronic hepatitis B (CHB) patients; however, it remains controversial. This study aimed to conduct comprehensive comparisons between the two antivirals. CHB patients initially treated with ETV or TDF between 2012 and 2015 at 20 referral centers in Korea were included. The primary outcome was the cumulative incidence of HCC. The secondary outcomes included death or liver transplantation, liver-related outcome, extrahepatic malignancy, development of cirrhosis, decompensation events, complete virologic response (CVR), seroconversion rate, and safety. Baseline characteristics were balanced using the inverse probability of treatment weighting (IPTW). Overall, 4210 patients were enrolled: 1019 received ETV and 3191 received TDF. During the median follow-ups of 5.6 and 5.5 years, 86 and 232 cases of HCC were confirmed in the ETV and TDF groups, respectively. There was no difference in HCC incidence between the groups both before (p = 0.36) and after IPTW was applied (p = 0.81). Although the incidence of extrahepatic malignancy was significantly higher in the ETV group than in the TDF group before weighting (p = 0.02), no difference was confirmed after IPTW (p = 0.29). The cumulative incidence rates of death or liver transplantation, liver-related outcome, new cirrhosis development, and decompensation events were also comparable in the crude population (p = 0.24–0.91) and in the IPTW-adjusted population (p = 0.39–0.80). Both groups exhibited similar rates of CVR (ETV vs. TDF: 95.1% vs. 95.8%, p = 0.38), and negative conversion of hepatitis B e antigen (41.6% vs. 37.2%, p = 0.09) or surface antigen (2.8% vs. 1.9%, p = 0.10). Compared to the ETV group, more patients in the TDF group changed initial antivirals due to side effects, including decreased kidney function (n = 17), hypophosphatemia (n = 20), and osteoporosis (n = 18). In this large-scale multicenter study, ETV and TDF demonstrated comparable effectiveness across a broad range of outcomes in patients with treatment-naïve CHB during similar follow-up periods. [ABSTRACT FROM AUTHOR]

Background/Aims In Korea, ledipasvir (LDV)/sofosbuvir (SOF) has been approved for the treatment of GT1/2/4/5/6 hepatitis C virus infections in adults and adolescents aged 12 to <18 years. Manufacturers in Korea are required to conduct post-marketing surveillance (PMS) and submit annual safety reports to MFDS. This study analysed the results from the 3rd LDV/SOF PMS report. Methods In this open-label, non-interventional study, case report forms of 61 patients were collected from 13 institutions in Korea from October 13, 2017 to October 12, 2018. Of these, 60 were included for safety analysis; one was excluded due to violation of the usage. Fifty-three out of the 60 patients were included in the effectiveness analysis; seven with missing information were excluded. Results Al 60 patients included were GT1-infected; 53.3% were aged ≥65 years; 51.7% were male; 35% were treatment-experienced; 40.0% and 10.0% had compensated and decompensated cirrhosis, respectively. Eighty percent had ≥1 comorbidity like history of cardiovascular disease, diabetes and hepatocellular carcinoma. Sixty-six point seven percent were on ≥1 comedication and the most commonly used medications were amlodipine, ursodeoxycholic acid and metformin. The LDV/SOF+RBV group (n=11) had more advanced liver diseases than the LDV/SOF group (n=49). The rate of adverse events (AEs) was 43.3% and was higher in the LDV/SOF+RBV (81.8%) groups. The rate of adenoma detection rates (ADRs) was 16.7% and was comparable. The most common ADRs were fatigue, headache, and nausea (n=2, respectively). Three and two patients discontinued LDV/SOF and RBV due to AEs, respectively. LDV/SOF was effective across patient subgroups; 52 out of 53 achieved SVR. Conclusions The 3rd year PMS data demonstrated a good safety profile and high effectiveness in Korean patients without significant safety signals. More cases with further information on safety and effectiveness will be collected for subsequent reports. [ABSTRACT FROM AUTHOR]

The guidelines are intended to provide practical information for the correct use of antibiotics for intra-abdominal infections in Korea. With the aim of realizing evidence-based treatment, these guidelines for the use of antibiotics were written to help clinicians find answers to key clinical questions that arise in the course of patient care, using the latest research results based on systematic literature review. The guidelines were prepared in consideration of the data on the causative pathogens of intra-abdominal infections in Korea, the antibiotic susceptibility of the causative pathogens, and the antibiotics available in Korea. [ABSTRACT FROM AUTHOR]

Background/Aims: We studied the impact of socioeconomic status (SES) on mortality in hepatocellular carcinoma patients and analyzed the effect of SES on initial treatment allocation. Methods: A cohort study was conducted using data from the National Health Insurance ServiceNational Sample Cohort of Korea. A total of 3,032 hepatocellular carcinoma patients who were newly diagnosed between January 2003 and December 2013 were included. Income level was categorized as Medical Aid and ≤30th, 31st–70th, or >70th percentile as an SES indicator. Results: The proportion of Medical Aid was 4.3%. The highest risks of all-cause mortality associated with Medical Aid were evident in the transcatheter arterial chemoembolization group (fully adjusted hazard ratio [HR], 2.40; 95% confidence interval [CI], 1.25 to 4.58), the other treatments group (fully adjusted HR, 2.86; 95% CI, 1.85 to 4.41), and the no treatment group (fully adjusted HR, 2.69; 95% CI, 1.79 to 4.04) but not in the curative treatment group. An association between the lower-income percentile and higher liver cancer-specific mortality was also observed, except in the curative treatment group. The association between income percentile and all-cause mortality was nonlinear, with a stronger association in the lower-income percentiles than in the higher income percentiles (p-value for nonlinear spline terms <0.05). Conclusions: Patients in the lower SES group, especially patients not eligible for curative treatment, had an increased risk of mortality. In addition, the association between SES and the risk for mortality was stronger in the lower-income percentile than in the moderate to higher income percentiles. [ABSTRACT FROM AUTHOR]

The total number, morbidity and mortality attributed to viraemic hepatitis C virus ( HCV) infections change over time making it difficult to compare reported estimates from different years. Models were developed for 15 countries to quantify and characterize the viraemic population and forecast the changes in the infected population and the corresponding disease burden from 2014 to 2030. With the exception of Iceland, Iran, Latvia and Pakistan, the total number of viraemic HCV infections is expected to decline from 2014 to 2030, but the associated morbidity and mortality are expected to increase in all countries except for Japan and South Korea. In the latter two countries, mortality due to an ageing population will drive down prevalence, morbidity and mortality. On the other hand, both countries have already experienced a rapid increase in HCV-related mortality and morbidity. HCV-related morbidity and mortality are projected to increase between 2014 and 2030 in all other countries as result of an ageing HCV-infected population. Thus, although the total number of HCV countries is expected to decline in most countries studied, the associated disease burden is expected to increase. The current treatment paradigm is inadequate if large reductions in HCV-related morbidity and mortality are to be achieved. [ABSTRACT FROM AUTHOR]

The role of hepatocellular carcinoma (HCC) surveillance is being questioned in alcoholic cirrhosis because of the relative low HCC risk. This study aimed to assess the risk and predictors of HCC in Korean patients with alcoholic cirrhosis by using competing risk analysis. A total of 745 patients with alcoholic cirrhosis were recruited at a university-affiliated hospital in Korea and randomly assigned to either the derivation (n = 507) and validation (n = 238) cohort. Subdistribution hazards model of Fine and Gray was used with deaths and liver transplantation treated as competing risks. Death records were confirmed from Korean government databases. A nomogram was developed to calculate the Alcohol-associated Liver Cancer Estimation (ALICE) score. The cumulative incidence of HCC was 15.3 and 13.3% at 10 years for derivation and validation cohort, respectively. Age, alpha-fetoprotein level, and albumin level were identified as independent predictors of HCC and incorporated in the ALICE score, which discriminated low, intermediate, and high risk for HCC in alcoholic cirrhosis at the cut-off of 60 and 100. The risk of HCC can be stratified by using a combination of readily available clinical parameters (age, AFP level, and albumin level) in patients with alcoholic cirrhosis. [ABSTRACT FROM AUTHOR]

Background and Aim: Several barriers prevent the proper screening, diagnosis, and treatment of hepatitis C virus (HCV) infection. We aimed to evaluate the status of HCV screening, confirmation, and treatment rates in a tertiary academic medical center in Korea. Methods: Patients who visited Severance Hospital between 2015 and 2019 were eligible in this retrospective study. The testing and positivity rates for anti‐HCV antibodies and HCV RNA were sequentially analyzed. Results: Between 2015 and 2019, 252 057 patients (117 131 men, 46.5%) who underwent anti‐HCV antibody testing were retrospectively reviewed. The median age of the study population was 51.0 years. Patients with positive anti‐HCV antibody test results (n = 2623, 1.0%) showed a higher proportion of liver cirrhosis (17.6% vs 2.0%) and unfavorable laboratory test results (all P < 0.05). The positivity rates were 1.3% and 0.8% in the medical and surgical departments, respectively. HCV RNA was tested in 1628 (62.1%) patients, with a 57.4% (n = 928) positivity rate. The medical department had a higher HCV RNA testing rate than the surgical department (75.4% vs 40.8%). Among the 928 patients who showed positivity for HCV RNA, 847 (90.7%) underwent genotype testing (mostly 1 and 2 [95.4%]). The treatment rate was 66.9% (n = 567); it was higher in the gastroenterology department (70.8%) than in the non‐gastroenterology departments (62.3%). Conclusions: A considerable proportion of patients testing positive for anti‐HCV antibodies were not referred for proper management. Systematic and automated screening and referral systems, which may help identify patients requiring treatment for HCV infection, are necessary even in tertiary academic medical centers. [ABSTRACT FROM AUTHOR]

Background/Aims: Glecaprevir/pibrentasvir (G/P) is a combination of direct-acting antiviral agents that is an approved treatment for chronic infections by all six hepatitis C virus (HCV) genotypes. However, there are limited data on the effect of G/P in Korean patients in actual real-world settings. We evaluated the real-life effectiveness and safety of G/P at a single institution in Korea. Methods: This retrospective, observational, cohort study used sustained virologic response at 12 weeks after treatment completion (SVR12) as the primary effectiveness endpoint. Safety and tolerability were also determined. Results: We examined 267 individuals who received G/P for chronic HCV infections. There were 148 females (55.4%), and the overall median age was 63.0 years (range, 25 to 87 years). Eightythree patients (31.1%) had HCV genotype-1 and 182 (68.2%) had HCV-2. A total of 212 patients (79.4%) were HCV treatment-naïve, 200 (74.9%) received the 8-week treatment, 13 (4.9%) had received prior treatment for hepatocellular carcinoma, 37 (13.7%) had chronic kidney disease stage 3 or higher, and 10 (3.7%) were receiving dialysis. Intention to treat (ITT) analysis indicated that 256 (95.9%) achieved SVR12. A modified ITT analysis indicated that SVR12 was 97.7% (256/262). Six patients failed therapy because of posttreatment relapse. SVR12 was significantly lower in those who received prior sofosbuvir treatment (p=0.002) and those with detectable HCV RNA at week 4 (p=0.027). Seventy patients (26.2%) experienced one or more adverse events, and most of them were mild. Conclusions: These real-life data indicated that G/P treatment was highly effective and well tolerated, regardless of viral genotype or patient comorbidities. [ABSTRACT FROM AUTHOR]

Aim: Neutrocytic ascites, traditionally defined as a polymorphonuclear neutrophil count ≥250/mm3, is infrequently reported during paracenteses to relieve malignant ascites (MA). This study aims to explore new potential diagnostic criteria to discriminate ascitic fluid infection associated with MA and to examine the clinical and laboratory characteristics of neutrocytic ascites. Methods: The investigators retrospectively collected data on paracenteses to relieve MA at the Emergency Department of National Cancer Center, Korea, from January 2014 to February 2017. We analyzed the patients whose ascites fulfilled the traditional criteria for classification as neutrocytic ascites; polymorphonuclear neutrophils ≥250/mm3 with no history of either hepatocellular carcinoma or liver cirrhosis. Results: In total, 1467 patients underwent paracentesis to relieve MA. Excluding 98 follow‐up paracenteses cases, 112 cases (8.2%) showed neutrocytic ascites. Of these 112 patients, 27 (24.1%) had positive culture results. Receiver‐operating characteristic analysis indicated that the area under the curve (AUC) values were 0.90 (95% CI 0.82‐0.95) and 0.86 (95% CI 0.78‐0.92) for polymorphonuclear neutrophil ratio and count, respectively. The difference between the two AUCs was not statistically significant (P =.29). Moreover, the best cutoff points were 70% and 1500/mm3 for polymorphonuclear neutrophil ratio and count, respectively. In addition, extensive liver metastasis was a significant independent risk factor of MA associated with ascitic fluid infection. Conclusions: Both polymorphonuclear neutrophil ratio and count had good discriminative abilities for culture results in MA. Polymorphonuclear neutrophil ratio was somewhat better despite lacking statistical significance compared to polymorphonuclear neutrophil count, with 70% as best cutoff. [ABSTRACT FROM AUTHOR]

The risk of developing hepatitis B virus (HBV)‐related hepatocellular carcinoma (HCC) is reduced by antiviral therapy. Here, we evaluated the chronological trends in HCC development risk starting in 2007, when entecavir reimbursement was first initiated in South Korea. Treatment‐naïve patients with chronic hepatitis B (CHB) receiving entecavir 0.5 mg/d were stratified into three groups according to entecavir start time: early (2007‐2010), middle (2011‐2012) and late (2013‐2014) cohorts Among 2442 patients, cumulative probabilities of developing HCC after 1, 3 and 5 years were, respectively, 1.7%, 5.1%, and 8.2% (early cohort; n = 672); 1.5%, 5.1% and 8.9% (middle cohort; n = 757); and 1.2%, 5.3% and 10.6% (late cohort; n = 1013; P >.05 between each pair). Older age, male, positive hepatitis B e antigen, liver cirrhosis, Child‐Pugh class B (vs A) and lower platelet count significantly predicted HCC development in univariate analysis (P <.001), whereas entecavir start time (early vs middle vs late cohorts) did not affect the risk of HCC development (P =.457). A multivariate analysis revealed that older age (adjusted hazard ratio [aHR]=1.041), male gender (aHR = 2.069), liver cirrhosis (aHR = 3.771) and Child‐Pugh class B (vs A, aHR = 1.548) were independently associated with an increased risk of HCC development, whereas higher platelet count was independently associated with a reduced risk of HCC development (aHR = 0.993; all P <.05). In conclusion, the risk of developing HCC among patients receiving entecavir in South Korea has been stable since 2007. To establish more effective HCC surveillance programs, further studies regarding the carcinogenic roles of nonviral factors are required. [ABSTRACT FROM AUTHOR]

Background/Aims: Sofosbuvir (SOF)-based therapy has been used in Korean patients with chronic hepatitis C virus (HCV) infection since January 2016. This study aimed to investigate the real-life effectiveness and safety of SOF-based therapy in genotype 2 HCV infection. Methods: From January to December 2016, 458 genotype 2 HCV-infected patients who received ≥1 dose of SOF-based therapy were consecutively enrolled in seven tertiary hospitals. Sustained virologic response (SVR) rates and safety were determined by intention-to-treat (ITT) and per-protocol (PP) analyses. Results: The mean age of the patients was 61.0 years; 183 (40%) were male, and 13.1% showed a high viral load (>6,000,000 IU/ mL). Among the 378 treatment-naïve patients, the SVR rates were 94.2% (ITT) and 96.7% (PP). Among the 80 treatmentexperienced patients, the SVR rates were 96.3% (ITT) and 98.7% (PP). Patients with a relatively high fibrosis-4 index score (>3.25) had similar SVR rates to those with a relatively low score (p=0.756). A total of 314 patients (68.6%) were treated with a reduced ribavirin dose at the prescriber’s discretion, but they showed similar SVR rates to those treated with the weight-based dose (ITT: 95.5% and 92.3%, PP: 97.4% and 96.3%, respectively). Adverse events were observed in 191 patients (41.7%), including 86 (18.8%) with anemia, but only one (0.2%) discontinued antiviral therapy due to nausea. Conclusions: SOF-based therapy showed high real-life efficacy and tolerability in Korean patients with genotype 2 chronic HCV infection, regardless of previous antiviral treatment experience and fibrosis score. A reduced ribavirin dose can be considered in this patient cohort. [ABSTRACT FROM AUTHOR]

Background/Aims: This study aimed to investigate the epidemiology of hepatitis C virus (HCV) infection in the Korean general population and the awareness and treatment status of HCV infection among anti-HCV-positive persons. Methods: We used data from the Korea National Health and Nutrition Examination Survey (KNHNES) collected between 2012 and 2016. All the participants aged ≥10 years in the KNHNES were tested for the anti-HCV antibody. Anti-HCV-positive persons were tested for HCV RNA and assessed for their awareness and treatment experience regarding HCV infection. Results: The prevalence of anti-HCV was 0.66% (95% confidence interval, 0.56% to 0.78%) among Koreans aged ≥10 years, representing an estimated 278,819 anti-HCV-positive persons, and 0.71% (95% confidence interval, 0.60% to 0.84%) among Koreans aged ≥20 years. The prevalence of anti-HCV increased with age and had significant geographic variation. The positive rate of HCV RNA in anti-HCV-positive persons was 33.5% and increased with age. The rate of HCV infection awareness was 15.2% (35/250) among anti- HCV-positive persons and 30.5% (18/59) among HCV RNApositive persons. Among the participants, 13.5% of HCV RNA-positive persons had been treated for HCV infection. Conclusions: The prevalence of anti-HCV among Koreans aged ≥20 years was 0.71%; one-third of anti-HCV-positive persons tested HCV RNA-positive. The awareness and treatment rates of HCV infection were low among HCV-infected persons. Therefore, active measures should be taken to diagnose and treat persons unaware of HCV infection. [ABSTRACT FROM AUTHOR]

Summary: Background: It is controversial whether chronic hepatitis B (CHB) patients have more non‐liver comorbidities than non‐CHB subjects. Aim: To characterise the demographics, comorbidity and health utilisation of CHB patients in South Korea and compare them to matched controls. Methods: Using the Health Insurance Review & Assessment Service (HIRA) 2007‐2016 database, adult patients with claims for CHB analysed. CHB cases and non‐CHB controls matched in a 1:4 ratio using propensity score matching method. Results: The age of CHB patients significantly increased from a mean 46.9 years in 2007 to 52.3 years in 2016. The proportions of persons having both liver‐related and non‐liver related comorbidities were higher in CHB patients compared to matched controls (dyslipidaemia [37.23% vs 23.77%, P < 0.0001], hypertension [29.39% vs 25.27%, P < 0.0001] chronic kidney disease (CKD) [3.02% vs 1.14%, P < 0.0001] and osteoporosis/fracture [OF] [4.09% vs 3.23%, P < 0.0001]). Approximately 50% of CHB patients had more than one comorbidity among CKD, diabetes, DLP, and OF. The odds of CKD in CHB patients were 1.42 times higher, and the odds of OF in CHB patients were 1.09 times higher than matched controls after adjustment for confounders (P < 0.0001). Conclusion: Prevalence of liver as well as non‐liver comorbidities in patients with CHB was higher than matched controls and increased over time. [ABSTRACT FROM AUTHOR]

Background and aims: Hepatitis C virus (HCV) and its sequelae present a significant source of economic and societal burden. Introduction of highly effective curative therapies has made HCV elimination attainable. The study used a predictive model to assess the clinical and economic impact of implementing national screening and treatment policies toward HCV elimination in Korea. Methods: A previously validated Markov disease progression model of HCV infection was employed to analyze the clinical and economic impact of various strategies for HCV diagnosis and treatment in Korea. In this analysis, the model compared the clinical and economic outcomes of current HCV-related interventions in Korea (7,000 patients treated and 4,200 patients newly diagnosed annually, starting in 2017) to four elimination scenarios: 1) initiating sufficient diagnosis and treatment interventions to meet the World Health Organization's GHSS elimination targets by 2030, 2) delaying initiation of interventions by one year, 3) delaying initiation of interventions by two years and 4) accelerating initiation of interventions to meet elimination targets by 2025. Modelled historical incidence of HCV was calibrated to match a viremic HCV prevalence of 0.44% in 2009. Elimination scenarios required 24,000 treatments and 34,000 newly diagnosed patients annually, starting in 2018, to reach the 2030 targets. Results: Compared to current "status quo" interventions, elimination (or accelerated elimination by 2025) would avert 23,700 (27,000) incident cases of HCV, 1,300 (1,400) liver-related deaths (LRDs) and 2,900 (3,100) cases of end-stage liver disease (ESLD) over the 2017–2030 time period. Postponing interventions by one (or two) years would avert 21,100 (18,600) new HCV infections, 920 (660) LRDs and 2,000 (1,400) cases of ESLD by 2030. Following elimination or accelerated elimination strategies would save 860 million USD or 1.1 billion USD by 2030, respectively, compared to the status quo, requiring an up-front investment in prevention that decreases spending on liver-related complications and death. Conclusions: By projecting the impact of interventions and tracking progress toward GHSS elimination targets using modelling, we demonstrate that Korea can prevent significant morbidity, mortality and spending on HCV. Results should serve as the backbone for policy and decision-making, demonstrating how aggressive prevention measures are designed to reduce future costs and increase the health of the public. [ABSTRACT FROM AUTHOR]

Aims: This study aimed to elucidate the epidemiological and clinical characteristics of chronic hepatitis C (CHC) patients in South Korea from 2007 to 2017 and to compare the treatment patterns between two periods before and after the first approval of direct-acting antivirals (DAA) in South Korea in 2015. Methods: This prospective, multicenter cohort enrolled 2,758 patients with hepatitis C virus (HCV) viremia at seven tertiary centers, and clinical data were prospectively collected with questionnaire surveys focused on lifetime risk factors related to HCV infection. Results: The HCV patients had a mean age of 57.3 years (50.8% male). Among them, 14.3% showed a positive history of transfusion before HCV screening and 5.6% reported intravenous drug use (IVDU), with significant differences in these risk factors between men and women. The proportions of patients with chronic hepatitis, liver cirrhosis and hepatocellular carcinoma (HCC) were 69.5%, 18.9%, and 11.5%, respectively. The mean alanine aminotransaminase level was within the upper normal limit at 49.9%, and the major genotypes were 1b (48.2%) and 2 (46.4%). The overall treatment rate was 53.8%, showing a rapid transition from interferon-based therapy to DAA therapy. In the post-DAA-approval era, the untreated group was older, had a higher prevalence of HCC, and had less education than the treated group. Conclusions: More than 90% of CHC patients were over 40 years old, the major genotypes were 1b and 2, and IVDU was observed in less than 6% of CHC patients. Approximately half of the patients underwent antiviral therapy even in the DAA era, showing an unmet need with regard to HCV elimination. [ABSTRACT FROM AUTHOR]

Background/Aims: The National Liver Cancer Surveillance Program (NLCSP) was established in 2003 to reduce the socioeconomic burden imposed by liver cancer (LC). We aimed to investigate the effectiveness of the NLCSP in South Korea with respect to survival benefits and cost, after adjusting for various confounding factors. Methods: We used the National Health Insurance Service claims data linked with the NLCSP from 2004 to 2015. The Cox proportional hazard model and generalized linear model were used to determine the effects of the NLCSP on the early detection of LC, survival, and medical costs. Results: From 2006 to 2010, 66,632 patients (surveillance group: 10,527 and no surveillance group: 56,105) newly diagnosed with LC were included in the study. The odds of the early detection of LC was 1.82 (95% confidence interval [CI], 1.73 to 1.93) times higher among patients who participated in the NLCSP once within the 2-year period prior to the diagnosis of LC than among those who did not participate in the surveillance program. The mortality rate of patients who participated in the NLCSP was 22.0% lower (hazard ratio, 0.78; 95% CI, 0.76 to 0.80) than that of those who did not participate. When compared with the group who did not participate in surveillance, the group who participated in the NLCSP had higher total medical costs; however, their cost per day was lower after adjustment during the follow-up period. Conclusions: This study highlights the survival benefit in patients who participated in the NLCSP and the need for continuous improvements of the NLCSP in South Korea. [ABSTRACT FROM AUTHOR]

Background and Aim: For genotype 2 chronic hepatitis C (CHC), the efficacy and safety of sofosbuvir plus ribavirin therapy (SOF + RBV) was better than pegylated interferon plus ribavirin therapy (PR) at a greater drug cost. This study investigated the cost‐effectiveness of SOF + RBV compared with PR for treatment‐naïve genotype 2 CHC in South Korea. Methods: Using a decision analytic Markov model, a cost‐effectiveness analysis comparing SOF + RBV with PR or no treatment for treatment‐naïve genotype 2 CHC was performed with probabilistic and deterministic sensitivity analyses from the payer's perspective in 2017. Three cohorts of patients aged 40–49, 50–59, and 60–69 years were simulated to progress through the fibrosis stages F0–F4 to end‐stage liver disease, hepatocellular carcinoma, or death. Published and calculated data on the clinical efficacy of the regimen, health‐related quality of life, costs, and transition probabilities were used. Results: While the incremental cost‐effectiveness ratio for PR was dominant over no treatment, the incremental cost‐effectiveness ratios for SOF + RBV were $20 058 for the patients in their 40s, $19 662 for those in their 50s, and $22 278 for those in their 60s compared with PR. Probabilistic sensitivity analysis indicated an 89.0% probability for the SOF + RBV to be cost‐effective at a willingness to pay of $29 754.4 (per‐capita gross domestic product in 2017) for the patients in their 40s and 94.1% and 89.1% for the patients in their 50s and 60s, respectively. Conclusions: The SOF + RBV is a cost‐effective option for genotype 2 treatment‐naïve CHC patients, especially for the patients with liver cirrhosis in Korea. [ABSTRACT FROM AUTHOR]

Summary: Although hepatitis C virus (HCV) genotype 3 infection is thought to be an important risk factor for hepatocellular carcinoma (HCC), current evidence is limited because only a few Western studies have evaluated the occurrence of HCC in patients with HCV genotype 3 infection. We evaluated the impact of genotype 3 and non‐3 on HCC incidence and on disease progression in chronic HCV patients; this is the first study reporting such findings in an Asian population. We performed a retrospective cohort study using the data of 1448 consecutive chronic HCV patients evaluated at three centres in Korea between January 2005 and December 2016. Of these, 604, 675 and 169 had genotype 1, genotype 2 and genotype 3 HCV infections, respectively. Over a mean follow‐up period of 53.2 months, 75 and 143 patients of all the patients developed HCC and experienced disease progression, respectively. The incidences of HCC were 1.10, 0.92 and 2.50 per 100 person‐years, and those of disease progression were 1.95, 1.62 and 6.72 per 100 person‐years for HCV genotypes 1, 2 and 3, respectively. In multivariate Cox regression analysis, genotype 3 was associated with an increased risk of HCC (hazard ratio [HR] = 4.26, 95% confidence interval [CI] = 2.02‐8.97) and an increased risk of disease progression (HR = 4.88, 95%; CI = 2.94‐8.08). Our study proposes that HCV genotype 3 is an independent risk factor for HCC and disease progression in chronic HCV patients. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to investigate the efficacy and safety of sofosbuvir plus ribavirin for the treatment of hepatitis C virus (HCV) genotype 2 infection and to determine the optimal ribavirin dosage. Methods: From May 2016 to March 2017, 199 patients received sofosbuvir plus ribavirin treatment for HCV genotype 2 infection at four centers in Jeollanam‐do Province, Korea. After excluding patients lost to follow‐up and those with insufficient data, we retrospectively assessed the data for 194 patients. The treatment efficacy and safety of sofosbuvir plus ribavirin were evaluated. Results: A sustained virological response was achieved in 189 patients (intention‐to‐treat [ITT] 97.4%; per protocol [PP]: 99.5%, both at 12 and 24 weeks) whose average ribavirin dosage was 937.1 mg/day. The most frequent adverse event was anemia (17.5%), and its incidence significantly increased (P < 0.001) with a higher ribavirin dosage per body weight. Discontinuation of ribavirin or dosage reduction occurred in 27 (14.2%). The ribavirin dosage reduction rate increased at a dosage of >15 mg/kg (area under the receiver operating characteristic curve 0.652, 95% confidence interval [CI] 0.54‐0.76, P = 0.01). Multivariate analysis showed that age ≥70 years, with liver cirrhosis, and female gender were associated with ribavirin dosage reduction. Conclusions: Remarkable outcomes were attained in patients with HCV genotype 2 infection treated with sofosbuvir plus ribavirin. Age ≥70 years, with liver cirrhosis, and female gender were associated with ribavirin dosage reduction. Thus, sustained virological response can be achieved with <1000 mg of ribavirin, with an optimal dosage of 15 mg/kg. [ABSTRACT FROM AUTHOR]

Background: The global burden of liver diseases, such as hepatocellular carcinoma and liver cirrhosis, is substantial. In this study, we estimated utility weights of liver disease-related health states in the general population using a visual analogue scale (VAS) and the standard gamble (SG) method.Methods: Depictions of standardized health states related to major liver diseases were developed based on patient education materials and previous publications. To fully reflect disease progression from diagnosis to prognosis, each health state comprised four parts: diagnosis, symptoms, treatment, and progression and prognosis. A total of 407 participants from the Korean general population evaluated the health states using the VAS and SG methods in computer-assisted personal interviews. After excluding illogical responses, mean utility weights were calculated for each health state.Results: The utility weights for health states were significantly different according to the existence of inconsistency in general. According to the VAS results, the health state with the highest utility was 'Chronic hepatitis B virus infection' (0.64), whereas the health state with the lowest utility was 'Hepatocellular carcinoma that requires palliative therapy' (0.17). Similarly, the SG results revealed that the health state with the highest utility was 'Chronic hepatitis B virus infection' (0.85), and the health state with the lowest utility was 'Hepatocellular carcinoma that requires palliative therapy' (0.40).Conclusions: The estimated utility weights in this study will be useful to measure the burden of liver diseases and evaluate cost-utility of programs for reducing the burden of liver diseases. [ABSTRACT FROM AUTHOR]

Background and Aims: This study aims to investigate the cost-effectiveness of a one-time hepatitis C virus (HCV) screening and treatment program in South Korea where hepatitis B virus (HBV) prevails, in people aged 40–70, compared to current practice (no screening). Methods: A published Markov model was used in conjunction with a screening and treatment decision tree to model patient cohorts, aged 40–49, 50–59 and 60–69 years, distributed across chronic hepatitis C (CHC) and compensated cirrhosis (CC) health states (82.5% and 17.5%, respectively). Based on a published seroepidemiology study, HCV prevalence was estimated at 0.60%, 0.80% and 1.53%, respectively. An estimated 71.7% of the population was screened. Post-diagnosis, 39.4% of patients were treated with a newly available all-oral direct-acting antiviral (DAA) regimen over 5 years. Published rates of sustained virologic response, disease management costs, transition rates and utilities were utilised. Results: Screening resulted in the identification of 43,635 previously undiagnosed patients across all cohorts. One-time HCV screening and treatment was estimated to be cost-effective across all cohorts; predicted incremental cost-effectiveness ratios ranged from $5,714 to $8,889 per quality-adjusted life year gained. Incremental costs associated with screening, treatment and disease management ranged from $156.47 to $181.85 million USD; lifetime costs-offsets associated with the avoidance of end stage liver disease complications ranged from $51.47 to $57.48 million USD. Conclusions: One-time HCV screening and treatment in South Korean people aged 40–70 is likely to be highly cost-effective compared to the current practice of no screening. [ABSTRACT FROM AUTHOR]

Hepatitis C virus (HCV) infection is a major cause of liver cirrhosis, hepatocellular carcinoma, and liver-related mortality. The new antiviral drugs against HCV, direct acting antivirals, result in >90% cure rate. This review aimed to summarize the current prevalence, clinical characteristics, outcomes, and treatment response associated with HCV infection, and countermeasures for optimal HCV control in South Korea. Based on a literature review, the current anti-HCV prevalence in the Korean population is 0.6 to 0.8%, with increasing prevalence according to age. The major HCV genotypes in Korean patients were genotype 1b and genotype 2. Successful antiviral treatment leads to significantly reduced liver related complications and mortality. However, only about one third of the individuals with HCV infection seem to be managed under the current national health insurance system, suggesting a remarkable rate of underdiagnoses and subsequent loss of opportunity to cure. A recent study in South Korea showed that targeted population screening for HCV infection is cost-effective. To prevent recently developed clusters of HCV infection in some clinics, mandatory surveillance rather than sentinel surveillance for HCV infection is required and governmental countermeasures to prevent reuse of syringes or other medical devises, and public education should be maintained. Moreover, one-time screening for a targeted population should be considered and a cost-effectiveness study supporting an optimal screening strategy is warranted. [ABSTRACT FROM AUTHOR]

Objectives: Chronic hepatitis B management is commonly targeted at reducing viral replication. However, the currently available antiviral therapies are associated with some problems, including resistance and numerous adverse effects. Ginseng has been reported to be effective for treating viral infections such as influenza and human immunodeficiency virus. However, there are currently few studies on the effects of ginseng in chronic hepatitis B. Thus, this study investigated the effects of ginseng together with antiviral agents in chronic hepatitis B. Subjects and methods: This was a prospective, single-blinded, randomized controlled trial, and single-center study. Thirty-eight patients were enrolled. The control group ( n = 19) was administered antiviral agents alone. The experimental group ( n = 19) was administered antiviral agents along with Korean Red Ginseng powder capsules (each dose is 1 gram (two capsules), a one-day dose is 3 grams). The baseline characteristics did not differ between the two groups. Differences in several non-invasive fibrosis serologic markers (type IV collagen, hyaluronic acid, transforming growth factor-β) and in the hepatitis B virus DNA levels were compared between the groups. Results: The non-invasive fibrosis serologic markers were further decreased in the experimental group, with significant differences after treatment observed for hyaluronic acid ( p = 0.032) and transforming growth factor-β ( p = 0.008), but not for type IV collagen ( p = 0.174). Conclusions: This study suggests the possibility of Korean Red Ginseng as a complementary therapy for chronic hepatitis B. [ABSTRACT FROM AUTHOR]

We estimated the disability weights in the South Korean population by using a paired comparison-only model wherein ‘full health’ and ‘being dead’ were included as anchor points, without resorting to a cardinal method, such as person trade-off. The study was conducted via 2 types of survey: a household survey involving computer-assisted face-to-face interviews and a web-based survey (similar to that of the GBD 2010 disability weight study). With regard to the valuation methods, paired comparison, visual analogue scale (VAS), and standard gamble (SG) were used in the household survey, whereas paired comparison and population health equivalence (PHE) were used in the web-based survey. Accordingly, we described a total of 258 health states, with ‘full health’ and ‘being dead’ designated as anchor points. In the analysis, 4 models were considered: a paired comparison-only model; hybrid model between paired comparison and PHE; VAS model; and SG model. A total of 2,728 and 3,188 individuals participated in the household and web-based survey, respectively. The Pearson correlation coefficients of the disability weights of health states between the GBD 2010 study and the current models were 0.802 for Model 2, 0.796 for Model 1, 0.681 for Model 3, and 0.574 for Model 4 (all P-values<0.001). The discrimination of values according to health state severity was most suitable in Model 1. Based on these results, the paired comparison-only model was selected as the best model for estimating disability weights in South Korea, and for maintaining simplicity in the analysis. Thus, disability weights can be more easily estimated by using paired comparison alone, with ‘full health’ and ‘being dead’ as one of the health states. As noted in our study, we believe that additional evidence regarding the universality of disability weight can be observed by using a simplified methodology of estimating disability weights. [ABSTRACT FROM AUTHOR]

Background: Tenofovir disoproxil fumarate (TDF) has demonstrated potent antiviral activity against hepatitis B virus (HBV) in clinical trials. Although its efficacy has been demonstrated in Caucasian populations, TDF has not previously been studied in Korean patients who present the predominance of HBV genotype C and of vertical or perinatal transmission.Objective: The aim of this study was to evaluate the efficacy of TDF in Korean chronic hepatitis B (CHB) patients in real-life practice, and to determine the clinical variables that contribute to virologic response.Setting: Large academic medical center in Korea.Method: We retrospectively investigated the efficacy of TDF treatment for more than 6 months in 151 nucleos(t)ide-naïve CHB patients.Main Outcome Measure: The primary endpoint was a virologic response (VR), defined as an HBV DNA level of <12 IU/mL. Secondary endpoints were rates of alanine aminotransaminase (ALT) normalization, hepatitis B e antigen (HBeAg) seroconversion, virologic breakthrough, and safety.Results: All patients were the genotype C2. The median duration of TDF treatment was 13 months (range 7-18 months). Ninety-two (61.0 %) patients were HBeAg positive. The mean pre-treatment HBV DNA level was 6.34 ± 1.42 log10 IU/mL. Among the 131 patients with elevated ALT levels at baseline, 128 (97.7 %) patients achieved ALT normalization during TDF treatment. VR was achieved in 97 (64.2 %) patients. The cumulative rates of VR at 6, 9, 12, and 18 months were 47.0, 59.4, 67.9, and 69.3 %, respectively. Among the 92 HBeAg-positive patients, 14 (15.2 %) patients achieved HBeAg seroconversion. In multivariate analysis, absolute HBV DNA levels at baseline (P < 0.001; OR 0.529; 95 % CI 0.560-0.744) and HBeAg positivity (P = 0.015; OR 0.731; 95 % CI 0.615-0.869) were significantly associated with VR. Virologic breakthrough was observed in four patients. These four patients had poor adherence to TDF. Most of the adverse events were mild in severity. No significant changes were observed in serum creatinine and phosphorus levels.Conclusions: TDF was effective and well tolerated in Korean genotype C CHB patients in real life practice, consistent with larger registration trials. The absolute HBV DNA levels at baseline and HBeAg positivity were significantly associated with VR. [ABSTRACT FROM AUTHOR]

Background: Previous animal studies have shown that Curcuma longa (turmeric) improves liver function. Turmeric may thus be a promising ingredient in functional foods aimed at improving liver function. The purpose of the study is to investigate the hepatoprotective effect of fermented turmeric powder (FTP) on liver function in subjects with elevated alanine transaminase (ALT) levels. Methods: A randomised, double-blind, placebo-controlled trial was conducted between November 2010 and April 2012 at the clinical trial center for functional foods of the Chonbuk National University Hospital. The trial included 60 subjects, 20 years old and above, who were diagnosed mild to moderate elevated ALT levels between 40 IU/L and 200 IU/L. Sixty subjects were randomised to receive FTP 3.0 g per day or placebo 3.0 g per day for 12 weeks. The treatment group received two capsules of FTP three times a day after meals, for 12 weeks. The primary efficacy endpoint was change in the ALT levels in the two groups. The secondary efficacy endpoints included its effect on aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), total bilirubin (TB), and lipid profiles. Safety was assessed throughout the study using ongoing laboratory tests. Adverse events (AEs) were also recorded. Results: Sixty subjects were randomised in the study (30 into the FTP group, 30 into the placebo group), and among them, twelve subjects were excluded from the analysis for protocol violation, adverse events or consent withdrawal. The two groups did not differ in baseline characteristics. After 12 weeks of treatment, 48 subjects were evaluated. Of the 48 subjects, 26 randomly received FTP capsules and 22 received placebo. The FTP group showed a significant reduction in ALT levels after 12 weeks of treatment compared with the placebo group (p = 0.019). There was also observed that the serum AST levels were significantly reduce in the FTP group than placebo group (p = 0.02). The GGT levels showed a tendency to decrease, while the serum alkaline phosphatase (ALP), TB, and lipids levels were not modified. There were no reported severe AEs during this study, or abnormalities observed on blood glucose, total protein, albumin, blood urea nitrogen (BUN), and creatinine levels. Conclusion: The data of this trial indicate that FTP is effective and safe, generally well-tolerated without severe AEs, in the treatment of subjects with elevated ALT levels over a 12 weeks period. Trial registration: ClinicalTrials.gov: NCT01634256 [ABSTRACT FROM AUTHOR]

Recently, the classification of fatty liver and the definition for non-alcoholic fatty liver disease (NAFLD) have been challenged. Herein, we aim to evaluate the burden of hepatic fibrosis in the missed and added populations following the proposal of the new definition of metabolic dysfunction-associated fatty liver (MAFLD) in a health check-up cohort. A total of 6775 subjects underwent both magnetic resonance elastography (MRE) and an abdominal ultrasound at 13 nationwide health check-up centers in Korea. Significant and advanced hepatic fibrosis was defined as ≥3.0 kPa and ≥3.6 kPa in the MRE test, respectively. The prevalence of sonographic fatty liver (FL) was 47.4%. Among the subjects with sonographic FL, 77.3% and 94% are compatible with NAFLD and with the new MAFLD definitions, respectively. Moreover, 72% of FL cases belong to both the NAFLD and MAFLD definitions, whereas 1.4% is compatible with neither. The population compatible with the MAFLD definition has the following coexisting liver diseases: alcohol-related (71.9%), hepatitis B (23.9%), hepatitis C (0.4%), and both alcohol and viral hepatitis (2.8%). The prevalence of significant and advanced hepatic fibrosis is considerable in the MAFLD-only group. However, the prevalence of significant and advanced hepatic fibrosis is similar in the NAFLD-only group, and neither the NAFLD nor MAFLD group compared to healthy controls. The added population (MAFLD-only group), according to the new MAFLD definition, has a higher metabolic and fibrosis burden when compared to those in the missed population (NAFLD-only group). [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 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. [ABSTRACT FROM AUTHOR]

Focuses on economic benefits of treating chronic hepatitis B (CHB) with lamivudine. Disease burden on health care system; Direct and indirect costs; Health care expenditure for CHB in South Korea; Costs of preventing CHB; Long-term benefits of lamivudine.