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Background/Aims: Glecaprevir/pibrentasvir (G/P) is the first pan-genotypic direct-acting antiviral combination therapy approved in Korea. An integrated analysis of five phase II and III trials was conducted to evaluate the efficacy and safety of G/P in Korean patients with chronic hepatitis C virus (HCV) infection. Methods: The study analyzed pooled data on Korean patients with HCV infection enrolled in the ENDURANCE 1 and 2, SURVEYOR II part 4 and VOYAGE I and II trials, which evaluated the efficacy and safety of 8 or 12 weeks of G/P treatment. The patients were either treatment-naïve or had received sofosbuvir or interferon-based treatment. Efficacy was evaluated by assessing the rate of sustained virologic response at 12 weeks posttreatment (SVR12). Safety was evaluated by monitoring adverse events (AEs) and laboratory assessments. Results: The analysis included 265 patients; 179 (67.5%) were HCV treatment-naïve, and most patients were either subgenotype 1B (48.7%) or 2A (44.5%). In the intention-to-treat population, 262 patients (98.9%) achieved SVR12. Three patients did not achieve SVR12: one had virologic failure and two had non-virologic failures. Most AEs were grade 1/2; eight patients (3.0%) experienced at least one grade ≥3 AE. No serious AEs related to G/P treatment were reported, and grade ≥3 hepatic laboratory abnormalities were rare (0.8%). Conclusions: G/P therapy was highly efficacious and well tolerated in Korean patients with HCV infection, with most patients achieving SVR12. The safety profile was comparable to that observed in a pooled analysis of a global pan-genotypic population of patients with HCV infection who received G/P. [ABSTRACT FROM AUTHOR]

Viral hepatitis is the most important cause of acute and chronic liver disease in Korea. Particularly, hepatitis B virus (HBV) is the leading cause of liver-related mortality. Because of the nationwide vaccinations in the 1980s, hepatitis B surface antigen positive rates substantially decreased from 8% to 3%. Moreover, the introduction of potent nucleoside or nucleotide analogs led to the effective treatment of patients who had already been infected by HBV. The remaining issue has been to develop novel drugs that can cure HBV infection. Hepatitis C virus (HCV), on the other hand, is a hepatotropic virus that is parenterally transmitted. In Korea, the prevalence of HCV is estimated to be approximately 1%. Although no effective vaccine for HCV has been developed yet, highly effective and safe direct-acting antiviral therapy, which has a short treatment duration of 8 – 12 weeks, has made HCV eradication possible globally. Currently, the unsolved issue regarding HCV management is low disease awareness among patients and health care providers. Therefore, nationwide testing for anti-HCV would be a solution to identify patients infected with HCV but with no symptoms. Lastly, the Hepatitis A virus (HAV) is orally transmitted and results in acute hepatitis. In Korea, the young adult population is a high-risk group since this group is not vaccinated against HAV. More active vaccination and improved hygiene would be necessary to prevent HAV infection. [ABSTRACT FROM AUTHOR]

Purpose Conditional survival estimates (CSE) can provide additional useful prognostic information on the period of survival after diagnosis, which helps in counseling patients with cancer on their individual prognoses. This study aimed to analyze conditional survival (CS) for hepatocellular carcinoma (HCC) using a Korean national registry. Materials and Methods Patients with HCC, registered in the Korean cancer registry database, were retrospectively reviewed. Overall survival (OS) was calculated using the Kaplan-Meier method. The 1-year CS at X year or month after diagnosis were calculated as CS1=OS(X+1)/OS(X). CS calculations were performed in each Barcelona Clinic Liver Cancer stage, after which patients at stage 0, A, and B underwent subgroup analysis using initial treatment methods. Results A total of 4,063 patients diagnosed with HCC from January 2008 to December 2010, and 2,721 who were diagnosed from January 2011 to December 2012, were separately reviewed. In 2008-2010, the 1-year CS of 1, 2, 3, 4, and 5-year survivors was 82.9%, 85.1%, 88.3%, 88.0%, and 88.6%, respectively. Patients demonstrated an increase in CSE over time in subgroup analysis, especially in the advanced stages. In 2011-2012, the 1-year CS of 6, 12, 18, 24, 30, and 36 months was 81.5%, 83.8%, 85.3%, 85.5%, 86.5%, and 88.8%, respectively. The subgroup analysis showed the same tendency towards increased CSE in the advanced stages. Conclusion Overall, the CS improved with each additional year after diagnosis in both groups. CSE may therefore provide a more accurate prognosis and hopeful message to patients who are surviving with or after treatment. [ABSTRACT FROM AUTHOR]

We investigated the accuracy of liver stiffness measurement (LSM) in chronic hepatitis C (CHC) in a multicenter, prospective study in South Korea. Between June 2005 and July 2009, 91 CHC patients without a previous history of antiviral treatment, clinical evidences of cirrhosis, coinfection with other viruses, and heavy alcohol consumption and with alanine aminotransferase (ALT) ≤ 5x upper limit of normal, total bilirubin ≤ 1.5 mg/dL, sufficient liver biopsy quality (≥ 15 mm and more than six portal tracts), interquartile range to median liver stiffness (LS) value ratio ≤ 0.21, and more than 10 valid measurements, were recruited. The Batts and Ludwig scoring system was used for histologic assessment. Age-platelet index (API), aspartate aminotransferase (AST)-to-platelet ratio index (APRI), and age-spleen-platelet ratio index (ASPRI) were calculated. Area under the receiver operating characteristic curve (AUROC) was used to evaluate the performance of LSM and other noninvasive models. The mean age was 47.9 years, and the mean LS value was 7.7 kPa (44 men and 47 women). LS value was highly correlated to the fibrosis stages ( r = 0.835, P < 0.001). The AUROCs of LSM were 0.909 for ≥ F2, 0.993 for ≥ F3, and 0.970 for F = 4 and were superior to those of API (0.72, 0.858, and 0.948, respectively), APRI (0.780, 0.887, and 0.904, respectively), and ASPRI (0.713, 0.862, and 0.957, respectively). The optimal cutoff LS values were 6.2 kPa for ≥ F2, 7.7 kPa for ≥ F3, and 11.0 kPa for F = 4. Our data suggest that LSM can accurately assess liver fibrosis in patients with CHC and be applied in South Korea. [ABSTRACT FROM AUTHOR]

Aims: To identify the normal range of liver stiffness (LS) values by recruiting healthy living liver and kidney donors in South Korea. Methods: Liver stiffness measurement (LSM) was performed in 69 healthy living liver and kidney donors who were admitted for transplantation. None of the subjects suffered from diabetes mellitus, hypertension, hepatitis B virus infection, hepatitis C virus infection, heart dysfunction, liver dysfunction or metabolic syndrome. Results: LSM failure rate was 2.7%. Among 12 liver donors (17.4%) with available liver histology, eight showed normal liver histology and four showed liver steatosis of <5% of the hepatocytes. The mean age of our study population was 38.9 ± 11.9 years (35 men and 34 women), with a mean LS value of 4.6 ± 0.5 kPa (range 3.3–5.6 kPa). LS values were not significantly different between men (4.6 ± 0.6 kPa) and women (4.5 ± 0.5 kPa, P=0.636), nor were they significantly different according to age ( P=0.851). Using the fifth and 95th percentiles, we determined the normal range of LS values to be 3.9–5.3 kPa. Conclusions: We identified the normal range of LS values and found that LS values were not significantly influenced by age and gender. [ABSTRACT FROM AUTHOR]

The worldwide burden of liver cancer has been estimated at 671,000 new cases for the year 2005. Hepatocellular carcinoma (HCC) accounts for between 85 and 90% of primary liver cancer and is one of the most frequent malignancies in Asia. In both Japan and Korea, the incidence exceeds 25 cases/100,000/year and ranks third in cancer deaths after stomach and lung cancer. In Korea the number of deaths from liver cancer increased from approximately 5,789 in 1983 to 9,966 in 1994, and then remained steady at 9,500/100,000 in 2003. In Japan the number of deaths from HCC increased until 2002, and then decreased to 34,089 in 2003, up to 15% of HCC cases are caused by hepatitis B virus (HBV) and ∼80% by hepatitis C virus (HCV) infection; the corresponding figures in Korea are ∼70 and ∼20%. Recent clinical data have shown that interferon and lamivudine treatment is effective in preventing the occurrence of HCC attributed to HCV and HBV infection, respectively, and that an aggressive vaccination program against the latter reduces the incidence of HCC. With the enormous efforts of researchers devoted to basic and clinical studies, the incidence of HCC is expected, in the near future, to gradually decline in both countries. Copyright © 2008 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Background/Aims The combination of glecaprevir and pibrentasvir (G/P) is the first pan-genotypic direct-acting antiviral agent therapy approved in South Korea. It is estimated that there are 300 thousand individuals with hepatitis C virus (HCV) antibody- positive in South Korea. Among chronic hepatitis C (CHC) patients, virus genotype (GT) 1 and 2 combined account for the vast majority (~99%) of CHC. We evaluated the efficacy and safety of G/P in South Korean CHC GT1 or 2 patients with or without compensated cirrhosis. Methods We pooled the data from five Phase II/III trials for sub-analysis of patients from South Korea who received G/P for either 8 or 12 weeks. Efficacy was evaluated as the rate of sustained virologic response at 12 weeks posttreatment (SVR12). Results The analysis included 265 patients (intention-to-treat population); 179 (67.5%) were HCV treatment-naïve, and 5 (1.9%) and 81 (30.6%) had previously received sofosbuvir or interferon-based treatment, respectively. A total of 262 of 265 patients (98.9%) achieved SVR12. There was one virologic failure (relapse at 12 weeks after treatment), one patient discontinued treatment due to adverse event (AE), which was assessed as not related to the treatment, and one patient had missing SVR12 result. G/P was safe and well-tolerated, with most of the AEs being grade 1 (mild) and eight of 265 patients (3.0%) reporting at least one AE of severity grade 3 or higher. Only two patients experienced grade 3 hepatic laboratory abnormalities; one hyperbilirubinemia and one alanine aminotransferase elevation. Conclusions G/P combination therapy for 8 or 12 weeks achieved a high efficacy with SVR12 rate of 98.9% among patients with CHC GT1 or 2 infection from South Korea. G/P was safe and had a favorable safety profile, comparable to that observed in the G/P global clinical trials. [ABSTRACT FROM AUTHOR]