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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]

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]

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]

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]

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]

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]