1.Efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for hepatitis C in Korea: a Phase 3b study
Jeong HEO ; Yoon Jun KIM ; Sung Wook LEE ; Youn-Jae LEE ; Ki Tae YOON ; Kwan Soo BYUN ; Yong Jin JUNG ; Won Young TAK ; Sook-Hyang JEONG ; Kyung Min KWON ; Vithika SURI ; Peiwen WU ; Byoung Kuk JANG ; Byung Seok LEE ; Ju-Yeon CHO ; Jeong Won JANG ; Soo Hyun YANG ; Seung Woon PAIK ; Hyung Joon KIM ; Jung Hyun KWON ; Neung Hwa PARK ; Ju Hyun KIM ; In Hee KIM ; Sang Hoon AHN ; Young-Suk LIM
The Korean Journal of Internal Medicine 2023;38(4):504-513
Despite the availability of direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection in Korea, need remains for pangenotypic regimens that can be used in the presence of hepatic impairment, comorbidities, or prior treatment failure. We investigated the efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for 12 weeks in HCV-infected Korean adults. Methods: This Phase 3b, multicenter, open-label study included 2 cohorts. In Cohort 1, participants with HCV genotype 1 or 2 and who were treatment-naive or treatment-experienced with interferon-based treatments, received sofosbuvir–velpatasvir 400/100 mg/day. In Cohort 2, HCV genotype 1 infected individuals who previously received an NS5A inhibitor-containing regimen ≥ 4 weeks received sofosbuvir–velpatasvir–voxilaprevir 400/100/100 mg/day. Decompensated cirrhosis was an exclusion criterion. The primary endpoint was SVR12, defined as HCV RNA < 15 IU/mL 12 weeks following treatment. Results: Of 53 participants receiving sofosbuvir–velpatasvir, 52 (98.1%) achieved SVR12. The single participant who did not achieve SVR12 experienced an asymptomatic Grade 3 ASL/ALT elevation on day 15 and discontinued treatment. The event resolved without intervention. All 33 participants (100%) treated with sofosbuvir–velpatasvir–voxilaprevir achieved SVR 12. Overall, sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir were safe and well tolerated. Three participants (5.6%) in Cohort 1 and 1 participant (3.0%) in Cohort 2 had serious adverse events, but none were considered treatment-related. No deaths or grade 4 laboratory abnormalities were reported. Conclusions: Treatment with sofosbuvir–velpatasvir or sofosbuvir–velpatasvir–voxilaprevir was safe and resulted in high SVR12 rates in Korean HCV patients.
2.Pediatric out-of-hospital cardiac arrest: incidence and outcomes in an urban city
Jong Yoon PARK ; Yong Hwan KIM ; Jun Ho LEE ; Dong Woo LEE ; Seong Jun AHN ; Kyoung Tak KEUM ; Seong Youn HWANG ; Kyoung Yul LEE
Journal of the Korean Society of Emergency Medicine 2022;33(2):141-148
Objective:
The aim of this study was to examine the incidence and outcomes of pediatric out-of-hospital cardiac arrests (OHCA) in Changwon city, South Korea.
Methods:
From the Out-of-Hospital Cardiac Arrest Surveillance registry and the Changwon Fire Department’s Emergency Medical Services data, we obtained a list of 119 assessed pediatric OHCAs occurred between January 2012 and December 2018. We analyzed basic demographic variables, the location of cardiac arrest, witnessed status, bystander cardiopulmonary resuscitation (CPR), time variables for CPR, dispatcher-assisted CPR, initial cardiac rhythm, automated defibrillator use, and clinical outcomes at hospital discharge.
Results:
A total of 2,954 OHCAs occurred during the study period, of which 72 were pediatric OHCAs. The rate of witnessed cardiac arrest was 30.6% (22/72), and bystander CPR was performed in 29 patients (40.3%). The rate of cardiac arrest occurring in public places was 16.7% (12/72). The rate of shockable rhythm in the initial electrocardiogram rhythm was 8.3% (6/72). Twelve patients (16.7%) survived to admission. The proportion of survivors discharged was 4.3% (3/70), and the rate of discharge with a good prognosis was 2.8% (2/70).
Conclusion
The incidence rate of pediatric OHCA was low in Changwon city. The survival rate was also low. Thus, studies with larger sample sizes and continuous monitoring in the community are needed.
3.Benzodiazepine Use and Long-Term Mortality in South Korean Adult Population: A Cohort Study
Tak Kyu OH ; Hye Youn PARK ; In-Ae SONG
Yonsei Medical Journal 2021;62(6):528-534
Purpose:
Studies have reported mixed results on the association between benzodiazepine use and mortality. Here, we investigated whether benzodiazepine use is associated with a higher risk of 5-year all-cause mortality, and examined the association between benzodiazepine use and 5-year disease-specific mortality.
Materials and Methods:
In this population-based cohort study, a nationally representative sample cohort in South Korea was examined. In 2010, benzodiazepine users were defined as individuals prescribed benzodiazepine continuously over 30 days for regular administration, and all other subjects were included in the control group. The primary endpoint was 5-year all-cause mortality, evaluated from 2011 to 2015. Propensity score (PS) matching and time-dependent Cox regression were performed for statistical analysis, which included benzodiazepine use during 2011–2015 as a time-dependent variable.
Results:
A total of 822414 adult individuals were included in the final analysis, and the all-cause 5-year mortality was recorded in 20991 individuals (2.7%). The benzodiazepine group included 30837 patients and the control group comprised 791377 patients.After PS matching, 61672 individuals (30836 in each group) were included in the final analysis. After PS matching, the 5-year allcause mortality in the benzodiazepine group was 10.0% (3082/30836), whereas that in the control group was 9.4% (2893/30836).In time-dependent Cox regression analysis of the PS-matched cohort, the benzodiazepine group showed 1.15-fold higher 5-year all-cause mortality (hazard ratio: 1.15, 95% confidence interval: 1.09–1.22; p<0.001) compared to the control group.
Conclusion
Benzodiazepine use was associated with increased 5-year all-cause mortality in the South Korean adult population.Further studies are needed to confirm these findings.
4.Prognostic Value of Alpha-Fetoprotein in Patients Who Achieve a Complete Response to Transarterial Chemoembolization for Hepatocellular Carcinoma
Jae Seung LEE ; Young Eun CHON ; Beom Kyung KIM ; Jun Yong PARK ; Do Young KIM ; Sang Hoon AHN ; Kwang-Hyub HAN ; Wonseok KANG ; Moon Seok CHOI ; Geum-Youn GWAK ; Yong-Han PAIK ; Joon Hyeok LEE ; Kwang Cheol KOH ; Seung Woon PAIK ; Hwi Young KIM ; Tae Hun KIM ; Kwon YOO ; Yeonjung HA ; Mi Na KIM ; Joo Ho LEE ; Seong Gyu HWANG ; Soon Sun KIM ; Hyo Jung CHO ; Jae Youn CHEONG ; Sung Won CHO ; Seung Ha PARK ; Nae-Yun HEO ; Young Mi HONG ; Ki Tae YOON ; Mong CHO ; Jung Gil PARK ; Min Kyu KANG ; Soo Young PARK ; Young Oh KWEON ; Won Young TAK ; Se Young JANG ; Dong Hyun SINN ; Seung Up KIM ;
Yonsei Medical Journal 2021;62(1):12-20
Purpose:
Alpha-fetoprotein (AFP) is a prognostic marker for hepatocellular carcinoma (HCC). We investigated the prognostic value of AFP levels in patients who achieved complete response (CR) to transarterial chemoembolization (TACE) for HCC.
Materials and Methods:
Between 2005 and 2018, 890 patients with HCC who achieved a CR to TACE were recruited. An AFP responder was defined as a patient who showed elevated levels of AFP (>10 ng/mL) during TACE, but showed normalization or a >50% reduction in AFP levels after achieving a CR.
Results:
Among the recruited patients, 569 (63.9%) with naïve HCC and 321 (36.1%) with recurrent HCC after complete resection were treated. Before TACE, 305 (34.3%) patients had multiple tumors, 219 (24.6%) had a maximal tumor size >3 cm, and 22 (2.5%) had portal vein tumor thrombosis. The median AFP level after achieving a CR was 6.36 ng/mL. After a CR, 473 (53.1%) patients experienced recurrence, and 417 (46.9%) died [median progression-free survival (PFS) and overall survival (OS) of 16.3 and 62.8 months, respectively]. High AFP levels at CR (>20 ng/mL) were independently associated with a shorter PFS [hazard ratio (HR)=1.403] and OS (HR=1.284), together with tumor multiplicity at TACE (HR=1.518 and 1.666, respectively). AFP non-responders at CR (76.2%, n=359 of 471) showed a shorter PFS (median 10.5 months vs. 15.5 months, HR=1.375) and OS (median 41.4 months vs. 61.8 months, HR=1.424) than AFP responders (all p=0.001).
Conclusion
High AFP levels and AFP non-responders were independently associated with poor outcomes after TACE. AFP holds clinical implications for detailed risk stratification upon achieving a CR after TACE.
5.Guidelines for Cancer Care during the COVID-19 Pandemic in South Korea
Jii Bum LEE ; Minkyu JUNG ; June Hyuk KIM ; Bo Hyun KIM ; Yeol KIM ; Young Seok KIM ; Byung Chang KIM ; Jin KIM ; Sung Ho MOON ; Keon-Uk PARK ; Meerim PARK ; Hyeon Jin PARK ; Sung Hoon SIM ; Hong Man YOON ; Soo Jung LEE ; Eunyoung LEE ; June Young CHUN ; Youn Kyung CHUNG ; So-Youn JUNG ; Jinsoo CHUNG ; Eun Sook LEE ; Hyun Cheol CHUNG ; Tak YUN ; Sun Young RHA
Cancer Research and Treatment 2021;53(2):323-329
At the end of 2019, the cause of pneumonia outbreaks in Wuhan, China, was identified as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In February 2020, the World Health Organization named the disease cause by SARS-CoV-2 as coronavirus disease 2019 (COVID-19). In response to the pandemic, the Korean Cancer Association formed the COVID-19 task force to develop practice guidelines. This special article introduces the clinical practice guidelines for cancer patients which will help oncologists best manage cancer patients during the COVID-19 pandemic.
6.Benzodiazepine Use and Long-Term Mortality in South Korean Adult Population: A Cohort Study
Tak Kyu OH ; Hye Youn PARK ; In-Ae SONG
Yonsei Medical Journal 2021;62(6):528-534
Purpose:
Studies have reported mixed results on the association between benzodiazepine use and mortality. Here, we investigated whether benzodiazepine use is associated with a higher risk of 5-year all-cause mortality, and examined the association between benzodiazepine use and 5-year disease-specific mortality.
Materials and Methods:
In this population-based cohort study, a nationally representative sample cohort in South Korea was examined. In 2010, benzodiazepine users were defined as individuals prescribed benzodiazepine continuously over 30 days for regular administration, and all other subjects were included in the control group. The primary endpoint was 5-year all-cause mortality, evaluated from 2011 to 2015. Propensity score (PS) matching and time-dependent Cox regression were performed for statistical analysis, which included benzodiazepine use during 2011–2015 as a time-dependent variable.
Results:
A total of 822414 adult individuals were included in the final analysis, and the all-cause 5-year mortality was recorded in 20991 individuals (2.7%). The benzodiazepine group included 30837 patients and the control group comprised 791377 patients.After PS matching, 61672 individuals (30836 in each group) were included in the final analysis. After PS matching, the 5-year allcause mortality in the benzodiazepine group was 10.0% (3082/30836), whereas that in the control group was 9.4% (2893/30836).In time-dependent Cox regression analysis of the PS-matched cohort, the benzodiazepine group showed 1.15-fold higher 5-year all-cause mortality (hazard ratio: 1.15, 95% confidence interval: 1.09–1.22; p<0.001) compared to the control group.
Conclusion
Benzodiazepine use was associated with increased 5-year all-cause mortality in the South Korean adult population.Further studies are needed to confirm these findings.
7.Guidelines for Cancer Care during the COVID-19 Pandemic in South Korea
Jii Bum LEE ; Minkyu JUNG ; June Hyuk KIM ; Bo Hyun KIM ; Yeol KIM ; Young Seok KIM ; Byung Chang KIM ; Jin KIM ; Sung Ho MOON ; Keon-Uk PARK ; Meerim PARK ; Hyeon Jin PARK ; Sung Hoon SIM ; Hong Man YOON ; Soo Jung LEE ; Eunyoung LEE ; June Young CHUN ; Youn Kyung CHUNG ; So-Youn JUNG ; Jinsoo CHUNG ; Eun Sook LEE ; Hyun Cheol CHUNG ; Tak YUN ; Sun Young RHA
Cancer Research and Treatment 2021;53(2):323-329
At the end of 2019, the cause of pneumonia outbreaks in Wuhan, China, was identified as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In February 2020, the World Health Organization named the disease cause by SARS-CoV-2 as coronavirus disease 2019 (COVID-19). In response to the pandemic, the Korean Cancer Association formed the COVID-19 task force to develop practice guidelines. This special article introduces the clinical practice guidelines for cancer patients which will help oncologists best manage cancer patients during the COVID-19 pandemic.
8.The Prognosis of Glyphosate herbicide intoxicated patients according to their salt types
Jeong Min GYU ; Kyoung Tak KEUM` ; Seongjun AHN ; Yong Hwan KIM ; Jun Ho LEE ; Kwang Won CHO ; Seong Youn HWANG ; Dong Woo LEE
Journal of The Korean Society of Clinical Toxicology 2021;19(2):83-92
Purpose:
Glyphosate herbicide (GH) is a widely used herbicide and has been associated with significant mortality as poisoned cases increases. One of the reasons for high toxicity is thought to be toxic effect of its ingredient with glyphosate. This study was designed to determine differences in the clinical course with the salt-type contained in GH.
Methods:
This was a retrospective study conducted at a single hospital between January 2013 and December 2017. We enrolled GH-poisoned patients visited the emergency department. According to salt-type, patients were divided into 4 groups: isopropylamine (IPA), ammonium (Am), potassium (Po), and mixed salts (Mi) groups. The demographics, laboratory variables, complications, and their mortality were analyzed to determine clinical differences associated with each salt-type. Addtionally, we subdivided patients into survivor and non-survivor groups for investigating predictive factors for the mortality.
Results:
Total of 348 GH-poisoned patients were divided as follows: IPA 248, Am 41, Po 10, and Mi 49 patients. There was no difference in demographic or underlying disease history, but systolic blood pressure (SBP) was low in Po group. The ratio of intentional ingestion was higher in Po and Mi groups. Metabolic acidosis and relatively high lactate level were presented in Po group.As the primary outcome, the mortality rates were as follows: IPA, 26 (10.5%); Am, 2 (4.9%); Po, 1 (10%); and Mi, 1 (2%). There was no statistically significant difference in the mortality and the incidence of complications. Additionally, age, low SBP, low pH, corrected QT (QTc) prolongation, and respiratory failure requiring mechanical ventilation were analyzed as independent predictors for mortality in a regression analysis.
Conclusion
There was no statistical difference in their complications and the mortality across the GH-salt groups in this study.
9.Initial Seizure Threshold in Ultra-Brief Pulse Width Right Unilateral Electroconvulsive Therapy
Hyo Seob KIM ; Sam Yi SHIN ; Seong Hoon JEONG ; Yeni KIM ; Tak YOUN ; Chi Hoon CHUNG ; Yong Sik KIM ; In Won CHUNG
Journal of Korean Neuropsychiatric Association 2020;59(4):311-318
Objectives:
The present study investigates the initial seizure threshold (IST) of an ultra-brief pulse width right unilateral electroconvulsive therapy (UBP-RUL ECT) in Korean patients with mental disorders to identify its predictive factors for clinical improvement.
Methods:
This study includes thirty patients who received 0.3-ms UBP-RUL ECT using upward titration to measure IST after the use of general anesthesia and muscle relaxation between December 2015 and June 2020. During the second session, the amount of charge that ranged between 500% to 600% of IST was applied as the stimulus intensity (SI). Demographic and clinical information was gathered from electronic medical records, and a stepwise variable selection was conducted to identify the relevant predictors of IST.
Results:
The mean age of study subjects was 49.7±18.3 years, and 12 (40.0%) patients were male. The mean IST and SI were 31.6±17.2 mC and 176.0±98.5 mC, respectively, which did not differ between males and females. The mean scores of the Clinical Global Impression-severity and the Clinical Global Impression-improvement before and after acute ECT were 5.8±0.8 and 2.1±0.7, respectively. The age and anesthetic dose per body weight were significant predictors of IST. However, the IST and SI were not associated with clinical improvement.
Conclusion
The present study demonstrated that the IST distribution for UBP-RUL ECT in Korean patients with mental disorders was comparable to those reported in previous literature. The IST was associated with age and anesthetic dose.
10.An integrated analysis of elbasvir/grazoprevir in Korean patients with hepatitis C virus genotype 1b infection
Youn Jae LEE ; Jeong HEO ; Do Young KIM ; Woo Jin CHUNG ; Won Young TAK ; Yoon Jun KIM ; Seung Woon PAIK ; Eungeol SIM ; Susila KULASINGAM ; Rohit TALWANI ; Barbara HABER ; Peggy HWANG
Clinical and Molecular Hepatology 2019;25(4):400-407
BACKGROUND/AIMS: In the Republic of Korea, an estimated 231,000 individuals have chronic hepatitis C virus (HCV) infection. The aim of the present analysis was to evaluate the safety and efficacy of elbasvir/grazoprevir (EBR/GZR) administered for 12 weeks in Korean patients who were enrolled in international clinical trial phase 3 studies.METHODS: This was a retrospective, integrated analysis of data from patients with HCV genotype (GT) 1b infection enrolled at Korean study sites in four EBR/GZR phase 3 clinical trials. Patients were treatment-naive or had previously failed interferon-based HCV therapy, and included those with human immunodeficiency virus coinfection or Child-Pugh class A cirrhosis. All patients received EBR 50 mg/GZR 100 mg once daily for 12 weeks. The primary endpoint was sustained virologic response at 12 weeks after completion of therapy (SVR12, HCV RNA <15 IU/mL).RESULTS: SVR12 was achieved by 73 of 74 (98.6%) patients. No patients had virologic failure and one discontinued from the study after withdrawing consent. SVR12 rates were uniformly high across all patient subgroups. A total of 16 patients had nonstructural protein 5A resistance-associated substitutions at baseline (16/73, 22%), all of whom achieved SVR12. Adverse events (AEs) reported in >5% of patients were fatigue (6.8%), upper respiratory tract infection (5.4%), headache (5.4%), and nausea (5.4%). Thirteen patients (17.6%) reported drug-related AEs, two serious AEs occurred, and two patients discontinued treatment owing to an AEs.CONCLUSIONS: In this retrospective analysis, EBR/GZR administered for 12 weeks was well-tolerated and highly effective in Korean patients with HCV GT1b infection.
Antiviral Agents
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Coinfection
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Fatigue
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Fibrosis
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Genotype
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Headache
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Hepacivirus
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Hepatitis C
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Hepatitis C, Chronic
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Hepatitis
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HIV
;
Humans
;
Nausea
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Republic of Korea
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Respiratory Tract Infections
;
Retrospective Studies
;
RNA

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