Impact of Interferon-Based Treatment on Quality of Life and Work Related Productivity from the Korean Cohort in the MOSAIC Study

( Sang Hoon Ahn ),( Won Hyeok Choe ),( Yoon Jun Kim ),( Jeong Heo ),( Dorota Latarska-smuga ),( Jiho Kang ),( Seung Woon Paik ) 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1

Aims: Chronic Hepatitis C Virus (HCV) infection increases the risk for progressive liver disease, hepatocellular carcinoma and negatively impacts the patient’s quality of life. HCV treatment is evolving with direct acting antivirals but IFN based therapy has been the standard of care for many years and remains available in some countries. The MOSAIC study aims to characterize patients with chronic HCV infection and assess the impact of IFN-containing treatment on health-related quality of life, work related productivity and health care utilization. Methods: MOSAIC is an international prospective multicenter observational study that has been conducted in 20 countries. Consecutive patients with chronic HCV infection were enrolled and those who initiated an IFN based regimen were prospectively followed for 48 weeks. We report results from the Korean cohort Results: 100 patients were enrolled: 86 were treatment naïve and 14 were treatment experienced. 33 patients initiated an IFN based regimen: 6 patients started IFN + RBV, 26 patients started Peg-IFN + RBV, none started Peg-IFN + RBV + DAA and 1 patient received other treatment. Among the treated cohort, demographic and disease characteristics were the following: the mean age was 54.5 years; 14 patients were male. 14 had minimal or no fibrosis, 2 portal fibrosis, 3 bridging fibrosis and 6 patients suffered from cirrhosis. HCV Genotype distribution was as follows: genotype 1: 11; genotype 2: 19 and genotype 3: 3. Table 1 describes the results at baseline and changes over 4, 12 and 48 weeks and end-of-treatment (EOT) for the quality of life and work productivity outcome measures (EQ-5D-5L, HCV-PRO and WPAI). Conclusions: Results from the Korean cohort of the MOSAIC study show a moderate trend for deterioration of health-related quality of life and work productivity associated with IFN based treatment for patients with chronic HCV infection during treatment period. Acknowledgements: The design, study conduct, analysis, and financial support of MOSAIC study were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the content of the abstract. All authors had access to all relevant data and participated in writing, review, and approval of this abstract. Medical writing support was provided by Olivier Van de Steen of Medeor-consulting, funded by AbbVie. Disclosures: Sang Hoon Ahn: served as an advisor and lecturer for Bristol-Myers Squibb, Gilead Sciences, F.Hoffmann-La Roche, Merck, AbbVie, and has received unrestricted grants from Bristol-Myers Squibb, Gilead Sciences, and F. Hoffmann-La Roche for investigator- initiated trials Won Hyeok Choe: Nothing to disclosure Yoon Jun Kim: Nothing to disclosure Jeong Heo: received a grant from GSK; Research support from BMS, and Roche; Advisor for Abbvie, BMS, Gilead Sciences, Pharma Essentia, SillaJen, and Johnson & Johnson. Dorota Latarska-Smuga, Jiho Kang: are employees of AbbVie, Inc. and may hold stock or stock options. Seung Woon Paik: received grant and research support from AbbVie, BMS, Gilead, GSK, Merck, Novartis, and Roche

ONYX-II: Efficacy of Ombitasvir/Paritaprevir/Ritonavir + Dasabuvir + Ribavirin in HCV Genotype 1b-Infected Patients with Compensated Cirrhosis from South Korea and Taiwan

( Seung Woon Paik ),( Chi-jen Chu ),( Yan Luo ),( Kwang-hyub Han ),( Jia-horng Kao ),( Jeong Heo ),( Cheng-yuan Peng ),( Yoon Jun Kim ),( Ting-tsung Chang ),( Young-suk Lim ),( Ming Lung Yu ),( Linda 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1

Background: Chronic hepatitis C virus (HCV) infection is associated with development of complications including hepatocellular carcinoma, liver failure and cirrhosis. Patients with cirrhosis are historically more difficult to cure. In southeastern Asia, the most prevalent HCV genotype (GT) is GT1b. In western populations, the 3 direct-acting antiviral (3-DAA) regimen of ombitasvir (OBV), ritonavir-boosted paritaprevir (PTV/r; identified by AbbVie and Enanta) and dasabuvir (DSV) ± ribavirin (RBV) demonstrated sustained virologic response (SVR) at post-treatment week 12 (SVR12) rates of 99% in patients with GT1b infection and compensated cirrhosis regardless of prior treatment experience. The regimen, however, has not been investigated in southeastern Asian populations. The ONYX-II study is evaluating the efficacy and safety of this regimen in Asian patients with HCV GT1b infection and compensated cirrhosis. Methods: Treatment-naive and interferon-based therapy-experienced patients with HCV GT1b-infection and compensated cirrhosis were enrolled in South Korea, Taiwan, and China, and received 12 weeks of OBV/PTV/r (25 mg/150 mg/100 mg once daily) and DSV (250 mg twice daily) with RBV (weight-based). Patients will be followed for 48 weeks after the last dose of study drugs. The primary objectives are to compare the SVR12 rate to the known SVR rate of telaprevir + peg-interferon (IFN) + RBV therapy, and to assess the safety of OBV/PTV/r + DSV + RBV. Results: Twenty-one and 20 subjects were enrolled in South Korea and Taiwan, respectively. Of South Korean patients, 52% were male and 71% were treatment-experienced; of Taiwanese patients, 45% were male and 65% were treatment-experienced. Safety data and SVR at post-treatment week 4 (SVR4) will be available for presentation. Conclusions: The ONYX-II study evaluates the 3-DAA regimen of OBV/PTV/r + DSV with RBV for Asian patients with compensated cirrhosis and HCV GT1b infection. Resultant data may provide evidence for treatment guidelines for HCV GT1b in this population.

Symposium: Current and future issues in hepatitis C treatment : Side effects of peginterferon and ribavirin treatment for hepatitis C and their management

Seung Woon Paik 대한간학회 2009 Clinical and Molecular Hepatology(대한간학회지) Vol.15 No.4(S)

한센병과 C형간염

백승운 ( Seung Woon Paik ) 대한내과학회 2006 대한내과학회지 Vol.70 No.1

만성 B형간염환자의 재발 방지 및 삶의 질 향상을 위한 시스템 다이내믹스 모델 개발

백승운 ( Seung Woon Paik ),최은옥 ( Eun Ok Choi ),김금순 ( Keum Soon Kim ),이명선 ( Myung Sun Yi ),곽상만 ( Sang Man Kwak ) 한국시스템다이내믹스학회 2006 한국시스템다이내믹스 연구 Vol.7 No.2

A conceptual system dynamics model is developed to represent the dynamic mechanism between the number of hepatitis B virus and the defense system of the body. The simulation results shows that the model behaves within the reasonable ranges. The developed conceptual model is a first attempt to quantify the dynamic mechanisms of the hepatitis B virus, where only feedback structures are considered without bio-organism data. The next step would be to incorporate the model with bio-organism theory and to carry out case studies to identify personal characteristics. Since the current model is a conceptual model where quantitative results are not based on the sound background, the usage is limited only within the qualitative basis. It could be a effective educational tool for the patients. It also shows what-to-do lists in order to be used for forecast purposes. * This study was funded by "the Korea Research Foundation Grant" (KRF-2004-042-E00147) in 2004.

간암의 치료

백승운(Seung Woon Paik) 대한내과학회 2001 대한내과학회지 Vol.61 No.6

N/A

Combined Use of AST to Platelet Ratio Index and Fibrosis-4 Score Can Risk Stratify Hepatocellular Carcinoma Risk in Chronic Hepatitis B Patients with Low Level Viremia

( Namyoung Paik ),( Dong Hyun Sinn ),( Jung Hee Kim ),( Wonseok Kang ),( Geum-youn Gwak ),( Yong-han Paik ),( Moon Seok Choi ),( Joon Hyeok Lee ),( Kwang Cheol Koh ),( Seung Woon Paik ) 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1

Aims: The prognosis of chronic hepatitis B virus (HBV) infected patientsshowing low level viremia (HBV DNA < 2,000 IU/mL) are generallyexcellent, yet, those with cirrhosis are still at risk for developing hepatocellularcarcinoma (HCC). Liver biopsy is the gold standard to differentiatecirrhosis in this population, yet, due to its invasiveness, manyhad to rely on noninvasive liver fibrosis predictors. We tested whethersimple noninvasive liver fibrosis predictors, the AST to platelet ratioindex (APRI) and the Fibrosis-4 (FIB-4), can effectively risk-stratify HCCrisk in patients with low level viremia.Methods: A retrospective cohort of 1,380 CHB patients with low levelviremia (HBV DNA < 2,000 IU/mL) was assessed for the developmentof HCC. Cirrhosis was defined clinically by cirrhotic configuration,varix, thrombocytopenia with splenomegaly. Based on APRI and FIB-4score, patients were divided into two groups based on known cutoff(0.5 for APRI and 1.45 for FIB-4), which has shown high negativepredictive value for advanced fibrosis.Results: During a median 5.7 years (range: 1.0-9.2 years) of follow-up,HCC developed in 65 patients. The HCC incidence rate was higherfor cirrhotic patients (40/237 patients, 16.7% at 5-years), but wasnot null for non-cirrhotic patients (25/1,143 patients, 1.9% at 5-years,p < 0.001). The AUROCs for the HCC development at 3/5 yearswas 0.78/0.73, 0.79/0.78, and 0.79/0.76 for cirrhosis, APRI and FIB-4,among overall cohort, respectively, and was 0.73/0.83 and 0.83/0.89for APRI and FIB-4, among non-cirrhotic patients. When stratifiedby APRI and FIB-4, the 5-year cumulative HCC incidence rate was13.7%, 2.8% and 1.4% for both high, any high, and both lowAPRI and FIB-4, among overall cohort (p < 0.001), and was 11.5%,2.4% and 0.2% for both high, any high, and both low APRI andFIB-4, among non-cirrhotic patients (p < 0.001), respectively.Conclusions: The combined use of APRI and FIB-4 can effectively riskstratify individuals risk for HCC, and can be useful in clinical practicefor the HCC prediction among patients with low level viremia, includingthose without clinical evidence of cirrhosis.

의학강좌 - 개원의를 위한 모범처방전 : 만성 B 형 간염에서 항바이러스 약제 처방원칙

백승운(Seung Woon Paik) 대한내과학회 2002 대한내과학회지 Vol.62 No.6

N/A

간의 원발성 평활근육종 1예

백승운(Seung Woon Paik),이종철(Jong Chul Rhee),김재준(Jae Jun Kim),고광철(Kwang Cheol Koh),이준혁(Joon Hyeok Lee),이종균(Jong Kyun Lee),이규택(Kyu Taek Lee),이풍렬(Poong Lyul Rhee),오영륜(Young Lyun Oh),안홍준(Hong Joon Ahn) 대한소화기학회 1998 대한소화기학회지 Vol.31 No.5

Primary hepatic leiomyosarcoma of the liver is a rare tumor, with fewer than 70 previously reported cases. There was only one case reported in Korea. We present the case of a 54-year-old man who presented with a mass in the right hepatic lobe on CT scan. Percutaneous biopsy was consistent with leiomyosarcoma. The patient was treated successfully by right lobectomy, and has been disease free for 19 months. We report the case of primary leiomyosarcoma of the liver with review of relevant literatures. (Korean J Gastroenterol 1998;31:691-695)

바이러스성 간염 C형간염의 치료 목표, 대상 및 치료

백승운 ( Seung Woon Paik ) 대한소화기학회 2008 대한소화기학회지 Vol.51 No.6

Hepatitis C virus (HCV) is a major cause of chronic hepatitis and hepatic fibrosis worldwide. Up to 85% of individuals infected with HCV develop chronic infection, which can progress to cirrhosis and hepatocellular carcinoma. The primary goal in the treatment of HCV infection is to reduce the mortality by preventing liver-related deaths associated with the development of hepatocellular carcinoma and decompensated cirrhosis. Pegylated interferons together with ribavirin are currently the standard of care for patients with chronic hepatitis. Here, I discuss the goals of treatment, indication and treatment of chronic hepatitis C. (Korean J Gastroenterol 2008;51: 368-371)