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      KCI등재 SCI SCIE SCOPUS

      Real-world Effectiveness and Safety of Direct-acting Antiviral Agents in Patients with Chronic Hepatitis C Genotype 2 Infection: Korean Multicenter Study

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      https://www.riss.kr/link?id=A107496398

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      다국어 초록 (Multilingual Abstract)

      Background: The advancement of treatment with direct-acting antiviral (DAA) agents has improved the cure rate of hepatitis C virus (HCV) infection close to 100%. The aim of our study was to assess the real-world effectiveness and safety of DAA regimen...

      Background: The advancement of treatment with direct-acting antiviral (DAA) agents has improved the cure rate of hepatitis C virus (HCV) infection close to 100%. The aim of our study was to assess the real-world effectiveness and safety of DAA regimens for the treatment of patients with chronic HCV genotype 2.
      Methods: We retrospectively analyzed the clinical data of patients treated with sofosbuvir plus ribavirin (SOF + RBV) or glecaprevir/pibrentasvir (G/P) for chronic HCV genotype 2 infection at seven university hospitals in the Korean southeast region.
      Results: SOF + RBV therapy produced an 89% and 98.3% sustained virologic response 12 week (SVR12) after treatment completion in the full analysis set and per-protocol set, respectively, and the corresponding values for G/P therapy were 89.5% and 99.2%, respectively. The difference between the treatments was probably because 6.2% (59/953) of patients in the SOF + RBV group did not complete the treatment and 9.8% (14/143) in the G/P group did not test HCV RNA after treatment completion. Adverse events (A/Es) were reported in 59.7% (569/953) and 25.9% (37/143) of the SOF + RBV and G/P groups, respectively. In the SOF + RBV group, 12 (1.26%) patients discontinued treatment owing to A/Es, whereas no patients discontinued treatment because of A/Es in the G/P group.
      Conclusion: In both treatment groups, SVR was high when treatment was completed.
      However, there was a high dropout rate in the SOF + RBV group, and the dropout analysis showed that these were patients with liver cirrhosis (LC; 43/285, 15.1%), especially those with decompensated LC (12/32, 37.5%). Therefore, an early initiation of antiviral therapy is recommended for a successful outcome before liver function declines. Furthermore, patients with decompensated LC who are considered candidates for SOF + RBV treatment should be carefully monitored to ensure that their treatment is completed, especially those with low hemoglobin and high alanine transaminase.

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      참고문헌 (Reference)

      1 Wirth TC, "The impact of the revolution in hepatitis C treatment on hepatocellular carcinoma" 27 (27): 1467-1474, 2016

      2 Ji F, "Sustained virologic response to direct-acting antiviral therapy in patients with chronic hepatitis C and hepatocellular carcinoma : a systematic review and meta-analysis" 71 (71): 473-485, 2019

      3 Omata M, "Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection : an open-label, phase 3 trial" 21 (21): 762-768, 2014

      4 Feld JJ, "Sofosbuvir and velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 infection" 373 (373): 2599-2607, 2015

      5 Chua JV, "Sofosbuvir and velpatasvir : a stellar option for patients with decompensated hepatitis C virus(HCV)cirrhosis" 4 (4): S8-, 2016

      6 Sato K, "Response-guided peginterferon-alpha-2b plus ribavirin therapy for chronic hepatitis C patients with genotype 2 and high viral loads" 42 (42): 854-863, 2012

      7 Jong Eun Yeon, "Recent update of the 2017 Korean Association for the Study of the Liver (KASL) treatment guidelines of chronic hepatitis C: Comparison of guidelines from other continents, 2017 AASLD/IDSA and 2016 EASL" 대한간학회 24 (24): 278-293, 2018

      8 Akahane T, "Real-world efficacy and safety of sofosbuvir + ribavirin for hepatitis C genotype 2 : a nationwide multicenter study by the Japanese Red Cross Liver Study Group" 49 (49): 264-270, 2019

      9 D'Ambrosio R, "Real-world effectiveness and safety of glecaprevir/pibrentasvir in 723 patients with chronic hepatitis C" 70 (70): 379-387, 2019

      10 von Wagner M, "Peginterferon-alpha2a(40KD)and ribavirin for 16 or 24 weeks in patients with genotype 2 or 3 chronic hepatitis C" 129 (129): 522-527, 2005

      1 Wirth TC, "The impact of the revolution in hepatitis C treatment on hepatocellular carcinoma" 27 (27): 1467-1474, 2016

      2 Ji F, "Sustained virologic response to direct-acting antiviral therapy in patients with chronic hepatitis C and hepatocellular carcinoma : a systematic review and meta-analysis" 71 (71): 473-485, 2019

      3 Omata M, "Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection : an open-label, phase 3 trial" 21 (21): 762-768, 2014

      4 Feld JJ, "Sofosbuvir and velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 infection" 373 (373): 2599-2607, 2015

      5 Chua JV, "Sofosbuvir and velpatasvir : a stellar option for patients with decompensated hepatitis C virus(HCV)cirrhosis" 4 (4): S8-, 2016

      6 Sato K, "Response-guided peginterferon-alpha-2b plus ribavirin therapy for chronic hepatitis C patients with genotype 2 and high viral loads" 42 (42): 854-863, 2012

      7 Jong Eun Yeon, "Recent update of the 2017 Korean Association for the Study of the Liver (KASL) treatment guidelines of chronic hepatitis C: Comparison of guidelines from other continents, 2017 AASLD/IDSA and 2016 EASL" 대한간학회 24 (24): 278-293, 2018

      8 Akahane T, "Real-world efficacy and safety of sofosbuvir + ribavirin for hepatitis C genotype 2 : a nationwide multicenter study by the Japanese Red Cross Liver Study Group" 49 (49): 264-270, 2019

      9 D'Ambrosio R, "Real-world effectiveness and safety of glecaprevir/pibrentasvir in 723 patients with chronic hepatitis C" 70 (70): 379-387, 2019

      10 von Wagner M, "Peginterferon-alpha2a(40KD)and ribavirin for 16 or 24 weeks in patients with genotype 2 or 3 chronic hepatitis C" 129 (129): 522-527, 2005

      11 Kanda T, "New antiviral therapies for chronic hepatitis C" 4 (4): 548-561, 2010

      12 Liu CH, "Nanomedicines in the treatment of hepatitis C virus infection in Asian patients : optimizing use of peginterferon alfa" 9 : 2051-2067, 2014

      13 Puoti M, "High SVR12 with 8-week and 12-week glecaprevir/pibrentasvir therapy : an integrated analysis of HCV genotype 1-6 patients without cirrhosis" 69 (69): 293-300, 2018

      14 Kim MN, "Hepatocellular carcinoma in patients with chronic hepatitis C virus infection in the Asia-Pacific region" 48 (48): 681-688, 2013

      15 Prenner SB, "Hepatocellular carcinoma decreases the chance of successful hepatitis C virus therapy with direct-acting antivirals" 66 (66): 1173-1181, 2017

      16 Kao JH, "Hepatitis C virus infection in Taiwan : past, present, and future" 115 (115): 65-66, 2016

      17 Ghany MG, "Hepatitis C guidance 2019 update : American Association for the Study of Liver Diseases-Infectious Diseases Society of America recommendations for testing, managing, and treating hepatitis C virus infection" 71 (71): 686-721, 2020

      18 Ioannou GN, "HCV eradication induced by direct-acting antiviral agents reduces the risk of hepatocellular carcinoma" 2017

      19 Forns X, "Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis(EXPEDITION-1) : a single-arm, open-label, multicentre phase 3 trial" 17 (17): 1062-1068, 2017

      20 Kwo PY, "Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis" 67 (67): 263-271, 2017

      21 Ikeda H, "Evaluation of 8-week glecaprevir/pibrentasvir treatment in direct-acting antiviral-naïve noncirrhotic HCV genotype 1 and 2infected patients in a real-world setting in Japan" 26 (26): 1266-1275, 2019

      22 Asselah T, "Efficacy of glecaprevir/pibrentasvir for 8 or 12 weeks in patients with hepatitis C virus genotype 2, 4, 5, or 6 infection without cirrhosis" 16 (16): 417-426, 2018

      23 European Association for the Study of the Liver, "EASL recommendations on treatment of hepatitis C 2018" 69 (69): 461-511, 2018

      24 European Association for Study of Liver, "EASL clinical practice guidelines : management of hepatitis C virus infection" 60 (60): 392-420, 2014

      25 Hengst J, "DAA-induced HCV clearance does not restore the altered cytokine and chemokine milieu in patients with chronic hepatitis C" 64 (64): S417-S418, 2016

      26 Verna EC, "DAA therapy and long-term hepatic function in advanced/decompensated cirrhosis : Real-world experience from HCV-TARGET cohort" 73 (73): 540-548, 2020

      27 Seong MH, "Clinical and epidemiological features of hepatitis C virus infection in South Korea : a prospective, multicenter cohort study" 85 (85): 1724-1733, 2013

      28 van der Meer AJ, "Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis" 308 (308): 2584-2593, 2012

      29 Kao JH, "A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection" 36 (36): 1101-1107, 2016

      30 Kim DY, "A nationwide seroepidemiology of hepatitis C virus infection in South Korea" 33 (33): 586-594, 2013

      31 정영걸, "2015년 대한간학회 C형간염 진료 가이드라인 개정, 무엇이 달라졌는가? – 유전자 2, 3형 만성 C형간염의 치료" 대한소화기학회 67 (67): 132-136, 2016

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      학술지 이력

      학술지 이력
      연월일 이력구분 이력상세 등재구분
      2023 평가예정 해외DB학술지평가 신청대상 (해외등재 학술지 평가)
      2020-01-01 평가 등재학술지 유지 (해외등재 학술지 평가) KCI등재
      2011-01-01 평가 등재학술지 유지 (등재유지) KCI등재
      2009-01-01 평가 등재학술지 유지 (등재유지) KCI등재
      2005-01-01 평가 SCI 등재 (등재유지) KCI등재
      2002-01-01 평가 등재학술지 선정 (등재후보2차) KCI등재
      1999-07-01 평가 등재후보학술지 선정 (신규평가) KCI등재후보
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      학술지 인용정보

      학술지 인용정보
      기준연도 WOS-KCI 통합IF(2년) KCIF(2년) KCIF(3년)
      2016 1.48 0.37 1.06
      KCIF(4년) KCIF(5년) 중심성지수(3년) 즉시성지수
      0.85 0.75 0.691 0.11
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