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Real-world Effectiveness and Tolerability of Interferon-free Direct-acting Antiviral for 15,849 Patients with Chronic Hepatitis C: A Multinational Cohort Study

Ji F 1 , Tran S 2 , Ogawa E 3 , Huang CF 4 , Suzuki T 5 , Wong YJ 6 Show all authors , Toyoda H 7 , Jun DW 8 , Li L 9 , Uojima H 10 , Nozaki A 11 , Chuma M 11 , Tseng CH 12 , Hsu YC 12 , Ishigami M 13 , Honda T 13 , Atsukawa M 14 , Haga H 15 , Enomoto M 16 , Trinh H 17 , Preda CM 18 , Vutien P 19 , Landis C 19 , Lee DH 20 , Watanabe T 21 , Takahashi H 22 , Abe H 23 , Asai A 24 , Eguchi Y 22 , Li J 25 , Wang X 26 , Li J 27 , Liu J 28 , Liang J 29 , Lam CP 30 , Huang R 25 , Ye Q 29 , Pan H 31 , Zhang J 31 , Cai D 32 , Wang Q 33 , Huang DQ 34 , Wong G 35 , Wong VW 35 , Li J 9 , Do S 36 , Furusyo N 37 , Nakamuta M 38 , Nomura H 39 , Kajiwara E 40 , Yoon EL 8 , Ahn SB 41 , Azuma K 42 , Dohmen K 43 , An J 44 , Song DS 45 , Cho HC 46 , Kawano A 47 , Koyanagi T 48 , Ooho A 49 , Satoh T 50 , Takahashi K 51 , Yeh ML 4 , Tsai PC 4 , Yasuda S 7 , Zhao Y 1 , Liu Y 1 , Okubo T 52 , Itokawa N 14 , Jun MJ 20 , Ishikawa T 53 , Takaguchi K 54 , Senoh T 54 , Zhang M 55 , Zhao C 56 , Alecu RI 18 , Xuan Tay W 6 , Devan P 6 , Liu JK 19 , Kozuka R 57 , Vargas-Accarino E 58 , Do AT 36 , Maeda M 2 , Chuang WL 4 , Huang JF 4 , Dai CY 4 , Cheung R 2 , Buti M 58 , Niu J 55 , Xie W 33 , Ren H 32 , Lim SG 34 , Wu C 25 , Yuen MF 30 , Shang J 28 , Zhu Q 59 , Ueno Y 15 , Tanaka Y 5 , Hayashi J 60 , Yu ML 4 , Nguyen MH 2

Affiliations 

  • 1 Department of Infectious Diseases, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
  • 2 Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University Medical Center, Palo Alto, CA, USA
  • 3 Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan
  • 4 Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung
  • 5 Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
  • 6 Gastroenterology & Hepatology, Changi General Hospital, Singhealth, Singapore
  • 7 Department of Gastroenterology, Ogaki Municipal Hospital, Ogaki, Japan
  • 8 Department of Internal Medicine, Hanyang University, College of Medicine, Seoul, Korea
  • 9 Department of Hepatology, The Third People's Hospital of Kunming City, Kunming, Yunnan, China
  • 10 Department of Gastroenterology, Internal Medicine, Kitasato University School of Medicine, Sagamihara, Japan
  • 11 Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan
  • 12 Division of Gastroenterology and Hepatology, Department of Internal Medicine, E-Da Cancer Hospital, Kaohsiung
  • 13 Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan
  • 14 Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan
  • 15 Department of Gastroenterology, Yamagata University Faculty of Medicine, Yamagata, Japan
  • 16 Department of Transfusion Medicine and Department of Hepatology, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan
  • 17 San Jose Gastroenterology, San Jose, CA, USA
  • 18 Gastroenterology & Hepatology Department, Clinic Fundeni Institute, Bucharest, Romania
  • 19 Division of Gastroenterology and Hepatology, University of Washington, Seattle, WA, USA
  • 20 Department of Gastroenterology, Good Gang-An Hospital, Busan, Korea
  • 21 Division of Gastroenterology and Hepatology, St. Marianna University School of Medicine, Kawasaki, Japan
  • 22 Liver Center, Saga University Hospital, Saga, Japan
  • 23 Division of Gastroenterology and Hepatology, Shinmatsudo Central General Hospital, Chiba, Japan
  • 24 2nd Department of Internal Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan
  • 25 Department of Infectious Diseases, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, Jiangsu, China
  • 26 Affiliated Traditional Chinese Medicine Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China
  • 27 Department of Gastroenterology and Hepatology, The Second People's Hospital of Tianjin, Tianjin, China
  • 28 Department of Infectious Diseases, Henan Provincial People's Hospital Affiliated to Zhengzhou University, Zhengzhou, Henan, China
  • 29 Department of Gastroenterology and Hepatology, The Third Central Hospital of Tianjin, Tianjin, China
  • 30 Department of Medicine, The University of Hong Kong, Hong Kong, China
  • 31 Department of Hepatology, Zhejiang Provincial People's Hospital Affiliated to Zhejiang University, Hangzhou, Zhejiang, China
  • 32 Department of Infectious Diseases, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China
  • 33 Center of liver diseases, Beijing Ditan Hospital Affiliated to Capital Medical University, Beijing, China
  • 34 Division of Gastroenterology and Hepatology, National University Hospital, Singapore
  • 35 Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China
  • 36 Digestive Health Associates of Texas, Dallas, TX, USA
  • 37 Taihaku Avenue Clinic, Fukuoka, Japan
  • 38 Department of Gastroenterology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan
  • 39 Department of Internal Medicine, Haradoi Hospital, Fukuoka, Japan
  • 40 Hepatology Clinic, Kajiwara Clinic, Kitakyushu, Japan
  • 41 Department of Internal Medicine, Nowon Eulji Medical Center, Eulji University College of Medicine, Seoul, Korea
  • 42 Department of Medicine, Kyushu Central Hospital, Fukuoka, Japan
  • 43 Department of Internal Medicine, Chihaya Hospital, Fukuoka, Japan
  • 44 Department of Internal Medicine, Hanyang University, College of Medicine, Guri Hospital, Guri, Korea
  • 45 Division of Hepatology, Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea
  • 46 Departments of Internal Medicine, Gyeongsang National University Hospital, Jinju, Korea
  • 47 Department of Medicine, Kitakyushu Municipal Medical Center, Fukuoka, Japan
  • 48 Department of Medicine, Fukuoka City Hospital, Fukuoka, Japan
  • 49 Department of Hepatology, Steel Memorial Yawata Hospital, Kitakyushu, Japan
  • 50 Center for Liver Disease, National Hospital Organization Kokura Medical Center, Kitakyushu, Japan
  • 51 Department of Medicine, Hamanomachi Hospital, Fukuoka, Japan
  • 52 Division of Gastoroentelorogy, Nippon Medcal School Chiba Hokusoh Hospital, Chiba, Japan
  • 53 Department of Gastroenterology, Saiseikai Niigata Hospital, Niigata, Japan
  • 54 Department of Hepatology, Kagawa Prefectural Central Hospital, Kagawa, Japan
  • 55 Department of Hepatology, The First Hospital of Jilin University, Changchun, Jilin, China
  • 56 Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
  • 57 Department of Hepatology, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan
  • 58 Liver Diseases Group, Vall d'Hebron Research Institute, Barcelona, Spain
  • 59 Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong University, Ji'nan, Shandong, China
  • 60 Kyushu General Internal Medicine Center, Haradoi Hospital, Fukuoka, Japan
J Clin Transl Hepatol, 2024 Jul 28;12(7):646-658.
PMID: 38993510 DOI: 10.14218/JCTH.2024.00089

Abstract

BACKGROUND AND AIMS: As practice patterns and hepatitis C virus (HCV) genotypes (GT) vary geographically, a global real-world study from both East and West covering all GTs can help inform practice policy toward the 2030 HCV elimination goal. This study aimed to assess the effectiveness and tolerability of DAA treatment in routine clinical practice in a multinational cohort for patients infected with all HCV GTs, focusing on GT3 and GT6.

METHODS: We analyzed the sustained virological response (SVR12) of 15,849 chronic hepatitis C patients from 39 Real-World Evidence from the Asia Liver Consortium for HCV clinical sites in Asia Pacific, North America, and Europe between 07/01/2014-07/01/2021.

RESULTS: The mean age was 62±13 years, with 49.6% male. The demographic breakdown was 91.1% Asian (52.9% Japanese, 25.7% Chinese/Taiwanese, 5.4% Korean, 3.3% Malaysian, and 2.9% Vietnamese), 6.4% White, 1.3% Hispanic/Latino, and 1% Black/African-American. Additionally, 34.8% had cirrhosis, 8.6% had hepatocellular carcinoma (HCC), and 24.9% were treatment-experienced (20.7% with interferon, 4.3% with direct-acting antivirals). The largest group was GT1 (10,246 [64.6%]), followed by GT2 (3,686 [23.2%]), GT3 (1,151 [7.2%]), GT6 (457 [2.8%]), GT4 (47 [0.3%]), GT5 (1 [0.006%]), and untyped GTs (261 [1.6%]). The overall SVR12 was 96.9%, with rates over 95% for GT1/2/3/6 but 91.5% for GT4. SVR12 for GT3 was 95.1% overall, 98.2% for GT3a, and 94.0% for GT3b. SVR12 was 98.3% overall for GT6, lower for patients with cirrhosis and treatment-experienced (TE) (93.8%) but ≥97.5% for treatment-naive patients regardless of cirrhosis status. On multivariable analysis, advanced age, prior treatment failure, cirrhosis, active HCC, and GT3/4 were independent predictors of lower SVR12, while being Asian was a significant predictor of achieving SVR12.

CONCLUSIONS: In this diverse multinational real-world cohort of patients with various GTs, the overall cure rate was 96.9%, despite large numbers of patients with cirrhosis, HCC, TE, and GT3/6. SVR12 for GT3/6 with cirrhosis and TE was lower but still excellent (>91%).

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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