Yuki Tahata1, Hayato Hikita1, Satoshi Mochida2, Nobuyuki Enomoto3, Norifumi Kawada4, Masayuki Kurosaki5, Akio Ido6, Daiki Miki7, Hitoshi Yoshiji8, Yasuhiro Takikawa9, Ryotaro Sakamori1, Yoichi Hiasa10, Kazuhiko Nakao11, Naoya Kato12, Yoshiyuki Ueno13, Hiroshi Yatsuhashi14, Yoshito Itoh15, Ryosuke Tateishi16, Goki Suda17, Taro Takami18, Yasunari Nakamoto19, Yasuhiro Asahina20, Kentaro Matsuura21, Taro Yamashita22, Tatsuya Kanto23, Norio Akuta24, Shuji Terai25, Masahito Shimizu26, Satoshi Sobue27, Tomokatsu Miyaki28, Akihiro Moriuchi29, Ryoko Yamada1, Takahiro Kodama1, Tomohide Tatsumi1, Tomomi Yamada30, Tetsuo Takehara31. 1. Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. 2. Department of Gastroenterology and Hepatology, Saitama Medical University, Saitama, Japan. 3. First Department of Internal Medicine, Faculty of Medicine, University of Yamanashi, Yamanashi, Japan. 4. Department of Hepatology, Graduate School of Medicine, Osaka City University, Osaka, Japan. 5. Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan. 6. Digestive and Lifestyle Diseases, Department of Human and Environmental Sciences, Kagoshima University Graduate School of Medicine and Dental Sciences, Kagoshima, Japan. 7. Department of Gastroenterology and Metabolism, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan. 8. Department of Gastroenterology, Nara Medical University, Nara, Japan. 9. Division of Hepatology, Department of Internal Medicine, Iwate Medical University, Iwate, Japan. 10. Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Ehime, Japan. 11. Department of Gastroenterology and Hepatology, Nagasaki University of Graduate School of Biomedical Sciences, Nagasaki, Japan. 12. Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba, Japan. 13. Department of Gastroenterology, Faculty of Medicine, Yamagata University, Yamagata, Japan. 14. Clinical Research Center, National Hospital Organization Nagasaki Medical Center, Nagasaki, Japan. 15. Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan. 16. Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan. 17. Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan. 18. Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan. 19. Second Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan. 20. Department of Gastroenterology and Hepatology, Department of Liver Disease Control, Tokyo Medical and Dental University, Tokyo, Japan. 21. Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan. 22. Department of General Medicine, Kanazawa University Hospital, Kanazawa, Japan. 23. The Research Center for Hepatitis and Immunology, National Center for Global Health and Medicine, Chiba, Japan. 24. Department of Hepatology, Toranomon Hospital, Tokyo, Japan. 25. Division of Gastroenterology and Hepatology, Graduate School of Medicine and Dental Sciences, Niigata University, Niigata, Japan. 26. Department of Gastroenterology/Internal Medicine, Gifu University Graduate School of Medicine, Gifu, Japan. 27. Department of Gastroenterology, Kasugai Municipal Hospital, Kasugai, Japan. 28. Department of Gastroenterology, Toyokawa City Hospital, Toyokawa, Japan. 29. Department of Gastroenterology, National Hospital Organization Kagoshima Medical Center, Kagoshima, Japan. 30. Department of Medical Innovation, Osaka University Hospital, Suita, Osaka, Japan. 31. Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. takehara@gh.med.osaka-u.ac.jp.
Abstract
BACKGROUND: Direct-acting antiviral (DAA) therapy enables a high rate of sustained virologic response (SVR) in patients with hepatitis C virus associated cirrhosis. However, the impact of DAA therapy on liver-related events in patients with cirrhosis is unclear. METHODS: A total of 350 patients with compensated and decompensated cirrhosis administered DAA therapy at 29 Japanese hospitals were enrolled (Child-Pugh class A [CP-A]: 195 patients, CP-B: 131 patients and CP-C: 24 patients). RESULTS: The SVR rates of patients with CP-A, CP-B and CP-C were 96.9%, 93.1% and 83.3%, respectively (p = 0.006). Seventy patients developed hepatocellular carcinoma (HCC), and male sex, previous HCC treatment, platelet counts < 10.0 × 104/µl, alpha-fetoprotein levels ≥ 5.0 ng/ml and CP-C were identified as significant factors in the multivariate analysis. The cumulative HCC occurrence/recurrence rates at 1 year were 6.6%/45.2%. The cumulative rate of decompensated cirrhotic events requiring hospital admission at 1 year was 9.1%. In the multivariate analysis, CP-B and CP-C were identified as significant factors. During the median observation period of 14.9 months, 13 patients died and one patient received liver transplant. The overall survival rates at 1 year were 98.4% in patients with CP-A, 96.4% in those with CP-B and 85.6% in those with CP-C (CP-A vs. CP-B: p = 0.759, CP-A vs. CP-C: p = 0.001 and CP-B vs. CP-C: p = 0.005). CONCLUSIONS: HCC development and mortality in patients with CP-B were not different from those with CP-A. On the other hand, in patients with CP-C, the development of HCC and decompensated cirrhotic events requiring hospital admission, and death were frequent. TRIAL REGISTRATION: University Hospital Medical Information Network (UMIN000036150).
BACKGROUND: Direct-acting antiviral (DAA) therapy enables a high rate of sustained virologic response (SVR) in patients with hepatitis C virus associated cirrhosis. However, the impact of DAA therapy on liver-related events in patients with cirrhosis is unclear. METHODS: A total of 350 patients with compensated and decompensated cirrhosis administered DAA therapy at 29 Japanese hospitals were enrolled (Child-Pugh class A [CP-A]: 195 patients, CP-B: 131 patients and CP-C: 24 patients). RESULTS: The SVR rates of patients with CP-A, CP-B and CP-C were 96.9%, 93.1% and 83.3%, respectively (p = 0.006). Seventy patients developed hepatocellular carcinoma (HCC), and male sex, previous HCC treatment, platelet counts < 10.0 × 104/µl, alpha-fetoprotein levels ≥ 5.0 ng/ml and CP-C were identified as significant factors in the multivariate analysis. The cumulative HCC occurrence/recurrence rates at 1 year were 6.6%/45.2%. The cumulative rate of decompensated cirrhotic events requiring hospital admission at 1 year was 9.1%. In the multivariate analysis, CP-B and CP-C were identified as significant factors. During the median observation period of 14.9 months, 13 patients died and one patient received liver transplant. The overall survival rates at 1 year were 98.4% in patients with CP-A, 96.4% in those with CP-B and 85.6% in those with CP-C (CP-A vs. CP-B: p = 0.759, CP-A vs. CP-C: p = 0.001 and CP-B vs. CP-C: p = 0.005). CONCLUSIONS: HCC development and mortality in patients with CP-B were not different from those with CP-A. On the other hand, in patients with CP-C, the development of HCC and decompensated cirrhotic events requiring hospital admission, and death were frequent. TRIAL REGISTRATION: University Hospital Medical Information Network (UMIN000036150).
Authors: Lauren A Beste; Pamela K Green; Kristin Berry; Matthew J Kogut; Stephen K Allison; George N Ioannou Journal: J Hepatol Date: 2017-09-20 Impact factor: 25.083