Chuan-Pin Lin1, Po-Cheng Liang1, Ching-I Huang1, Ming-Lun Yeh1,2, Po-Yao Hsu1, Cheng-Ting Hsu1, Yu-Ju Wei3, Ta-Wei Liu3, Ming-Yen Hsieh3, Nai-Jen Hou3, Tyng-Yuang Jang4, Yi-Hung Lin5, Chih-Wen Wang5, Zu-Yau Lin1,2, Shinn-Cherng Chen1,2, Chung-Feng Huang1,2, Jee-Fu Huang1,2,6, Chia-Yen Dai1,2, Wan-Long Chuang1,2, Ming-Lung Yu1,2,7,8,9. 1. Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan. 2. Faculty of Internal Medicine and Hepatitis Research Center, School of Medicine, College of Medicine, and Center for Cancer Research and Liquid Biopsy, Kaohsiung Medical University, Kaohsiung, Taiwan. 3. Department of Internal Medicine, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung, Taiwan. 4. Department of Internal Medicine, Pingtung Hospital, Ministry of Health and Welfare, Ping-Tung, Taiwan. 5. Department of Internal Medicine, Kaohsiung Municipal Siaogang Hospital, Kaohsiung, Taiwan. 6. Department of Occupational Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan. 7. Insitute of Biomedical Sciences, National Sun Yat-Sen University, Kaohsiung, Taiwan. 8. Center For Intelligent Drug Systems and Smart Bio-devices (IDS2B) and Department of Biological Science and Technology, College of Biological Science and Technology, National Chiao Tung University, Hsin-Chu, Taiwan. 9. Center for Lipid Science and Aging Research Center, Kaohsiung Medical University, Kaohsiung, Taiwan.
Abstract
BACKGROUND/AIMS: Undetectable HCV RNA 12 weeks after the end of treatment (SVR12) has been the valid efficacy endpoint in the era of direct-acting antivirals (DAAs). Its concordance with SVR4 and SVR24 and long-term durability is unknown in Taiwanese chronic hepatitis C (CHC) patients. METHODS: A total of 1080 CHC patients who received all-oral DAAs and an achieved end-of-treatment virological response (EOTVR), defined as undetectable HCV RNA at the end of therapy, were consecutively enrolled. HCV RNA was monitored 4, 12, and 24 weeks after EOT. Patients who achieved SVR24, defined as undetectable HCV RNA 24 weeks after EOT, were followed annually for assessing SVR durability. RESULTS: Eleven (1.02%) patients experienced HCV RNA reappearance after EOT. The most frequent timing of RNA reappearance was observed at SVR4 (n = 7), followed by SVR12 (n = 3) and SVR 24 (n = 1). The positive predictive value (PPV) and negative predictive value (NPV) of SVR4 in predicting SVR12 were 99.7% and 100%, respectively, whereas the PPV and NPV of SVR12 in predicting SVR24 were 99.9% and 100%, respectively. Pyrosequencing confirmed delayed relapse rather than reinfection for the patient who had detectable HCV RNA at SVR24. Among 978 patients who achieved SVR24, after a median follow-up period of 17.3±8.2 months, the SVR durability is 100% up to a 4-year follow-up. CONCLUSION: Achievement of SVR12 provides excellent durability of HCV seroclearance after DAA therapy. On-demand HCV RNA beyond SVR12 should be recommended for patients with unexplainable abnormal liver function or high-risk behaviors.
BACKGROUND/AIMS: Undetectable HCV RNA 12 weeks after the end of treatment (SVR12) has been the valid efficacy endpoint in the era of direct-acting antivirals (DAAs). Its concordance with SVR4 and SVR24 and long-term durability is unknown in Taiwanese chronic hepatitis C (CHC) patients. METHODS: A total of 1080 CHCpatients who received all-oral DAAs and an achieved end-of-treatment virological response (EOTVR), defined as undetectable HCV RNA at the end of therapy, were consecutively enrolled. HCV RNA was monitored 4, 12, and 24 weeks after EOT. Patients who achieved SVR24, defined as undetectable HCV RNA 24 weeks after EOT, were followed annually for assessing SVR durability. RESULTS: Eleven (1.02%) patients experienced HCV RNA reappearance after EOT. The most frequent timing of RNA reappearance was observed at SVR4 (n = 7), followed by SVR12 (n = 3) and SVR 24 (n = 1). The positive predictive value (PPV) and negative predictive value (NPV) of SVR4 in predicting SVR12 were 99.7% and 100%, respectively, whereas the PPV and NPV of SVR12 in predicting SVR24 were 99.9% and 100%, respectively. Pyrosequencing confirmed delayed relapse rather than reinfection for the patient who had detectable HCV RNA at SVR24. Among 978 patients who achieved SVR24, after a median follow-up period of 17.3±8.2 months, the SVR durability is 100% up to a 4-year follow-up. CONCLUSION: Achievement of SVR12 provides excellent durability of HCV seroclearance after DAA therapy. On-demand HCV RNA beyond SVR12 should be recommended for patients with unexplainable abnormal liver function or high-risk behaviors.
Authors: Adriaan J van der Meer; Bart J Veldt; Jordan J Feld; Heiner Wedemeyer; Jean-François Dufour; Frank Lammert; Andres Duarte-Rojo; E Jenny Heathcote; Michael P Manns; Lorenz Kuske; Stefan Zeuzem; W Peter Hofmann; Robert J de Knegt; Bettina E Hansen; Harry L A Janssen Journal: JAMA Date: 2012-12-26 Impact factor: 56.272
Authors: Christoph Sarrazin; Vasily Isakov; Evguenia S Svarovskaia; Charlotte Hedskog; Ross Martin; Krishna Chodavarapu; Diana M Brainard; Michael D Miller; Hongmei Mo; Jean-Michel Molina; Mark S Sulkowski Journal: Clin Infect Dis Date: 2016-10-12 Impact factor: 9.079
Authors: Edward Gane; Victor de Ledinghen; Douglas E Dylla; Giuliano Rizzardini; Mitchell L Shiffman; Stephen T Barclay; Jose Luis Calleja; Zhenyi Xue; Margaret Burroughs; Julio A Gutierrez Journal: J Viral Hepat Date: 2021-09-08 Impact factor: 3.517