1. Concordance of SVR12, SVR24 and SVR durability in Taiwanese chronic hepatitis C patients with direct-acting antivirals
- Author
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Ming-Lun Yeh, Chih-Wen Wang, Cheng-Ting Hsu, Tyng-Yuang Jang, Yi-Hung Lin, Chung-Feng Huang, Shinn-Cherng Chen, Wan-Long Chuang, Nai-Jen Hou, Ming-Lung Yu, Ta-Wei Liu, Po-Yao Hsu, Ching-I Huang, Zu-Yau Lin, Po-Cheng Liang, Chia-Yen Dai, Jee-Fu Huang, Yu-Ju Wei, Chuan-Pin Lin, and Ming-Yen Hsieh
- Subjects
RNA viruses ,Male ,Chronic Hepatitis ,Sustained Virologic Response ,Molecular biology ,Hepacivirus ,DIRECT ACTING ANTIVIRALS ,Gastroenterology ,Chronic Liver Disease ,Virological response ,Sequencing techniques ,Immunodeficiency Viruses ,Pathology and laboratory medicine ,Multidisciplinary ,Hepatitis C virus ,Antimicrobials ,Liver Diseases ,Drugs ,virus diseases ,RNA sequencing ,Medical microbiology ,Middle Aged ,Viral Load ,Antivirals ,Predictive value ,Cirrhosis ,Oncology ,Viruses ,RNA, Viral ,Medicine ,Drug Therapy, Combination ,Female ,Pathogens ,Research Article ,Adult ,medicine.medical_specialty ,Genotype ,End of therapy ,Concordance ,Science ,Gastroenterology and Hepatology ,Microbiology ,Antiviral Agents ,Chronic hepatitis ,Microbial Control ,Virology ,Internal medicine ,Retroviruses ,Gastrointestinal Tumors ,medicine ,Humans ,Abnormal liver function ,Aged ,Medicine and health sciences ,Pharmacology ,Treatment Guidelines ,Health Care Policy ,Biology and life sciences ,Flaviviruses ,business.industry ,Lentivirus ,Carcinoma ,Organisms ,Viral pathogens ,HIV ,Cancers and Neoplasms ,RNA ,Hepatocellular Carcinoma ,Hepatitis C, Chronic ,Hepatitis viruses ,digestive system diseases ,Microbial pathogens ,Research and analysis methods ,Health Care ,Molecular biology techniques ,business ,Follow-Up Studies - 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.
- Published
- 2021