Concordance of SVR12, SVR24 and SVR durability in Taiwanese chronic hepatitis C patients with direct-acting antivirals.
<h4>Background/aims</h4>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) pati...
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doaj-2e7b5d3bc7c343608fce8fbaecfe95982021-07-29T04:32:53ZengPublic Library of Science (PLoS)PLoS ONE1932-62032021-01-01162e024547910.1371/journal.pone.0245479Concordance of SVR12, SVR24 and SVR durability in Taiwanese chronic hepatitis C patients with direct-acting antivirals.Chuan-Pin LinPo-Cheng LiangChing-I HuangMing-Lun YehPo-Yao HsuCheng-Ting HsuYu-Ju WeiTa-Wei LiuMing-Yen HsiehNai-Jen HouTyng-Yuang JangYi-Hung LinChih-Wen WangZu-Yau LinShinn-Cherng ChenChung-Feng HuangJee-Fu HuangChia-Yen DaiWan-Long ChuangMing-Lung Yu<h4>Background/aims</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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.https://doi.org/10.1371/journal.pone.0245479 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Chuan-Pin Lin Po-Cheng Liang Ching-I Huang Ming-Lun Yeh Po-Yao Hsu Cheng-Ting Hsu Yu-Ju Wei Ta-Wei Liu Ming-Yen Hsieh Nai-Jen Hou Tyng-Yuang Jang Yi-Hung Lin Chih-Wen Wang Zu-Yau Lin Shinn-Cherng Chen Chung-Feng Huang Jee-Fu Huang Chia-Yen Dai Wan-Long Chuang Ming-Lung Yu |
spellingShingle |
Chuan-Pin Lin Po-Cheng Liang Ching-I Huang Ming-Lun Yeh Po-Yao Hsu Cheng-Ting Hsu Yu-Ju Wei Ta-Wei Liu Ming-Yen Hsieh Nai-Jen Hou Tyng-Yuang Jang Yi-Hung Lin Chih-Wen Wang Zu-Yau Lin Shinn-Cherng Chen Chung-Feng Huang Jee-Fu Huang Chia-Yen Dai Wan-Long Chuang Ming-Lung Yu Concordance of SVR12, SVR24 and SVR durability in Taiwanese chronic hepatitis C patients with direct-acting antivirals. PLoS ONE |
author_facet |
Chuan-Pin Lin Po-Cheng Liang Ching-I Huang Ming-Lun Yeh Po-Yao Hsu Cheng-Ting Hsu Yu-Ju Wei Ta-Wei Liu Ming-Yen Hsieh Nai-Jen Hou Tyng-Yuang Jang Yi-Hung Lin Chih-Wen Wang Zu-Yau Lin Shinn-Cherng Chen Chung-Feng Huang Jee-Fu Huang Chia-Yen Dai Wan-Long Chuang Ming-Lung Yu |
author_sort |
Chuan-Pin Lin |
title |
Concordance of SVR12, SVR24 and SVR durability in Taiwanese chronic hepatitis C patients with direct-acting antivirals. |
title_short |
Concordance of SVR12, SVR24 and SVR durability in Taiwanese chronic hepatitis C patients with direct-acting antivirals. |
title_full |
Concordance of SVR12, SVR24 and SVR durability in Taiwanese chronic hepatitis C patients with direct-acting antivirals. |
title_fullStr |
Concordance of SVR12, SVR24 and SVR durability in Taiwanese chronic hepatitis C patients with direct-acting antivirals. |
title_full_unstemmed |
Concordance of SVR12, SVR24 and SVR durability in Taiwanese chronic hepatitis C patients with direct-acting antivirals. |
title_sort |
concordance of svr12, svr24 and svr durability in taiwanese chronic hepatitis c patients with direct-acting antivirals. |
publisher |
Public Library of Science (PLoS) |
series |
PLoS ONE |
issn |
1932-6203 |
publishDate |
2021-01-01 |
description |
<h4>Background/aims</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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. |
url |
https://doi.org/10.1371/journal.pone.0245479 |
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