{"title":"台湾一项全国性 HCV 登记研究显示，针对治疗无效患者的通用 8 周 Glecaprevir/Pibrentasvir 的实际疗效和安全性","authors":"Chun-Chi Yang, Chung-Feng Huang, Te-Sheng Chang, Ching-Chu Lo, Chao-Hung Hung, Chien-Wei Huang, Lee-Won Chong, Pin-Nan Cheng, Ming-Lun Yeh, Cheng-Yuan Peng, Chien-Yu Cheng, Jee-Fu Huang, Ming-Jong Bair, Chih-Lang Lin, Chi-Chieh Yang, Szu-Jen Wang, Tsai-Yuan Hsieh, Tzong-Hsi Lee, Pei-Lun Lee, Wen-Chih Wu, Chih-Lin Lin, Wei-Wen Su, Sheng-Shun Yang, Chia-Chi Wang, Jui-Ting Hu, Lein-Ray Mo, Chun-Ting Chen, Yi-Hsiang Huang, Chun-Chao Chang, Chia-Sheng Huang, Guei-Ying Chen, Chien-Neng Kao, Chi-Ming Tai, Chun-Jen Liu, Mei-Hsuan Lee, Hsing-Tao Kuo, Pei-Chien Tsai, Chia-Yen Dai, Jia-Horng Kao, Han-Chieh Lin, Wang-Long Chuang, Kuo-Chih Tseng, Chi-Yi Chen, Ming-Lung Yu","doi":"10.1007/s40121-024-00968-5","DOIUrl":null,"url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>Eight-week glecaprevir/pibrentasvir (GLE/PIB) is indicated for treatment-naïve (TN) patients with chronic hepatitis C (CHC), with or without compensated cirrhosis. Given that the Taiwanese government is committed to eliminating hepatitis C virus (HCV) by 2025, this study aimed to measure real-world evidence for TN patients using 8-week GLE/PIB in the Taiwan HCV Registry (TACR).</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>The data of patients with CHC treated with 8-week GLE/PIB were retrieved from TACR, a nationwide registry program organized by the Taiwan Association for the Study of the Liver (TASL). Treatment efficacy, defined as a sustained virologic response at posttreatment week 12 (SVR12), was assessed in the modified intention-to-treat (mITT) population, which excluded patients who were lost to follow-up or lacked SVR12 data. The safety profile of the ITT population was assessed.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>A total of 7246 (6897 without cirrhosis; 349 with cirrhosis) patients received at least one dose of GLE/PIB (ITT), 7204 of whom had SVR12 data available (mITT). The overall SVR12 rate was 98.9% (7122/7204) among all patients, 98.9% (6780/6856) and 98.3% (342/348) among patients without and with cirrhosis, respectively. For the selected subgroups, which included patients with genotype 3 infection, diabetes, chronic kidney disease, people who injected drugs, and those with human immunodeficiency virus coinfection, the SVR12 rates were 95.1% (272/286), 98.9% (1084/1096), 99.0% (1171/1183), 97.4% (566/581), and 96.1% (248/258), respectively. Overall, 14.1% (1021/7246) of the patients experienced adverse events (AEs). Twenty-two patients (0.3%) experienced serious AEs, and 15 events (0.2%) resulted in permanent drug discontinuation. Only one event was considered treatment drug related.</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>Eight-week GLE/PIB therapy was effective and well tolerated in all TN patients, regardless of cirrhosis status.</p>","PeriodicalId":13592,"journal":{"name":"Infectious Diseases and Therapy","volume":"75 1","pages":""},"PeriodicalIF":4.7000,"publicationDate":"2024-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan\",\"authors\":\"Chun-Chi Yang, Chung-Feng Huang, Te-Sheng Chang, Ching-Chu Lo, Chao-Hung Hung, Chien-Wei Huang, Lee-Won Chong, Pin-Nan Cheng, Ming-Lun Yeh, Cheng-Yuan Peng, Chien-Yu Cheng, Jee-Fu Huang, Ming-Jong Bair, Chih-Lang Lin, Chi-Chieh Yang, Szu-Jen Wang, Tsai-Yuan Hsieh, Tzong-Hsi Lee, Pei-Lun Lee, Wen-Chih Wu, Chih-Lin Lin, Wei-Wen Su, Sheng-Shun Yang, Chia-Chi Wang, Jui-Ting Hu, Lein-Ray Mo, Chun-Ting Chen, Yi-Hsiang Huang, Chun-Chao Chang, Chia-Sheng Huang, Guei-Ying Chen, Chien-Neng Kao, Chi-Ming Tai, Chun-Jen Liu, Mei-Hsuan Lee, Hsing-Tao Kuo, Pei-Chien Tsai, Chia-Yen Dai, Jia-Horng Kao, Han-Chieh Lin, Wang-Long Chuang, Kuo-Chih Tseng, Chi-Yi Chen, Ming-Lung Yu\",\"doi\":\"10.1007/s40121-024-00968-5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<h3 data-test=\\\"abstract-sub-heading\\\">Introduction</h3><p>Eight-week glecaprevir/pibrentasvir (GLE/PIB) is indicated for treatment-naïve (TN) patients with chronic hepatitis C (CHC), with or without compensated cirrhosis. Given that the Taiwanese government is committed to eliminating hepatitis C virus (HCV) by 2025, this study aimed to measure real-world evidence for TN patients using 8-week GLE/PIB in the Taiwan HCV Registry (TACR).</p><h3 data-test=\\\"abstract-sub-heading\\\">Methods</h3><p>The data of patients with CHC treated with 8-week GLE/PIB were retrieved from TACR, a nationwide registry program organized by the Taiwan Association for the Study of the Liver (TASL). Treatment efficacy, defined as a sustained virologic response at posttreatment week 12 (SVR12), was assessed in the modified intention-to-treat (mITT) population, which excluded patients who were lost to follow-up or lacked SVR12 data. The safety profile of the ITT population was assessed.</p><h3 data-test=\\\"abstract-sub-heading\\\">Results</h3><p>A total of 7246 (6897 without cirrhosis; 349 with cirrhosis) patients received at least one dose of GLE/PIB (ITT), 7204 of whom had SVR12 data available (mITT). The overall SVR12 rate was 98.9% (7122/7204) among all patients, 98.9% (6780/6856) and 98.3% (342/348) among patients without and with cirrhosis, respectively. For the selected subgroups, which included patients with genotype 3 infection, diabetes, chronic kidney disease, people who injected drugs, and those with human immunodeficiency virus coinfection, the SVR12 rates were 95.1% (272/286), 98.9% (1084/1096), 99.0% (1171/1183), 97.4% (566/581), and 96.1% (248/258), respectively. Overall, 14.1% (1021/7246) of the patients experienced adverse events (AEs). Twenty-two patients (0.3%) experienced serious AEs, and 15 events (0.2%) resulted in permanent drug discontinuation. Only one event was considered treatment drug related.</p><h3 data-test=\\\"abstract-sub-heading\\\">Conclusion</h3><p>Eight-week GLE/PIB therapy was effective and well tolerated in all TN patients, regardless of cirrhosis status.</p>\",\"PeriodicalId\":13592,\"journal\":{\"name\":\"Infectious Diseases and Therapy\",\"volume\":\"75 1\",\"pages\":\"\"},\"PeriodicalIF\":4.7000,\"publicationDate\":\"2024-04-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Infectious Diseases and Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s40121-024-00968-5\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Infectious Diseases and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40121-024-00968-5","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan
Introduction
Eight-week glecaprevir/pibrentasvir (GLE/PIB) is indicated for treatment-naïve (TN) patients with chronic hepatitis C (CHC), with or without compensated cirrhosis. Given that the Taiwanese government is committed to eliminating hepatitis C virus (HCV) by 2025, this study aimed to measure real-world evidence for TN patients using 8-week GLE/PIB in the Taiwan HCV Registry (TACR).
Methods
The data of patients with CHC treated with 8-week GLE/PIB were retrieved from TACR, a nationwide registry program organized by the Taiwan Association for the Study of the Liver (TASL). Treatment efficacy, defined as a sustained virologic response at posttreatment week 12 (SVR12), was assessed in the modified intention-to-treat (mITT) population, which excluded patients who were lost to follow-up or lacked SVR12 data. The safety profile of the ITT population was assessed.
Results
A total of 7246 (6897 without cirrhosis; 349 with cirrhosis) patients received at least one dose of GLE/PIB (ITT), 7204 of whom had SVR12 data available (mITT). The overall SVR12 rate was 98.9% (7122/7204) among all patients, 98.9% (6780/6856) and 98.3% (342/348) among patients without and with cirrhosis, respectively. For the selected subgroups, which included patients with genotype 3 infection, diabetes, chronic kidney disease, people who injected drugs, and those with human immunodeficiency virus coinfection, the SVR12 rates were 95.1% (272/286), 98.9% (1084/1096), 99.0% (1171/1183), 97.4% (566/581), and 96.1% (248/258), respectively. Overall, 14.1% (1021/7246) of the patients experienced adverse events (AEs). Twenty-two patients (0.3%) experienced serious AEs, and 15 events (0.2%) resulted in permanent drug discontinuation. Only one event was considered treatment drug related.
Conclusion
Eight-week GLE/PIB therapy was effective and well tolerated in all TN patients, regardless of cirrhosis status.
期刊介绍：
Infectious Diseases and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of infectious disease therapies and interventions, including vaccines and devices. Studies relating to diagnostic products and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to, bacterial and fungal infections, viral infections (including HIV/AIDS and hepatitis), parasitological diseases, tuberculosis and other mycobacterial diseases, vaccinations and other interventions, and drug-resistance, chronic infections, epidemiology and tropical, emergent, pediatric, dermal and sexually-transmitted diseases.
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