Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan

被引：1

作者：

Yang, Chun-Chi ^{[1
]}

Huang, Chung-Feng ^{[2
,3
,4
]}

Chang, Te-Sheng ^{[5
,6
]}

Lo, Ching-Chu ^{[7
]}

Hung, Chao-Hung ^{[8
]}

Huang, Chien-Wei ^{[9
]}

Chong, Lee-Won ^{[10
,11
]}

Cheng, Pin-Nan ^{[12
,13
]}

Yeh, Ming-Lun ^{[2
,3
,14
]}

Peng, Cheng-Yuan ^{[15
,16
]}

Cheng, Chien-Yu ^{[17
]}

Huang, Jee-Fu ^{[2
,3
,14
,18
,19
,20
]}

Bair, Ming-Jong ^{[21
,22
]}

Lin, Chih-Lang ^{[23
,24
]}

Yang, Chi-Chieh ^{[25
]}

Wang, Szu-Jen ^{[26
]}

Hsieh, Tsai-Yuan ^{[27
]}

Lee, Tzong-Hsi ^{[28
]}

Lee, Pei-Lun ^{[29
]}

Wu, Wen-Chih ^{[30
]}

Lin, Chih-Lin ^{[31
]}

Su, Wei-Wen ^{[32
]}

Yang, Sheng-Shun ^{[33
]}

Wang, Chia-Chi ^{[34
,35
]}

Hu, Jui-Ting ^{[36
]}

Mo, Lein-Ray ^{[37
]}

Chen, Chun-Ting ^{[27
,38
]}

Huang, Yi-Hsiang ^{[39
,40
,41
]}

Chang, Chun-Chao ^{[42
,43
]}

Huang, Chia-Sheng ^{[44
]}

Chen, Guei-Ying ^{[45
]}

Kao, Chien-Neng ^{[46
]}

Tai, Chi-Ming ^{[47
,48
]}

Liu, Chun-Jen ^{[49
]}

Lee, Mei-Hsuan ^{[50
]}

Kuo, Hsing-Tao ^{[1
]}

Tsai, Pei-Chien ^{[2
,3
,14
]}

Dai, Chia-Yen ^{[2
,3
,14
]}

Kao, Jia-Horng ^{[49
]}

Lin, Han-Chieh ^{[39
,40
,41
]}

Chuang, Wang-Long ^{[2
,3
]}

Tseng, Kuo-Chih ^{[51
,52
]}

Chen, Chi-Yi ^{[53
]}

Yu, Ming-Lung ^{[2
,3
,8
,14
,18
,19
,20
]}

机构：

[1] Chi Mei Med Ctr, Dept Internal Med, Div Gastroenterol & Hepatol, Tainan, Taiwan

[2] Kaohsiung Med Univ, Kaohsiung Med Univ Hosp, Hepatobiliary Div, Dept Internal Med, 100,Tzyou 1st Rd, Kaohsiung, Taiwan

[3] Kaohsiung Med Univ, Kaohsiung Med Univ Hosp, Hepatitis Ctr, 100,Tzyou 1st Rd, Kaohsiung, Taiwan

[4] Kaohsiung Med Univ, Coll Med, PhD Program Translat Med, Acad Sinica, Kaohsiung, Taiwan

[5] ChiaYi Chang Gung Mem Hosp, Dept Internal Med, Div Hepatogastroenterol, Chiayi, Taiwan

[6] Chang Gung Univ, Coll Med, Taoyuan, Taiwan

[7] St Martin De Porres Hosp, Dept Internal Med, Div Gastroenterol, Chiayi, Taiwan

[8] Kaohsiung Chang Gung Mem Hosp, Dept Internal Med, Div Hepatogastroenterol, Kaohsiung, Taiwan

[9] Kaohsiung Armed Forces Gen Hosp, Dept Gastroenterol, Kaohsiung, Taiwan

[10] Fu Jen Catholic Univ, Sch Med, New Taipei City, Taiwan

[11] Shin Kong Wu Ho Su Mem Hosp, Dept Internal Med, Div Hepatol & Gastroenterol, Taipei, Taiwan

[12] Natl Cheng Kung Univ Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Tainan, Taiwan

[13] Natl Cheng Kung Univ, Coll Med, Tainan, Taiwan

[14] Kaohsiung Med Univ, Hepatitis Res Ctr, Coll Med, Ctr Liquid Biopsy & Cohort Res, Kaohsiung, Taiwan

[15] China Med Univ Hosp, Ctr Digest Med, Dept Internal Med, Taichung, Taiwan

[16] China Med Univ, Sch Med, Taichung, Taiwan

[17] Taoyuan Gen Hosp, Div Infect Dis, Dept Internal Med, Minist Hlth & Welf, Taoyuan, Taiwan

[18] Natl Sun Yat Sen Univ, Sch Med, Kaohsiung, Taiwan

[19] Natl Sun Yat Sen Univ, Coll Med, Doctoral Program Clin & Expt Med, Kaohsiung, Taiwan

[20] Natl Sun Yat Sen Univ, Ctr Excellence Metab Associated Fatty Liver Dis, Kaohsiung, Taiwan

[21] Taitung Mackay Mem Hosp, Dept Internal Med, Div Gastroenterol, Taitung, Taiwan

[22] Mackay Med Coll, New Taipei City, Taiwan

[23] Chang Gung Univ, Liver Res Unit, Dept Hepatogastroenterol, Chang Gung Mem Hosp Keelung,Coll Med, Keelung, Taiwan

[24] Chang Gung Univ, Chang Gung Mem Hosp Keelung, Coll Med, Community Med Res Ctr, Keelung, Taiwan

[25] Show Chwan Mem Hosp, Dept Gastroenterol, Div Internal Med, Changhua, Taiwan

[26] Yuans Gen Hosp, Dept Internal Med, Div Gastroenterol, Kaohsiung, Taiwan

[27] Triserv Gen Hosp, Natl Def Med Ctr, Dept Internal Med, Div Gastroenterol, Taipei, Taiwan

[28] Far Eastern Mem Hosp, Div Gastroenterol, New Taipei City, Taiwan

[29] Chi Mei Med Ctr, Dept Internal Med, Div Gastroenterol & Hepatol, Tainan, Taiwan

[30] Wen Chih Wu Clin, Kaohsiung, Taiwan

[31] Taipei City Hosp, Renai Branch, Dept Gastroenterol, Taipei, Taiwan

[32] Changhua Christian Hosp, Dept Gastroenterol & Hepatol, Changhua, Taiwan

[33] Taichung Vet Gen Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Taichung, Taiwan

[34] Tzu Chi Univ, Taipei Tzu Chi Hosp, Buddhist Tzu Chi Med Fdn, Taipei, Taiwan

[35] Tzu Chi Univ, Taipei Tzu Chi Hosp, Sch Med, Taipei, Taiwan

[36] Cathay Gen Hosp, Liver Ctr, Taipei, Taiwan

[37] Tainan Municipal Hosp, Div Gastroenterol, Show Chwan Med Care Corp, Tainan, Taiwan

[38] Triserv Gen Hosp, Natl Def Med Ctr, Dept Internal Med, Div Gastroenterol,Penghu Branch, Taipei, Taiwan

[39] Taipei Vet Gen Hosp, Dept Med, Div Gastroenterol & Hepatol, Taipei, Taiwan

[40] Taipei Vet Gen Hosp, Healthcare & Serv Ctr, Taipei, Taiwan

[41] Natl Yang Ming Chiao Tung Univ, Inst Clin Med, Coll Med, Taipei, Taiwan

[42] Taipei Med Univ Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Taipei, Taiwan

[43] Taipei Med Univ, Coll Med, Sch Med, Dept Internal Med,Div Gastroenterol & Hepatol, Taipei, Taiwan

[44] Yang Ming Hosp, Chiayi, Taiwan

[45] Penghu Hosp, Minist Hlth & Welf, Penghu, Taiwan

[46] Natl Taiwan Univ Hosp, Hsin Chu Branch, Hsinchu, Taiwan

[47] I Shou Univ, E Da Hosp, Dept Internal Med, Div Gastroenterol & Hepatol, Kaohsiung, Taiwan

[48] I Shou Univ, Coll Med, Sch Med Int Students, Kaohsiung, Taiwan

[49] Natl Taiwan Univ Hosp, Dept Internal Med, Hepatitis Res Ctr, Taipei, Taiwan

[50] Natl Yang Ming Chiao Tung Univ, Inst Clin Med, Taipei, Taiwan

来源：

INFECTIOUS DISEASES AND THERAPY | 2024年 / 13卷 / 06期

关键词：

Hepatitis C; Direct-acting antivirals; Glecaprevir; Pibrentasvir; Real world; Taiwan;

D O I：

10.1007/s40121-024-00968-5

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

Introduction Eight-week glecaprevir/pibrentasvir (GLE/PIB) is indicated for treatment-na & iuml;ve (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.

引用

页码：1199 / 1213

页数：15

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