Effectiveness and safety of 8-week glecaprevir/pibrentasvir in HCV treatment-naive patients with compensated cirrhosis: real-world experience from Taiwan nationwide HCV registry

被引：7

作者：

Chang, Te-Sheng ^{[1
,2
]}

Huang, Chung-Feng ^{[3
,4
,5
]}

Kuo, Hsing-Tao ^{[6
]}

Lo, Ching-Chu ^{[7
]}

Huang, Chien-Wei ^{[8
]}

Chong, Lee-Won ^{[9
,10
]}

Cheng, Pin-Nan ^{[11
]}

Yeh, Ming-Lun ^{[3
,4
,12
]}

Peng, Cheng-Yuan ^{[13
,14
]}

Cheng, Chien-Yu ^{[15
]}

Huang, Jee-Fu ^{[3
,4
,16
]}

Bair, Ming-Jong ^{[17
,18
]}

Lin, Chih-Lang ^{[19
,20
]}

Yang, Chi-Chieh ^{[21
]}

Wang, Szu-Jen ^{[22
]}

Hsieh, Tsai-Yuan ^{[23
]}

Lee, Tzong-Hsi ^{[24
]}

Lee, Pei-Lun ^{[25
]}

Wu, Wen-Chih ^{[26
]}

Lin, Chih-Lin ^{[27
]}

Su, Wei-Wen ^{[28
]}

Yang, Sheng-Shun ^{[29
,30
,31
]}

Wang, Chia-Chi ^{[4
,32
,33
]}

Hu, Jui-Ting ^{[34
]}

Mo, Lein-Ray ^{[35
]}

Chen, Chun-Ting ^{[36
]}

Huang, Yi-Hsiang ^{[37
,38
]}

Chang, Chun-Chao ^{[39
,40
]}

Huang, Chia-Sheng ^{[41
]}

Chen, Guei-Ying ^{[42
]}

Kao, Chien-Neng ^{[43
]}

Tai, Chi-Ming ^{[44
,45
]}

Liu, Chun-Jen ^{[46
,47
]}

Lee, Mei-Hsuan ^{[48
]}

Tsai, Pei-Chien ^{[3
]}

Dai, Chia-Yen ^{[3
]}

Kao, Jia-Horng ^{[46
,47
]}

Lin, Han-Chieh

Chuang, Wang-Long ^{[3
,4
]}

Chen, Chi-Yi ^{[49
]}

Tseng, Kuo-Chih ^{[50
,51
]}

Hung, Chao-Hung ^{[52
]}

Yu, Ming-Lung ^{[3
,4
,12
,52
,53
]}

机构：

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

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

[3] Kaohsiung Med Univ, Kaohsiung Med Univ Hosp, Coll Med, Dept Internal Med,Hepatobiliary Div, Kaohsiung, Taiwan

[4] Kaohsiung Med Univ, Kaohsiung Med Univ Hosp, Coll Med, Hepatitis Ctr, Kaohsiung, Taiwan

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

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

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

[8] Kaohsiung Armed Forces Gen Hosp, Div Gastroenterol, Kaohsiung, Taiwan

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

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

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

[12] Kaohsiung Med Univ, Ctr Liquid Biopsy & Cohort Res, Kaohsiung, Taiwan

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

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

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

[16] Kaohsiung Med Univ, Coll Med, Hepatitis Res Ctr, Kaohsiung, Taiwan

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

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

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

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

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

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

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

[24] Far Eastern Mem Hosp, Div Gastroenterol & Hepatol, New Taipei City, Taiwan

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

[26] Wen Chih Wu Clin, Kaohsiung, Taiwan

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

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

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

[30] Natl Chung Hsing Univ, Inst Biomed Sci, Taichung, Taiwan

[31] Natl Chung Hsing Univ, Coll Med, Dept Postbaccalaureate Med, Taichung, Taiwan

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

[33] Tzu Chi Univ, Sch Med, Taipei, Taiwan

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

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

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

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

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

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

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

[41] Yang Ming Hosp, Chiayi, Taiwan

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

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

[44] E Da Hosp, Dept Internal Med, Kaohsiung, Taiwan

[45] I Shou Univ, Coll Med, Sch Med, Kaohsiung, Taiwan

[46] Natl Taiwan Univ Hosp, Hepatitis Res Ctr, Taipei, Taiwan

[47] Natl Taiwan Univ Hosp, Dept Internal Med, Taipei, Taiwan

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

[49] Ditmanson Med Fdn Chiayi Christian Hosp, Dept Med, Div Gastroenterol & Hepatol, Chiayi, Taiwan

[50] Buddhist Tzu Chi Med Fdn, Dalin Tzu Chi Hosp, Dept Internal Med, Chiayi, Taiwan

来源：

HEPATOLOGY INTERNATIONAL | 2023年 / 17卷 / 03期

关键词：

Compensated cirrhosis; GLE; PIB; HCV; Sustained virologic response; C VIRUS-INFECTION; THERAPY;

D O I：

10.1007/s12072-023-10506-z

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

BackgroundLarge-scale real-world data of the 8-week glecaprevir/pibrentasvir (GLE/PIB) therapy for treatment-naive patients of chronic hepatitis C virus (HCV) infection with compensated cirrhosis is scarce.MethodsThe TASL HCV Registry (TACR) is an ongoing nationwide registry program that aims to set up a database and biobank of patients with chronic HCV infection in Taiwan. In this study, data were analyzed as of 31 October 2021 for treatment-naive HCV patients with compensated cirrhosis receiving 8-week GLE/PIB therapy. Effectiveness reported as sustained virologic response at off-therapy week 12 (SVR12) and safety profiles were assessed. Patient characteristics potentially related to SVR12 were also evaluated.ResultsOf the 301 patients enrolled, 275 had available SVR12 data. The SVR12 rate was 98.2% (270/275) in the modified intention-to-treat (mITT) population and 89.7% (270/301) in the ITT population. For those mITT patients with genotype 3, FibroScan > 20 kPa, platelet < 150,000/mu l, and FibroScan > 20 kPa and platelet < 150,000/mu l, the SVR12 rates were 100% (6/6), 100% (12/12), 98.0% (144/147), 100% (7/7), respectively. Overall, 24.9% (75/301) patients experienced adverse events (AEs). The most frequent AEs (> 5%) included fatigue (9.0%) and pruritus (7.0%). Seven (2.3%) patients experienced serious AEs and two (0.7%) resulted in permanent drug discontinuation. None of them were considered as GLE/PIB-related.ConclusionsIn this large-scale real-world Taiwanese cohort, 8-week GLE/PIB therapy was efficacious and well tolerated for treatment-naive compensated cirrhosis patients. SVR12 rates were similarly high as in the clinical trials, including those with characteristics of advanced liver disease.

引用

页码：550 / 561

页数：12

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