Multicenter Study

. 2023 Apr;17(2):291-302.

doi: 10.1007/s12072-022-10475-9. Epub 2023 Jan 26.

Sofosbuvir/velpatasvir/voxilaprevir for patients with chronic hepatitis C virus infection previously treated with NS5A direct-acting antivirals: a real-world multicenter cohort in Taiwan

Chen-Hua Liu^{1

2

3}, Cheng-Yuan Peng^{4

5}, Chun-Jen Liu^{1

2

6}, Chi-Yi Chen⁷, Ching-Chu Lo⁸, Kuo-Chih Tseng^{9

10}, Pei-Yuan Su¹¹, Wei-Yu Kao^{12

13

14

15}, Ming-Chang Tsai^{16

17}, Hung-Da Tung¹⁸, Hao-Tsai Cheng^{19

20}, Fu-Jen Lee²¹, Chia-Sheng Huang²², Ke-Jhang Huang²³, Yu-Lueng Shih²⁴, Sheng-Shun Yang^{25

26

27}, Jo-Hsuan Wu²⁸, Hsueh-Chou Lai^{4

5}, Yu-Jen Fang³, Po-Yueh Chen⁷, Jow-Jyh Hwang⁸, Chi-Wei Tseng^{9

10}, Wei-Wen Su¹¹, Chun-Chao Chang^{12

13

14}, Pei-Lun Lee¹⁸, Jyh-Jou Chen¹⁸, Chi-Yang Chang²¹, Tsai-Yuan Hsieh²⁴, Chung-Hsin Chang²⁵, Yi-Jie Huang²⁵, Jia-Horng Kao^{29

30

31

32}

Affiliations

¹ Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
² Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
³ Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Yunlin, Taiwan.
⁴ Department of Internal Medicine, Center for Digestive Medicine, China Medical University Hospital, Taichung, Taiwan.
⁵ School of Medicine, China Medical University, Taichung, Taiwan.
⁶ Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine Hospital, Taipei, Taiwan.
⁷ Division of Gastroenterology and Hepatology, Department of Internal Medicine, Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi, Taiwan.
⁸ Department of Internal Medicine, St. Martin De Porres Hospital, Daya, Chiayi, Taiwan.
⁹ Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan.
¹⁰ School of Medicine, Tzuchi University, Hualien, Taiwan.
¹¹ Division of Gastroenterology, Department of Internal Medicine, Changhua Christian Hospital, Changhua, Taiwan.
¹² Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan.
¹³ Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.
¹⁴ TMU Research Center for Digestive Medicine, Taipei Medical University, Taipei, Taiwan.
¹⁵ Taipei Cancer Center, Taipei Medical University, Taipei, Taiwan.
¹⁶ Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan.
¹⁷ School of Medicine, Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan.
¹⁸ Division of Gastroenterology and Hepatology, Chi-Mei Hospital, Liouying, Taiwan.
¹⁹ Division of Gastroenterology and Hepatology, Department of Internal Medicine, New Taipei Municipal TuCheng Hospital, New Taipei City, Taiwan.
²⁰ Department of Gastroenterology and Hepatology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.
²¹ Division of Gastroenterology and Hepatology, Department of Internal Medicine, Fu Jen Catholic University Hospital, New Taipei City, Taiwan.
²² Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yang Ming Hospital, Chiayi, Taiwan.
²³ Division of Gastroenterology and Hepatology, Department of Internal Medicine, China Medical University Beigang Hospital, Yunlin, Taiwan.
²⁴ Division of Gastroenterology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.
²⁵ Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.
²⁶ School of Medicine, Chung Shan Medical University, Taichung, Taiwan.
²⁷ Institute of Biomedical Sciences, National Chung Hsing University, Taichung, Taiwan.
²⁸ Shiley Eye Institute and Viterbi Family Department of Ophthalmology, Hamilton Glaucoma Center, University of California, San Diego, CA, USA.
²⁹ Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. kaojh@ntu.edu.tw.
³⁰ Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. kaojh@ntu.edu.tw.
³¹ Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine Hospital, Taipei, Taiwan. kaojh@ntu.edu.tw.
³² Department of Medical Research, National Taiwan University Hospital, Taipei, Taiwan. kaojh@ntu.edu.tw.

PMID: 36701081
DOI: 10.1007/s12072-022-10475-9

Multicenter Study

Sofosbuvir/velpatasvir/voxilaprevir for patients with chronic hepatitis C virus infection previously treated with NS5A direct-acting antivirals: a real-world multicenter cohort in Taiwan

Chen-Hua Liu et al. Hepatol Int. 2023 Apr.

. 2023 Apr;17(2):291-302.

doi: 10.1007/s12072-022-10475-9. Epub 2023 Jan 26.

Authors

Affiliations

¹ Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
² Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
³ Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Yunlin, Taiwan.
⁴ Department of Internal Medicine, Center for Digestive Medicine, China Medical University Hospital, Taichung, Taiwan.
⁵ School of Medicine, China Medical University, Taichung, Taiwan.
⁶ Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine Hospital, Taipei, Taiwan.
⁷ Division of Gastroenterology and Hepatology, Department of Internal Medicine, Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi, Taiwan.
⁸ Department of Internal Medicine, St. Martin De Porres Hospital, Daya, Chiayi, Taiwan.
⁹ Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan.
¹⁰ School of Medicine, Tzuchi University, Hualien, Taiwan.
¹¹ Division of Gastroenterology, Department of Internal Medicine, Changhua Christian Hospital, Changhua, Taiwan.
¹² Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan.
¹³ Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.
¹⁴ TMU Research Center for Digestive Medicine, Taipei Medical University, Taipei, Taiwan.
¹⁵ Taipei Cancer Center, Taipei Medical University, Taipei, Taiwan.
¹⁶ Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan.
¹⁷ School of Medicine, Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan.
¹⁸ Division of Gastroenterology and Hepatology, Chi-Mei Hospital, Liouying, Taiwan.
¹⁹ Division of Gastroenterology and Hepatology, Department of Internal Medicine, New Taipei Municipal TuCheng Hospital, New Taipei City, Taiwan.
²⁰ Department of Gastroenterology and Hepatology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.
²¹ Division of Gastroenterology and Hepatology, Department of Internal Medicine, Fu Jen Catholic University Hospital, New Taipei City, Taiwan.
²² Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yang Ming Hospital, Chiayi, Taiwan.
²³ Division of Gastroenterology and Hepatology, Department of Internal Medicine, China Medical University Beigang Hospital, Yunlin, Taiwan.
²⁴ Division of Gastroenterology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.
²⁵ Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.
²⁶ School of Medicine, Chung Shan Medical University, Taichung, Taiwan.
²⁷ Institute of Biomedical Sciences, National Chung Hsing University, Taichung, Taiwan.
²⁸ Shiley Eye Institute and Viterbi Family Department of Ophthalmology, Hamilton Glaucoma Center, University of California, San Diego, CA, USA.
²⁹ Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan. kaojh@ntu.edu.tw.
³⁰ Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan. kaojh@ntu.edu.tw.
³¹ Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine Hospital, Taipei, Taiwan. kaojh@ntu.edu.tw.
³² Department of Medical Research, National Taiwan University Hospital, Taipei, Taiwan. kaojh@ntu.edu.tw.

PMID: 36701081
DOI: 10.1007/s12072-022-10475-9

Abstract

Background: Real-world data are scarce about the effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) for retreating East Asian patients with hepatitis C virus (HCV) infection who previously received NS5A direct-acting antivirals (DAAs). We conducted a multicenter study to assess the performance of SOF/VEL/VOX in patients who were not responsive to prior NS5A inhibitors in Taiwan.

Methods: Between September 2021 and May 2022, 107 patients who failed NS5A inhibitor-containing DAAs with SOF/VEL/VOX salvage therapy for 12 weeks were included at 16 academic centers. The sustained virologic response at off-treatment week 12 (SVR₁₂) was assessed in the evaluable (EP) and per-protocol (PP) populations. The safety profiles were also reported.

Results: All patients completed 12 weeks of treatment and achieved an end-of-treatment virologic response. The SVR₁₂ rates were 97.2% (95% confidence interval (CI) 92.1-99.0%) and 100% (95% CI 96.4-100%) in EP and PP populations. Three (2.8%) patients were lost to off-treatment follow-up and did not meet SVR₁₂ in the EP population. No baseline factors predicted SVR₁₂. Two (1.9%) not-fatal serious adverse events (AE) occurred but were unrelated to SOF/VEL/VOX. Sixteen (15.0%) had grade 2 total bilirubin elevation, and three (2.8%) had grade 2 alanine transaminase (ALT) elevation. Thirteen (81.3%) of the 16 patients with grade 2 total bilirubin elevation had unconjugated hyperbilirubinemia. The estimated glomerular filtration rates (eGFR) were comparable between baseline and SVR₁₂, regardless of baseline renal reserve.

Conclusions: SOF/VEL/VOX is highly efficacious and well-tolerated for East Asian HCV patients previously treated with NS5A inhibitor-containing DAAs.

Clinical trials registration: The study was not a drug trial. There was no need for clinical trial registration.

Keywords: Direct-acting antiviral; Effectiveness; Hepatitis C virus; Pangenotypic; Resistance-associated substitution; Safety; Sofosbuvir; Sustained virologic response; Velpatasvir; Voxilaprevir.

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Sofosbuvir/velpatasvir/voxilaprevir for patients with chronic hepatitis C virus infection previously treated with NS5A direct-acting antivirals: a real-world multicenter cohort in Taiwan

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Sofosbuvir/velpatasvir/voxilaprevir for patients with chronic hepatitis C virus infection previously treated with NS5A direct-acting antivirals: a real-world multicenter cohort in Taiwan

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