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Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease: real-world data in Taiwan

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Abstract

Background

Data regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) for East Asian patients with chronic hepatitis C virus (HCV) infection and compensated liver disease are limited. We evaluated the performance of SOF/VEL for 12 weeks for HCV-infected patients with compensated liver disease in a large real-world cohort in Taiwan.

Methods

Between July 2019 and March 2020, 1880 HCV-infected patients with compensated liver disease who received SOF/VEL 400/100 mg once daily for 12 weeks were included at 15 academic centers in Taiwan. The sustained virologic response at off-treatment week 12 (SVR12) was assessed for evaluable (EP) and per-protocol populations (PP). The tolerance was also reported.

Results

The SVR12 rates by EP and PP analyses were 95.6% [1798 of 1880 patients; 95% confidence interval (CI) 94.6–96.5%] and 99.3% (1798 of 1811 patients; 95% CI 98.8–99.6%), respectively. Among 82 patients who failed to achieve SVR12, 13 (15.9%) were attributed to virologic failures. The SVR12 rates were comparable regardless of baseline characteristics. A total of 1859 (98.9%) patients completed 12-week SOF/VEL treatment. Four (0.2%) patients discontinued treatment due to adverse events (AEs). All patients with serious AEs or deaths were judged not related to SOF/VEL. The AEs occurring in ≥ 10% included headache (16.8%), fatigue (16.2%), nausea (11.8%), and insomnia (11.1%). Nine (0.5%) and 2 (0.1%) patients had grade 3 total bilirubin and alanine aminotransferase elevations.

Conclusions

SOF/VEL for 12 weeks is efficacious and well-tolerated by chronic HCV-infected patients with compensated liver disease in Taiwan.

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Data availability

Data sharing is not applicable to this article as no new data were created or analyzed in this study.

Abbreviations

HCV:

Hepatitis C virus

HCC:

Hepatocellular carcinoma

IFN:

Interferon

DAA:

Direct acting antiviral

SOF:

Sofosbuvir

VEL:

Velpatasvir

SVR:

Sustained virologic response

HBV:

Hepatitis B virus

HIV:

Human immunodeficiency virus

FDC:

Fixed-dose combination

GT:

Genotype

DDI:

Drug–drug interaction

PI:

Protease inhibitor

LLOQ:

Lower limit of quantification

ULN:

Upper limit of normal

eGFR:

Estimated glomerular filtration rate

RNA:

Ribonucleic acid

DNA:

Deoxyribonucleic acid

AST:

Aspartate aminotransferase

ALT:

Alanine aminotransferase

FIB-4:

Fibrosis index based on 4 parameters

APRI:

Aspartate aminotransferase-to-platelet ratio index

AE:

Adverse event

IQR:

Interquartile range

CI:

Confidence interval

RBV:

Ribavirin

RAS:

Resistance-associated substitution

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Acknowledgements

The authors thank Hui-Ju Lin and Pin-Chin Huang for clinical data management; the 7th Core Lab of National Taiwan University Hospital and the 1st Common Laboratory of National Taiwan University Hospital, Yun-Lin Branch for instrumental and technical support.

Funding

The study was supported by Ministry of Science and Technology, Taiwan (106-2314-B-002-138-MY3, 107-2314-B-002-038-MY2).

Author information

Authors and Affiliations

  1. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan

    Chen-Hua Liu, Chun-Jen Liu, Chien-Ching Hung & Jia-Horng Kao

  2. Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan

    Chen-Hua Liu, Chun-Jen Liu & Jia-Horng Kao

  3. Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Yunlin, Taiwan

    Chen-Hua Liu & Yu-Jen Fang

  4. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi, Taiwan

    Po-Yueh Chen & Chi-Yi Chen

  5. Division of Gastroenterology and Hepatology, Chi-Mei Medical Center, Liouying, Tainan, Taiwan

    Jyh-Jou Chen & Pei-Lun Lee

  6. Department of Internal Medicine, St. Martin De Porres Hospital, Daya, Chiayi, Taiwan

    Ching-Chu Lo & Jow-Jyh Huang

  7. Division of Gastroenterology, Department of Internal Medicine, Changhua Christian Hospital, Changhua, Taiwan

    Wei-Wen Su & Pei-Yuan Su

  8. Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan

    Kuo-Chih Tseng & Chi-Wei Tseng

  9. School of Medicine, Tzuchi University, Hualien, Taiwan

    Kuo-Chih Tseng & Chi-Wei Tseng

  10. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yang Ming Hospital, Chiayi, Taiwan

    Chia-Sheng Huang

  11. Division of Gastroenterology and Hepatology, Department of Internal Medicine, China Medical University Beigang Hospital, Yunlin, Taiwan

    Ke-Jhang Huang

  12. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan

    Sheng-Shun Yang, Chung-Hsin Chang & Yi-Jie Huang

  13. School of Medicine, Chung Shan Medical University, Taichung, Taiwan

    Sheng-Shun Yang

  14. Institute of Biomedical Sciences, National Chung Hsing University, Taichung, Taiwan

    Sheng-Shun Yang

  15. Center for Digestive Medicine, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan

    Cheng-Yuan Peng & Hsueh-Chou Lai

  16. School of Medicine, China Medical University, Taichung, Taiwan

    Cheng-Yuan Peng & Hsueh-Chou Lai

  17. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan

    Ming-Chang Tsai

  18. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan

    Wei-Yu Kao & Chun-Chao Chang

  19. Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan

    Wei-Yu Kao & Chun-Chao Chang

  20. Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan

    Wei-Yu Kao & Chun-Chao Chang

  21. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Fu Jen Catholic University Hospital, Taipei, Taiwan

    Chi-Yang Chang & Fu-Jen Lee

  22. Division of Gastroenterology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan

    Yu-Lueng Shih & Tsai‐Yuan Hsieh

  23. Department of Tropical Medicine and Parasitology, National Taiwan University College of Medicine, Taipei, Taiwan

    Chien-Ching Hung

  24. Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, 7 Chung-Shan South Road, Taipei, 10002, Taiwan

    Jia-Horng Kao

Authors
  1. Chen-Hua Liu
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  3. Jyh-Jou Chen
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Contributions

Conception and design: CHL and JHK. Analysis and interpretation of data: CHL. Drafting of the article: CHL and JHK. Critical revision of the article for important intellectual content: CHL, PYC, JJC, CCL, WWS, KCT, CJL, CSH, KJH, SSY, CYP, MCT, WYK, CYC, YLS, YJF, CYC, PLL, JJH, PYS, CWT, CCH, CHC, YJH, HCL, CCC, FJL, TYH, and JHK. Final approval of the article: CHL, PYC, JJC, CCL, WWS, KCT, CJL, CSH, KJH, SSY, CYP, MCT, WYK, CYC, YLS, YJF, CYC, PLL, JJH, PYS, CWT, CCH, CHC, YJH, HCL, CCC, FJL, TYH, and JHK. Provision of study materials or patients: CHL, PYC, JJC, CCL, WWS, KCT, CJL, CSH, KJH, SSY, CYP, MCT, WYK, CYC, YLS, YJF, CYC, PLL, JJH, PYS, CWT, CCH, CHC, YJH, HCL, CCC, FJL, TYH, and JHK. Statistical expertise: CH Liu. Administrative, technical, or logistic support: CHL and JHK. Collection and assembly of data: CHL.

Corresponding author

Correspondence to Jia-Horng Kao.

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Conflict of interest

Chen-Hua Liu: advisory board for Abbvie, Gilead Sciences, Merck Sharp & Dohme; speaker’s bureau for Abbott, Abbvie, Gilead Sciences, Merck Sharp & Dohme; research grant from Abbvie, Gilead Science, Merck Sharp & Dohme. Sheng-Shun Yang: advisory board for Abbvie, Roche, Ipsen; speaker’s bureau for Abbvie, Bristol-Myers Squibb, Gilead Sciences, Ipsen, Merck Sharp & Dohme. Chien-Ching Hung: advisory board for Abbvie, Gilead Sciences, ViiV Healthcare; speaker’s bureau for Gilead Sciences; research grant from Gilead Sciences, ViiV Healthcare, Merck Sharp & Dohme. Jia- Horng Kao: advisory board for Abbott, Abbvie, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Roche; speaker’s bureau for Abbott, Abbvie, Bayer, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, and Roche. All other authors declare no competing interests.

Ethical approval

The study was approved by the Research Ethics Committee of each participating center (ID: 202007043RIND) and was conducted in accordance with the principles of Declaration of Helsinki in 1975.

Animal research

This was not an animal research.

Consent to participate

This was a retrospective study with clinical data collection, and the Research Ethics Committee of each participating center approved to waive the patient consent.

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All the authors consented the publish work.

Clinical trials registration

The was a retrospective observation study and was not a drug trial. There was no need for clinical trial registration.

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12072_2021_10158_MOESM1_ESM.pdf

Supplementary file1 Supplementary Figure 1. eGFR changes between baseline and SVR12 according to baseline CKD stage. (PDF 23 KB)

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Liu, CH., Chen, PY., Chen, JJ. et al. Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease: real-world data in Taiwan. Hepatol Int 15, 338–349 (2021). https://doi.org/10.1007/s12072-021-10158-x

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