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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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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.

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Data availability

All data collection was approved by the Research Ethics Committee of each participating center.

Abbreviations

HCV:

Hepatitis C virus

DAA:

Direct-acting antiviral

HCC:

Hepatocellular carcinoma

SVR:

Sustained virologic response

IFN:

Interferon

RAS:

Resistance-associated substitution

WHO:

World Health Organization

SOF:

Sofosbuvir

VEL:

Velpatasvir

VOX:

Voxilaprevir

FDC:

Fixed-dose combination

GT:

Genotype

RBV:

Ribavirin

LLOQ:

Lower limit of quantification

HBV:

Hepatitis B virus

HIV:

Human immunodeficiency virus

RNA:

Ribonucleic acid

DNA:

Deoxyribonucleic acid

DDI:

Drug-drug interaction

DM:

Diabetes mellitus

HTN:

Hypertension

ULN:

Upper limit of normal

AST:

Aspartate aminotransferase

ALT:

Alanine aminotransferase

eGFR:

Estimated glomerular filtration rate

FIB-4:

Fibrosis index based on four parameters

AE:

Adverse event

IQR:

Interquartile range

CI:

Confidence interval

MAFLD:

Metabolic dysfunctional-associated fatty liver disease

DILI:

Drug-induced liver injury

NUC:

Nucleot(s)ide analogue

OATP:

Organic anion transport protein

DCV:

Daclatasvir

ASV:

Asunaprevir

PrOD:

Paritaprevir/ritonavir/ombitasvir plus dasabuvir

EBR:

Elbasvir

GZR:

Grazoprevir

GLE:

Glecaprevir

PIB:

Pibrentasvir

LDV:

Ledipasvir

CKD-EPI:

Chronic kidney disease epidemiology collaboration

CTCAE:

Common terminology criteria for adverse events

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Acknowledgements

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

Funding

None.

Author information

Authors and Affiliations

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

    Chen-Hua Liu, Chun-Jen Liu & 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. Department of Internal Medicine, Center for Digestive Medicine, China Medical University Hospital, Taichung, Taiwan

    Cheng-Yuan Peng & Hsueh-Chou Lai

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

    Cheng-Yuan Peng & Hsueh-Chou Lai

  6. Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine Hospital, Taipei, Taiwan

    Chun-Jen Liu & Jia-Horng Kao

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

    Chi-Yi Chen & Po-Yueh Chen

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

    Ching-Chu Lo & Jow-Jyh Hwang

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

    Kuo-Chih Tseng & Chi-Wei Tseng

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

    Kuo-Chih Tseng & Chi-Wei Tseng

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

    Pei-Yuan Su & Wei-Wen Su

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

    Wei-Yu Kao & Chun-Chao Chang

  13. 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

  14. TMU Research Center for Digestive Medicine, Taipei Medical University, Taipei, Taiwan

    Wei-Yu Kao & Chun-Chao Chang

  15. Taipei Cancer Center, Taipei Medical University, Taipei, Taiwan

    Wei-Yu Kao

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

    Ming-Chang Tsai

  17. School of Medicine, Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan

    Ming-Chang Tsai

  18. Division of Gastroenterology and Hepatology, Chi-Mei Hospital, Liouying, Taiwan

    Hung-Da Tung, Pei-Lun Lee & Jyh-Jou Chen

  19. Division of Gastroenterology and Hepatology, Department of Internal Medicine, New Taipei Municipal TuCheng Hospital, New Taipei City, Taiwan

    Hao-Tsai Cheng

  20. Department of Gastroenterology and Hepatology, Department of Internal Medicine, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan

    Hao-Tsai Cheng

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

    Fu-Jen Lee & Chi-Yang Chang

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

    Chia-Sheng Huang

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

    Ke-Jhang Huang

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

    Yu-Lueng Shih & Tsai‐Yuan Hsieh

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

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

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

    Sheng-Shun Yang

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

    Sheng-Shun Yang

  28. Shiley Eye Institute and Viterbi Family Department of Ophthalmology, Hamilton Glaucoma Center, University of California, San Diego, CA, USA

    Jo-Hsuan Wu

  29. Department of Medical Research, National Taiwan University Hospital, Taipei, Taiwan

    Jia-Horng Kao

Authors
  1. Chen-Hua Liu
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  2. Cheng-Yuan Peng
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  3. Chun-Jen Liu
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  28. Tsai‐Yuan Hsieh
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  30. Yi-Jie Huang
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  31. Jia-Horng Kao
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Contributions

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

Corresponding author

Correspondence to Jia-Horng Kao.

Ethics declarations

Conflicts 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. 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, Roche. All other authors declare no competing interests.

Animal research

This study was not an animal research.

Ethical approval

The study was approved by the Research Ethics Committee of each participating center (ID: 202109016RIND) and was conducted in accordance with the principles of the Declaration of Helsinki in 1975.

Consent to participate

Each participant consented to this work and provided informed consent.

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Liu, CH., Peng, CY., Liu, CJ. et al. 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. Hepatol Int 17, 291–302 (2023). https://doi.org/10.1007/s12072-022-10475-9

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