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Letters to the Editor

Sofosbuvir-based direct-acting antivirals for patients with decompensated hepatitis C virus–related cirrhosis

Liu, Chen-Huaa,b,c,*; Liu, Chun-Jena,b,d; Kao, Jia-Hornga,b,d,e

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Journal of the Chinese Medical Association: May 2022 - Volume 85 - Issue 5 - p 647-648
doi: 10.1097/JCMA.0000000000000715
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DEAR EDITOR,

We read with great interest the original contribution regarding the safety and tolerability of sofosbuvir (SOF)-based direct-acting antivirals (DAAs) for patients with decompensated hepatitis C virus (HCV)–related cirrhosis in Taiwan by Su et al.1 Although the authors performed a comprehensive literature review and patient assessment in their report, several other recent studies from Taiwan also corroborate the authors’ findings about caring for patients with HCV in this special clinical setting.

Reimbursement for DAAs for HCV in Taiwan began in 2017; however, all approved regimens contained protease inhibitors, which are considered to be a contraindication for patients with decompensated cirrhosis. Generic SOF-based DAAs, an alternative treatment option for this vulnerable group of patients, can be offered in the form of out-of-pocket payments following health authority review. In our previous study, among 43 patients with Child-Pugh B or C cirrhosis, the sustained virologic response (SVR12) rates using SOF in combination with ledipasvir (LDV), daclatasvir, and velpatasvir (VEL) with or without ribavirin (RBV) for 12 weeks were 80%, 100%, and 100%, respectively, indicating successful eradication of HCV in 90.7% of the patients.2 The approval of SOF/LDV with RBV in 2018 substantially advanced HCV care by removing drug and financial barriers, although this genotype-specific regimen can be applied only to HCV genotype 1 infection. In another of our studies, a SVR12 was achieved in 23 of 26 (88.5%) patients who received brand-name SOF/LDV plus RBV for 12 weeks.3 In June 2019, pangenotypic SOF/VEL was made available to HCV patients without restrictions. A subsequent multicenter study of 107 patients with Child-Pugh B or C cirrhosis reported SVR12 rates in evaluable and per-protocol populations of 89.7% and 100%, respectively, with SOF/VEL plus RBV for 12 weeks.4 In addition, in another study of the most difficult-to-treat population with combined liver and kidney failure who were treated with full-dose SOF/VEL and renally adjusted RBV for 12 weeks, the SVR12 remained excellent under judicious monitoring.5

In line with the findings of Su et al, patient tolerability was generally good and the causal relationship between SOF-based DAAs and severe adverse events was limited in our studies.2–5 This is particularly relevant for patients with decompensated HCV–related cirrhosis because a shortage of organs limits accessibility to transplantation. Although a significant proportion of patients with SVR12 have improved Child-Pugh and model for end-stage liver disease scores, a short-term state of score “purgatory” does not necessarily reflect long-term clinical improvement, and hence prudent surveillance is needed to secure long-term outcomes.6,7 Furthermore, a recent survey of the general population indicated that the rate of HCV reinfection was low following treatment-induced SVR12.8

Although treating patients with decompensated HCV–related cirrhosis remains challenging, the reports from Su et al and our group confirm the excellent antiviral responses and good tolerability of SOF-based DAA treatment in Taiwan. Based on the low risk of reinfection, healthcare providers should actively scale up screening and treatment for patients with HCV with a focus on health promotion and viral elimination.9

REFERENCES

1. Su PS, Wu SH, Chu CJ, Su CW, Lin CC, Lee SD, et al. Sofosbuvir-based antiviral therapy provided highly treatment efficacy, safety, and good tolerability for Taiwanese chronic hepatitis C patients with decompensated cirrhosis. J Chin Med Assoc 2022;85:152–9.
2. Liu CH, Huang YJ, Yang SS, Chang CH, Yang SS, Sun HY, et al. Generic sofosbuvir-based interferon-free direct acting antiviral agents for patients with chronic hepatitis C virus infection: a real-world multicenter observational study. Sci Rep 2018;8:13699.
3. Liu CH, Liu CJ, Su TH, Yang HC, Hong CM, Tseng TC, et al. Real-world effectiveness and safety of sofosbuvir and ledipasvir with or without ribavirin for patients with hepatitis C virus genotype 1 infection in Taiwan. PLoS One 2018;13:e0209299.
4. Liu CH, Chen CY, Su WW, Liu CJ, Lo CC, Huang KJ, et al. Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis. Clin Mol Hepatol 2021;27:575–88.
5. Liu CH, Chen CY, Su WW, Tseng KC, Lo CC, Liu CJ, et al. Sofosbuvir/velpatasvir with or without low-dose ribavirin for patients with chronic hepatitis C virus infection and severe renal impairment. Gut 2022;71:176–84.
6. Cheung MCM, Walker AJ, Hudson BE, Verma S, McLauchlan J, Mutimer DJ, et al.; HCV Research UK. Outcomes after successful direct-acting antiviral therapy for patients with chronic hepatitis C and decompensated cirrhosis. J Hepatol 2016;65:741–7.
7. Verna EC, Morelli G, Terrault NA, Lok AS, Lim JK, Di Bisceglie AM, et al. DAA therapy and long-term hepatic function in advanced/decompensated cirrhosis: Real-world experience from HCV-TARGET cohort. J Hepatol 2020;73:540–8.
8. Liu CH, Peng CY, Kao WY, Yang SS, Shih YL, Lin CL, et al. Hepatitis C virus reinfection in patients on haemodialysis after achieving sustained virologic response with antiviral treatment. Aliment Pharmacol Ther 2022;55:434–45.
9. Waked I, Esmat G, Elsharkawy A, El-Serafy M, Abdel-Razek W, Ghalab R, et al. Screening and treatment program to eliminate Hepatitis C in Egypt. N Engl J Med 2020;382:1166–74.
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