Efficacy of Sofosbuvir and Velpatasvir in Achieving Sustained Virological Response in Patients with End-Stage Renal Disease Infected with Hepatitis C Virus
DOI:
https://doi.org/10.36283/ziun-pjmd14-4/073Keywords:
End-stage renal disease, Hepatitis C, genotype III, ETR, SVRAbstract
Background: Hepatitis C virus (HCV) infection remains a critical concern globally, especially in populations with end-stage renal disease (ESRD) on haemodialysis. This study aims to evaluate the efficacy and safety of a fixed-dose combination of Sofosbuvir and Velpatasvir (SOF/VEL) in achieving sustained virological response at 12 weeks post-treatment (SVR12) among ESRD patients infected with genotype III HCV
Methods: A prospective cohort study was conducted at the Sindh Institute of Urology and Transplantation, Karachi, from January 2023 to December 2024. Inclusion criteria were patients aged ≥18 years with ESRD on maintenance hemodialysis for ≥3 months and genotype III HCV infection. Patients received SOF/VEL (400 mg/100 mg) daily with ribavirin (400 mg) once weekly for 12 weeks. Primary outcome measured was SVR12. Statistical analyses involved Chi-square and Student's t-tests, with significance set at p<0.05.
Results: Of 109 enrolled patients (mean age 30.45 ± 8.98 years; 75.2% male), 105 (96.3%) achieved an end-of-treatment response (ETR), while SVR12 was attained in 91 (84.3%) patients. The mean duration of dialysis was 3.1 ± 1.2 years. The most common adverse effects were fatigue (28%), headache (18%), and nausea (12%). Significant biochemical improvements at treatment completion were noted in ALT (p=0.001) and AST (p=0.021), although biochemical changes were not significantly correlated with SVR12.
Conclusion: The combination therapy of Sofosbuvir and Velpatasvir demonstrated good efficacy (84.3% SVR12) and a manageable safety profile in ESRD patients on hemodialysis infected with HCV genotype III. Further multi-center studies with larger sample sizes are necessary to validate and generalize these results, emphasizing the potential of SOF/VEL therapy in this challenging patient population.
References
1. Panezai MQ, Taha Yaseen R, Lail G, et al.: Correlation of model for End Stage Liver Disease (MELD), meld-sodium (MELD-Na), and child-Turcotte-Pugh (CTP) score with frailty in patients with hepatitis C virus (HCV) related cirrhosis. Cureus. 2023 Jun, 15:e40574. 10.7759/cureus.40574
2. Akbar N, Tasneem AA, Khan RTY, et al.: Utility of BE3A score in predicting outcome of patients with hepatitis-C related decompensated cirrhosis treated with direct acting antiviral therapy. IJCMCR. IJCMCR. 2021, 16:002. 10.46998/IJCMCR.2021 Dec.16.000382
3. Panezai MQ, Taha Yaseen R, Ahmed Khan S, et al.: Predictors of frailty in patients with liver cirrhosis. Cureus. 2024 Jun, 16:e61626. 10.7759/cureus.61626
4. Kumar V, Aslam M, Kalwar S, Hyder A, Tareen K, Kumar S, Taha Yaseen Khan R, Tasneem AA, Hassan Luck N. Utility of the Platelet-to-Lymphocyte Ratio in Predicting Advanced Liver Fibrosis in the Hepatitis C Virus (HCV)-Infected Population. Cureus. 2025 Apr 24;17(4):e82882. doi: 10.7759/cureus.82882. PMID: 40416293; PMCID: PMC12103697.
5. Brzdęk M, Zarębska-Michaluk D, Invernizzi F, Cilla M, Dobrowolska K, Flisiak R. Decade of optimizing therapy with direct-acting antiviral drugs and the changing profile of patients with chronic hepatitis C. World J Gastroenterol. 2023 Feb 14;29(6):949-966. doi: 10.3748/wjg.v29.i6.949. PMID: 36844142; PMCID: PMC9950869.
6. Kumar K, Das B, Naveed A, Kumar S, Tassaduq Khan M, Memon R. Prevalence of HCV Infection in End Stage Renal Disease (ESRD) Patients on Maintenance Hemodialysis: HCV Infection in End Stage Renal Disease. PJHS-Lahore [Internet]. 2023 Feb. 28 [cited 2025 Jul. 31];4(02):95-8. Available from: https://thejas.com.pk/index.php/pjhs/article/view/564
7. Arora A, Bansal N, Sharma P, Singla V, Gupta V, Tyagi P, Malik M, Kumar A. Hepatitis C Virus Infection in Patients with End-Stage Renal Disease: A Study from a Tertiary Care Centre in India. J Clin Exp Hepatol. 2016 Mar;6(1):21-5. doi: 10.1016/j.jceh.2015.04.004. Epub 2015 Apr 29. PMID: 27194892; PMCID: PMC4862010.
8. Zaki MSE. The effect of Hepatitis C Virus infection on cardiovascular complications in end stage kidney disease patients on regular hemodialysis. Electron Physician. 2017 Feb 25;9(2):3857-3861. doi: 10.19082/3857. PMID: 28465818; PMCID: PMC5410917.
9. Chou CY, Wang IK, Liu JH, Lin HH, Wang SM, Huang CC. Comparing survival between peritoneal dialysis and hemodialysis treatment in ESRD patients with chronic hepatitis C infection. Perit Dial Int. 2010 Jan-Feb;30(1):86-90. PMID: 20056985.
10. Carriero D, Fabrizi F, Uriel AJ, Park J, Martin P, Dieterich DT. Treatment of dialysis patients with chronic hepatitis C using pegylated interferon and low-dose ribavirin. Int J Artif Organs. 2008 Apr;31(4):295-302. doi: 10.1177/039139880803100404. PMID: 18432584.
11. Fabrizi F, Dulai G, Dixit V, Bunnapradist S, Martin P. Meta-analysis: interferon for the treatment of chronic hepatitis C in dialysis patients. Aliment Pharmacol Ther. 2003 Dec;18(11-12):1071-81. doi: 10.1046/j.1365-2036.2003.01780.x. PMID: 14653826.
12. Nehra V, Rizza SA, Temesgen Z. Sofosbuvir/velpatasvir fixed-dose combination for the treatment of chronic hepatitis C virus infection. Drugs Today (Barc). 2017 Mar;53(3):177-189. doi: 10.1358/dot.2017.53.3.2604176. PMID: 28447075.
13. Sise ME, Backman E, Ortiz GA, Hundemer GL, Ufere NN, Chute DF, Brancale J, Xu D, Wisocky J, Lin MV, Kim AY, Thadhani R, Chung RT. Effect of Sofosbuvir-Based Hepatitis C Virus Therapy on Kidney Function in Patients with CKD. Clin J Am Soc Nephrol. 2017 Oct 6;12(10):1615-1623. doi: 10.2215/CJN.02510317. Epub 2017 Sep 7. PMID: 28882857; PMCID: PMC5628711.
14. Sise ME, McQuaid T, Martin P. Sofosbuvir-based hepatitis C therapies in patients with chronic and end-stage kidney disease. Nephrol Dial Transplant. 2022 Nov 23;37(12):2327-2334. doi: 10.1093/ndt/gfab072. PMID: 33848334.
15. 15- Taneja S, Duseja A, Mehta M, De A, Verma N, Premkumar M, Dhiman RK, Singh V, Singh MP, Ratho RK, Ramachandran R, Kumar V, Kohli HS. Sofosbuvir and Velpatasvir combination is safe and effective in treating chronic hepatitis C in end-stage renal disease on maintenance haemodialysis. Liver Int. 2021 Apr;41(4):705-709. doi: 10.1111/liv.14685. PMID: 33025685.
16. Liu CH, Chen CY, Su WW, Tseng KC, Lo CC, Liu CJ, Chen JJ, Peng CY, Shih YL, Yang SS, Huang CS, Huang KJ, Chang CY, Tsai MC, Kao WY, Fang YJ, Chen PY, Su PY, Tseng CW, Huang JJ, Lee PL, Lai HC, Hsieh TY, Chang CH, Huang YJ, Lee FJ, Chang CC, Kao JH. Sofosbuvir/velpatasvir with or without low-dose ribavirin for patients with chronic hepatitis C virus infection and severe renal impairment. Gut. 2022 Jan;71(1):176-184. doi: 10.1136/gutjnl-2020-323569. Epub 2021 Jan 6. PMID: 33408122.
17. Borgia SM, Dearden J, Yoshida EM, Shafran SD, Brown A, Ben-Ari Z, Cramp ME, Cooper C, Foxton M, Rodriguez CF, Esteban R, Hyland R, Lu S, Kirby BJ, Meng A, Markova S, Dvory-Sobol H, Osinusi AO, Bruck R, Ampuero J, Ryder SD, Agarwal K, Fox R, Shaw D, Haider S, Willems B, Lurie Y, Calleja JL, Gane EJ. Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis. J Hepatol. 2019 Oct;71(4):660-665. doi: 10.1016/j.jhep.2019.05.028. Epub 2019 Jun 11. PMID: 31195062.
18. Fabrizi F, Tripodi F, Cerutti R, Nardelli L, Alfieri CM, Donato MF, Castellano G. Recent Information on Pan-Genotypic Direct-Acting Antiviral Agents for HCV in Chronic Kidney Disease. Viruses [Internet]. 2022 [cited 2025 Jun 11];14:2570. doi: https://doi.org/10.3390/v14112570.
19. Liu C-H, Kao J-H. Pan-genotypic direct-acting antivirals for patients with hepatitis C virus infection and chronic kidney disease stage 4 or 5. Hepatology International. 2022 Jul;16:1001–1019. doi: https://doi.org/10.1007/s12072-022-10390-z.
20. Salama II, Raslan HM, Abdel-Latif GA, Salama SI, Sami SM, Shaaban FA, Abdelmohsen AM, Fouad WA. Impact of direct-acting antiviral regimens on hepatic and extrahepatic manifestations of hepatitis C virus infection. World Journal of Hepatology [Internet]. 2022 Jun;14:1053–1073. doi: https://doi.org/10.4254/wjh.v14.i6.1053.
21. Chen R, Xiong Y, Zeng Y, Wang X, Xiao Y, Zheng Y. The efficacy and safety of direct-acting antiviral regimens for end-stage renal disease patients with HCV infection: a systematic review and network meta-analysis. Frontiers in public health. 2023 Sep;11. doi: https://doi.org/10.3389/fpubh.2023.1179531.
22. Shahd Hamran, Al-Rajhi AA, Kawthar Jasim, Al-Theyab MA, Elahtam M, Al-Hail MK, Wadha Al-Fahaidi, Khamis YA, Yara Dweidri, Abdel-Naser Elzouki, et al. Efficacy and Safety of Adding Ribavirin to Sofosbuvir-Based Direct-Acting Antivirals (DAAs) in Re-Treating Non-Genotype 1 Hepatitis C—A Systematic Review and Meta-Analysis. Diseases [Internet]. 2025 [cited 2025 Oct 16];13:138–138. doi: https://doi.org/10.3390/diseases13050138.
23. Mita E, Liu LJ, Shing D, Force L, Aoki K, Nakamoto D, Ishizaki A, Konishi H, Mizutani H, Ng LJ. Real-world Safety and Effectiveness of 24-week Sofosbuvir and Ribavirin Treatment in Patients Infected with Rare Chronic Hepatitis C Virus Genotypes 3, 4, 5, or 6 in Japan. Internal Medicine [Internet]. 2023 [cited 2024 Jan 14];62:1405–1414. doi: https://doi.org/10.2169/internalmedicine.0067-22.
24. Omar H, Maksoud MHA, Goma AA, Hassan EA, Atta NA, Khalil M, Hegazy MS, Zaky S, Esmat G. Effectiveness and safety of SOF/VEL containing rescue therapy in treating chronic HCV-GT4 patients previously failed NS5A inhibitors-based DAAs. Egyptian Liver Journal. 2024 March;14. doi: https://doi.org/10.1186/s43066-024-00321-y.
25. Cheng P-N, Mo L-R, Chen C-T, Chen C-Y, Huang C-F, Kuo H-T, Lo C-C, Tseng K-C, Huang Y-H, Tai C-M, et al. Sofosbuvir/Velpatasvir for Hepatitis C Virus Infection: Real-World Effectiveness and Safety from a Nationwide Registry in Taiwan. Infectious Diseases and Therapy. 2021 Dec;11:485–500. doi: https://doi.org/10.1007/s40121-021-00576-7.
Downloads
Published
Issue
Section
License
Copyright (c) 2025 Pakistan Journal of Medicine and Dentistry
This work is licensed under a Creative Commons Attribution 4.0 International License.
This is an open-access article distributed under the terms of the CreativeCommons Attribution License (CC BY) 4.0 https://creativecommons.org/licenses/by/4.0/
Metrics
How to Cite
