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Multicenter Study
. 2025 Apr;29(2):164-171.
doi: 10.1111/hdi.13198. Epub 2025 Jan 21.

Hepatitis C Treatment With Generic Sofosbuvir-Based Regimens in Patients Undergoing Hemodialysis

Nawal Afredj  1   2 , Mustapha Boumendjel  3   4 , Hassen Mahiou  2   5 , Othmane Drir  1   2 , Ibtissem Ouled Cheikh  1   2 , Hibatallah Belimi  1   2 , Rafik Kerbouche  1   2 , Nawal Guessab  1   2 , Arezki Zaidi  6 , Fouad Boutra  3   4 , M'hamed Nakmouche  2   5 , Nabil Debzi  1   2
Affiliations
Multicenter Study

Hepatitis C Treatment With Generic Sofosbuvir-Based Regimens in Patients Undergoing Hemodialysis

Nawal Afredj et al. Hemodial Int. 2025 Apr.

Abstract

Objectives: To assess the efficacy and safety of locally manufactured generic sofosbuvir-based direct-acting antivirals in the treatment of Hepatitis C virus (HCV) infected patients on maintenance hemodialysis.

Patients and methods: We have conducted a retrospective multicenter study including patients on maintenance hemodialysis, treated with sofosbuvir-based regimens between 01/01/2017 and 09/30/2021. Patients were treated for 12 or 24 weeks, with sofosbuvir 400 mg + ledipasvir 90 mg 3 times/week, or sofosbuvir 3 times/week + daclatasvir 60 mg/d, or sofosbuvir + daclatasvir in coformulation, 3 times/week. Sustained virological response was defined as a negative HCV RNA test 12 weeks after treatment. The occurrence of serious adverse events during treatment defines intolerance to treatment. Statistical analysis was performed using SPSS software (version 25).

Results: A total of 120 patients were treated; the mean age was 50 ± 14.17 years [18-78], 50% were men. Twenty-two patients (n = 22; 18.3%) were previously treated with pegylated Interferon. Genotype 1 was predominant (n = 68; 82%). Most of the patients (n = 53; 44.2%) had no significant fibrosis, and 24 (20%) had cirrhosis. The SVR rate was 93.3% (CI 95% [88.8; 97.8]) (n = 112), the serious adverse events rate was 10.8% (CI 95% [0.054-0.166]) (n = 13), including 2 deaths unrelated to direct-acting antivirals. Early treatment discontinuation occurred in 5.8% (n = 7), and a relapse in 0.8% (n = 1). On multivariate analysis, risk factors for serious adverse events included advanced liver fibrosis, thrombocytopenia, hypoalbuminemia, high bilirubin level, and pre-treatment status.

Conclusion: Locally manufactured generic sofosbuvir-based regimens are safe and effective in maintenance hemodialysis patients. However, they should be closely monitored to manage comorbidities and complications during treatment.

Keywords: daclatasvir; generic drug; hemodialysis; hepatitis C; sofosbuvir.

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References

    1. S. Mesbah, “Emerging and Re‐Emerging Infectious Diseases: Risk and Response in Algeria,” Medecine Tropicale: Revue du Corps de Sante Colonial 69, no. 1 (February 2009): 27–32.
    1. A. Bensalem, K. Selmani, N. Hihi, et al., “Eastern Region Represents a Worrying Cluster of Active Hepatitis C in Algeria in 2012,” Journal of Medical Virology 88, no. 8 (2016): 1394–1403.
    1. National Office of Statistics (Algeria), National Office of Statistics: Algeria Population and Housing Census 2008 2008.
    1. M. Jadoul, B. Bieber, P. Martin, et al., “Prevalence, Incidence, and Risk Factors for Hepatitis C Virus Infection in Haemodialysis Patients,” Kidney International 95 (2019): 939–947.
    1. A. Bruchfeld, D. Roth, P. Martin, et al., “Elbasvir Plus Grazoprevir in Patients With Hepatitis C Virus Infection and Stage 4‐5 Chronic Kidney Disease: Clinical, Virological, and Health‐Related Quality‐Of‐Life Outcomes From a phase3, Multicentre, Randomised, Double‐Blind, Placebo‐Controlled Trial,” Lancet Gastroenterology and Hepatology 2 (2017): 585–594.

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