Effect and Safety of Sofosbuvir and Daclatasvir in the Treatment of Hepatitis C Virus Infection Among Yemeni Patients Who Are Undergoing Hemodialysis [Accepted]
Abstract
Background: Hepatitis C (HCV) infection is the most commonly acquired infection for patients on hemodialysis and is associated with significant morbidity and disease progression. The efficacy and the safety of direct-acting antivirals (DAA) in patients with HCV in Yemen are still under investigation. Objective: To evaluate the effectiveness and safety of Sofosbuvir and Daclatasvir in the treatment of HCV infection among Yemeni patients who are on hemodialysis.
Method: Prospective study of twenty-eight Yemeni patients confirmed with HCV infection who were undergoing hemodialysis during the period from the beginning of January 2023 to the end of December 2024. This study was conducted in the dialysis department at Al Gomhori Hospital in Taiz City, Yemen.
Results: During the study period, a Total of 28 Yemeni patients were included: 14 (50%) males and 14 (50%) females, aged 18 to 70 years, with a mean age of 44 ± 12 years. The viral load at the beginning of the study was low in most patients (21, 75%), moderate in 1 (4%), and high in 6 (21%). Early virological response ( EVR) was achieved in 25 (89.03%) patients. One patient(3,6%) had detectable target post treatment, one patient (3,6%) died during the study period, and one patient (3,6%) experienced a side effect that led to discontinuation of the drugs. After 12 weeks of stopping the drugs, sustained virological response (SVR) was achieved in 25 (100%) patients. Conclusion: The combination of Sofosbuvir and daclatasvir was effective and safe in treating HCV infection among Yemeni patients undergoing hemodialysis
References
Li C, Liang J, Xiang H, Chen H, Tian J. Effectiveness of direct-acting antivirals in maintenance hemodialysis patients complicated with chronic hepatitis C. Medicine. 2020;99(48):e23384.
Cheema SUR, Rehman MS, Hussain G, Cheema SS, Gilani N. Efficacy and tolerability of sofosbuvir and daclatasvir for treatment of hepatitis C genotype 1 & 3 in patients undergoing hemodialysis-a prospective interventional clinical trial. BMC Nephrology. 2019;20(1):438.
Le Pogam S, Le Chapois D, Christen R, Dubois F, Barin F, Goudeau A. Hepatitis C in a hemodialysis unit: molecular evidence for nosocomial transmission. Journal of Clinical Microbiology. 1998;36(10):3040-3.
Sawinski D, Kaur N, Ajeti A, Trofe-Clark J, Lim M, Bleicher M, et al. Successful treatment of hepatitis C in renal transplant recipients with direct-acting antiviral agents. American Journal of Transplantation. 2016;16(5):1588-95.
Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Symonds WT, et al. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. New England Journal of Medicine. 2013;368(1):34-44.
Pol S, Bourliere M, Lucier S, Hezode C, Dorival C, Larrey D, et al. Safety and efficacy of daclatasvir-sofosbuvir in HCV genotype 1-mono-infected patients. Journal of Hepatology. 2017;66(1):39-47.
Garimella T, You X, Wang R, Huang S-P, Kandoussi H, Bifano M, et al. A review of daclatasvir drug–drug interactions. Advances in therapy. 2016;33(11):1867-84.
Tosun GG, Sultanova F, Hizel K. Efficacy and Safety of the Paritaprevir/Ritonavir/Ombitasvir/Dasabuvir Regimen for Chronic Hepatitis C in Hemodialysis Patients. Mediterranean Journal of Infection Microbes and Antimicrobials. 2019.
Kassim A, Alathwary R, Al-hogami T. Response of HCV Yemeni patients to sofosbuvir/ledipasvir in combination with ribavirin. Open Access Library Journal. 2019;6:e5507.
Ahmed RH, Al-Nagar N, Al-Subol I, Al-Wahbi R, Al-Sabahi M, Al-Sabahi M, et al. The Prevalence and Associated Factors of Hepatitis B and C Virus in Hemodialysis Patients in Ibb Governorate, Yemen. Cureus. 2024;16(9).
Aman K, Al-Dubai SA, Aman R, Hawash A, Alshagga M, Kassim S. Prevalence and associated factors of hepatitis C virus infection among renal disease patients on maintenance hemodialysis in three health centers in Aden, Yemen: a cross sectional study. Saudi Journal of Kidney Diseases and Transplantation. 2015;26(2):380-5.
Agarwal SK, Bagchi S, Yadav RK. Hemodialysis patients treated for hepatitis C using a sofosbuvir-based regimen. Kidney international reports. 2017;2(5):831-5.
Sperl J, Frankova S, Kreidlova M, Merta D, Tothova M, Spicak J. Combination of sofosbuvir and daclatasvir in the treatment of genotype 3 chronic hepatitis C virus infection in patients on maintenance hemodialysis. Therapeutics and clinical risk management. 2017:733-8.
Ghanaat K, Sharafi H, Alavian SM. The efficacy and safety of sofosbuvir/daclatasvir fixed-dose combination in Iranian hemodialysis patients with hepatitis C virus infection. Nephrourol Mon. 2021;13(2).
Bhat MA, Mir AN, Parry MA, Parray IA. Prevalence of Hepatitis C Virus Infection and Efficacy of Sofosbuvir–Velpatasvir and Sofosbuvir–Daclatasvir Treatment Regimens in End-stage Renal Disease Patients on Maintenance Hemodialysis. Saudi Journal of Kidney Diseases and Transplantation. 2023;34(6):570-5.
Wang K, Yao H, Zhou X, Liu H, Zhao J. Efficacy and safety of sofosbuvir plus daclatasvir in hemodialysis patients with genotype 1b or 2a hepatitis C virus infection: a single-arm, prospective real-world study. Frontiers in Medicine. 2025;12:1576654.
Li M, Chen J, Fang Z, Li Y, Lin Q. Sofosbuvir-based regimen is safe and effective for hepatitis C infected patients with stage 4–5 chronic kidney disease: a systematic review and meta-analysis. Virology journal. 2019;16(1):34.
Poustchi H, Majd Jabbari S, Merat S, Sharifi AH, Shayesteh AA, Shayesteh E, et al. The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment. Journal of Gastroenterology and Hepatology. 2020;35(9):1590-4.
Goel A, Bhadauria DS, Kaul A, Verma A, Tiwari P, Rungta S, et al. Acute hepatitis C treatment in advanced renal failure using 8 weeks of pan-genotypic daclatasvir and reduced-dose sofosbuvir. Nephrology Dialysis Transplantation. 2021;36(10):1867-71.
Refbacks
- There are currently no refbacks.
____________________________________________________________________________________________________________________________________________
Health Dynamics || Open Access Journal || Online version only || Publisher: Knowledge Dynamics || ISSN: 3006-5518 (online) || Contact: healthdynamics.journal@gmail.com; +8801814901991; +6282136364408