Use of sofosbuvir based regimen in patients with end-stage renal disease and chronic hepatitis C; an open label, non-randomized, single arm, single center study from Pakistan
Gastroenterology and Hepatology from Bed to Bench,
9 March 2020
Aim: we aimed to determine the virological response and safety of Sofosbuvir-based direct-acting antiviral agents (DAAs) in chronic hepatitis C (CHC) patients on long-term hemodialysis (HD).
Background: With the advent of interferon-free DAAs, the treatment of CHC has been revolutionized. Pakistan is among the countries where novel sofosbuvir (SOF)-free antiviral agents are not available.
Methods: This non-randomized, single-arm, open-label study enrolled all HD patients with chronic HCV infection after informed consent. They were treated with SOF in combination with Ribavirin (RBV) with either interferon (IFN group) or daclatasvir (DAC group), with the virological response assessed according to standard guidelines. Data were analyzed using SPSS version 20.00.
Results: Out of 133 patients, the majority (72.9%) were males with the mean age of 31.92 ± 9.88 years. Most patients (50.3%) had HCV genotype (GN) 1, followed by GN 3 in 42.9%, 4 in 1.48% and 2 in 0.7%, while mix GN was documented in 6 (4.4%) patients. Among these, 60 (45.1 %) patients received standard SOF, IFN, and RBV (IFN group) and 73 (54.9 %) received SOF, DAC and RBV (DAC group). End of treatment and sustained virological response at 12 weeks post-treatment were achieved in 133 (100%) and 129 (97 %) patients, respectively. The adverse effects were anemia in 58 (43.6 %) patients and elevated alanine transaminases in 11 (8.1%) patients.
Conclusion: SOF in combination with either IFN or DAC is an equally efficacious and effective treatment regimen for patients on maintenance HD, especially in resource-poor countries.
Keywords: End-stage renal disease, hemodialysis, Hepatitis C virus, Interferon, Sofosbuvir, Sustained virological response.
(Please cite as: Mandhwani R, Hanif FM, Lail GH, Luck NH, Khalid MA, Muh ul Haque MM, et al. Use of Sofosbuvir based regimen in patients with end-stage renal disease and chronic hepatitis C; an open label, non-randomized, single arm, single center study from Pakistan. Gastroenterol Hepatol Bed Bench 2020;13(2):141-146).
- End stage renal disease
- hepatitis C virus
- anti-viral treatment response
- sustained virological response
Azmi AN, Tan SS, Mohamed R. Hepatitis C and kidney disease: an overview and approach to management. World J Hepatol 2015;7:78-92.
Agarwal SK, Bagchi S, Yadav RK. Hemodialysis Patients Treated for Hepatitis C Using a Sofosbuvir-based Regimen. Kidney Int Rep 2017;2:831-5.
Mahmud HM, Siddiqui M, Bashir B, Ali SF, Baloch AA, Masroor M. Hemodialysis patients profile at Dow University of Health Sciences, Karachi. Pakistan. Pak J Med Sci 2014;30:1327-30.
Siddiqui AR, Abbas Z, Luck NH, Hassan SM, Aziz T, Mubarak M, et al. Experience of fibrosing cholestatic hepatitis with hepatitis C virus in kidney transplant recipients. Transplant Proc 2012;44:721-4.
Hepatitis C guidance: AASLD-IDSA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org/full-report/hcv-testing-and-linkage-care. (accessed August 6th 2018).
Stamm LM, Brainard DM, Mchutchison JG. Sofosbuvir/velpatasvir for patients with chronic genotype 3 HCV infection with compensated cirrhosis: Response to EASL Recommendations on Treatment of Hepatitis C 2018. J Hepatol 2018;69:461-511.
Siddiqui AR, Abbas Z, Luck NH, Hassan SM, Aziz T, Mubarak M, et al. Effectiveness of sofosbuvir and ribavirin for eradicating hepatitis C virus in renal transplant recipients in Pakistan: where resources are scarce. Exp Clin Transplant 2017;15:63-7.
Li T, Qu Y, Guo Y, Wang Y, Wang L. Efficacy and safety of direct-acting antivirals-based antiviral therapies for hepatitis C virus patients with stage 4-5 chronic kidney disease: a meta-analysis. Liver Int 2017;37:974-81.
Aggarwal A, Yoo ER, Perumpail RB, Cholankeril G, Kumari R, Daugherty TJ, et al. Sofosbuvir Use in the Setting of End-stage Renal Disease: A Single Center Experience. J Clin Transl Hepatol 2017;5:23-26.
Saxena V, Koraishy FM, Sise ME, Lim JK, Schmidt M, Chung RT, et al. Safety and efficacy of sofosbuvir-containing regimens in hepatitis C-infected patients with impaired renal function. Liver Int 2016;36:807-16.
Farooqi JI, Alam A, Abbas Z, Naqvi AB, Zuberi BF, Nawaz AA. Hep-net opinion about the management of patients with chronic hepatitis C in Pakistan in the era of available DAA. J Postgrad Med Inst 2016;30:6-14.
Sułowicz W, Radziszewski A, Chowaniec E. Hepatitis C virus infection in dialysis patients. HemodialInt 2007;11:286-95.
Aguirre valadez J, Garcíajuárez I, Rincónpedrero R, Torre A. Management of chronic hepatitis C virus infection in patients with end-stage renal disease: a review. Ther Clin Risk Manag 2015;11:329-38.
Rahnavardi M, Hosseini moghaddam SM, Alavian SM. Hepatitis C in hemodialysis patients: current global magnitude, natural history, diagnostic difficulties, and preventive measures. Am J Nephrol 2008;28:628-40.
Berenguer M. Treatment of chronic hepatitis C in hemodialysis patients. Hepatology 2008;48:1690-9.
Fabrizi F, Martin P, Dixit V, Bunnapradist S, Dulai G. Meta-analysis: effect of hepatitis C virus infection on mortality in dialysis. Aliment Pharmacol Ther 2004;20:1271-7.
Nakayama E, Akiba T, Marumo F, Sato C. Prognosis of anti-hepatitis C virus antibody-positive patients on regular hemodialysis therapy. J Am SocNephrol 2000;11:1896-902.
Fabrizi F, Messa P. Therapy of hepatitis C by direct-acting anti-virals: the end of HCV in dialysis population?. Expert Rev Clin Pharmacol 2015;8:785-93.
Messina JP, Humphreys I, Flaxman A, Brown A, Cooke GS, Pybus OG, et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology 2015;61:77-87.
Gane EJ, Robson RA, Bonacini M, et al. Anti-viral Efficacy and Pharmacokinetics (pk) of Sofosbuvir (sof) in Patients with Severe Renal Impairment.Available at: http://www.natap.org/2014/AASLD/AASLD_85.htm. Accessed January 5, 2019
Bhamidimarri KR, Kalyan ram B, Czul F, Levy C, Hernandez M, Jeffers L, et al. Safety, efficacy and tolerability of half-dose sofosbuvir plus simeprevir in treatment of Hepatitis C in patients with end stage renal disease. J Hepatol 2015;63:763-5.
Desnoyer A, Pospai D, Lê MP, Gervais A, Heurgué-Berlot A, Laradi A, et al. Pharmacokinetics, safety and efficacy of a full dose sofosbuvir-based regimen given daily in hemodialysis patients with chronic hepatitis C. J Hepatol 2016;65:40-7.
Prabhu RA, Nair S, Pai G, Reddy NP, Suvarna D. Interventions for dialysis patients with hepatitis C virus (HCV) infection. Cochrane Database Syst Rev 2015;:CD007003.
- Abstract Viewed: 137 times
- PDF Downloaded: 41 times