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Endocrine, Metabolic & Immune Disorders - Drug Targets

Editor-in-Chief

ISSN (Print): 1871-5303
ISSN (Online): 2212-3873

Research Article

Sofosbuvir/Ledipasvir for Treatment of Chronic Hepatitis C Infection in Adult Patients with β- Thalassemia Major: A Real-Life Study

Author(s): Tamer A. Elbedewy, Sherief Abd-Elsalam*, Sahar Mohamed Mostafa, Raghda Samir Abdellatif, Amina Fouad, Mona Youssef, Yousry Esam-Eldin Abo-Amer and Mohamed A. Elsebaey

Volume 22, Issue 3, 2022

Published on: 02 February, 2021

Page: [290 - 296] Pages: 7

DOI: 10.2174/1871530321666210202150538

Price: $65

Abstract

Background & Aims: Patients with thalassemia have a lifelong need for blood transfusion, which makes them more risky to hepatitis C virus (HCV). Iron overload and chronic HCV are considered risk factors for patients with thalassemia to develop liver insults. The aim of the present study is to investigate the safety and efficacy of sofosbuvir/ledipasvir in the treatment of chronic HCV infection in Egyptian adult patients with β- thalassemia major.

Methods: A retrospective study included 53 patients with β-thalassemia major with chronic HCV treated with sofosbuvir (400 mg) and ledipasvir (90 mg) as a single pill fixed-dose combination once daily for 12 weeks. The effectiveness of the treatment was assessed by the sustained virologic response (SVR) at 12 weeks after the end of the treatment.

Results: SVR was achieved in 96.23% of patients. 47.17% of patients had minor side effects. There was a significant reduction in ALT, AST, and serum ferritin 12 weeks post-therapy. There was an insignificant change in hemoglobin level or blood transfusion requirement 12 weeks posttherapy. There was no change in iron chelators doses throughout the study period.

Conclusion: Sofosbuvir/ledipasvir regimen seems to be safe and highly effective in the treatment of chronic HCV in patients with β-thalassemia major.

Keywords: β- Thalassemia major, HCV, sofosbuvir/ledipasvir, cirrhosis, chronic liver disease, blood diseases.

Graphical Abstract

[1]
Higgs, D.R.; Engel, J.D.; Stamatoyannopoulos, G. Thalassaemia. Lancet, 2012, 379(9813), 373-383.
[http://dx.doi.org/10.1016/S0140-6736(11)60283-3] [PMID: 21908035]
[2]
Al-Naamani, K.; Al-Zakwani, I.; Al-Sinani, S.; Wasim, F.; Daar, S. Prevalence of hepatitis C among multi-transfused thalassaemic patients in Oman: Single centre experience. Sultan Qaboos Univ. Med. J., 2015, 15(1), e46-e51.
[PMID: 25685385]
[3]
Di Marco, V.; Capra, M.; Gagliardotto, F.; Borsellino, Z.; Cabibi, D.; Barbaria, F.; Ferraro, D.; Cuccia, L.; Ruffo, G.B.; Bronte, F.; Di Stefano, R.; Almasio, P.L.; Craxì, A. Liver disease in chelated transfusion-dependent thalassemics: the role of iron overload and chronic hepatitis C. Haematologica, 2008, 93(8), 1243-1246.
[http://dx.doi.org/10.3324/haematol.12554] [PMID: 18556410]
[4]
Hodroj, M.H.; Bou-Fakhredin, R.; Nour-Eldine, W.; Noureldine, H.A.; Noureldine, M.H.A.; Taher, A.T. Thalassemia and malignancy: An emerging concern? Blood Rev., 2019, 37, 100585.
[http://dx.doi.org/10.1016/j.blre.2019.06.002] [PMID: 31253373]
[5]
Alavian, S.M.; Tabatabaei, S.V. Treatment outcome of chronic hepatitis C in sickle cell disease and thalassemic patients with interferon and ribavirin. Eur. J. Gastroenterol. Hepatol., 2010, 22(1), 123-124.
[http://dx.doi.org/10.1097/MEG.0b013e32832e0a66] [PMID: 19959942]
[6]
Burt, M.J.; Cooksley, W.G. The influence of iron on chronic hepatitis C. J. Gastroenterol. Hepatol., 1998, 13(3), 330-333.
[http://dx.doi.org/10.1111/j.1440-1746.1998.01549.x] [PMID: 9570251]
[7]
Van Thiel, D.H.; Friedlander, L.; Fagiuoli, S.; Wright, H.I.; Irish, W.; Gavaler, J.S. Response to interferon α therapy is influenced by the iron content of the liver. J. Hepatol., 1994, 20(3), 410-415.
[http://dx.doi.org/10.1016/S0168-8278(94)80017-0] [PMID: 8014455]
[8]
Ahmed, O.A.; Kaisar, H.H.; Hawash, N.; Samir, H.; Shabana, S.S.T.; Hassan A Fouad, M.; Rizk, F.; Abd-Elsalam, S. Efficacy of sofosbuvir plus ribavirin with or without peginterferon-alfa in treatment of a cohort of Egyptian patients with hepatitis C virus infection. Infect. Disord. Drug Targets, 2017, 17(2), 95-100.
[http://dx.doi.org/10.2174/1871526517666170417143216] [PMID: 28413993]
[9]
Abd-Elsalam, S.; Sharaf-Eldin, M.; Soliman, S.; Elfert, A.; Badawi, R.; Ahmad, Y.K. Efficacy and safety of sofosbuvir plus ribavirin for treatment of cirrhotic patients with genotype 4 hepatitis C virus in real-life clinical practice. Arch. Virol., 2018, 163(1), 51-56.
[http://dx.doi.org/10.1007/s00705-017-3573-0] [PMID: 28983675]
[10]
Ahmed, O.A.; Kaisar, H.H.; Badawi, R.; Hawash, N.; Samir, H.; Shabana, S.S.; Fouad, M.H.A.; Rizk, F.H.; Khodeir, S.A.; Abd-Elsalam, S. Efficacy and safety of sofosbuvir-ledipasvir for treatment of a cohort of Egyptian patients with chronic hepatitis C genotype 4 infection. Infect. Drug Resist., 2018, 11, 295-298.
[http://dx.doi.org/10.2147/IDR.S153060] [PMID: 29535545]
[11]
Ahmed, O.A.; Elsebaey, M.A.; Fouad, M.H.A.; Elashry, H.; Elshafie, A.I.; Elhadidy, A.A.; Esheba, N.E.; Elnaggar, M.H.; Soliman, S.; Abd-Elsalam, S. Outcomes and predictors of treatment response with sofosbuvir plus daclatasvir with or without ribavirin in Egyptian patients with genotype 4 hepatitis C virus infection. Infect. Drug Resist., 2018, 11, 441-445.
[http://dx.doi.org/10.2147/IDR.S160593] [PMID: 29628768]
[12]
Abdelmoemen, G.; Khodeir, S.A.; Abou-Saif, S.; Kobtan, A.; Abd-Elsalam, S. Prevalence of occult hepatitis C virus among hemodialysis patients in Tanta university hospitals: a single-center study. Environ. Sci. Pollut. Res. Int., 2018, 25(6), 5459-5464.
[http://dx.doi.org/10.1007/s11356-017-0897-y] [PMID: 29214477]
[13]
Said, E.M.; Abdulaziz, B.A.; El Kassas, M.; El Attar, I.H.; Emadeldeen, M.; Abd-Elsalam, S.M. High success rates for the use of sofosbuvir/ombitasvir/paritaprevir/ritonavir + ribavirin and sofosbuvir/simeprevir/daclatasvir + ribavirin in retreatment of chronic hepatitis C infection after unsuccessful sofosbuvir/daclatasvir therapy: a real-life experience. Arch. Virol., 2020, 165(7), 1633-1639.
[http://dx.doi.org/10.1007/s00705-020-04639-x] [PMID: 32356185]
[14]
Soliman, H.; Ziada, D.; Salama, M.; Hamisa, M.; Badawi, R.; Hawash, N.; Selim, A.; Abd-Elsalam, S. Predictors for fibrosis regression in chronic HCV patients after the treatment with DAAS: Results of a Real-world Cohort Study. Endocr. Metab. Immune Disord. Drug Targets, 2020, 20(1), 104-111.
[http://dx.doi.org/10.2174/1871530319666190826150344] [PMID: 31448717]
[15]
Mohamed, A.A.; El-Toukhy, N.E.R.; Said, E.M.; Gabal, H.M.R.; AbdelAziz, H.; Doss, W.; El-Hanafi, H.; El Deeb, H.H.; Mahmoud, S.; Elkadeem, M.; Shalby, H.S.; Abd-Elsalam, S. Hepatitis C Virus: Efficacy of New DAAs Regimens. Infect. Disord. Drug Targets, 2020, 20(2), 143-149.
[http://dx.doi.org/10.2174/1871526519666190121114003] [PMID: 30663575]
[16]
Inati, A.; Taher, A.; Ghorra, S.; Koussa, S.; Taha, M.; Aoun, E.; Sharara, A.I. Efficacy and tolerability of peginterferon alpha-2a with or without ribavirin in thalassaemia major patients with chronic hepatitis C virus infection. Br. J. Haematol., 2005, 130(4), 644-646.
[http://dx.doi.org/10.1111/j.1365-2141.2005.05645.x] [PMID: 16098081]
[17]
Sinakos, E.; Kountouras, D.; Koskinas, J.; Zachou, K.; Karatapanis, S.; Triantos, C.; Vassiliadis, T.; Goulis, I.; Kourakli, A.; Vlachaki, E.; Toli, B.; Tampaki, M.; Arvaniti, P.; Tsiaoussis, G.; Bellou, A.; Kattamis, A.; Maragkos, K.; Petropoulou, F.; Dalekos, G.N.; Akriviadis, E.; Papatheodoridis, G.V. Treatment of chronic hepatitis C with direct-acting antivirals in patients with β-thalassaemia major and advanced liver disease. Br. J. Haematol., 2017, 178(1), 130-136.
[http://dx.doi.org/10.1111/bjh.14640] [PMID: 28439915]
[18]
Nagral, A.; Jhaveri, A.; Sawant, S.; Parikh, N.S.; Nagral, N.; Merchant, R.; Gandhi, M. Treatment of chronic hepatitis C infection with direct acting antivirals in adolescents with thalassemia major. Indian J. Pediatr., 2019, 86(2), 148-153.
[http://dx.doi.org/10.1007/s12098-018-2752-7] [PMID: 30097845]
[19]
Ahsani, M.R.; Bafti, M.S.; Esmailizadeh, A.K.; Mohammadabadi, M.R. Genotyping of isolates of Clostridium perfringens from vaccinated and unvaccinated sheep. Small Rumin. Res., 2011, 95(1), 65-69.
[http://dx.doi.org/10.1016/j.smallrumres.2010.09.001]
[20]
Ahsani, M.R.; Mohammadabadi, M.R.; Shamsaddini, M.B. Clostridium perfringens isolate typing by multiplex PCR. J. Venom. Anim. Toxins Incl. Trop. Dis., 2010, 16(4), 573-578.
[http://dx.doi.org/10.1590/S1678-91992010000400006]
[21]
Mohammadabadi, M.R.; Soflaei, M.; Mostafavi, H.; Honarmand, M. Using PCR for early diagnosis of bovine leukemia virus infection in some native cattle. Genet. Mol. Res., 2011, 10(4), 2658-2663.
[http://dx.doi.org/10.4238/2011.October.27.2] [PMID: 22057961]
[22]
Mohammadabadi, M.R.; Shaikhaev, G.O.; Sulimova, G.E.; Rahman, O.; Mozafari, M.R. Detection of bovine leukemia virus proviral DNA in Yaroslavsl, Mongolian and black pied cattle by PCR. Cell. Mol. Biol. Lett., 2004, 9, 766-768.
[23]
Shahdadnejad, N.; Mohammadabadi, M.R.; Shamsadini, M. Typing of clostridium perfringens isolated from broiler chickens using multiplex PCR. Genetics in the third millennium, 2016, 14(4), 4368-4374.
[24]
Zandi, E.; Mohammadabadi, M.R.; Ezzatkhah, M.; Esmailizadeh, A.K. Typing of toxigenic isolates of clostridium perfringens by multiplex pcr in ostrich. Iran. J. Appl. Anim. Sci., 2014, 4, 509-514.
[25]
Thalassaemia International Federation. Viral hepatitis C in thalassaemia. 2014.http://www.ukts.org/pdfs/hepatitis/hcvpositionpaperfinal.pdf
[26]
Alavian, S.; Tabatabaei, S.; Lankarani, K. Epidemiology of HCV infection among thalassemia patients in eastern mediterranean countries: A quantitative review of literature. Iran. Red Crescent Med. J., 2010, 12(4), 365-376.
[27]
Mangia, A.; Sarli, R.; Gamberini, R.; Piga, A.; Cenderello, G.; Piazzolla, V.; Santoro, R.; Caruso, V.; Quarta, A.; Ganga, R.; Copetti, M.; Forni, G. Randomised clinical trial: sofosbuvir and ledipasvir in patients with transfusion-dependent thalassaemia and HCV genotype 1 or 4 infection. Aliment. Pharmacol. Ther., 2017, 46(4), 424-431.
[http://dx.doi.org/10.1111/apt.14197] [PMID: 28660640]
[28]
Sizmann, D.; Boeck, C.; Boelter, J.; Fischer, D.; Miethke, M.; Nicolaus, S.; Zadak, M.; Babiel, R. Fully automated quantification of hepatitis C virus (HCV) RNA in human plasma and human serum by the COBAS AmpliPrep/COBAS TaqMan system. J. Clin. Virol., 2007, 38(4), 326-333.
[http://dx.doi.org/10.1016/j.jcv.2006.12.021] [PMID: 17344093]
[29]
COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0. Product information 2013. 2017, http://molecular.roche.com/assays/Pages/COBASAmpliPrepCOBASTaqManHCVQuanTest_v2.aspx
[30]
Giardina, P.J.V.; Forget, B.G. Thalassemia syndromes. Hematology: basic principles and practice; Hoffman, R.; Benz, E.J.; Shattil, S.J.; Furie, B.; Silberstein, L.E.; McGlave, P.; Heslop, H., Eds.; Elsevier Churchill Livingstone: Philadelphia, 2008.
[31]
Bonder, A.; Afdhal, N. Utilization of FibroScan in clinical practice. Curr. Gastroenterol. Rep., 2014, 16(2), 372.
[http://dx.doi.org/10.1007/s11894-014-0372-6] [PMID: 24452634]
[32]
Thalassemia International Federation. Guidelines for the clinical management of thalassemia., (3rd ed. ), 2014.http://www.thalassemia.org.cy/publications/tif-publications/
[33]
AASLD/IDSA HCV Guidance Panel. Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology, 2015, 62(3), 932-954.
[http://dx.doi.org/10.1002/hep.27950] [PMID: 26111063]
[34]
Sidhu, M.; Meenia, R.; Yasmeen, I. Prevalence of transfusion-transmitted infections in multiple blood transfused thalassemia patients: a report from a tertiary care center in North India. Ann. Trop. Med. Public Health, 2015, 8(5), 202-205.
[http://dx.doi.org/10.4103/1755-6783.159849]
[35]
Murray, K.F. Treatment of chronic hepatitis C in children. Viral hepatitis in children: unique features and opportunities; Jonas, M.M., Ed.; Humana Press: New York, 2010, pp. 67-88.
[http://dx.doi.org/10.1007/978-1-60761-373-2_5]
[36]
Nagral, A.; Sawant, S.; Nagral, N.; Parikh, P.; Malde, P.; Merchant, R. Generic direct acting antivirals in treatment of chronic hepatitis C infection in patients of thalassemia major. J. Clin. Exp. Hepatol., 2017, 7(3), 172-178.
[http://dx.doi.org/10.1016/j.jceh.2017.08.002] [PMID: 28970702]
[37]
Origa, R.; Ponti, M.L.; Filosa, A.; Galeota Lanza, A.; Piga, A.; Saracco, G.M.; Pinto, V.; Picciotto, A.; Rigano, P.; Madonia, S.; Rosso, R.; D’Ascola, D.; Cappellini, M.D.; D’Ambrosio, R.; Tartaglione, I.; De Franceschi, L.; Gianesin, B.; Di Marco, V.; Forni, G.L. Italy for THAlassemia and hepatitis C Advance - Società Italiana Talassemie ed Emoglobinopatie (ITHACA-SITE). Treatment of hepatitis C virus infection with direct-acting antiviral drugs is safe and effective in patients with hemoglobinopathies. Am. J. Hematol., 2017, 92(12), 1349-1355.
[http://dx.doi.org/10.1002/ajh.24911] [PMID: 28929515]
[38]
Sharara, A.I.; Rustom, L.B.O.; Marrache, M. Sofosbuvir/velpatasvir for chronic hepatitis C infection in patients with transfusion dependent thalassemia. Am. J. Hematol., 2019, 94(2), E43-E45.
[39]
Abo-Amer, Y.E.; Badawi, R.; El-Abgeegy, M.; Elsergany, H.F.; Mohamed, A.A.; Mostafa, S.M.; Alegaily, H.S.; Soliman, S.; Elnawasany, S.; Abd-Elsalam, S. Quadruple Therapy Offers High SVR Rates in Patients with HCV Genotype 4 with Previous Treatment Failure. Adv. Virol., 2020, 2020, 9075905.
[http://dx.doi.org/10.1155/2020/9075905] [PMID: 32774374]
[40]
Elhendawy, M.; Abo-Ali, L.; Abd-Elsalam, S.; Hagras, M.M.; Kabbash, I.; Mansour, L.; Atia, S.; Esmat, G.; Abo-ElAzm, A.R.; El-Kalla, F.; Kobtan, A. HCV and HEV: two players in an Egyptian village, a study of prevalence, incidence, and co-infection. Environ. Sci. Pollut. Res. Int., 2020, 27(27), 33659-33667.
[http://dx.doi.org/10.1007/s11356-020-09591-6] [PMID: 32533486]
[41]
Zied, H.Y.; Abo Alnasr, N.M.; El-Bendary, A.S.; Abd-Elsalam, S.; Hagag, R.Y. Effect of treatment with direct antiviral agents (DAAs) on glycemic control in patients with type 2 diabetes mellitus & hepatitis C virus genotype 4. Diabetes Metab. Syndr., 2020, 14(4), 679-682.
[http://dx.doi.org/10.1016/j.dsx.2020.05.024] [PMID: 32438332]
[42]
Elbedewy, T.A.; Elashtokhy, H.E.A.; Abd-Elsalam, S.; Suliman, M.A. Hepatitis C Virus Infection and Treatment as Independent Prognostic Factors in Diffuse Large B-Cell Lymphoma Egyptian Patients. Curr. Cancer Drug Targets, 2020, 20(8), 638-645.
[http://dx.doi.org/10.2174/1568009620666200511084731] [PMID: 32392114]
[43]
Zamani, F.; Ajdarkosh, H.; Safarnezhad-Tameshkel, F.; Azarkeivan, A.; Keyvani, H.; Naserifar, F.; Vafaeimanesh, J. The effectiveness of sofosbuvir and daclatasvir in the treatment of hepatitis C in thalassaemia major patients and their effect on haematological factors. Indian J. Med. Microbiol., 2018, 36(2), 224-229.
[http://dx.doi.org/10.4103/ijmm.IJMM_18_90] [PMID: 30084415]
[44]
Hézode, C.; Colombo, M.; Bourlière, M.; Spengler, U.; Ben-Ari, Z.; Strasser, S.I.; Lee, W.M.; Morgan, L.; Qiu, J.; Hwang, P.; Robertson, M.; Nguyen, B.Y.; Barr, E.; Wahl, J.; Haber, B.; Chase, R.; Talwani, R.; Marco, V.D. C-EDGE IBLD Study Investigators. Elbasvir/grazoprevir for patients with hepatitis C virus infection and inherited blood disorders: A phase III study. Hepatology, 2017, 66(3), 736-745.
[http://dx.doi.org/10.1002/hep.29139] [PMID: 28256747]

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