The Safety of Direct-Acting Antiviral Treatment for Hepatitis C Virus in Egyptian Patients With Ischemic Heart Disease and Mildly Impaired Systolic Function

Document Type : Original Article

Authors

1 Department of Cardiology, Tanta University, Tanta, Egypt.

2 Department of Tropical Medicine, Tanta University, Tanta, Egypt.

Abstract

Background: Hepatitis C virus (HCV) infection is considered a public health problem in Egypt. The use of direct-acting antivirals (DAAs) in patients infected with HCV has been shown to be effective. The cardiac safety of these antivirals remains uncertain, however. This study aimed to assess the safety of the use of DAAs in patients suffering from ischemic heart disease (IHD) with mildly impaired systolic function.
Method: This prospective cohort study was performed on 200 patients with chronic HCV infection scheduled for DAA use. The patients were divided into 2 groups: Group I comprised 96 patients with IHD and mildly impaired systolic function and Group II comprised 104 patients without IHD and with normal left ventricular ejection fractions. Both groups received sofosbuvir (400 mg) and daclatasvir (60 mg) daily for 12 weeks. Electrocardiography and echocardiography were performed prior to the start, during, and after 12 weeks of treatment.
Result: At the end of the treatment period, no changes were observed in the patients’ cardiac symptoms and signs. No significant changes were also detected in electrocardiographic parameters, including the QTc interval in Group I (P =0.60) or Group II (P =0.63). Moreover, no changes were recorded in both groups regarding left ventricular systolic and diastolic functions (ie, the dimension, the ejection fraction, the transmitral E/A ratio, the E/E’ ratio, and the deceleration time), the tricuspid annular plane systolic excursion, right ventricular systolic pressure, and the mean pulmonary artery pressure.
Conclusions: The use of DAAs to treat Egyptian patients infected with HCV was safe in those suffering from IHD with mildly impaired systolic function. The treatment with DAAs exerted no effects on the QTc interval and the function of the left and right ventricles. (Iranian Heart Journal 2021; 22(3): 13-22)

Keywords

References

  1. Messina JP, Humphreys I, Flaxman A, et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology. 2015; 61(1):77-87. doi:10.1002/hep.27259
  2. Sanchez MJ, Bergasa NV. Hepatitis C associated cardiomyopathy: potential pathogenic mechanisms and clinical implications. Med Sci Monit. 2008 May; 14(5):RA55-63. PMID: 18443562.
  3. Zardi EM, Abbate A, Zardi DM, Dobrina A, Margiotta D, Van Tassell BW, Afeltra A, Sanyal AJ. Cirrhotic cardiomyopathy. J Am Coll Cardiol. 2010 Aug 10; 56(7):539-49. doi: 10.1016/j.jacc.2009.12.075. Erratum in: J Am Coll Cardiol. 2010 Sep 14; 56(12):1000. Van Tassel, Benjamin W [corrected to Van Tassell, Benjamin W]. PMID: 20688208.
  4. Keating GM. Sofosbuvir: a review of its use in patients with chronic hepatitis C. Drugs. 2014 Jul; 74(10):1127-46. doi:10.1007/s40265-014-0247-z. PMID:24958336.
  5. Petta S, Maida M, Macaluso FS, Barbara M, Licata A, Craxì A, Cammà C. Hepatitis C Virus Infection Is Associated With Increased Cardiovascular Mortality: A Meta-Analysis of Observational Studies. Gastroenterology. 2016 Jan; 150(1):145-155.e4; quiz e15-6. doi: 10.1053/j.gastro.2015.09.007. Epub 2015 Sep 18. PMID: 26386298.
  6. Sherman RE, Li J, Shapley S et al (2013) Expediting drug development—the FDA’s new“breakthrough therapy” designation. N Engl J Med 369:1877–1880.
  7. Fontaine H, Lazarus A, Pol S, Pecriaux C, Bagate F, Sultanik P, Boueyre E, Corouge M, Mallet V, Vallet-Pichard A, Sogni P, Duboc D; Cochin Hepatology and Cardiology Group. Bradyarrhythmias Associated with Sofosbuvir Treatment. N Engl J Med. 2015 Nov 5; 373(19):1886-8. doi: 10.1056/NEJMc1505967. PMID: 26535533.
  8. Lashen SA, Sanhoury MI. Syncope following sofosbuvir therapy for chronic hepatitis c: a report of two cases. J Liver Res Disord Ther. 2016; 2(4):102-103. DOI: 10.15406/jlrdt.2016.02.00032
  9. Doss W, Esmat G, El-Serafy M et al (2016) Real-life results of sofosbuvir based therapy for egyptian patients with hepatitis C and advanced fibrosiscirrhosis. J Hepatol 64:S772
  10.  El Raziky M, Gamil M, Ashour MK, Sameea EA, Doss W, Hamada Y, Van Dooren G, DeMasi R, Keim S, Lonjon-Domanec I, Hammad R, Hashim MS, Hassany M, Waked I. Simeprevir plus sofosbuvir for eight or 12 weeks in treatment-naïve and treatment-experienced hepatitis C virus genotype 4 patients with or without cirrhosis. J Viral Hepat. 2017 Feb; 24(2):102-110. doi: 10.1111/jvh.12625. Epub 2016 Oct 27. PMID: 27790789.
  11. Pugh RN, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Br J Surg. 1973 Aug; 60(8):646-9. doi:10.1002/bjs.1800600817. PMID:4541913.
  12. Mosteller RD. Simplified calculation of body-surface area. N Engl J Med. 1987 Oct 22;317(17):1098. doi:10.1056/NEJM198710223171717. PMID: 3657876.
  13. Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L et al (2015) Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr 28(1): 1–39.e14. https://doi.org/10.1016/j.echo.2014.10.003.
  14. Rudski LG, Lai WW, Afilalo J et al (2010) Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography. J Am Soc Echocardiogr 23:685–713.
  15. FDA hepatitis update—important safety information. (2015): Harvoni and Sovaldi. USFDA /bulletins, f97c71.
  16. Domont F, Cacoub P. Chronic hepatitis C virus infection, a new cardiovascular risk factor? Liver Int. 2016; 36(5): 621–627. DOI: https://doi.org/10.1111/liv.13064)
  17. Biomy R, Abdelshafy M, Abdelmonem A, Abu-Elenin H, Ghaly G. Effect of Chronic Hepatitis C Virus Treatment by Combination Therapy on Cardiovascular System. Clin Med Insights Cardiol. 2017; 11:1179546817713204. Published 2017 Jun 22. doi:10.1177/1179546817713204
  18. Durante-Mangoni E, Parrella A, Vitrone M et al (2017) Electrophysiological adverse effects of direct acting antivirals in patients with chronic hepatitis C. J Clin Pharmacol 57:924–930).
  19. Ahmad T, Yin P, Saffitz J, Pockros P, Lalezari J, Shiffman M, Freilich B, Zamparo J, Brown K, Dimitrova D, Kumar M, Manion D, Chiozzi M, Wolf R, Hughes E, Muir A and Hernandez1 A. (2015): Cardiac Dysfunction Associated With a Nucleotide Polymerase Inhibitor for Treatment of Hepatitis C. Hepatology, 62(2):409-16. 
  20. Renard S, Borentain P, Salaun E, Benhaourech S, Maille B, Darque A, Bregigeon S, Colson P, Laugier D, Gaubert, R and Habib G. (2015):  Severe Pulmonary Arterial Hypertension in Patients Treated for Hepatitis C with Sofosbuvir. Chest, 149(3): 6973.
  21. Novo G, Macaione F, Giannitrapani L, Minissale MG, Bonomo V, Indovina F, Petta S, Soresi M, Montalto G, Novo S, Craxi A, Licata A. Subclinical cardiovascular damage in patients with HCV cirrhosis before and after treatment with direct antiviral agents: a prospective study. Aliment Pharmacol Ther. 2018 Oct; 48(7):740-749. doi:10.1111/apt.14934. Epub 2018 Aug 10. PMID: 30095177.
Iranian Heart Journal
Volume 22, Issue 3
July 2021
Pages 13-22

Files

Share

How to cite

Statistics