Jsmc-10338

HARVONI VERSUS 3D REGIMENS OUTCOMES AMONG HCV INFECTED PATIENTS VISITED KURDISTAN CENTRE FOR GASTROENTEROLOGY AND HEPATOLOGY (KCGH)

Mohammed Omer Lak a, Mohammed Omer Mohammed b, Muhsin A. Mohammed a, and Ali Jabbar Ahmad a

a Kurdistan Board candidate, Kurdistan Center for Gastroenterology, Kurdistan Region, Iraq.

b College of Medicine, University of Sulaimani, Kurdistan Region, Iraq.

Submitted: 15/6/2021; Accepted: 28/2/2022; Published: 21/3/2022

DOI Link: https://doi.org/10.17656/jsmc.10338

ABSTRACT

Background

Approximately 3% of the world’s population is infected by the Hepatitis C virus (HCV), and more than 2/3rd of patients have chronic hepatitis. The recent revolutions in HCV treatment have led the World Health Organization to target its elimination as a public health threat by 2030.

Objectives

To evaluate and compare the efficacy of two therapeutic regimens in HCV management.

Patients and Methods

This is a comparative prospective clinical study was conducted on 88 patients with HCV at Kurdistan Center for gastroenterology and hepatology (KCGH) in a teaching hospital in the Sulaimaniah City-Kurdistan region of Iraq from January 2020 to December 2020.

The patients were divided into two groups; one group received Harvoni (sofosbuvir/ledipasvir), and the other group was given three-drug regimens (Exviera plus Viekrax (ombitasvir/paritaprevir/ritonavir plus dasabuvir) for 12 weeks. The collected data before and after treatment were analyzed through Statistical Package for the Social Sciences (SPSS version 26.0).

Results

The patients’ mean age was found to be 38.6 years. Males were accounted for a more significant number of the patients (55.7%). The two groups were not significantly different in terms of age, gender, nationality, occupation, BMI, DM, and risk factors (P-value>0.05). But a significant difference was seen between them in terms of their initial glomerular filtration rate (p-value=0.003). In addition, the patients’ gender, age, and HCV genotype were not significantly correlated with their sustain virology response (SVR). Also, a significant difference was observed between the two groups in terms of SVR after three months of treatment, such that more patients who received Harvoni achieved SVR. Moreover, there was a significant relationship between the initial fibrosis stage and the patients’ SVR to the treatment (p-value=0.01).

Conclusion

Compared to the 3 D regimens (Exviera plus Viekrax), Harvoni was more effective for treating patients with chronic HCV.

KEYWORDS

HCV, Harvoni, Three-drug regimen, KCGH.

References

1. Stanaway JD, Flaxman AD, Naghavi M, Fitzmaurice C, Vos T, Abubakar I, Abu-Raddad LJ, et al. The global burden of viral hepatitis from 1990 to 2013: findings from the Global Burden of Disease Study 2013. The Lancet. 2016 Sep 10;388(10049):1081-8.

2. Global progress report on HIV, viral hepatitis, and sexually transmitted infections, 2021. Accountability for the global health sector strategies 2016–2021: actions for impact. Geneva: World Health Organization; 2021. Licence: CC BY-NC-SA 3.0 IGO.

3. Thomas DL, Astemborski J, Rai RM, Frank A. Anania, MD; Melody Schaeffer, BSN; Noya Galai et al. The natural history of hepatitis C virus infection: host, viral, and environmental factors. JAMA 2000;284:450–6 10.1001/jama.284.4.450. https://doi.org/10.1001/ Jama.284.4.450

4. Simmonds P, Alberti A, Alter HJ, Bonino F, Bradley DW, Brechot C, et al. A proposed system for the nomenclature of hepatitis C viral genotypes. HEPATOLOGY 1994;19:1321-1324. Volume19, Issue5 May 1994 Pages 1321-1324.

5. Mohd Hanafiah K, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. HEPATOLOGY 2013;57:1333-1342. Volume 30, Issue 12, Mar 9 2012, Pages 2212-2219

6. Asselah T, Marcellin P, Schinazi RF. Treatment of hepatitis C virus infection with direct-acting antiviral agents: 100% cure? Liver Int. 2018;38 Suppl 1:7-13.

7. Ghany MG, Morgan TR, AASLD-IDSA hepatitis C guidance panel. Hepatitis C guidance 2019 update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America recommends testing, managing, and treating hepatitis C virus infection. Hepatology. 2020 Feb;71(2):686-721.

8. Sarrazin C, Isakov V, Svarovskaia ES, Hedskog C, Martin R, Chodavarapu K, et al. Late relapse versus hepatitis C virus reinfection in patients with a sustained virologic response after sofosbuvir-based therapies. Clin Infect Dis 2017; 64:44–52. Volume 64, Issue 1, Jan 1 2017, Pages 44–52, https://doi.org/10.1093/cid/ciw676

9. Carrat F, Fontaine H, Dorival C, Simony M, Diallo A, Hezode C, et al. Clinical outcomes in patients with chronic hepatitis C after direct-acting antiviral treatment: a prospective cohort study. Lancet 2019; Volume 393, Issue 10179, 6–12 April 2019, Pages 1453-1464

10. McHutchison JG, Lawitz EJ, Shiffman ML, Muir AJ, Galler GW, McCone J, et al. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med 2009; 361: 580-593. DOI: 10.1056/NEJMoa0808010

11. Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, et al. Boceprevir for untreated chronic HCV genotype one infection. N Engl J Ned 2011;364:1195-1206. DOI: 10.1056/NEJMoa1010494

12. Hilgenfeldt EG, Schlachterman A and Firpi RJ. Hepatitis C: treatment of difficult to treat patients. World J Hepatol 2015; 7: 1953–1963. 2015 Jul 28. DOI: 10.4254/with.v7.i15.1953

13. Bulterys M, Hamid SS. Treatment of people diagnosed with chronic hepatitis C virus infection. Bulletin of the World Health Organization. 2018 Aug 1;96(8):515. 2018 Aug 1. doi: 10.2471/BLT.18.219295

14. Soeiro CA, Gonçalves CA, Marques MS, Méndez MJ, Tavares AP, Horta AM, et al. Glomerular filtration rate change during chronic hepatitis C treatment with Sofosbuvir/Ledipasvir in HCV/HIV Coinfected patients treated with Tenofovir and a boosted protease inhibitor: an observational prospective study. BMC Infectious Diseases. 2018 Dec;18(1):1-6.. https://doi.org/10.1186/s12879-018-3278-3.

15. Kareem BO, Salih GF. Hepatitis C Virus Genotyping In Sulaimani Governorate. European Scientific Journal. 2014 May 1;10(15).

16. Rahim BR, Hussain AH, Mohammed MO, Rashid KJ. Epidemiological and Clinical Characteristics of Hepatitis C Viral Infections in Tertiary Centres in Sulaimani City/Kurdistan Region of Iraq. Kurdistan Journal of Applied Research. 2017 Jul 30;2(2):29-35.

17. Rahim BR, Hussain AH, Mohammed MO, Rashid KJ. Epidemiological and Clinical Characteristics of Hepatitis C Viral Infections in Tertiary Centres in Sulaimani City/Kurdistan Region of Iraq. Kurdistan Journal of Applied Research. 2017 Jul 30;2(2):29-35.

18. Mahmud S, Akbarzadeh V, Abu-Raddad LJ. The epidemiology of hepatitis C virus in Iran: systematic review and meta-analyses. Scientific reports. 2018 Jan 9;8(1):1-25.

19. Sallam M, Batarseh R, Natsheh A, Abbadi J, Al-Fraihat E, Yaseen A, et al. An update on hepatitis C virus genotype distribution in Jordan: a 12-year retrospective study from a tertiary care teaching hospital in Amman. BMC infectious diseases. 2020 Dec;20(1):1-1.

20. Khudhair HA, Albakaa AA, Hussein KR. Detection the Prevalence of Hepatitis C Virus among Iraqi People. bioRxiv. 2020 Jan 1.

21. Saab S, Park SH, Mizokami M, Omata M, Mangia A, Eggleton E, Zhu Y, Knox SJ, Pang P, Subramanian M, Kowdley K. Safety and efficacy of ledipasvir/sofosbuvir for the treatment of genotype one hepatitis C in subjects aged 65 years or older. Hepatology. 2016 Apr;63(4):1112-9.

22. Simoes P, Asaad A, Abed J, Engelson ES, Kotler DP. Effect of Gender on the Response to Hepatitis C Treatment in an Inner-City Population. Women's Health Issues. 2015 May-Jun;25(3):289-93. DOI: 10.1016/j.whi.2015.02.008. PMID: 25965157.

23. Su F, Green P.K, Berry K, Ioannou G.N. The association between race/ethnicity and the effectiveness of direct antiviral agents for hepatitis C virus infection. Hepatology (Baltimore, Md.). 2017; 65(2), 426–438. DOI: 10.1002/hep.28901.

24. Ledipasvir/Sofosbuvir (Harvoni): For the Treatment of Chronic Hepatitis C Virus (CHC) G1 Infection in Adults [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2015 Jul. EXECUTIVE SUMMARY. Available from: https://www.ncbi.nlm.nih.gov/books/NBK362652/

25. Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, et al. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir ± dasabuvir ± ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: J Viral Hepat. 2019 Jun;26(6):685-696. DOI: 10.1111/jvh.13080. Epub 2019 Mar 5. PMID: 30739368; PMCID: PMC6849558.

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