Login Register Cart 0
Generic placeholder image

Current Drug Safety

Editor-in-Chief

ISSN (Print): 1574-8863
ISSN (Online): 2212-3911

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Research Article

Ledipasvir/Sofosbuvir versus Daclatasvir/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype 4 Patients

Author(s): Lamiaa N. Abdelaty, Ahmed A. Elnaggar, Amira A. Said and Raghda R.S. Hussein*

Volume 15, Issue 1, 2020

Page: [53 - 60] Pages: 8

DOI: 10.2174/1574886314666191001151314

Abstract

Background: Chronic Hepatitis C (CHC) is a common progressive healthcare challenge that leads to liver cirrhosis, liver failure, and hepatocellular carcinoma. The optimum therapy was a combination of pegylated interferon and ribavirin, which was associated with moderate response and severe side effects. Sofosbuvir revolutionized CHC treatment, especially in combination with other antiviral agents.

Objective: The aim of this study was to compare and evaluate the safety and efficacy of sofosbuvir/ daclatasvir versus sofosbuvir/ledipasvir for the treatment of non-cirrhotic naïve patients with chronic Hepatitis C Virus (HCV) genotype 4 infection for 12 weeks.

Methods: One hundred CHC genotype 4 patients (70 females, 30 males) were recruited from the hepatology clinic at the Beni-Suef general hospital. Patients were randomly allocated into two groups that received a 12 weeks treatment of either sofosbuvir 400 mg/daclatasvir 60 mg or sofosbuvir 400 mg/ledipasvir 90 mg. The sustained virological response 12 weeks post-treatment (SVR12) (HCV RNA < Lower Limit of Quantification (LLOQ)) was determined to evaluate efficacy. The clinical laboratory tests and any reported adverse effects starting from the administration of the first dose till 30 days after the last dose were assessed to evaluate safety.

The main outcome measure was the assessment of the safety, efficacy and compliance of sofosbuvir/ daclatasvir versus sofosbuvir/ledipasvir for the treatment of non-cirrhotic naïve CHC genotype 4 patients for 12 weeks.

Results: SVR12 was achieved by 98% and 96% of patients receiving sofosbuvir plus ledipasvir and sofosbuvir plus daclatasvir, respectively. The most common adverse events reported were headache, and fatigue. No patients discontinued treatment due to adverse events.

Conclusion: The findings from this study suggest that the 12 weeks treatment regimens of sofosbuvir plus daclatasvir and sofosbuvir plus ledipasvir were both efficacious and well-tolerated in patients with HCV genotype 4 infection.

Impact on Practice: In this paper, we report on the most recent approaches in the treatment of Hepatitis C genotype 4 patients in Egypt. This is significant because this article focuses on comparing the efficacy and tolerability of the most commonly used antiviral drugs in Egypt.

Keywords: Hepatitis C, sustained virological response, polymerase chain reaction, adverse effects, ledipasvir/sofosbuvir, daclatasvir/sofosbuvir, lower limit of quantification.

« Previous Next »
Graphical Abstract

[1]
Keating GM, Vaidya A. Sofosbuvir: First global approval. Drugs 2014; 74(2): 273-82.
[http://dx.doi.org/10.1007/s40265-014-0179-7] [PMID: 24442794]
[2]
McCombs J, Matsuda T, Tonnu-Mihara I, et al. The risk of long-term morbidity and mortality in patients with chronic hepatitis C: Results from an analysis of data from a Department of Veterans Affairs Clinical Registry. JAMA Intern Med 2014; 174(2): 204-12.
[http://dx.doi.org/10.1001/jamainternmed.2013.12505] [PMID: 24193887]
[3]
Wantuck JM, Ahmed A, Nguyen MH. Review article: The epidemiology and therapy of chronic hepatitis C genotypes 4, 5 and 6. Aliment Pharmacol Ther 2014; 39(2): 137-47.
[http://dx.doi.org/10.1111/apt.12551] [PMID: 24251930]
[4]
Kamal SM, Nasser IA. Hepatitis C genotype 4: What we know and what we don’t yet know. Hepatology 2008; 47(4): 1371-83.
[http://dx.doi.org/10.1002/hep.22127] [PMID: 18240152]
[5]
Elwan N, Elfert A, Abd-Elsalam S, et al. Study of hepatic steatosis index in patients with chronic HCV infection. Int J Curr Microbiol Appl Sci 2016; 5(5): 266-74.
[http://dx.doi.org/10.20546/ijcmas.2016.505.029]
[6]
Abd-Elsalam S, Sharaf-Eldin M, Soliman S, Elfert A, Badawi R, Ahmad YK. 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): 51-6.
[http://dx.doi.org/10.1007/s00705-017-3573-0] [PMID: 28983675]
[7]
Frank C, Mohamed MK, Strickland GT, et al. The role of parenteral antischistosomal therapy in the spread of hepatitis C virus in Egypt. Lancet 2000; 355(9207): 887-91.
[http://dx.doi.org/10.1016/S0140-6736(99)06527-7] [PMID: 10752705]
[8]
Rao MR, Naficy AB, Darwish MA, et al. Further evidence for association of hepatitis C infection with parenteral schistosomiasis treatment in Egypt. BMC Infect Dis 2002; 2: 29.
[http://dx.doi.org/10.1186/1471-2334-2-29] [PMID: 12464161]
[9]
Khattab MA, Ferenci P, Hadziyannis SJ, et al. Management of hepatitis C virus genotype 4: Recommendations of an International expert panel. J Hepatol 2011; 54(6): 1250-62.
[http://dx.doi.org/10.1016/j.jhep.2010.11.016] [PMID: 21316497]
[10]
Abdel-Razek W, Waked I. Optimal therapy in genotype 4 chronic hepatitis C: Finally cured? Liver Int 2015; 35(1): 27-34.
[http://dx.doi.org/10.1111/liv.12724] [PMID: 25529085]
[11]
Stedman CA. Current prospects for interferon-free treatment of hepatitis C in 2012. J Gastroenterol Hepatol 2013; 28(1): 38-45.
[http://dx.doi.org/10.1111/jgh.12028] [PMID: 23137126]
[12]
Bacon BR, Gordon SC, Lawitz E, et al. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med 2011; 364(13): 1207-17.
[http://dx.doi.org/10.1056/NEJMoa1009482] [PMID: 21449784]
[13]
Poordad F, McCone J Jr, Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011; 364(13): 1195-206.
[http://dx.doi.org/10.1056/NEJMoa1010494] [PMID: 21449783]
[14]
Tanamly MD, Tadros F, Labeeb S, et al. Randomised double-blinded trial evaluating silymarin for chronic hepatitis C in an Egyptian village: Study description and 12-month results. Dig Liver Dis 2004; 36(11): 752-9.
[http://dx.doi.org/10.1016/j.dld.2004.06.015] [PMID: 15571006]
[15]
Elsharkawy A, Fouad R, El Akel W, et al. Sofosbuvir-based treatment regimens: Real life results of 14 409 chronic HCV genotype 4 patients in Egypt. Aliment Pharmacol Ther 2017; 45(5): 681-7.
[http://dx.doi.org/10.1111/apt.13923] [PMID: 28070899]
[16]
Kamal S. Hepatitis C Developing Countries. Academic Press 2018; pp. 209-46.
[17]
Pol S, Corouge M, Vallet-Pichard A. Daclatasvir-sofosbuvir combination therapy with or without ribavirin for hepatitis C virus infection: From the clinical trials to real life. Hepat Med 2016; 8: 21-6.
[http://dx.doi.org/10.2147/HMER.S62014] [PMID: 27019602]
[18]
Cha A, Budovich A. Sofosbuvir: A new oral once-daily agent for the treatment of hepatitis C virus infection. P&T 2014; 39(5): 345-52.
[PMID: 24883006]
[19]
Lawitz E, Poordad FF, Pang PS, et al. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): An open-label, randomised, phase 2 trial. Lancet 2014; 383(9916): 515-23.
[http://dx.doi.org/10.1016/S0140-6736(13)62121-2] [PMID: 24209977]
[20]
Afdhal N, Reddy KR, Nelson DR, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med 2014; 370(16): 1483-93.
[http://dx.doi.org/10.1056/NEJMoa1316366] [PMID: 24725238]
[21]
Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med 2014; 370(20): 1889-98.
[http://dx.doi.org/10.1056/NEJMoa1402454] [PMID: 24725239]
[22]
Sangiovanni A, Prati GM, Fasani P, et al. The natural history of compensated cirrhosis due to hepatitis C virus: A 17-year cohort study of 214 patients. Hepatology 2006; 43(6): 1303-10.
[http://dx.doi.org/10.1002/hep.21176] [PMID: 16729298]
[23]
Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med 2014; 370(3): 211-21.
[http://dx.doi.org/10.1056/NEJMoa1306218] [PMID: 24428467]
[24]
Omar H, El Akel W, Elbaz T, et al. Generic daclatasvir plus sofosbuvir, with or without ribavirin, in treatment of chronic hepatitis C: Real-world results from 18 378 patients in Egypt. Aliment Pharmacol Ther 2018; 47(3): 421-31.
[http://dx.doi.org/10.1111/apt.14428] [PMID: 29193226]
[25]
Ahmed OA, Safwat E, Khalifa MO, et al. Sofosbuvir plus daclatasvir in treatment of chronic hepatitis c genotype 4 infection in a cohort of Egyptian patients: An experiment the size of Egyptian village. Int J Hepatol 2018; 20189616234
[http://dx.doi.org/10.1155/2018/9616234] [PMID: 29755792]
[26]
Babatin MA, Alghamdi AS, Albenmousa A, et al. Efficacy and safety of simeprevir or daclatasvir in combination with sofosbuvir for the treatment of hepatitis C genotype 4 infection. J Clin Gastroenterol 2018; 52(5): 452-7.
[http://dx.doi.org/10.1097/MCG.0000000000000896] [PMID: 28767462]
[27]
Fontaine H, Hezode C, Zoulim F, et al. LP28: Efficacy of the oral sofosbuvir-based combinations in HCV genotype 4-mono-infected patients from the French observational cohort anrs CO22 hepather. J Hepatol 2015; 62: S278.
[http://dx.doi.org/10.1016/S0168-8278(15)30182-3]
[28]
Mehta R, Kabrawala M, Nandwani S, et al. Safety and efficacy of sofosbuvir and daclatasvir for hepatitis C virus infection in patients with β-Thalassemia major. J Clin Exp Hepatol 2018; 8(1): 3-6.
[http://dx.doi.org/10.1016/j.jceh.2017.06.002] [PMID: 29743790]
[29]
Kohli A, Kapoor R, Sims Z, et al. Ledipasvir and sofosbuvir for hepatitis C genotype 4: A proof-of-concept, single-centre, open-label phase 2a cohort study. Lancet Infect Dis 2015; 15(9): 1049-54.
[http://dx.doi.org/10.1016/S1473-3099(15)00157-7] [PMID: 26187031]
[30]
Ahmed OA, Kaisar HH, Badawi R, et al. 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: 295-8.
[http://dx.doi.org/10.2147/IDR.S153060] [PMID: 29535545]
[31]
Davis GL, Lau JY. Factors predictive of a beneficial response to therapy of hepatitis C. Hepatology 1997; 26(3)(Suppl. 1): 122S-7S.
[http://dx.doi.org/10.1002/hep.510260721] [PMID: 9305676]
[32]
Wyles D, Pockros P, Morelli G, et al. Ledipasvir-sofosbuvir plus ribavirin for patients with genotype 1 hepatitis C virus previously treated in clinical trials of sofosbuvir regimens. Hepatology 2015; 61(6): 1793-7.
[http://dx.doi.org/10.1002/hep.27814] [PMID: 25846014]
[33]
Al Zaabi A, A, Hassan N, Strauch C, Al Zaabi M, Shahwan M. Safety and economic evaluation of patients treated for hepatitis with antiviral daclatasvir and sofosbuvir combined vs. ledipasvir/ sofosbuvir 90mg/400mg in a medical institution in the U.A.E. J Pharm Sci Res 2017; 10(3): 501-5.
[34]
Joharji H, Al-Jedai A, Alkortas D, et al. Efficacy of generic sofosbuvir and branded daclatasvir compared to sofosbuvir and ledipasvir combination in the treatment of genotype 4 hepatitis C Virus. Am J Transplant 2017; 17(Suppl. 3): 970-1.

Rights & Permissions Print Cite
Article Metrics
9
2
© 2024 Bentham Science Publishers | Privacy Policy