Generic placeholder image

Infectious Disorders - Drug Targets

Author(s): Sherief Abd-Elsalam*, Rehab Badawi, Sally Elnawasany, Mohamed Yousef, Loai Mansour, Nehad Hawash, Reham A. Elkhouly, Shaimaa Soliman, Amal Selim, Abdelrahman Kobtan and Asem Elfert

DOI: 10.2174/1871526518666180912121835

DownloadDownload PDF Flyer Cite As
Sofosbuvir, Pegylated Interferon and Ribavirin in the Treatment of an Egyptian Cohort with Hepatitis C Virus Infection in Real-Life Clinical Practice

Page: [179 - 184] Pages: 6

  • * (Excluding Mailing and Handling)

Abstract

Background & Aims: Hepatitis C virus infection is a major public health problem in Egypt with a risk for morbidity and mortality due to chronic liver disease complications. Worldwide, Egypt has the highest prevalence of HCV infection with the overall prevalence of about 14.7%. The aim of this study was to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus Pegylated Interferon (Peg- IFNa) and Ribavirin (RBV) in Egyptian patients with chronic hepatitis C virus (HCV) infection.

Methods: This study was carried out in 1200 patients with chronic hepatitis C virus infection who were eligible for interferon therapy. They were treated with the triple therapy of sofosbuvir 400 mg once daily, Peg-INF subcutaneous injection weekly for 12 weeks in combination with oral weight-based ribavirin. The primary outcome measures were the number of patients with successful eradication of the virus evidenced by the sustained virologic response (SVR) at 12 Weeks. After discontinuation of Therapy (SVR12), the secondary outcome measures were the incidence of adverse effects associated with the tested HCV therapy.

Result: The mean age of the patients was 49.32 ± 6.97 years. 45.9% of them were males and 54.1% were females.70 patients (5.8%) had a history of previous HCV treatment. ''1077 (89.8%)'' of patients achieved successful eradication of virus while ''106 (8.8%)'' were resistant to treatment and ''17 (1.4%)'' stopped treatment. Good predictors of response to the triple therapy were female gender, treatment naive and non-cirrhotic patients.

Conclusion: The triple regimen of Pegylated interferon, sofosbuvir plus ribavirin is safe and effective in the treatment of Egyptian patients with hepatitis C virus and is associated with real-life SVR12 rates of 89.8%.

Keywords: Hepatitis C virus, clinical practice, treatment, Egypt, infection, interferon.

Graphical Abstract

[1]
Elwan, N.; Elfert, A.; Abd-Elsalam, S. Study of Hepatic Steatosis Index in Patients with Chronic HCV Infection. Int. J. Curr. Microbiol. Appl. Sci., 2016, 5(5), 266-274.
[2]
McCombs, J.; Matsuda, T.; Tonnu-Mihara, I.; Saab, S.; Hines, P.; L’italien, G.; Juday, T.; Yuan, Y. 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), 204-212.
[3]
El-Zanaty, F.; Way, A. Management of hepatitis C virus genotype 4: recommendations of an international expert panel. J. Hepatol., 2011, 54, 1250-1262.
[4]
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.
[5]
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.
[6]
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.
[7]
Yau, A.H.; Yoshida, E.M. Hepatitis C drugs: the end of the pegylated interferon era and the emergence of all-oral interferon-free antiviral regimens: a concise review. Can. J. Gastroenterol. Hepatol., 2014, 28(8), 445-451.
[8]
Bhatia, H.K.; Singh, H.; Grewal, N.; Natt, N.K. Sofosbuvir: A novel treatment option for chronic hepatitis C infection. J. Pharmacol. Pharmacother., 2014, 5(4), 278-284.
[9]
Hepatitis C guidance: AASLD-IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus. Hepatology, 2015, 62(3), 932-954.
[10]
EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J. Hepatol., 2014, 60(2), 392-420.
[11]
Manns, M.; Vierling, J.M.; Bacon, B.R. High sustained viral repsonse at 12- and 24-week follow-up of MK-7152 with pegylated interferon alfa-2a and ribavirin in HCV genotype 1 treatment-naive non-cirrhotic patients. J. Hepatol., 2013, 58(Suppl. N1), 1.
[12]
McOmish, F.; Yap, P.L.; Dow, B.C.; Follett, E.A.; Seed, C.; Keller, A.J.; Cobain, T.J.; Krusius, T.; Kolho, E.; Naukkarinen, R. Geographical distribution of hepatitis C virus genotypes in blood donors: an international collaborative survey. J. Clin. Microbiol., 1994, 32(4), 884-892.
[13]
Khattab, M.A.; Ferenci, P.; Hadziyannis, S.J.; Colombo, M.; Manns, M.P.; Almasio, P.L.; Esteban, R.; Abdo, A.A.; Harrison, S.A.; Ibrahim, N.; Cacoub, P.; Eslam, M.; Lee, S.S. Management of hepatitis C virus genotype 4: recommendations of an international expert panel. J. Hepatol., 2011, 54(6), 1250-1262.
[14]
Abd Elrazek, A.E.; Bilasy, S.E.; Elbanna, A.E.; Elsherif, A.E. Prior to the oral therapy, what do we know about HCV-4 in Egypt: a randomized survey of prevalence and risks using data mining computed analysis. Medicine (Baltimore), 2014, 93(28)e204
[15]
Derbala, M.F.; Al Kaabi, S.R.; El Dweik, N.Z.; Pasic, F.; Butt, M.T.; Yakoob, R.; Al-Marri, A.; Amer, A.M.; Morad, N.; Bener, A. Treatment of hepatitis C virus genotype 4 with peginterferon alfa-2a: impact of bilharziasis and fibrosis stage. World J. Gastroenterol., 2006, 12(35), 5692-5698.
[16]
Lange, C.M.; Zeuzem, S. Perspectives and challenges of interferon-free therapy for chronic hepatitis C. J. Hepatol., 2013, 58(3), 583-592.
[17]
Zhang, J.; Nguyen, D.; Hu, K.Q. Chronic Hepatitis C Virus Infection: A Review of Current Direct-Acting Antiviral Treatment Strategies. N. Am. J. Med. Sci. (Boston), 2016, 9(2), 47-54.
[18]
Lawitz, E.; Mangia, A.; Wyles, D.; Rodriguez-Torres, M.; Hassanein, T.; Gordon, S.C.; Schultz, M.; Davis, M.N.; Kayali, Z.; Reddy, K.R.; Jacobson, I.M.; Kowdley, K.V.; Nyberg, L.; Subramanian, G.M.; Hyland, R.H.; Arterburn, S.; Jiang, D.; McNally, J.; Brainard, D.; Symonds, W.T.; McHutchison, J.G.; Sheikh, A.M.; Younossi, Z.; Gane, E.J. Sofosbuvir for previously untreated chronic hepatitis C infection. N. Engl. J. Med., 2013, 368(20), 1878-1887.
[19]
Kowdley, K.V.; Lawitz, E.; Crespo, I.; Hassanein, T.; Davis, M.N.; DeMicco, M.; Bernstein, D.E.; Afdhal, N.; Vierling, J.M.; Gordon, S.C.; Anderson, J.K.; Hyland, R.H.; Dvory-Sobol, H.; An, D.; Hindes, R.G.; Albanis, E.; Symonds, W.T.; Berrey, M.M.; Nelson, D.R.; Jacobson, I.M. Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial. Lancet, 2013, 381(9883), 2100-2107.
[20]
Hathorn, E.; Elsharkawy, A.M. Management of hepatitis C genotype 4 in the directly acting antivirals era. BMJ Open Gastroenterol., 2016, 3(1)e000112
[21]
Lawitz, E.; Poordad, F.; Brainard, D.M.; Hyland, R.H.; An, D.; Dvory-Sobol, H.; Symonds, W.T.; McHutchison, J.G.; Membreno, F.E. Sofosbuvir with peginterferon-ribavirin for 12 weeks in previously treated patients with hepatitis C genotype 2 or 3 and cirrhosis. Hepatology, 2015, 61(3), 769-775.
[22]
Doss, W.; Shiha, G.; Hassany, M.; Soliman, R.; Fouad, R.; Khairy, M.; Samir, W.; Hammad, R.; Kersey, K.; Jiang, D.; Doehle, B.; Knox, S.J.; Massetto, B.; McHutchison, J.G.; Esmat, G. Sofosbuvir plus ribavirin for treating Egyptian patients with hepatitis C genotype 4. J. Hepatol., 2015, 63(3), 581-585.
[23]
Hayashida, K.; Shoji, I.; Deng, L.; Jiang, D.P.; Ide, Y.H.; Hotta, H. 17β-estradiol inhibits the production of infectious particles of hepatitis C virus. Microbiol. Immunol., 2010, 54(11), 684-690.
[24]
Tang, S.; Yue, M.; Wang, J.; Su, J.; Yu, R.; Zhou, D.; Xu, K.; Cai, L.; Zhang, Y.; Wang, J. Association of genetic variants in estrogen receptor α with HCV infection susceptibility and viral clearance in a high-risk Chinese population. Eur. J. Clin. Microbiol. Infect. Dis., 2014, 33(6), 999-1010.
[25]
Elwan, N.; Amr, K.; Elyamany, S. Evaluating the Role of Interleukin-12 B gene polymorphism in prediction of disease progression in patients with chronic hepatitis C virus infection. Infect. Disord. Drug Targets, 2017, 


 [Epub ahead of print].
[26]
Shimizu, I. Impact of oestrogens on the progression of liver disease. Liver Int., 2003, 23(1), 63-69.
[27]
Abdel-Rahman, M.; El-Sayed, M.; El Raziky, M.; Elsharkawy, A.; El-Akel, W.; Ghoneim, H.; Khattab, H.; Esmat, G. Coinfection with hepatitis C virus and schistosomiasis: fibrosis and treatment response. World J. Gastroenterol., 2013, 19(17), 2691-2696.
[28]
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.
[29]
Ahmed, O.A.; Safwat, E.; Khalifa, M.O.; Elshafie, A.I.; Fouad, M.H.A.; Salama, M.M.; Naguib, G.G.; Eltabbakh, M.M.; Sherief, A.F.; Abd-Elsalam, S. 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