Sofosbuvir in combination with ribavirin or simeprevir: real-life study of patients with hepatitis C genotype 4

Adel Abdel-Moneim, Alaa Aboud, Mohamed Abdel-Gabbar, Mohamed I Zanaty, Amr A Abd Elbary, Mohamed Ramadan, Adel Abdel-Moneim, Alaa Aboud, Mohamed Abdel-Gabbar, Mohamed I Zanaty, Amr A Abd Elbary, Mohamed Ramadan

Abstract

Background: The discovery of direct-acting antiviral agents (DAA) is an outstanding achievement of modern medicine in the current century. The current study aimed to explore the effectiveness and safety of two regimens sofosbuvir (SOF) in combination with either ribavirin (RBV) or simeprevir (SMV) in chronic hepatitis C (CHC) genotype (GT) 4 patients in Egypt.

Methods: A total of 201 patients, treatment-naïve and experienced, with CHC GT4 infection were allocated into two groups based on the type of the regimen used. All eligible patients were treated orally with SOF plus daily oral weight-based RBV (24 weeks; group 1), or SOF plus daily oral SMV (12 weeks; group 2).

Results: In the patients who received SOF/RBV therapy for 24 weeks, a sustained virological response (SVR12) was achieved by 89% (90/101) of all patients, 92% (49/53) of naïve patients and 85% (41/48) of experienced patients. In the SOF/SMV group, the SVR12 rate was 92% (92/100) for overall patients, 93% (70/75) of naïve patients and 88% (22/25) of experienced patients. Adverse events (AEs) were reported in 70% of patients in the SOF/RBV group and 42% patients in the SOF/SMV group. The most common AEs in both groups were fatigue, headache, nausea, and dyspnea.

Conclusions: The present comparative study suggests that both SOF/RBV and SOF/SMV combination regimens are highly effective in CHC GT4 treatment. However, the two-DAA regimen (SOF/SMV) may offer well-tolerated treatment, with a shorter duration and better safety compared to SOF/RBV.

Keywords: Egyptian patients; chronic hepatitis C genotype 4; ribavirin; simeprevir; sofosbuvir.

Conflict of interest statement

Conflict of Interest: None.

Figures

Figure 1
Figure 1
Patient disposition and the study design
Figure 2
Figure 2
Percentages of overall, treatment-naïve and treatment-experienced patients who achieved SVR12 after treatment with SOF/RBV (Group 1) and SOF/SMV (Group 2) SOF, sofosbuvir; SMV, simeprevir; RBV, ribavirin; NR, non-response; SVR12 sustained virological response 12 weeks after the end of treatment.

References

    1. Thrift AP, El-Serag HB, Kanwa F. Global epidemiology and burden of HCV infection and HCV-related disease. Nat Rev Gastroenterol Hepatol. 2017;14:122–132.
    1. 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.
    1. Doss W, Shiha G, Hassany M, et al. Sofosbuvir plus ribavirin for treating Egyptian patients with hepatitis C genotype 4. J Hepatol. 2015;63:581–585.
    1. Khattab MA, Ferenci P, Hadziyannis SJ, et al. Management of hepatitis C virus genotype 4:recommendations of an international expert panel. J Hepatol. 2011;54:1250–1262.
    1. Kandeel A, Genedy M, El-Refai S, Funk AL, Fontanet A, Talaat M. The prevalence of hepatitis C virus infection in Egypt 2015:implications for future policy on prevention and treatment. Liver Int. 2017;37:45–53.
    1. Abdel-Moneim A, Ramadan SH. Medication of chronic hepatitis C:a review on sofosbuvir as a new antiviral drug. ASRJETS. 2015;13:1–23.
    1. World Health Organization. Progress report on access to hepatitis C treatment: focus on overcoming barriers in low-and middle-income countries. March 2018. [[Accessed October 27, 2018]]. Available from: .
    1. Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty M, Ramadan M. Retreatment efficacy of sofosbuvir/ombitasvir/paritaprevir/ritonavir +ribavirin for hepatitis C virus genotype 4 patients. Dig Dis Sci. 2018;63:1341–1347.
    1. Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013;368:1878–1887.
    1. Jacobson IM, Gordon SC, Kowdley KV, et al. FUSION Study. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013;368:1867–1877.
    1. Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty M, Ramadan M. A sofosbuvir-based quadruple regimen is highly effective in HCV type 4-infected Egyptian patients with DAA treatment failure. J Hepatol. 2018;68:1313–1315.
    1. Hanno A, Elwazzan D, Ibrahim M, Hafez R. A real life study on treatment of Egyptian patients with HCV genotype IV with simeprevir and sofosbuvir. Health. 2016;8:780–786.
    1. Medivir AB. Simeprevir approved in the European Union for the treatment of adults with hepatitis C genotype 1 and 4 infection. May 2014. [[Accessed October 27, 2018]]. Available from: .
    1. Jensen DM, O'Leary J, Pockros P, et al. Safety and efficacy of sofosbuvir-containing regimens for hepatitis C:real-world experience in a diverse, longitudinal observational cohort. Hepatology. 2014;40:219A–220A. [Abstract]
    1. European Association for the Study of the Liver; EASL recommendations on treatment of hepatitis C 2015. J Hepatol. 2015;63:199–236.
    1. Sterling RK, Lissen E, Clumeck N, et al. Development of a simple noninvasive index to predict significant fibrosis patients with HIV/HCV co-infection. Hepatology. 2006;43:1317–1325.
    1. 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;174:204–212.
    1. Ruane PJ, Ain D, Stryker R, et al. Sofosbuvir plus ribavirin for the treatment of chronic genotype 4 hepatitis C virus infection in patients of Egyptian ancestry. J Hepatol. 2015;62:1040–1046.
    1. Buti M, Calleja JL, Lens S, et al. Simeprevir in combination with sofosbuvir in treatment-naïve and -experienced patients with hepatitis C virus genotype 4 infection:a Phase III, open-label, single-arm study (PLUTO) Aliment Pharmacol Ther. 2017;45:468–475.
    1. 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;45:681–687.
    1. 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;163:51–56.
    1. Feld JJ, Jacobson IM, Sulkowski MS, Poordad F, Tatsch F, Pawlotsky JM. Ribavirin revisited in the era of direct-acting antiviral therapy for hepatitis C virus infection. Liver Int. 2017;37:5–18.
    1. Eletreby R, Elakel W, Said M, et al. Real life Egyptian experience of efficacy and safety of Simeprevir/Sofosbuvir therapy in 6211 chronic HCV genotype IV infected patients. Liver Int. 2017;37:534–541.
    1. El Raziky M, Gamil M, Ashour MK, et al. 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;24:102–110.
    1. Kau A, Vermehren J, Sarrazin C. Treatment predictors of a sustained virologic response in hepatitis B and C. J Hepatol. 2008;49:634–651.
    1. Buti M, Esteban R. Management of direct antiviral agent failures. Clin Mol Hepatol. 2016;22:432–438.
    1. Antaki N, Bibert S, Kebbewar K, et al. IL28B polymorphisms predict response to therapy among chronic hepatitis C patients with HCV genotype 4. J Viral Hepat. 2013;20:59–64.
    1. Asselah T, De Muynck S, Broët P, et al. IL28B polymorphism is associated with treatment response in patients with genotype 4 chronic hepatitis C. J Hepatol. 2012;56:527–532.
    1. Pawlotsky JM. Hepatitis C virus resistance to direct-acting antiviral drugs in interferon-free regimens. Gastroenterology. 2016;151:70–86.
    1. Zuckerman A, Chastain CA, Naggie S. Retreatment options following HCV direct-acting antiviral failure. Curr Treat Options Infect Dis. 2017;9:389–402.

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