Manal El-Hamamsy, Gouda K Helal, Soheir AbolAzm, Mohamed El Kassas, Heba A Abdel-Aziz, Sara Shaheen
Manal El-Hamamsy1,2, Gouda K Helal34, Soheir AbolAzm5, Mohamed El Kassas6, Heba A Abdel-Aziz7*, Sara Shaheen8
1Prof. of Clinical Pharmacy, Faculty of Pharmacy, King Abdulaziz University.
2Prof. of Clinical Pharmacy, Faculty of Pharmacy, Ain-Shams University.
3Prof. of Pharmacology, and Dean of the Faculty of Pharmacy, Heliopolis University.
4Prof. of Pharmacology, Faculty of Pharmacy, Al Azhar University.
5Prof. of Pharmacology, Faculty of Medicine, Cairo University.
6Lecturer of Endemic Medicine, Faculty of Medicine, Helwan University.
7Ph. D. Student, Ain Shams University, Egypt.
8Assistant Professor of Clinical Pharmacy, Faculty of Pharmacy, Ain-Shams University.
Volume - 13,
Issue - 12,
Year - 2020
Hepatitis C Virus has been a universal rising problem and the leading cause of liver cirrhosis and its related complications principally hepatic decompensation and hepatocellular carcinoma. The annual prevalence is estimated at 3-4 million subjects. Egypt is considered among the highest endemic seropositive areas globally having more than 5% related to the adult inhabitants. In Egypt, hepatitis C virus, genotype 4 is responsible for about 90% of the cases. In addition to their efficacy, DAA therapies target to significantly cut the cumulative total economic burden of HCV. The previous established and published studies related to new treatment regimens for hepatitis C virus in Egypt focused mainly on governmental hospitals / institutes, and nearly none focused on the private sector. This is a retrospective observational study focused on efficacy and safety evaluation of sofosbuvir (SOF) + ribavirin (RBV), SOF + daclatasvir (DCV), and SOF + daclatasvir (DCV) + RBV compared with SOF + pegylated interferon alfa (pegIFN) + RBV in the treatment of naïve non-cirrhotic patients infected with hepatitis C virus in Egypt. The population in this study were 200 Egyptian patients, diagnosed with chronic hepatitis C genotype 4 who were non-cirrhotic, not diagnosed with hepatocellular carcinoma (HCC), and didn’t have a liver transplant or co-infections. Those patients received treatment in private hospitals and clinics between 2014 and 2017. Results of this study showed that treatment with DAAs was associated with dramatic increase in SVR12 rate. The achieved SVR12 rates in this study were 91.7% for SOF + pegIFN + RBV, 75% for SOF + RBV, 96% for SOF + RBV + DCV, and 94% for SOF + DCV. Among the studied baseline patient characteristics, the viral load was found to be a significant independent predictor of the expected SVR12 rate. Safety assessment revealed that the most common side effect in this study were anaemia and thrombocytopenia. Anaemia was found to be significantly associated with regimens containing RBV and the initial haemoglobin level, while thrombocytopenia was found to be associated with the initial patient platelets count and pegINF containing regimen.
Cite this article:
Manal El-Hamamsy, Gouda K Helal, Soheir AbolAzm, Mohamed El Kassas, Heba A Abdel-Aziz, Sara Shaheen. Clinical Evaluation of Some Sofosbuvir-Based Regimens for the Treatment of Hepatitis C in Private healthcare sector in Egypt. Research J. Pharm. and Tech. 2020; 13(12):5903-5908. doi: 10.5958/0974-360X.2020.01030.6
1. Simaranjit, K., et al. Triple Combination Antiviral Therapy. Research Journal of Pharmacy and Technology. 7(10); 2014: 1190.
2. Attia, D., et al. The adverse effects of interferon‐free regimens in 149 816 chronic hepatitis C treated Egyptian patients. Alimentary pharmacology and therapeutics. 47(9); 2018: 1296-1305.
3. El Raziky, M., 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. Journal of viral hepatitis. 24(2); 2017: 102-110.
4. Gower, E., et al. Global epidemiology and genotype distribution of the hepatitis C virus infection. Journal of hepatology. 61(1); 2014: S45-S57.
5. El‐Akel, W., et al. National treatment programme of hepatitis C in Egypt: hepatitis C virus model of care. Journal of viral hepatitis. 24(4); 2017: 262-267.
6. Gayam, V., et al. Sofosbuvir Based Regimens in the Treatment of Chronic Hepatitis C with Compensated Liver Cirrhosis in Community Care Setting. International journal of hepatology. 2018(2018:
7. Mangia, A. and V. Piazzolla. Overall efficacy and safety results of sofosbuvir-based therapies in Phase II and III studies. Digestive and Liver Disease. 46(2014: S179-S185.
8. Doss, W., et al. Sofosbuvir plus ribavirin for treating Egyptian patients with hepatitis C genotype 4. Journal of hepatology. 63(3); 2015: 581-585.
9. Kanda, T., et al., Hepatitis C virus genotype 4-infection and interferon-free treatment in Egypt. 2018, Springer.
10. Elsisi, G.H., et al. Cost-Effectiveness Analysis of New Hepatitis C Virus Treatments in Egyptian Cirrhotic and Noncirrhotic Patients: A Societal Perspective. Value in health regional issues. 13(2017: 7-15.
11. Maan, R., et al. Safety and effectiveness of direct-acting antiviral agents for treatment of patients with chronic hepatitis C virus infection and cirrhosis. Clinical Gastroenterology and Hepatology. 14(12); 2016: 1821-1830. e6.
12. Zegers, M., et al. Evidence-based interventions to reduce adverse events in hospitals: a systematic review of systematic reviews. BMJ open. 6(9); 2016: e012555.
13. Sulkowski, M.S., et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. New England Journal of Medicine. 370(3); 2014: 211-221.
14. Bhatia, H.K., et al. Sofosbuvir: A novel treatment option for chronic hepatitis C infection. Journal of Pharmacology and Pharmacotherapeutics. 5(4); 2014: 278-284.
15. Rodriguez-Torres, M., et al. Sofosbuvir (GS-7977) plus peginterferon/ribavirin in treatment-naïve patients with HCV genotype 1: A randomized, 28-day, dose-ranging trial. Journal of Hepatology. 58(4); 2013: 663-668.
16. Chen, C.-P., et al. Evaluation of cost-effectiveness of peginterferon plus ribavirin for chronic hepatitis C treatment and direct-acting antiviral agents among HIV-infected patients in the prison and community settings. Journal of Microbiology, Immunology and Infection. 52(4); 2019: 556-562.