Efficacy of Sofosbuvir Plus Ribavirin with and without Pegylated Interferon in Management of Egyptian Chronic Hepatitis C Patients

Background and study aim: Egypt is one of the highest prevalence of antibodies to hepatitis C virus (HCV) in the world, estimated nationally at 6.3%. Applying best treatment protocol has a great impact on the national disease burden. DAAs open the door to decrease HCV prevalence as well as to treat infected subjects. Patients and Methods: In this study 1000 patients treated by Pegylated interferon, Sofosbuvir and weight adjusted Ribavirin. Another group of 1000 patients treated by Sofosbuvir and weight adjusted Ribavirin. Results: Two groups showed sustained virological response : 90.1% and 72.3% respectively. Both groups approved that previous treatment status and viral load has no impact on response prediction. Both showed that males are more likely to respond than females. Conclusion: Addition of Direct Acting Antivirals (DAAs), like sofosbovir, to the standard treatment with interferon and ribavirin improved the duration of the treatment and the sustained virological response (SVR). Treating of cirrhotics byPEGINF+SOF+RBV and SOF+RBV leads to decrease success rates. Validation of SVR once will be a golden rule.


INTRODUCTION
The World Health Organization has declared hepatitis C a global health problem, with approximately 3% of the world's population (roughly 170-200 million people) infected with HCV.In the US, approximately 3 million people are chronically infected, many of whom are still undiagnosed.In Egypt the situation is quite worse.[1] In Egypt, hepatitis C is highly endemic, in 2015, a demographic health survey (DHS) was carried out in Egypt revealing HCV anti-body prevalence nationwide of 6.7 % and HCV RNA of 4.4% in age group

. [2]
The goal of antiviral therapy is to cure hepatitis C via a sustained elimination of the virus.Importantly, long-term benefits of sustained virological response (SVR) are the reduction of

HCV-related hepatocellular carcinoma and overall mortality. [3]
The development of pegylated interferon α (PEG-IFN) improved the pharmacokinetics of IFN, allowing more convenient dosing intervals and resulting in higher SVR.[4] In HCV G4, the most prevalent in Egypt.Sustained virological response in Egyptian patients treated with PEG-IFN alfa-2a and ribavirin was estimated to be around 60%. [5] The standard treatment of the HCV was PEG IFN+RBV.The preliminary results indicated that 51% of patients (most with HCV genotype 4, which causes approximately 90% of HCV infections in Egypt) achieved a sustained virological response [6] The development of direct-acting antiviral agents (DAAs) against HCV has revolutionized the treatment of chronic hepatitis C. In 2011, the first selective protease inhibitors (PI) were approved for patients with HCV Genotype1.Boceprevir (Victrelis®) and telaprevir (Incivek®; Incivo®) improve SVR rates by up to 75% in naïve HCV Genotype1 patients.Treatment with interferon is associated with troublesome side effects, including influenza-like symptoms, depression, fatigue, and cytopenias, and requires weekly subcutaneous injections.A substantial proportion of patients with HCV infection are either unable or unwilling to receive an interferon based regimen.

[10]
A pilot study evaluated the INF-free combination of SOF+RBV for 12 weeks in HCV-G4 patients of Egyptian ancestry showing 79% SVR12 in Naïve and 59%in experienced patients.[11] This study aims to evaluate the efficacy of Sofosbuvir plus Ribavirin with or without pegylated interferon in management of Egyptian chronic hepatitis C patients.

RESULTS
Group I: Age is ranged between 19 and 60 years old (mean 50 ± 7 years), Males represent 52.9% of the group and females represent 47.1% of the group, 24.9% of patient was diabetics, Naïve patients represent 72.1% of the group and experienced patients represent 27.9% of the group.

Conclusion: Addition of Direct Acting
Antivirals (DAAs), like sofosbovir, to the treatment with interferon and ribavirin improved the duration of the treatment and the sustained virological response (SVR).Treating of cirrhotic by PEGINF+SOF+RBV or SOF+RBV leads to increase success rates.Validation of SVR once will be a golden rule.

Funding:
None.Conflicts of interest: None.Ethical approval:Approved