Safety and Efficacy af Sofosbuvir and Simiprevir Regimen Versus Sofosbuvir, Peginterferon and Ribavirin Regimen for Treatment of Chronic Hepatitis C Virus
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- Category: Vol. 85, December 2017
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Safety and Efficacy af Sofosbuvir and Simiprevir Regimen Versus Sofosbuvir, Peginterferon and Ribavirin Regimen for Treatment of Chronic Hepatitis C Virus, AMANY H. LASHIN, MOHAMED S. ABDELAZIZ, HATEM S. ABD EL-RAOUF, HANY R. EL-KHOLY and MARWA E. SAID
Abstract
Background: Hepatitis C virus infects about 185 million people equating 2.8% of worldwide population and about 500,000 people die annually from hepatitis-c related liver diseases. The most common clinical presentation of the disease is the chronic hepatitis and its complications such as: Com-pensated cirrhosis, portal hypertension, decompensated cir-rhosis and hepatocellular carcinoma (HCC). Therapeutic management of chronic HCV patients traditionally depended on combination of peg-interferon (IFN) with ribavirin but this regimen showed many serious side effects beside its non-satisfactory efficacy. In 2013, a second generation of direct acting antiviral agents (DAAs) gave a promising efficacy and safety. Although many IFN free regimens were approved, further evaluations are needed for these regimens.
Aim: To compare sofosbuvir plus simeprevir regimen versus sofosbuvir plus peg-interferon and ribavirin regimen in patients with chronic hepatitis C infection.
Patients and Methods: This is a prospective study con-ducted on 90 patients of chronic HCV who were admitted to the Viral Hepatitis Center in Damanhour Medical National Institute in Egypt during the last 3 months of 2015 and were selected according to the inclusion and exclusion criteria set by the institute. 56% of overall participants had cirrhosis and 77% were treatment-experienced. Patients were assigned according IFN eligibility criteria into two groups: 45 patients received IFN-based regimen: Sofosbuvir+Peg IFN alpha+ Ribavirin (SOF/RBV/PEG-IFN) and 45 patients received IFN-free regimen: Simeprevir+Sofosbuvir (SIM/SOF). Both reg-imens were given for 12 weeks. Primary end point was the rate of achieving SVR12, while secondary end point was the occurrence of virologic relapse.
Results: The SVR rate of both groups was 100% and 97.8% for SIM/SOF and SOF/RBV/PEG-IFN groups respec-tively. Only one patient had a virological failure and she was in the IFN based treatment but these results showed no statistical significance. Virological relapse occurred in only