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العنوان
Efficacy and Safety of Sofosbuvir based regimens in Hepatitis C virus Egyptian patients with compensated liver disease: Real world Study: Single center experience
الناشر
Tamer Adel Abou El-Ela ;
المؤلف
Abou El-Ela ;tamer .
هيئة الاعداد
باحث / تامر عادل ابو العلا
مشرف / تارى عبدالحميد سلمان
مناقش / م كلثوم محمد الحداد
مناقش / ألفت محمد ھندى
الموضوع
Liver - Diseases
تاريخ النشر
2017.
عدد الصفحات
241 p. :
اللغة
الإنجليزية
الدرجة
ماجستير
التخصص
الكبد
تاريخ الإجازة
18/7/2018
مكان الإجازة
جامعة المنوفية - معهد الكبد - قسم طب الكبد
الفهرس
Only 14 pages are availabe for public view

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Abstract

The hepatitis C virus (HCV) is a major public health problem and a leading cause of chronic liver disease. An estimated 180 million people are infected worldwide and 350000-500000 HCV related deaths are reported annually (Hepatitis C. Fact sheet, 2011). Data from the Egypt Demographic and Health Survey estimated the prevalence of HCV viraemia to be 7.3% in 2013 with predominance of genotype 4 (Gower et al., 2014). Optimal therapy for patients with hepatitis C virus genotype 4 (HCV-4) infection is changing rapidly; the standard of care for a long time has been a combination of pegylated interferon (PEG-IFN) and ribavirin (RBV), with modest response rates and considerable adverse events (Abdel-Razek and Waked, 2015). Recent advances in drug development have led to a number of direct antiviral agents (DAAs) which deliver high rates of SVR with substantial improvements in the side effect profiles (Gaetano, 2014). On November 22, 2013, FDA approved Simeprevir which is an NS3/4A protease inhibitor and the first once-daily protease inhibitor for the treatment of chronic hepatitis C with a combination antiviral regimen for adults with compensated liver disease (Anaka et al., 2014). On December 6, 2013, sofosbuvir was approved for the treatment of chronic hepatitis C as a component of a combination antiviral treatment regimen in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection (FDA website, 2013). Daclatasvir, produced by Bristol-Myers Squibb, is the first-in-class NS5A inhibitor that demonstrated a satisfactory multiphase rapid HCV RNA decline without significant adverse events. It is highly effective against genotypes 1–
SUMMARY AND CONCLUSION
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4 and several clinical trials assessed the efficacy of daclatasvir with different compounds (Nettles et al., 2011). The aim of our study was to evaluate the efficacy, predictors of response and adverse events of Sofosbuvir based regimens in HCV Egyptian patients with compensated liver disease.
This study included 700 patients with chronic HCV infection. These patients were evaluated and treated in outpatient’s clinics of National Liver Institute, Menoufiya University from February 2015 to July 2016. The patients were enrolled after obtaining their informed consent to receive 4 Sofosbuvir based regimens and were classified into 4 groups according to the regimen of treatment. group (1): included 159 patients received Sofosbuvir plus PegIFN and Ribavirin for 12 weeks. In this group: 141 patients (90.97%) achieved sustained virological response (SVR). Among cirrhotic patients, SVR was 90.56% and among treatmentexperienced patients, SVR was 86.8%. Four patients didn’t continue 12 weeks treatment in this group. The most common adverse events during treatment were flu-like illness (15.1%), anemia (12.6%), neutropenia (10.1%) and GIT disorders (5.7%). group (2): included 138 patients received Sofosbuvir plus Ribavirin for 24 weeks. In this group: 110 patients (81.5%) achieved sustained virological response (SVR). Among cirrhotic patients, SVR was 79.16% and among treatmentexperienced patients, SVR was 78.3%. Three patients didn’t continue 12 weeks treatment. The most common adverse events during treatment were anemia in (18.8%), hyperbilirubinemia (18.1%) and fatigue (6.5%).