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العنوان
Efficacy and Safety of Simeprevir-Sofosbuvir Combined Therapy for Treatment of chronic Hepatitis C Virus Infection /
المؤلف
Abdel-Raouf, Doaa Elbadry.
هيئة الاعداد
باحث / دعاء البدري عبد الرؤوف اسماعيل
مشرف / أشرف محمود عثمان
مناقش / مها توفيق محمود بركات
مناقش / خالد عبد العظيم عيد
الموضوع
C Virus.
تاريخ النشر
2018.
عدد الصفحات
105 p. ;
اللغة
الإنجليزية
الدرجة
ماجستير
التخصص
طب الجهاز الهضمي
الناشر
تاريخ الإجازة
31/10/2018
مكان الإجازة
جامعة أسيوط - كلية الطب - Department of Tropical Medicine and Gastroenterology
الفهرس
Only 14 pages are availabe for public view

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Abstract

Summary
The current study included 100 patients with chronic HCV infection eligible to receive Simeprevir (150 mg/d) - Sofosbuvir (400 mg/d) combination for 12 weeks according to the Guidelines of the Ministry of Health. They were recruited from Sohag Cardiac and Digestive center (Ministry of Health).
The mean age of the study group was 52.78±8.61 years. About 59% of included patients were males. Around 40% of our study population were overweight. The percentage of obesity was only 15%. About 98% of the study population were naïve for HCV antiviral therapy. About 34% of cases had liver cirrhosis.
Regarding demographic data and comorbid diseases, we found no significant differences between those with chronic hepatitis C and those with HCV related liver cirrhosis with the exception of age where those with liver cirrhosis had significantly higher mean age (55.11 ± 6.98; P = 0.04). The mean values of albumin and platelets were lower in cirrhotic patients when compared to those with chronic hepatitis. However, the mean value of INR was prolonged in cirrhotic patients. There was no significant difference between both groups regarding other parameters.
Patients with liver cirrhosis had significantly lower Hb and platelets count at the end of study when compared with chronic hepatitis. However, patients with liver cirrhosis had higher mean level of bilurubin. Other parameters had no significant differences between both groups
HCV RNA by PCR was negative in 99% of patients at 4 weeks, it was negative in 94% at 12 weeks of therapy (end of treatment virological response), also it was negative in 89% [12 weeks after end of therapy (SVR)] and 6% were non responder at end of therapy. We could not find any factor to be associated with sustained virological response.
Patients with chronic hepatitis showed significantly higher ETVR and SVR in comparison to those with LC (97% and 94% versus 88.2% and 79.4% ) respectively.
During the study period, ALT and AST improved significantly but bilirubin increased significantly. This was constant for both groups at 12 and 24 weeks after the treatment onset. The side effects of therapy in our study were rare and mild in most cases.
The most frequent side effects were headache and anemia; each was seen in 12% of our cases; followed by leucopenia (6%), photosensitivity (4%) and jaundice (3%).
There was significant difference between cirrhotic patients and chronic hepatitis regarding the occurence of jaundice and anemia where cirrhotic patients had higher frequency of them. However, there was no significant difference between both groups regarding the frequency of other side effect.
Conclusion
In conclusion, we found in this study of patients with chronic hepatitis C and HCV related cirrhosis that the combination of Simeprevir - Sofosbuvir is efficacious and well tolerated. This combination represents a good therapeutic option in treatment-naïve and treatment-experienced patients. Patients with chronic hepatitis C showed significantly higher ETVR and SVR in comparison to those with LC (97% and 94% versus 88.2% and 79.4% ) respectively.