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العنوان
Efficacy and Safety of Sofosbuvir Plus
Daclatasvir with or without Ribavirin
in Treatment of Egyptian Patients
Infected with chronic HCV:
المؤلف
Anwar, Mohammed El Sayed.
هيئة الاعداد
باحث / محمد السيد أنور السيد
مشرف / محمــــد كمـــال شاكـــر
مشرف / هبــة محمــد عبـــد اللاه
مناقش / زينــب محمـــد حفنــي
تاريخ النشر
2021.
عدد الصفحات
306 P. :
اللغة
الإنجليزية
الدرجة
الدكتوراه
التخصص
الطب (متفرقات)
تاريخ الإجازة
1/1/2021
مكان الإجازة
جامعة عين شمس - كلية الطب - قسم طب المناطق الحارة
الفهرس
Only 14 pages are availabe for public view

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Abstract

The current study was designed to describe the efficacy and safety of Sofosbuvir plus Daclatasvir with or without Ribavirin in treatment of chronic HCV in a cohort of Egyptian patients who were referred to the viral hepatitis unit in El -Fayoum general hospital.
To fulfill such purpose, we studied 200 chronic HCV patients distributed on two groups of treatment regimen group I received Sofosbuvir plus Daclatasvir without Ribavirin; group II received Sofosbuvir plus Daclatasvir with Ribavirin.
All patients were subjected before treatment to detailed history taking, clinical examination, radiological assessment with abdominal ultrasonography and laboratory investigations including: HCV RNA assay by PCR, liver profile tests, complete blood picture, creatinine, INR, alpha-fetoprotein, fasting blood sugar and HbA1c for diabetics.
Some patients were subjected to abdominal CT with contrast if hepatic focal lesions were detected by abdominal ultrasonography or if there was marked elevation of alpha-fetoprotein, while patients > 65 years were subjected to echocardiography.
The treatment duration was 12 weeks and patients were categorized to 2 groups: group I patients were treatment naïve, and had no cirrhosis or had normal liver tests. They were treated with SOF‐DCV without RBV.
group II patients who were treatment naive or had previously failed interferon‐based therapy, patients with cirrhosis, and those who had serum albumin <3.5 g/dL, bilirubin >1.2 mg/dL, INR>1.2 and/or platelet count <150 000/cmm and were treated with SOF‐DCV‐RBV.
All patients were evaluated every 4 weeks by (ALT – AST - Total bilirubin – creatinine – CBC) and after treatment with (HCV RNA assay by PCR at week 16 and week 24 - ALT – AST - Total bilirubin – creatinine – CBC – alpha-fetoprotein – abdominal ultrasonography - fasting blood sugar and HbA1c for diabetics).
All cases were negative HBsAg and 32 female patients in the childbearing period do pregnancy test and show negative results.
In the current study, concerning viral response, SVR12 rate was achieved by 92.5% in the overall patients (185/200); by 98% (98/100) in group I, and by 87% (87/100) in group II.
Concerning safety and tolerability, The main adverse effects recorded during and after 12 weeks of treatments were fatigue (46%), (66%); headache (24%), (40%); gastrointestinal upset (15%), (43%); and nausea (10%), (15%) in group 1 and group 2, respectively.
Only one female patient in group II developed HCC.
All patients completed treatment till the end of course.