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العنوان
Evaluation of Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir plus Ribavirin Based Therapy for chronic Hepatitis C with or without Compensated Cirrhosis in Haemodialysis Patients \
المؤلف
Abdelmenem, Mai Mohamed Naguib.
هيئة الاعداد
باحث / مـى محمد نجيب عبد المنعم
مشرف / نجوى على صبرى
مشرف / أشرف أحمد أبو بكر
مشرف / ساره محمود زكى
تاريخ النشر
2020.
عدد الصفحات
152 p. :
اللغة
الإنجليزية
الدرجة
ماجستير
التخصص
العلوم الصيدلية
تاريخ الإجازة
1/1/2020
مكان الإجازة
جامعة عين شمس - كلية الصيدلة - الصيدلة الإكلينيكية
الفهرس
Only 14 pages are availabe for public view

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Abstract

This study was a prospective, cohort, open-label trial for 9 months (3 months therapy + 6 months follow up after therapy); to evaluate the efficacy and safety of ombitasvir, paritaprevir and ritonavir plus RBV based therapy for chronic hepatitis C with or without compensated cirrhosis in HCV treatment naïve patients receiving long-term haemodialysis.
A total of 50 HCV treatment naïve patients with or without compensated cirrhosis on regular hemodialysis enrolled in the study. They received 25 mg ombitasvir, 150 mg paritaprevir, and 100 mg ritonavir (2 capsules Qurevo®) plus ribavirin 200 mg daily for 12 weeks.
Qurevo was given once daily (on the day of dialysis, it was given after dialysis session);. In contrast, Ribavirin was given once daily (on the day of dialysis, it was given 4 hrs before dialysis session). After treatment, patients were followed-up for up to 24 weeks.
The cases involved in the study recruited from Al-Maadi armed forces hospital. Medical and drug history was taken; along with baseline laboratory assessment (including CBC, liver, renal functions, AFP, HCV RNA and FibroTest score). Patients were followed up at the nephrology and Hepatology departments for the whole study period and subjected to assessment of (Quantitative PCR for HCV RNA testing every month during therapy, and at 3 and 6 months after the end of treatment) and (Anti-HCV antibody every three months during therapy and at 3 and 6 months after the end of treatment). During the study, 3 patients were withdrawn due to suffering nondrug related complications & drug interactions complication leaving 47 patients who completed the study period.
Regarding basic demographic and clinical data, the study included 24(48%) female patients, while males were 26 (52%). The mean age of all patients was (48.12 ± 15.42) years.
Regarding Sustained Virological Response (SVR 12 and 24) data, SVR achievement rate was 88% at 3 and 6-months assessments.
Qurevo withdrawal rate during therapy was 6%; while Qurevo resistance rate after therapy was 6%.
There were comparable results between cirrhotic and non-cirrhotic patients as regards RBV, Qurevo usage and withdrawal rates; and SVR achievement (p > 0.05).
These results lead us to the fact that; Qurevo regimen was effective in the achievement of SVR in cirrhotic patients with Child-Pugh score A on regular dialysis; along with non-cirrhotic ones. These results support the use of Qurevo, even in cirrhotic patients.
The average AFP and hemoglobin levels were increased during serial 6 measurements (especially during 3rd and 6th months follow up after Qurevo therapy) with high significant difference (p < 0.05 each), while the average platelets, TLC, albumin and total bilirubin levels were increased during serial 6 measurements (especially during 3rd and 6th months follow up after Qurevo therapy) with high significant difference (p < 0.05 each).
Regarding liver enzymes, the average AST and ALT levels were decreased during serial 6 measurements (especially during 3rd and 6th months follow up after Qurevo therapy) with high significant difference (p < 0.05 each). On the other hand, INR measurements were comparable during serial measurements (p > 0.05).
Regarding HCV RNA, there were marked reduction starting from 1st and 2nd month of Qurevo therapy.
Kaplan-Meier survival curve showing increased survival probability starting from 2nd month of Qurevo therapy with high significant difference (Log-rank test P = 0.0001).