Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir

Study Overview
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Brief Summary
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To evaluate the early detection of HCC in patients Taking Sofosbuvir and Daclatasvir.

Detailed Description
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Methodology: Design: Prospective, randomized study used to detect early incidence of HCC in patients taking Sofosbuvir and Daclatasvir to treat HCV. Patients will be recruited from the National Hepatology and Tropical Medicine Research Institute (NHTMRI) Duration of study: 24 weeks from starting the DAAs Methods: Patients will go through examination and lab. Workup three times in this study: FIRST time: Before starting antiviral therapy, all included patients will undergo through physical examination, lab workup including HCV-RNA quantitative, fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, Pregnancy test ( Ladies in child bearing period), AFP as a marker of HCC. Included patients will also undergo through diagnostic procedures as Abdominal ultrasonography and ECG (men >40, women>50). Second time: At the end of antiviral therapy (12 weeks), virological response to therapy will be assessed by quantitative HCV RNA detection, using PCR. Patients will lab workup including , fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, AFP as a marker of HCC. The abdominal ultrasonography will be repeated any suspected focal lesion of the liver will be evaluated with triphasic CT scan or MRI to assess the occurrence or the recurrence of HCC. Third and last time: At 24 weeks ( Patients will be off treatment for the previous 12 weeks) , virological response to therapy will be assessed by quantitative HCV RNA detection, using PCR. Patients will lab workup including, fasting plasma glucose or HbA1C if diabetic, serum creatinine, CBC, AST, ALT, prothrombin Concentration or INR, total bilirubin, serum albumin, AFP as a marker of HCC. The abdominal ultrasonography will be repeated any suspected focal lesion of the liver will be evaluated with triphasic CT scan or MRI to assess the occurrence or the recurrence of HCC.

Official Title
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Study of the Early Occurrence of Hepatocellular Carcinoma (HCC) in Egyptian HCV Infected Patients Receiving Sofosbuvir and Daclatasvir

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Sofosbuvir 400 mg, Daclatasvir, Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients have positive HCV-RNA and taking DAAS to treat it. Both sexes will be included Age above 18 to 75 years old Child Pugh score ( A and B ) Exclusion Criteria: Total serum bilirubin<3 mg/dl Serum albumin > 2.8 g/dl INR≥ 1.7 Platelet count< 50000/mm3 IF any of the above criteria is not caused by liver disease, the patient can be included in the study. HCC, except 4 weeks after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI). Extra- hepatic malignancy. Pregnancy or inability to use effective contraception. Inadequately controlled diabetes mellitus (HbA1c>9%).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Patients taking Sofosbuvir and Daclatasvir | Drug: Sofosbuvir 400 mg, Daclatasvir, Ribavirin<br>* No intervention made this is an observational study to monitor the already existing protocols of the facility<br>|
| Group B<br>Patients taking Sofosbuvir,Daclatasvir, and Ribavirin | Drug: Sofosbuvir 400 mg, Daclatasvir, Ribavirin<br>* No intervention made this is an observational study to monitor the already existing protocols of the facility<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCC | occurence of HCC | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Daclatasvir, HCC, HCV, Sofosbuvir