Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC

Study Overview
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Brief Summary
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The study will recruit 150 patients with HCV related HCC ,after HCC treatment the patients will undergo treatment with different regimens of DAAs.

Detailed Description
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The study will recruit 150 patients with HCV related HCC All the studied patients underwent or will undergo one of the curative interventions for HCC either hepatic resection or thermal ablation . after 1 month of achievement of laboratory and radiological response to HCC intervention the patient will be treated with one of the interferon free regimens : Sofosbuvir+Ribavirin Sofosbuvir+Simeprevir± Ribavirin Sofosbuvir+ Daclatasvir ± Ribavirin Sofosbuvir+ Ledipasvir ± Ribavirin the treatment duration will be justified either 12 or 24 weeks after treatment the patient will continue on regular follow up to detect HCV cure or recurrence , HCC cure or recurrence and long term follow up of natural history

Official Title
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Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC

Conditions
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Hepatitis C, Chronic, Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Sofosbuvir
* Drug: Ribavirin
* Drug: Simeprevir
* Drug: daclatasvir
* Drug: Ledipasvir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70 years old Confirmed HCV viremia by PCR CHILD Pugh A or B7,B8 Confirmed HCC either by laboratory ,imaging or histopathological criteria Underwent or candidate for curative intervention for HCC (BCLC stage 0 ,A) Willing to be treated for HCV and signing informed consent Exclusion Criteria: Patients below 18 or above 70 years old patients with advanced liver condition CHILD score ≥ B9 Patients with advanced HCC status (BCLC≥ B) Patients with combined HBV ,HIV infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sofosbuvir +Ribavirin<br>Sofosbuvir 400 mg/day +ribavirin for 24 weeks | Drug: Sofosbuvir<br>* Sofosbuvir 400 mg orally once daily<br>* Other names: GS-7977;Drug: Ribavirin<br>* Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)<br>* Other names: Rebetol®;|
| Experimental: Sofosbuvir+Simeprevir±Ribavirin<br>Sofosbuvir 400 mg/day +Simeprevir 150 mg/day ± ribavirin for 12 weeks | Drug: Sofosbuvir<br>* Sofosbuvir 400 mg orally once daily<br>* Other names: GS-7977;Drug: Ribavirin<br>* Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)<br>* Other names: Rebetol®;Drug: Simeprevir<br>* Simeprevir 150 mg orally once daily<br>* Other names: TMC435;|
| Experimental: Sofosbuvir+Daclatasvir±Ribavirin<br>Sofosbuvir 400 mg/day +Daclatasvir 60 mg/day ± ribavirin for 12 weeks | Drug: Sofosbuvir<br>* Sofosbuvir 400 mg orally once daily<br>* Other names: GS-7977;Drug: Ribavirin<br>* Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)<br>* Other names: Rebetol®;Drug: daclatasvir<br>* Daclatasvir 60 mg orally once daily<br>* Other names: BMS-790052;|
| Experimental: Sofosbuvir+Ledipasvir±Ribavirin<br>Sofosbuvir 400 mg/day +Ledipasvir 90 mg/day ±ribavirin for 12 weeks | Drug: Sofosbuvir<br>* Sofosbuvir 400 mg orally once daily<br>* Other names: GS-7977;Drug: Ribavirin<br>* Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)<br>* Other names: Rebetol®;Drug: Ledipasvir<br>* Ledipasvir 90 mg orally once daily<br>* Other names: Co-formulated with Sofosbuvir in one tablet (Harvoni ® );|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment |  | 12 weeks after the last dose of study drugs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with virologic failure during treatment or relapse after treatment |  | from baseline until 12 weeks after the last dose of study drugs | 
| Percentage of Participants who will show any radiological or laboratory changes denoting local or denovo recurrence of HCC |  | Follow up will be done from baseline for up to 36 months for detection of sustained HCC treatment,tumoral progression or denovo occurrence | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV-HCC-DAAs