Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure

Study Overview
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Brief Summary
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Now many cases reported failure to HCV treatment with Sofosbuvir/ Daclatasvir. retreat those patients is challenging. So, we aimed to Study the efficacy and safety of Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to prior Sofosbuvir/ Daclatasvir regimens in an open-labeled randomized trial.

Detailed Description
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HCV management with new DAAs is now promising. However, many cases reporting treatment failure either non-responder or relapse to HCV treatment with Sofosbuvir/ Daclatasvir. retreat those patients is challenging. So, we aimed to Study the efficacy and safety of Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to prior Sofosbuvir/ Daclatasvir regimens in a multicenter open-labeled randomized trial.

Official Title
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Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin Versus Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin in the Management of Hepatitis C Patients Fauilre to Prior Sofosbuvir/ Daclatasvir (An Open-labeled Randomized Trial)

Conditions
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HCV Coinfection

Intervention / Treatment
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* Drug: Sofosbuvir
* Drug: Simeprevir
* Drug: Daclatasvir
* Drug: Ribavirin
* Drug: Ombitasvir/paritaprevir/ritonavir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with proven CHC genotype 4 18 years old or more, prior HCV treatment failure to sofosbuvir /daclatasvir compensated liver disease. Exclusion Criteria: Patients with combined HCV/HBV co-infection, hepatocellular carcinoma (HCC), decompensated liver cirrhosis (Child-Pugh score above 6), and non-genotype 4 were excluded.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sof/sim/dac<br>Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin | Drug: Sofosbuvir<br>* Sofosbuvir 400 mg oral pills<br>Drug: Simeprevir<br>* Simeprevir 150 mg oral pills<br>Drug: Daclatasvir<br>* Daclatasvir 60 mg oral pills<br>Drug: Ribavirin<br>* Ribavirin 200 mg oral pills<br>|
| Active Comparator: sof/omb/parit<br>Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin | Drug: Sofosbuvir<br>* Sofosbuvir 400 mg oral pills<br>Drug: Ribavirin<br>* Ribavirin 200 mg oral pills<br>Drug: Ombitasvir/paritaprevir/ritonavir<br>* Ombitasvir/paritaprevir/ritonavir oral pills<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SVR rate | The primary endpoint was the achievement of SVR at week 12 (SVR12) post-treatment. The potential adverse events were evaluated in each visit for the development of adverse events or any significant interactions. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV, DAAs, Non-responder