The SIM-SOF Trial for Hepatitis C

Study Overview
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Brief Summary
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Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin.

Detailed Description
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Patients can be treatment naive or prior null response to Peg/RBV, and must be genotype subtype 1a. Must have Child's Class A cirrhosis/compensated and no history of decompensation

Official Title
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The SIM-SOF Trial: A Randomized Trial Comparing Simeprevir-Sofosbuvir Versus Peginterferon/Ribavirin/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype-1a-infected Patients With Cirrhosis

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Pegylated Interferon alfa-2b
* Drug: Simeprevir
* Drug: Ribavirin
* Drug: Sofosbuvir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic hepatitis c, cirrhosis biopsy-proven, or via fibrotest, CPT score less than 7, genotype 1a, INR 2.3 or less, serum albumin greater than 2.7 gm/dL, total bilirubin less than 3 gm/dL, platelet count 50,000 per cubic milliliter or more GFR >50 ml/min Exclusion Criteria: non genotype 1a, history of CPT class B or C or decompensation or history of same, HIV or HBV coinfection, prior treatment with boceprevir, telaprevir or any other direct acting antiviral agent, uncontrolled psychiatric or cardiopulmonary disorders, planning pregnancy or unwilling/unable to practice contraception

Ages Eligible for Study
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Minimum Age: 18 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: Standard<br>Pegylated Interferon Alfa-2b (1.5 ugm/kg/week subcutaneously) plus ribavirin (1000-1200 mg daily orally) plus sofosbuvir (400 mg daily) for 12 weeks | Drug: Pegylated Interferon alfa-2b<br>* 1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total<br>* Other names: Pegintron;Drug: Ribavirin<br>* 1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir<br>* Other names: Ribavirin Ribasphere Ribapak;Drug: Sofosbuvir<br>* 12 weeks of combination sofosbuvir and simeprevir<br>* Other names: Sovaldi;|
| Experimental: Simeprevir + Sofosbuvir<br>(SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks | Drug: Simeprevir<br>* 150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks<br>* Other names: Olysio;Drug: Sofosbuvir<br>* 12 weeks of combination sofosbuvir and simeprevir<br>* Other names: Sovaldi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants With Sustained Virologic Response 12 (SVR-12) | Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy | 12 weeks post-therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum HCV RNA Level |  | 4 and 12 weeks into therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cirrhosis