The Effect of Adding Metformin to the Treatment of Hepatitis C

Study Overview
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Brief Summary
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Insulin resistance is known to adversely effect viral response to treatment in hepatitis C patients We are aiming to study the effect of an insulin sensitizer, metformin, in viral response of hepatitis C to treatment with pegylated interferon and ribavirin in a double blind randomized controlled trial

Detailed Description
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Subjects with hepatitis C will be randomized to receive standard treatment with or without metformin. The results will be compared.

Official Title
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Effect and Safety of Adding Metformin to the Standard Treatment of Hepatitis C on Sustained Viral Response

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Metformin
* Drug: pegylated interferon
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic hepatitis C Iranian nationality Treatment naive Exclusion Criteria: cirrhosis diabetes mellitus HBV/HIV coinfection contraindications of metformin, interferon, ribavirin severe medical conditions (e.g. CHF, CRF, psychosis, ...) not consenting

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>standard treatment with pegylated interferon and ribavirin + placebo | Drug: pegylated interferon<br>* 180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype<br>Drug: Ribavirin<br>* 800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype<br>|
| Experimental: Metformin<br>standard treatment with pegylated interferon and ribavirin + metformin | Drug: Metformin<br>* 500 mg oral three times a day for 6 months<br>Drug: pegylated interferon<br>* 180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype<br>Drug: Ribavirin<br>* 800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment |  | 6 months after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effects leading to discontinuation of treatment |  | anytime during the study | 
| Rapid viral response, defined as undetectable viral RNA one month after start of treatment |  | one month after start of treatment | 
| Early viral response, defined as undetectable viral RNA or 2 log drop in viral count three month after start of treatment |  | three months after start of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, metformin, Insulin Resistance