The Effect of Adding Metformin to the Treatment of Hepatitis C

Tehran University of Medical Sciences140 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

140

Conditions

Hepatitis C

Interventions

MetforminDRUG

500 mg oral three times a day for 6 months

pegylated interferonDRUG

180 micrograms, or 1.5 micrograms/kg body weight weekly SQ injection for 6 or 12 months depending on genotype

RibavirinDRUG

800-1200 mg PO given in 2 divided doses for 6 to 12 months depending on weight and genotype

Eligibility

Sex: ALLMin age: 15 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Shariati Hospital

Tehran, Tehran Province, Iran

Outcomes

Primary Outcomes

Sustained viral response, defined as undetectable virus RNA 6 months after end of treatment

Time frame: 6 months after end of treatment

Secondary Outcomes

adverse effects leading to discontinuation of treatment

Time frame: anytime during the study

Rapid viral response, defined as undetectable viral RNA one month after start of treatment

Time frame: 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

Time frame: three months after start of treatment

Data from ClinicalTrials.gov

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