Metformin therapy in HCV infection

• Research type

  Research Study

• Full title

  A Study of the the antiviral activity of Metformin as an anti-Hepatitis C virus agent in patients with chronic Hepatitis C virus infection.

• IRAS ID

  45833

• Contact name

  Stephen Ryder

• Sponsor organisation

  Nottingham University Hospitals NHS Trust

• Eudract number

  2010-022850-18

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Hepatitis C virus infection (HCV) is a major cause of cirrhosis and death from liver disease worldwide. Current therapy for HCV with interferon based therapies results in cure rates of around 50-55% which leaves a significant number of patients without effective therapy. HCV induces (can bring on) insulin resistance and insulin resistance is a factor known to reduce the response to anti-HCV therapy. This finding stimulated initial studies looking at agents that may reduce insulin resistance as additional therapy in HCV infection. A study using metformin in addition to interferon and ribavirin showed a non-significant increase in cure rates (53% vs. 42%), but this was limited to patients with type 1 infection AND demonstrable insulin resistance. The assumption was made that the potential effect of metformin was likely to be on insulin resistance and thus by modulating this enhances response. We (Prof M Harris, University of Leeds) have data (currently unpublished)suggesting that metformin may have an anti-viral effect independent of its effect on insulin resistance, thus raising the possibility that metformin may have a direct anti-viral effect in vivo. Given that the development of specific anti-HCV agents which target viral proteins such as its polymerase and protease are in trial development but have so far proved either highly toxic or are likely to have a huge cost there is considerable rationale for looking at alternative potential anti-HCV agents and in this context metformin is cheap, readily available and has an excellent safety profile. This pilot study therefore addresses the question "Does metformin therapy result in a significant drop in HCV viral load in chronically infected patients?"

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  10/H0406/80

• Date of REC Opinion

  11 Oct 2010

• REC opinion

  Favourable Opinion