Hepatitis C Rimantadine + Antiviral Combination Therapy -HepRiACT v2.0

• Research type

  Research Study

• Full title

  A clinical study to evaluate the biological effects of administering rimantadine in patients with hepatitis C virus (HCV) infection alongside standard combination therapy with pegylated interferon and ribavirin.

• IRAS ID

  84521

• Contact name

  Mark Aldersley

• Sponsor organisation

  Leeds Teaching Hospitals Trust

• Eudract number

  2011-002781-21

• ISRCTN Number

  n/a

• Research summary

  Hepatitis C virus (HCV) affects over 170 million people worldwide and is a major cause of cirrhosis and liver cancer. Current treatment with interferon and ribavirin is not virus-specific, and is ineffective in half of patients. Research is therefore desperately needed to find new drugs with specific anti-viral effects. It is hoped that this leads to a more individualised approach to HCV treatment, where a number of directly acting drugs are used in combination to improve response rates and therefore reduce the personal and public burden of chronic liver disease and cancer.The HepRiACT trial aims to demonstrate a specific antiviral effect for rimantadine in the treatment of HCV. Rimantadine is used to treat flunza A by blocking the viral M2 protein. This is structurally similar to the HCV protein, p7. Our research lead first demonstrated the sensitivity of p7 to rimantadine. Recent work has defined both the mode of action as well as the specific resistance mechanisms for rimantadine-mediated HCV inhibition, validating rimantadine as a drug worthy of further investigation. HepRiACT marks the first translational clinical output from these exciting laboratory findings.HepRiACT will monitor virus evolution in response to standard drug treatment (pegylated interferon and ribavirin), given with or without rimantadine. Proof of an antiviral effect will support the inclusion of rimantadine in the newly emerging era of HCV combination therapy, provide a new field of antiviral development and could ultimately reduce the number of people with HCV progressing to cirrhosis and/or cancer.HepRiACT will additionally provide new links between the Leeds Institute of Molecular Medicine (LIMM) and the St. James Hospital Liver Unit. This represents a hitherto untapped resource expediting research into virus-associated liver cirrhosis and cancer. The linkages created through HepRiACT represent a unique opportunity for Leeds to become a leader within this research area.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  11/YH/0343

• Date of REC Opinion

  14 Oct 2011

• REC opinion

  Further Information Favourable Opinion