Fluvastatin Enhances Chronic Hepatitis C Treatment Response in Combination With Pegylated Interferon-Alpha and Ribavirin

BERLIN, March 31, 2011 /PRNewswire/ --

- Well-known Statin Could be Recycled as HCV Therapy Supplement

New data presented today at the International Liver Congress(TM) confirm the antiviral activity of fluvastatin - commonly used as a cholesterol-lowering treatment - in patients with chronic hepatitis C (HCV).[1]

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Patients had improved early and sustained virological response (EVR and SVR) when treated with the current standard of care - pegylated Interferon-alpha and ribavirin (PegIFNalpha/RBV) - and fluvastatin. The results show patients receiving fluvastatin and PegIFNalpha/RBV achieve higher rates of EVR and SVR - 75.96% and 63.46% - to those receiving placebo and PegIFNalpha/RBV - 61.9% and 49.52% respectively.

EASL's Secretary General, Professor Heiner Wedemeyer, said: "We know that metabolic syndrome (MS), the main treatment indication for statins, is associated with severe fibrosis and lower treatment responses in chronic HCV patients.[2] The confirmation that the combination of fluvastatin and PegIFNalpha/RBV could provide better clinical outcomes for those patients with co-morbid chronic HCV and MS is very exciting for clinicians".

Even in patients without MS, the study shows that responses to treatment are still higher in patients treated with fluvastatin and PegIFNalpha/RBV (EVR 85.36% versus 71.42% and SVR 74.39% vs. 58.44).

"Today, healthcare professionals have to be mindful when considering health provision and treatment costs. We cannot overlook the importance of opportunities to maximise more affordable drugs' potential to complement the current standard of care for chronic HCV management," said Professor Wedemeyer.

This new study concludes that the synergistic effects between fluvastatin and PegIFNalpha/RBV shows lipid lowering drugs may favour HCV clearance and be useful as a chronic HCV treatment, irrespective of the presence of metabolic syndrome.

Notes to Editors

About the study

In the double-blind pilot study, 209 treatment naive HCV genotype 1b patients were given either PegIFNalpha/RBV and 20 mg of fluvastatin (104 patients) or PegIFNalpha/RBV and 20 mg of placebo (105 patients) for 48 weeks. Study medication was administered for 72 weeks (48 weeks in association with PegIFN-ribavirin plus 24 weeks in follow-up) in all patients, irrespective their lipid profile.

Both EVR and SVR are makers of a drug's efficacy as an HCV treatment: EVR is measured by detectable HCV RNA at week 4, but undetectable HCV RNA at week 12, maintained to the end of treatment; SVR is measured by undetectable HCV RNA 24 weeks after the end of treatment.

About fluvastatin

Fluvastatin has previously shown promise as an HCV treatment: a 2008 study of 31 patients found the drug exhibited antiviral activity against HCV, although the authors described the effect as modest, variable, and often short-lived.[3]

Fluvastatin is a statin, a class of drug that improves blood cholesterol levels primarily by inhibiting a liver enzyme called HMG Co-A reductase, thus reducing the liver's ability to make cholesterol.[4]

About metabolic syndrome

Metabolic syndrome (MS) is a combination of medical disorders that increase the risk of developing cardiovascular disease and diabetes. It is also linked with a higher risk to develop severe fibrosis in chronic HCV patients.[2]

About EASL

EASL is the leading European scientific society involved in promoting research and education in hepatology. EASL attracts the foremost hepatology experts and has an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.

EASL's main focus on education and research is delivered through numerous events and initiatives, including:

- The International Liver Congress(TM) ( http://www.easl.eu/_the-international-liver-congress/general-information) which is the main scientific and professional event in hepatology worldwide

- Meetings (http://www.easl.eu/_events) including Monothematic and Special conferences, Post Graduate courses and other endorsed meetings that take place throughout the year

- Clinical and Basic Schools of Hepatology (http://www.easl.eu/_education ), a series of events covering different aspects in the field of hepatology

- Journal of Hepatology ( https://www.easl.eu/members/journal-of-hepatology) published monthly

- Participation in a number of policy initiatives at European level

About The International Liver Congress(TM) 2011

The International Liver Congress(TM) 2011, the 46th annual meeting of the European Association for the study of the Liver, is being held at the Internationales Congress Centrum, Berlin, Germany from March 30 - April 3, 2011. The congress annually attracts over 7,500 clinicians and scientists from around the world and provides an opportunity to hear the latest research, perspectives and treatments of liver disease from principal experts in the field.

References

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[1] Georgescu, E. et al. Potential enhancement of both early (EVR) and sustained (SVR) virological response by fluvastatin in chronic hepatitis C trated [sic] with standard pegifn-ribavirin therapy. A pilot study. Abstract presented at The International Liver Congress(TM) 2011

[2] Tsochatzis E et al. Metabolic syndrome is associated with severe fibrosis in chronic viral hepatitis and non-alcoholic steatohepatitis. Aliment Pharmacol Ther. 2008 Jan 1;27(1):80-9. Epub 2007 Oct 5

[3] Bader T, Fazili J, Madhoun M, et al. (April 2008). Fluvastatin Inhibits Hepatitis C Replication in Humans. Am. J. Gastroenterol. 103 (6): 1383. doi:10.1111/j.1572-0241.2008.01876.x. PMID 18410471

[4] http://heartdisease.about.com/cs/cholesterol/a/statins.htm. Accessed 16.03.2011