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

Well-known Statin Could be Recycled as HCV Therapy Supplement

BERLIN, March 31, 2011 - 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) (
www.easl.eu/_the-international-liver-congress/general-information)
which is the main scientific and professional event in hepatology worldwide

- Meetings (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 (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

———————————

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

For further information on the studies, or to request an interview, please do not hesitate to contact the EASL Press Office on: Email: easlpressoffice at cohnwolfe.com, Travis Taylor: Onsite tel: +44(0)7843-069-451, Vicky O'Connor: Offsite tel: +44(0)20-7331-5342