First Vaccine for Viral Hepatitis C Could Become a Reality

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, Germany, Thursday 31 March 2011: /PRNewswire/ — New data presented today at the International Liver CongressTM confirm the antiviral activity of fluvastatin – commonly used as a cholesterol-lowering treatment – in patients with chronic hepatitis C (HCV).1

Patients had improved early and sustained virological response (EVR and SVR) when treated with the current standard of care – pegylated Interferon-alpha and ribavirin (PegIFNα/RBV) – and fluvastatin. The results show patients receiving fluvastatin and PegIFNα/RBV achieve higher rates of EVR and SVR – 75.96% and 63.46% – to those receiving placebo and PegIFNα/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 PegIFNα/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 PegIFNα/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 PegIFNα/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 naïve HCV genotype 1b patients were given either PegIFNα/RBV and 20 mg of fluvastatin (104 patients) or PegIFNα/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:

About The International Liver CongressTM 2011
The International Liver Congress™ 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.

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

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 CongressTM 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

Posted: April 2011

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