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:
- The International Liver CongressTM which is the main scientific and professional event in hepatology worldwide
- Meetings including Monothematic and Special conferences, Post Graduate courses and other endorsed meetings that take place throughout the year
- Clinical and Basic Schools of Hepatology, a series of events covering different aspects in the field of hepatology
- Journal of Hepatology published monthly
- Participation in a number of policy initiatives at European level
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
NEW STUDIES PROVIDE BENEFICIAL INSIGHTS EXPANDING THE POOL OF LIVER GRAFTS AND TRANSPLANTS
Donation after cardiac death may broaden the scope of organ donor selection
Berlin, Germany, Friday 1 April 2011: /PRNewswire/ — Findings from two new studies presented today at the International Liver CongressTM confirm that there are options for clinicians to expand the pool of liver grafts for use in patients with liver disease.
A UK retrospective study analysed liver transplant donation after cardiac death (DCD) between May 2001 and October 2010.1 86 DCD allografts were used for transplantation and included 19 paediatric recipients. Overall the study found positive outcomes of transplant, with an overall patient survival of 89.9%, 85.6% and 83.6% at one, three and five years respectively.
The second Italian Liver Match cohort study, evaluated the survival of liver grafts from HBcAb+ve donors in patients (recipients) with hepatitis, by analysing data from 1477 adult liver transplantations from June 2007 to May 2009. Of these, 1237 were HBcAb negative and 240 HBcAb positive donors, with unadjusted two-year graft survival of 80 and 69 percent respectively. The two-year study found HBcAb positive donor grafts survive better when allocated to HBsAg positive recipients but have worse outcomes when given to all categories of HBsAg negative recipients, regardless of their HBcAb/HBsAb status. In addition, as graft loss was unrelated to hepatitis HBV recurrence it is unlikely that this is due to insufficient HBV prophylaxis.
Currently, the optimal use of hepatitis B core antibody positive (HBcAb+ve) donor liver graft is mandatory in a number of European countries such as Italy, but current recommendations are not supported by strong evidence-based data. This study highlights that organ allocation needs to be considered on a like for like basis and the potential need for adjustment of current organ allocation policies in Mediterranean countries.
Daniele Prati, EASL’s Scientific Committee Member and Press Committee Chairman commented: “Too many patients continue to die while waiting for a liver transplantation. Finding organ donors is an ongoing challenge and any research that helps to expand the pool of available organs is welcome. As clinicians we always want the best possible outcomes for our patients and both studies provide encouraging results and additional viable options.
Notes to Editors
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 CongressTM which is the main scientific and professional event in hepatology worldwide
- Meetings including Monothematic and Special conferences, Post Graduate courses and other endorsed meetings that take place throughout the year
- Clinical and Basic Schools of Hepatology, a series of events covering different aspects in the field of hepatology
- Journal of Hepatology published monthly
- Participation in a number of policy initiatives at European level
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 |
| Dimple Natali: Onsite tel: +44 79 00 13 89 04 |
| Vicky O'Conner: Offsite tel: +44 20 7331 5342 |
References
1. Angelico M et al. The Current Allocation Policy of Liver Grafts from HBCAB Postive Donors Needs to be Improved: Evidence from the Liver-Match Cohort Study. Presented at The International Liver CongressTM 2011
2. Jassem W et al. Liver Transplant After Cardiac Death Donation: Single-Centre Long-term Results. Presented at the International Liver CongressTM 2011.
FIRST VACCINE FOR VIRAL HEPATITIS C COULD BECOME A REALITY
Berlin, Germany, Friday 1 April 2011: /PRNewswire/ — Early data from phase I trials of an HCV vaccine presented today at the International Liver CongressTM show encouraging results, with high immunogenicity and good safety profile.1,2
In the first study1, a therapeutic T-cell vaccine, based on novel adenoviral vectors was used on a small population of treatment naive patients with chronic genotype 1 HCV infection. Intra-muscular vaccination was administered 2 or 14 weeks into a 48-week course of treatment with Peg-IFNa2a/ribavirin. 50% of vaccinated patients had CD4+ and CD8+ HCV specific T-cell responses as detected by ELISpot at 2-8 weeks post boost, showing a strong immunogenicity for the vaccine. Local and systemic adverse events to vaccination were mild, with no evidence of liver immunopathology (measured by liver transaminase levels).
The second study2 looked at the potential for a prophylactic vaccine based on similar novel adenoviral vectors technology (replicative-defective human Ad6 and a novel simian AdCh3 vector that encode 1985 amino-acids derived from the NS3-5 region of a genotype-1b strain). 27 healthy volunteers were vaccinated following a double prime, heterologous boost strategy. The vaccine induced polyfunctional CD4+ and CD8+ T cells responses which were maintained up to 52 weeks post prime. Overall vaccination was very well tolerated with mild/moderate local and systemic reactions and no serious adverse advents.
Professor Heiner Wedemeyer, EASL’s Secretary General commented: “Vaccines are an exciting area of research now with the potential to add to the range of treatments available for patients with chronic viral hepatitis. These are early data but results are very encouraging indeed and as experts, we look forward to more scientific evidence being made available to support this new technology as a future treatment option as well as potentially preventing infection."
Previous research and data presented at the International Liver Congress shows that vaccination with adenoviral vectors induced highly potent and durable T-cell responses in healthy human and that similar vectors may prevent chronic infection in animals.3 This is the first time the immunogenicity and safety of vaccination was tested on HCV patients and healthy subjects.
Notes to Editors
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 CongressTM which is the main scientific and professional event in hepatology worldwide
- Meetings including Monothematic and Special conferences, Post Graduate courses and other endorsed meetings that take place throughout the year
- Clinical and Basic Schools of Hepatology, a series of events covering different aspects in the field of hepatology
- Journal of Hepatology published monthly
- Participation in a number of policy initiatives at European level
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 |
| Isabelle Scali: Onsite tel: +44 7717 435 103 |
| Vicky O'Conner: Offsite tel: +44 20 7331 5342 |
References
1. Kelly C et al. A therapeutic vaccine for HCV based on novel, rare, adenoviral vectors. Abstract Presented at The International Liver CongressTM 2011
2. Barnes E. Phase I trials of a highly immunogenic and durable T-cell vaccine for Hepatitis C virus based on novel, rare, adenoviral vectors. Abstract presented at the International Liver CongressTM 2011.
3. Folgori A et al. A T-cell HCV vaccine eliciting effective immunity against heterologous virus challenge in chimpanzees. Nature Medicine - 12, 190 - 197 (2006)
THALIDOMIDE SHOWS EFFICACY AS ADJUVANT THERAPY FOR HEPATOCELLULAR CARCINOMA PATIENTS
Well-known drug provides new hope for difficult to treat liver cancer patients
Berlin, Germany, Saturday 2 April 2011: /PRNewswire/ — Thalidomide has shown potential to be used as the first adjuvant therapy for hepatocellular carcinoma (HCC), according to data presented at the International Liver CongressTM 2011.1
A new study found thalidomide gave HCC patients who’d undergone grossly curative resection surgical removal of the cancerous part of the liver double the two-year disease free survival rate (65%) compared to placebo (33%).
However, the study did find that the two-year overall survival rate was comparable between patients treated with thalidomide and patients given placebo – 84.2% and 85.7% respectively.
Daniele Prati, EASL’s Scientific Committee Member and Press Committee Chairman, commented: “Current options for adjuvant therapy in HCC are very limited and clinical trial results have been disappointing. Thalidomide has already been proven to work well in a number of other areas and this study shows it could potentially benefit HCC patients who are particularly difficult to treat. Overall, it is important to continue research in evaluating adjuvant therapy in HCC."
Surgery is the main form of treatment for HCC, but is only possible for a small proportion of those afflicted. Even after curative resection, recurrence is common and is the main cause of death. Adjuvant therapy that is, chemotherapy after surgery – is thus attempted to try to improve outcomes.2
The study is promising because there is currently no adjuvant therapy for HCC patients following curative resection.
Indeed, the most up-to-date Cochrane Review of adjuvant therapies for HCC (conducted prior to this thalidomide study) found insufficient evidence to show that previously investigated adjuvant therapies increased survival for HCC, and only limited evidence to suggest that adjuvant therapy was useful in disease-free survival.2
In the double-blind, placebo controlled, randomized, comparative phase-II study, 42 patients were given 200mg per day oral dose of thalidomide (Arm A, 21 patients) or 200mg per day oral dose of placebo (Arm B, 21 patients). Patients started treatment within 6 weeks of complete tumour resection and carried on treatment for 12 months, or until they encountered disease recurrence, intolerably toxicity, or withdrew consent. Overall, thalidomide showed a good tolerability profile.
Thalidomide is currently approved by the European Medicines Agency (EMA) and Food and Drug Administration (FDA) in the US for the treatment of multiple myeloma (a cancer of the bone marrow).3,4
Notes to Editors
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 CongressTM which is the main scientific and professional event in hepatology worldwide
- Meetings including Monothematic and Special conferences, Post Graduate courses and other endorsed meetings that take place throughout the year
- Clinical and Basic Schools of Hepatology, a series of events covering different aspects in the field of hepatology
- Journal of Hepatology published monthly
- Participation in a number of policy initiatives at European level
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. Ho M-C et al. A randomized pilot phase II study of thalidomide as adjuvant therapy in patient with high recurrence risk hepatocellular carcinoma. Abstract Presented at The International Liver CongressTM 2011
2. Samuel M et al. Neoadjuvant and adjuvant therapy for surgical resection of hepatocellular carcinoma. Cochrane Database of Systematic Reviews 2009, Issue 1. Art. No.: CD001199. DOI: 10.1002/14651858.CD001199.pub2.
3. European Medicines Agency. http://www.ema.europa.eu/ema/index.jsp?. Accessed 09.03.2011.
4. EU-orphan. http://www.euorphan.com:81/active_substance/Default.aspx? Accessed 09.03.2011
