[ Back to EurekAlert! ] Public release date: 24-Apr-2013
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Contact: Dimple Natali
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European Association for the Study of the Liver

Direct-acting antivirals now ready for prime time

Studies show encouraging data in a wide range of HCV patient populations

Amsterdam, The Netherlands, Wednesday 24 April 2013: New data from a number of clinical trials presented for the first time at the International Liver Congress™ 2013 demonstrate encouraging results in the use of new direct-acting antiviral agents (DAAs) for the treatment of hepatitis C.

The following covers key results from the much anticipated Phase III trials conducted among HCV patients with a range of genotypes (GT 1 to 6) on DAA treatment.

POSITRON

NEUTRINO

EASL Secretary General Prof. Mark Thursz commented on the studies: "Unlike the US, in Europe and Asia genotype 3 is quite common. As such for European audiences the interferon-free results in genotype 3 are not as impressive as expected; however the side effect profile and lack of viral resistance means that longer treatment durations will be evaluated in the near future. In the meantime, we feel it's not time to bury pegylated interferon just yet."

"Many patients can tolerate 12 weeks of an interferon based regime particularly when it produces SVR rates of more than 90%; so clearly the results of the NEUTRINO study will be welcomed by clinicians and patients" added Prof. Thursz.

STARTVerso™1

QUEST-1 and -2

Prof. Mark Thursz commented on the exciting protease inhibitor data showcased at the congress: "With genotype-1 the most common and most challenging type of HCV to cure, both studies have demonstrated extremely encouraging results with cleaner profiles than existing protease inhibitors. It is unlikely telaprevir and boceprevir will remain in the hepatic armoury for much longer."

"We truly are in a prime time for HCV therapy; these effective new treatment options have the potential to pave the way for future interferon-sparing regimens and we look forward to using them in the clinic" added Prof Thursz.

Other promising Phase II data presented at the congress may provide further options:

ELECTRON

IFN and RBV Free Regimen

AVIATOR

EASL Secretary General Prof. Mark Thursz commented further: "With such high success rates and increased safety and tolerability with novel DAAs, patients can be optimistic about oral treatment regimens in the not-too-distant future."

Disclaimer: The data referenced in this release is based on the submitted abstract. More recent data may be presented at the International Liver Congress™ 2013.

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Notes to Editors

Worldwide estimates indicate that approximately 200 million people are chronically infected with the hepatitis C virus and at risk of developing liver cirrhosis and/or liver cancer. Every year, 3 million people are infected with hepatitis C and more than 350,000 people die from hepatitis C-related liver diseases.

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 2013

The International Liver Congress™ 2013, the 48th annual meeting of the European Association for the study of the Liver, is being held at the RAI Convention Centre in Amsterdam from April 24 – 28, 2013. The congress annually attracts in excess of 9000 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.

1 Jacobson, I et al, TREATMENT WITH SOFOSBUVIR+RIBAVIRIN FOR 12 WEEKS ACHIEVES SVR12 OF 78% IN GT2/3 INTERFERON- INELIGIBLE, -INTOLERANT, OR -UNWILLING PATIENTS: RESULTS OF THE PHASE 3 POSITRON TRIAL. Presented at the International Liver Congress™ 2013

2 Lawitz, E et al, SOFOSBUVIR + PEGINTERFERON + RIBAVIRIN FOR 12 WEEKS ACHIEVES 90% SVR12 IN GENOTYPE 1, 4, 5, OR 6 HCV INFECTED PATIENTS: THE NEUTRINO STUDY. Presented at the International Liver Congress™ 2013

3 Ferenci, P et al, FALDAPREVIR PLUS PEGYLATED INTERFERON ALFA-2A AND RIBAVIRIN IN CHRONIC HCV GENOTYPE-1 TREATMENT-NAÏVE PATIENTS: FINAL RESULTS FROM STARTVERSO1, A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE III TRIAL. Presented at the International Liver Congress™ 2013

4 Jacobson, I et al, SIMEPREVIR (TMC435) WITH PEGINTERFERON/RIBAVIRIN FOR CHRONIC HCV GENOTYPE-1 INFECTION IN TREATMENT-NAÏVE PATIENTS; RESULTS FROM QUEST-1, A PHASE III TRIAL. Presented at the International Liver Congress™ 2013

5 Manns M, et al, SIMEPREVIR (TMC435) WITH PEGINTERFERON/RIBAVIRIN FOR CHRONIC HCV GENOTYPE-1 INFECTION IN TREATMENT-NAÏVE PATIENTS; RESULTS FROM QUEST-2, A PHASE III TRIAL. Presented at the International Liver Congress™ 2013

6 Gane EJ, et al, ALL-ORAL SOFOSBUVIR-BASED 12-WEEK REGIMENS FOR THE TREATMENT OF CHRONIC HCV INFECTION: THE ELECTRON STUDY Presented at the International Liver Congress™ 2013

7 Everson, GT et al, INTERIM ANALYSIS OF AN INTERFERON (IFN)- AND RIBAVIRIN (RBV)-FREE REGIMEN OF DACLATASVIR (DCV), ASUNAPREVIR (ASV), AND BMS-791325 IN TREATMENT-NAIVE, HEPATITIS C VIRUS GENOTYPE 1-INFECTED PATIENTS. Presented at the International Liver Congress™ 2013

8 Kowdley, KV et al, SAFETY AND EFFICACY OF INTERFERON-FREE REGIMENS OF ABT-450/R, ABT-267, ABT-333 +/- RIBAVIRIN IN PATIENTS WITH CHRONIC HCV GT1 INFECTION: RESULTS FROM THE AVIATOR STUDY. Presented at the International Liver Congress™ 2013

9 EASL Clinical Practice Guidelines: Management of hepatitis C virus infection. European Association for the Study of the Liver. Journal of Hepatology 2011;55:245

10 Hepatitis C Fact Sheet. World Health Organisation factsheet. Available at http://www.who.int/mediacentre/factsheets/fs164/en/index.html. Last accessed 28.03.13



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