The future looks bright for HCV patients who have failed to respond to current treatments

April 1, 2011

Berlin, Germany, Friday 1st April 2011: Highly anticipated data from a number of clinical trials presented for the first time at the International Liver CongressTM confirmed that a range of new proteases inhibitors will help treat patients who have previously failed therapy for the treatment of chronic hepatitis C.1,2,3,4,5

The treatments have been tested for efficacy and safety in combination with PegIFN-alpha and in patients that have previously failed treatment (either non-responder or ). Following different treatment and dosing, all of the trials demonstrated good response rates at key timepoints during the treatment period and with remarkably high sustained viral response rates.

These findings provide new hope for a growing number of HCV patients who cannot currently be effectively treated for chronic hepatitis. It is known that one of the most important determinants of poor treatment response is the of the patient (with polymorphic mutation on IL28B gene for genotype 1). The current standard of care for chronic HCV is the combination of PegIFN-alpha and ribavirin6, but only 40-54% of patients infected with HCV genotype 1 achieve a sustained virological response (SVR).7 Retreatment with standard of care regimens only achieves SVR in 10-20% of patients but the new trial data released at the International Liver Congress show SVR rates of 40-80% when protease inhibitors are used even in the presence of the IL-28b .

Professor Heiner Wedemeyer, EASL's Secretary General commented on the exciting new data being showcased at the congress: "Up until now, telling a patient that their treatment has failed has been particularly difficult knowing that there were no other options available and their disease was progressing. These results completely change the situation because patients who did not have successful treatment in the past now have a realistic chance of being cured. For both clinicians and patients, this is a new era in the treatment of viral hepatitis C, which is very exciting."

With new research currently being published in terms of treatment options, EASL is publishing the first clinical practice guidelines for the management of virus infection, which provide experts recommendations on the standard of care for the diagnosis, treatment and monitoring of patients with chronic HCV infection and associated complications. The guidelines will be updated to include new treatments once approved by the European Medicines Agency (EMA).

More information: References

1. Flamm et al. HIGH SUSTAINED VIROLOGIC RESPONSE (SVR) AMONG GENOTYPE 1 PREVIOUS NON-RESPONDERS AND RELAPSERS TO PEGINTERFERON/RIBAVIRIN WHEN RE-TREATED WITH BOCEPREVIR (BOC) PLUS PEGINTERFERON ALFA-2A/RIBAVIRIN. LB#1366. Presented at the International Liver CongressTM. 31st March 2011.

2. Zeuzem et al. THE ASPIRE TRIAL: TMC435 IN TREATMENT-EXPERIENCED PATIENTS WITH GENOTYPE-1 HCV INFECTION WHO HAVE FAILED PREVIOUS PEGIFN/RBV TREATMENT. LB #1376. Presented at the International Liver CongressTM. 31st March 2011.

3. Zeuzem S et al. REALIZE trial final results: Telaprevir-based regimen for genotype 1 hepatitis C virus infection in patients with prior null response, partial response or relapse to peginterferon/ribavirin. #2371. Presented at the International Liver CongressTM. 31st March 2011

4. Sulkowski M et al. SILEN-C2: SUSTAINED VIROLOGIC RESPONSE (SVR) AND SAFETY OF BI201335 COMBINED WITH PEGINTERFERON ALFA-2A AND RIBAVIRIN (P/R) IN CHRONIC HCV GENOTYPE-1 PATIENTS WITH NON-RESPONSE TO P/R . #744. Presented at the International Liver CongressTM. 01 April 2011

5. Jacobson I et al. TELAPREVIR SUBSTANTIALLY IMPROVED SVR RATES ACROSS ALL IL28B GENOTYPES IN THE ADVANCE TRIAL. LB #1369. Presented at the International Liver CongressTM. 31st March 2011

6. Fried, M. W. et al. "Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection." New England Journal of Medicine 347.13 (2002): 975-82

7. Hadziyannis, S. J. et al. "Peginterferon-alpha 2a and ribavirin combination therapy in chronic hepatitis C - A randomized study of treatment duration and ribavirin dose." Annals of Internal Medicine 140.5 (2004): 346-55

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