Berlin, Germany, Saturday 02 April 2011: Exciting new data presented today at the International Liver CongressTM 2011 show that quadruple therapy in chronic hepatitis C (HCV) patients suppressed the emergence of resistant variants and resulted in a 100% rate of sustained virological response - undetectable HCV RNA - 12 weeks after treatment (SVR12).1
In the quadruple therapy study, HCV patients were given four drugs in combination; pegylated Interferon-alpha (PegIFN-alpha); ribavirin (RBV); and two different direct-acting antivirals (DAAs) BMS-650032 (an HCV NS3 protease inhibitor) and BMS-790052 (an HCV NS5A replication complex inhibitor).
The current standard of care (SoC) for HCV therapy is PegIFN-alpha plus RBV – a dual therapy. The addition of DAAs (currently in phase-III clinical trials) marks the next step in treatment evolution – a triple therapy. However, the new data presented today suggests that quadruple therapy could be the next generation of treatment for chronic HCV patients.
Professor Heiner Wedemeyer, EASL'S Secretary General, said: "Quadruple therapy is possibly the future of HCV treatment; this study goes a way to confirming that. While it's expected that the first DAAs and triple therapy will be approved for use later this year, quadruple therapy appears to have a more profound effect on virological response, with less of a resistance problem."
The study may also provide new hope for a growing number of HCV patients who cannot be effectively treated for chronic hepatitis with current treatments.
The Phase-IIa trial looked at a cohort of 21 HCV genotype 1 null responders (patients who have failed to respond to previous treatment), of whom 19 had an unfavourable IL28B genotype, which predisposes HCV patients to treatment failure.
Only about 30% of null responders to PegIFN-alpha/RBV treatment achieve sustained virological response (SVR) when retreated with PegIFN-alpha/RBV plus telaprevir, demonstrating a high unmet medical need.1
More information: 1. Lok A et al. Quadruple therapy with BMS-790052, BMS-650032 and peg-IFNRBV for 24 weeks results in 100% SVR12 in HCV genotype 1 null responders. Abstract presented at The International Liver CongressTM 2011. http://www1.easl.eu/easl2011/program/Orals/418.htm
Provided by European Association for the Study of the Liver
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EASL 46th Annual Meeting
March 30th - April 3rd 2011
Berlin, Germany
Quadruple Therapy With BMS-790052, BMS-650032 and Peg-IFN/RBV for 24 Weeks Results in 100% SVR12 in HCV Genotype 1 Null Responders: "HCV infection can be cured without interferon & ribavirin: 2 orals BMS790052+BMS650032"
Reported by Jules Levin
EASL 2011 April 2 Berlin Germany
Presented by Anna Lok
from Jules of NATAP: this is the biggest story & news to come out of this meeting, needless to say, and the biggest advancement in medicine in 50 years. In this study 4/11 null-responders receiving BMS-790052 (NS5A inhibitor) + BMS-650032 (protease inhibitor) alone for 24 weeks achieved SVR12 & SVR24. The presentation says "HCV infection can be cured without interferon & ribavirin". BMS-790052 & BMS-650032 with peg/RBV for 24 weeks: 10/10 patients achieved SVR12 & 9/10 achieved SVR24: "QUAD therapy can result in a high rate of cure in this difficult to treat population" (1 patient < LLOQ at week 24 post treatment undetectable on retesting 35 days later). This is the proof of concept we have been waiting for that at least some patients can be cured without peg/rbv, now these are the hardest to treat patients null-responders.
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