Quadruple therapy shows 100 percent SVR for HCV patients previously unresponsive to treatment
Is this treatment approach the next HCV therapy frontier?
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
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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.
http://www.eurekalert.org/pub_releases/2011-04/eaft-qts040111.php
References
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
Bristol-Myers Interferon-Free Combo Cured Hepatitis Patients
By Naomi Kresge - Apr 2, 2011 12:48 PM ET
Bristol-Myers Squibb Co. (BMY)’s cocktail of two experimental drugs cured four hepatitis C patients in the first success for a therapy that excludes often-toxic existing drugs.
The combination had a higher rate of success when paired with the current standard treatment in the 21-person trial, curing nine of 10 patients, researchers said today at the Berlin meeting of the European Association for the Study of the Liver. The study points to the next generation of drugs for the evasive virus, said Mark Thursz, a professor of hepatology at Imperial College London and vice-secretary of EASL.
Bristol-Myers, based in New York, is among about a dozen companies trying to make better drug combinations that either include interferon, a decades-old shot that causes flu-like symptoms and only works in half of patients, or that replace interferon entirely. At stake is leadership in a market that Jefferies International Ltd. estimates may total $15 billion a year by 2019.
“This is perhaps one of the most exciting developments this year,” Thursz said in an interview. “For some patients who are not going to tolerate interferon, this is the light at the end of the tunnel.”
Bristol-Myers plans to begin the last trials required for regulatory approval this year, Douglas Manion, the drugmaker’s head of neuroscience and virology research, said in an interview.
Toughest-to-Treat
Today’s trial studied the Bristol-Myers drugs, BMS-790052 and BMS-650032, in patients for whom existing therapies hadn’t been successful, “the toughest-to-treat population,” Manion said.
Ten patients got the two drugs together with interferon and generic ribavirin. All showed no sign of the virus 12 weeks after the treatment was over. One patient had signs of virus at 24 weeks and was again virus-free in another follow-up test 35 days later.
Of 11 patients who took the Bristol-Myers combination alone, five had cleared the virus from their bodies at the end of treatment. Four remained virus-free after 24 weeks.
Patients may start treatment earlier if they aren’t faced with the toxic side effects of traditional hepatitis C drugs, said Howard Liang, a Boston-based analyst for Leerink Swann & Co., in an interview.
“If you have an interferon-free regimen, the market expands fairly dramatically,” Liang said.
Side Effects
Side effects of the existing interferon regimen are often severe enough to force patients to take time off work, said Charles Gore, president of the Geneva-based patient advocacy group World Hepatitis Alliance.
Roche Holding AG (ROG) of Basel, Switzerland, sells a version of interferon under the brand name Pegasys, while Merck & Co. of Whitehouse Station, New Jersey markets a form called PegIntron.
Merck, Vertex Pharmaceuticals Inc. (VRTX) and Johnson & Johnson are expected to bring the first new hepatitis C drugs in a decade to the market this year. About 90 percent of patients who responded quickly to treatment with Johnson & Johnson (JNJ) and Vertex’s telaprevir were cured, Cambridge, Massachusetts-based Vertex said in two studies last year. Three-quarters of all patients were cured. Patients who responded quickly to Merck’s boceprevir showed similarly high cure rates in studies last year, with about two-thirds of all patients being cured.
The Vertex and Merck trials included people who hadn’t yet been treated, an easier-to-cure group than those in today’s smaller study. By comparison, about 30 percent of those who hadn’t responded to previous treatment were cured after trying telaprevir plus standard therapy, researchers said.
Seeking Partners
Merck is seeking partnerships to gain its own hepatitis C drug combinations, Patrick Bergstedt, general manager of the infectious diseases franchise, said in an interview.
“We’re behind the others,” Bergstedt said. “We need to partner to fill the gap.”
Bristol-Myers expects an “element of consolidation” as companies use acquisitions, partnerships and research and development collaborations to gain their own hepatitis C drug combinations, Manion said. After signing a development deal with Princeton, New Jersey-based Pharmasset Inc. (VRUS) in January, Bristol- Myers is “talking to pretty much every company out there,” he said.
“This is like trying to redesign a car as you’re rolling down the road at 100 miles per hour, because the data are coming so fast,” he said. “What an exciting time.”
To contact the reporter on this story: Naomi Kresge in Frankfurt at nkresge@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
http://www.bloomberg.com/news/2011-04-02/bristol-myers-interferon-free-combo-cured-hepatitis-c-patients.html?cmpid=yhoo
Bristol-Myers Presents HCV Data
Recently, Bristol-Myers Squibb Company (NYSE: BMY - News) presented encouraging data from a phase II study (n=48) which evaluated its candidate BMS-790052 as a combination therapy for treating patients suffering from the hepatitis C virus (HCV). Bristol-Myers presented data from the mid-stage study at the 46th annual meeting of the European Association for the Study of the Liver in Germany.
The double-blind study evaluated BMS-790052 at three doses (3 mg, 10 mg or 60 mg) in treatment-naïve patients infected with genotype 1 chronic HCV. Results from the study revealed that the rate of SVR12 (sustained virologic response – absence of detectable HCV at 12 weeks post treatment ) achieved by patients treated with a combination of BMS-790052, PEG-interferon alfa and ribavirin (the standard of care) was higher across all evaluated doses than those receiving placebo in combination with PEG-interferon alfa and ribavirin. The patients were divided equally into four groups.
Patients in the 10 mg arm achieved the highest rate (92%) of SVR12. 83% and 42% patients achieved SVR12 in the 60 mg and 3 mg arms of BMS-790052 respectively. Adverse events and serious adverse events were found to be consistent with those in the PEG-Interferon alfa and ribavirin arm across all 3 doses of BMS-790052.
We believe that if BMS-790052 is developed and commercialized successfully then it would not only boost Bristol-Myers’ portfolio but would provide a wider choice to HCV patients in a lucrative market that has a huge unmet need.
http://finance.yahoo.com/news/BristolMyers-Presents-HCV-zacks-732778265.html?x=0&.v=1
More On The Study; EASL; BMS-790052 Plus PEG-Interferon Alfa/Riba Achieved Up to 92% SVR-Naïve Geno1 HCV Patients
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