Boehringer hails hepatitis C candidate
pharmafile | November 9, 2011 | News story | Sales and Marketing | BI201335, Boehringer Ingelheim, HCV, Incivo, Victrelis, hepatitis C
Boehringer Ingelheim believes that one of its investigational drugs for liver disease hepatitis C (HCV) could shorten patients’ treatment time and help in hard-to-treat cases.
The treatment of hepatitis C has moved forward recently, with Janssen’s Incivo (telaprevir) and Merck and Roche’s Victrelis (boceprevir) both recently launched in Europe.
Boehringer says its drug BI 201335 could cut the time a patient needed to take the drug to 12 weeks, matching the performance of Incivo.
The phase IIb studies SILEN-C1 and SILEN-C3 combined the protease inhibitor with standard of care pegylated interferon (PegIFN) and ribavirin (RBV) – which is only successful in about half of all cases – in previously untreated genotype 1 (GT1) HCV patients.
SILEN-C3 showed BI 201335 could improve sustained viral response (SVR) – increasing the likelihood of curing the disease – compared to 48 weeks of treatment with PegIFN/RBV alone.
Among patients achieving an extended rapid viral response (eRVR), 12 weeks with BI 201335 was sufficient to achieve SVR.
Patients with undetectable HCV RNA in the blood before week 12 had similar SVR rates, whether they were treated for 12 weeks (82%) or 24 weeks (81%).
And SILEN-C1 demonstrated that most patients with difficult to treat HCV subtypes, such as the viral GT1a – the hardest genotype to treat – or the IL-28B non-CC gene variant (polymorphism), achieved SVR.
Of patients with GT1a, the SVR rate was 82%, while 84% of those with GT1b achieved it. Meanwhile 71% for patients with the non-CC polymorphism of the IL-28B gene – who are less likely to achieve SVR with PegIFN/RBV treatment – and all those with the CC polymorphism, achieved SVR. Where IL-28B genotyping was missing, 86% achieved SVR.
HCV is a key cause of chronic liver disease and liver transplant, and is estimated to infect chronically 170 million people worldwide.
“Reducing the length of treatment time for HCV patients is one of several important goals for Boehringer Ingelheim as we seek to innovate a better cure for this chronic disease,” said Klaus Dugi, Boehringer’s corporate senior vice president medicine.
Results from phase III studies for the drug are expected in 2013, but if BI 201335 continues its progress, Boehringer faces stiff competition in the market.
Adam Hill
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