Terms used in these reports:
- RVR (Rapid virological response)= No virus detected at week 4
- eRVR(Extended rapid virological response) = No virus detected at week 4 and week 12
- EVR (Early Virological Response) — 2 log drop of HCV RNA after 12 weeks.
- cEVR = Complete Early Virological Response — No virus detected after 12 Weeks.
- SVR12 (Sustained virological response) = No virus detected at 12 weeks after completion of treatment.
- SVR24 = No virus detected at 24 weeks after completion of treatment.
Boehringer Ingelheim are developing a combination therapy that consists of a polymerase inhibitor BI 207127 and a protease inhibitor BI 201335 taken together with or without Ribavirin. Current research is showing good results for patients with the most difficult to treat genotype-1.
Like many of the other DAA’s (Direct Acting Antivirals) in development, these studies are being conducted without the use of Interferon and will be an all oral (in the form of pills) treatment.
70–76% of participants who received BI 207127 and BI 201335 with Ribavirin in the phase II studies achieved undetectable HCV RNA at week 12.
57% of participants who received BI 201335 and BI 207127 without Ribarivin achieved viral response at week 12
SVR12 (A sustained virolgical response that shows 12 after treatment), which is considered highly predictive of SVR and cure of the virus, was achieved after having 16 weeks of treatment in 59% of patients.
A copy of the Press release containing the latest research into BI 207127 and BI 201335 that was unveiled at the American Association for the Study of Liver Diseases Liver Meeting (AASLD 2011) is below.
BI 201335 plus BI 207127
Data from pre-specified interim analysis of Phase IIb SOUND-C21 trial with Boehringer Ingelheim’s two investigational HCV direct-acting antivirals presented at AASLD
Boehringer Ingelheim today announced results from a pre-specified interim analysis of a Phase IIb study, named SOUND-C2. These data showed the combination of two oral direct acting anti hepatitis C virus (HCV) compounds (the protease inhibitor BI 201335 and the polymerase inhibitor BI 207127, with and without ribavirin (RBV), was successful in providing virological response rates at week 12 in treatment-naïve patients with the most difficult to treat genotype-1 (GT1) HCV.
The shortest treatment duration tested in the study (16 weeks) achieved SVR12 in 59% of patients. None of the five study arms included treatment with interferon.
“Results from the interim analysis of SOUND-C2 look promising,” said Stefan Zeuzem, M.D., Chief of the Department of Medicine and Professor of Medicine at the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany and lead investigator of the study. “They highlight the potential of BI 201335 plus BI 207127 to lessen the burden of existing treatments for a large portion of patients by offering a potential treatment option without the inclusion of interferon.”
The use of interferon in HCV treatment is challenging for a number of patients due to suboptimal response rates, contraindications or severe side effects and treatment durations.
All five treatment arms of the interferon-free oral combination therapy of BI 201335/BI 207127/RBV showed high virologic response rates through week 12, defined by measuring the level of HCV RNA in patients’ blood:
70–76% of patients who received BI 201335 once daily + BI 207127 three times daily or twice daily with Ribavirin achieved undetectable HCV RNA at week 12, with 13–21% of patients developing a viral load breakthrough during treatment
57% of patients who received BI 201335 once daily + BI 207127 three times dailywithout Ribavirin achieved viral response at week 12.SVR12, which is considered highly predictive of SVR and cure of the virus, was achieved after 16 weeks of treatment in 59% of patients.
The safety and tolerability profile was comparable to other direct acting antiviral regimens.
