Date: 2011-11-07
Type of information:
phase: 2b
Announcement: results
Company: Boehringer Ingelheim (Germany)
Product: BI 201335
Action mechanism: BI 201335 is an oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV).
Disease: chronic hepatitis C
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: Boehringer Ingelheim has 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 infected with the most difficult to treat genotype-1 (GT1) HCV. 1 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. These data were presented today at the American Association for the Study of Liver Diseases (AASLD) 2011 Liver Meeting in San Francisco, USA. 1 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 patient blood: 70–76% of patients who received BI 201335 once daily (QD) + BI 207127 three times daily (TID) or twice daily (BID) with RBV 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 QD + BI 207127 TID without RBV achieved viral response at week 12 SVR12, which is considered highly predictive of SVR and cure of the infection, was achieved after 16 weeks of treatment in 59% of patients. The safety and tolerability profile was comparable to other direct acting antiviral regimens.
