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Phase 3 data show viral cure rates achieved in a broad range of patients with genotype-1 hepatitis C taking investigational compound faldaprevir plus PegIFN/RBV
Date:11/2/2013

1% (PegIFN/RBV) of patients. Further, AEs leading to the discontinuation of faldaprevir occurred in 1% (120mg) and 3% (240mg) of patients.

In STARTVerso™3, AEs of at least moderate intensity in the 12- and 24-week faldaprevir arms included gastrointestinal side effects, which occurred in 20% (12-week), 17% (24-week) and 6% (PegIFN/RBV alone) of patients. Anemia occurred in 10% of patients in both faldaprevir arms (12- and 24-week) and 5% of patients taking (PegIFN/RBV alone). Rash, photosensitivity, and jaundice occurred in </= 5% of faldaprevir patients (12- or 24-week arms). Further, AEs leading to the discontinuation of faldaprevir occurred in 7% (12-week) and 8% (24-week) of patients. In STARTVerso™4 to date, nausea has occurred in 28% and 44% of patients taking 120mg and 240mg faldaprevir regimens, respectively. Additionally, fatigue has occurred in 32% (120mg) and 35% (240mg) of patients, diarrhea has occurred in 25% (120mg) and 28% (240mg) of patients, headache has occurred in 24% (120mg) and 25% (240mg) of patients, asthenia has occurred in 26% (120mg) and 21% (240mg) of patients, and decreased appetite has occurred in 24% (120mg) and 20% (240mg) of patients. Thus far, discontinuation of faldaprevir due to AEs leading to the discontinuation of faldaprevir has occurred in 1% (120mg and 240mg) of patients. Serious AEs occurred in 14% (120mg) and 8% (240mg) of patients, resulting in one death from Stevens-Johnson syndrome (SJS) with onset 145 days after discontinuing treatment while on systemic antibiotics.

Additional Boehringer Ingelheim Data at the Meeting
Additional late breaking data from Boehringer Ingelheim's collaborative interferon-free trial with Presidio Pharmaceuticals will be presented on Monday, November 4. This ongoing Phase 2a study evaluates a 12-week, all-oral regimen of Boehringer Ingelheim's investigational compounds, faldaprevir and deleobuvir, in combination with Presidio's investigational pan-genotypic NS5
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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