New data from Boehringer Ingelheim's hepatitis C virus (HCV) clinical development program have been accepted for presentation at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), also known as The Liver Meeting®, taking place November 1-5 in Washington, D.C.
Presentations will include data from several studies evaluating Boehringer Ingelheim's investigational compound, faldaprevir, including final results from the STARTVerso™ 1, 2 and 3 pivotal trial programs (NCT01343888, NCT01297270, NCT01358864) in treatment-naive and treatment-experienced patients. End-of-treatment results from STARTVerso 4™ (NCT01399619) evaluating HIV/HCV co-infected patients will also be presented.
Additionally, data will be presented from studies evaluating drug-drug interactions of faldaprevir with common birth control and anti-addiction medications, as well as a study evaluating faldaprevir pharmacokinetics, safety, and tolerability in patients with renal impairment. Final results from SOUND-C3 (NCT01132313), a Phase 2b study from Boehringer Ingelheim's interferon-free development program, will also be presented.
Together these studies explore the use of Boehringer Ingelheim's investigational HCV compounds in a broad range of patients with HCV, in addition to helping understand the potential for interactions with several commonly used medications. Also, they offer insight into the clinical profile of the compounds for researchers and healthcare professionals looking for potential new treatment options for patients with HCV.
"We are pleased to see the presentation of the final results from STARTVerso™ 1, 2 and 3, Boehringer Ingelheim's pivotal Phase 3 program in our hepatitis C portfolio, as well as other important analyses evaluating various patient subgroups at this year's AASLD meeting," said Peter Piliero, M.D., Vice President, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "These data, combined with that of our interferon-free trial, SOUND-C3, are evidence of our commitment to researching new therapeutic options for patients infected with HCV."
Faldaprevir and deleobuvir are investigational compounds and not approved by the FDA. Their safety and efficacy have not been established.
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