DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Faldaprevir
BI 201335
http://clinicaltrials.gov/ct2/show/NCT01343888
CAS Number: 801283-95-4
Molecular Formula: C40H49BrN6O9S
Molecular Weight: 869.82 g.mol
RIDGEFIELD, Conn., March 4, 2013
Boehringer Ingelheim Pharmaceuticals, Inc. announced the first interim results in HCV/HIV co-infected patients from the company’s ongoing hepatitis C (HCV) clinical trial program, HCVerso™. These results, from the Phase 3 trial STARTVerso™ 4, were presented today at the 20th annual Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta, GA.
The interim results showed that 80% of HCV/HIV co-infected patients achieved early treatment success (ETS)*, as defined by the study protocol, when given an investigational HCV regimen that included faldaprevir (BI 201335). Results were consistent across patients regardless of HIV therapy or prior HCV treatment status, including patients who were HCV treatment-naive or had previously relapsed during HCV treatment with pegylated interferon and ribavirin (PegIFN/RBV). Patients who achieved ETS were eligible for randomization to a shortened duration of treatment (24 weeks versus 48 weeks). Investigators also reported on-treatment virologic response at week 12, which showed that 84% of all study patients had undetectable levels of hepatitis C virus.
For more information, please visit http://us.boehringer-ingelheim.com
Faldaprevir, also known as BI 201335, is an investigational, oral protease inhibitor that is specifically designed to target viral replication in the liver. The ongoing multi-study Phase 3 STARTVerso™ trial program, evaluating faldaprevir combined with PegIFN/RBV in treatment-naive, treatment-experienced and HIV co-infected patients with chronic genotype-1 HCV, is near clinical completion. BI 207127 is an investigational NS5B non-nucleoside polymerase inhibitor that has shown the potential to eliminate interferon from HCV treatment when combined in a regimen with faldaprevir and RBV. Phase 2 trials of this interferon-free regimen have been completed and Phase 3 HCVerso™ trials investigating this regimen are now underway.
Faldaprevir and BI 207127 are investigational compounds and not approved by the FDA. Their safety and efficacy have not been established.
Hepatitis C is a blood-born infectious disease and a leading cause of chronic liver disease,transplant and failure that affects as many as 150 million people globally. In the United States, an estimated 4.1 million Americans have been infected with HCV, of which approximately 3.2 million have chronic HCV infection. Since 1999 there has been a significant increase in deaths due to chronic HCV, accounting for 15,000 deaths in the United States in 2007.
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