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Boehringer Ingelheim Announces Interim Results Evaluating Virologic Response Rates in HCV/HIV Co-Infected Patients Treated with Faldaprevir
Date:3/4/2013

RIDGEFIELD, Conn., March 4, 2013 /PRNewswire/ -- Today 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.

"Several factors influence the likelihood of treatment success in HCV mono-infected patients, including personal genetic makeup, viral genotype and stage of liver disease. Co-infection with HIV contributes additional factors, including potential drug-drug interactions, that influence treatment decisions and outcomes," said lead study investigator Douglas Dieterich , MD, Professor of Medicine, Liver Diseases at Mount Sinai Medical Center, New York, NY. "The early virologic response data from STARTVerso™ 4 are encouraging, especially given the inclusion of patients with cirrhosis, and we look forward to the final trial outcomes."

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