Boehringer Ingelheim's Faldaprevir-Based Treatment Regimen Achieved Viral Cure in up to 80 Percent of Patients with Hepatitis C in Phase 3 Pivotal Trial

Source: PharmaManufacturing.com

Apr 23, 2013

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc. today announced results from the pivotal Phase 3 STARTVerso trial of faldaprevir in combination with pegylated interferon and ribavirin. In previously untreated patients with genotype-1 hepatitis C virus (HCV) who received once-daily faldaprevir plus PegIFN/RBV, 79% and 80% in the 120mg and 240mg arms, respectively, achieved viral cure when measured 12 weeks after treatment was completed. This is compared with 52% of patients receiving PegIFN/RBV plus placebo.

In addition, protocol-defined early treatment success (ETS) was achieved by 87% and 89% of patients treated with the faldaprevir-based regimen (120mg or 240mg, respectively), meaning they were eligible for an overall shorter treatment duration of 12 weeks faldaprevir/24 weeks PegIFN/RBV. Of those patients who completed treatment early, 86% and 89% (120mg or 240mg, respectively) went on to achieve viral cure (SVR12). This demonstrates that an overall treatment regimen of 24 weeks was sufficient to achieve viral cure in most patients, cutting treatment duration in half when compared to treatment with PegIFN/RBV alone (48 weeks). A goal in HCV treatment innovation is to reduce the amount of time patients are exposed to treatment with interferon.

STARTVerso included a diverse range of genotype-1a and 1b patients, including patients with compensated cirrhosis (a condition where the liver is heavily scarred but still able to function), who are challenging to treat and cure. The results will be presented tomorrow at EASL's International Liver Conference (ILC) as part of the official press conference and by Professor Peter Ferenci as a late-breaking oral presentation on April 27 (abstract #3281).

"In the STARTVerso study, faldaprevir has shown efficacy in a range of genotype-1a and 1b HCV patients with and without cirrhosis," said Principal Investigator Professor Peter Ferenci of the Medical University Vienna. "The viral cure rates and potential for shorter treatment duration seen in STARTVerso are very encouraging for the many patients currently facing a year of interferon-based treatment."

Serious adverse events were experienced by 6% (n=8) of placebo patients, 7% (n=17) of patients receiving 120mg faldaprevir and 7% (n=17) of patients receiving 240mg faldaprevir. Anemia (11%, 13%, 12%), rash (6%, 8%, 9%) and gastrointestinal issues (3%, 7%, 12%) were the most common Grade 2-4 adverse events in the placebo, faldaprevir 120mg and faldaprevir 240mg arms, respectively. No rash events were life-threatening; 1% of patients discontinued treatment in each study arm due to rash. Adverse events led to discontinuation of study medications in 4% (n=5), 4% (n=10) and 5% (n=14) in the placebo, faldaprevir 120mg and faldaprevir 240mg arms, respectively.

"With the results of the first of our pivotal faldaprevir trials, STARTVerso(TM)1, now available, Boehringer Ingelheim is making strides toward our short-term goal of providing a treatment option with a shorter duration for HCV patients eligible for interferon-based regimens, " said Peter Piliero, MD, vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We are developing faldaprevir as a potential foundation for both interferon-based and interferon-free treatment regimens. We are optimistic that ongoing studies with our pipeline compounds will lead to faldaprevir-based interferon-free regimens for patients with HCV."

In separate abstracts at EASL's ILC meeting, sub-analyses from Boehringer Ingelheim's interferon-free Phase 2b SOUND-C2 study are also being presented. These include data regarding viral response rates by level of fibrosis (abstract #1227), predictors of anemia (abstract #1186) and pharmacokinetic modeling of the relationship between virologic response and the level of faldaprevir or BI 207127 found in the blood (abstract #1212). The SOUND-C2 trial evaluated the interferon-free combination of faldaprevir and BI 207127, an investigational non-nucleoside NS5B polymerase inhibitor, plus ribavirin.

Presentation abstracts can be accessed through the congress website.
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