Monday, December 16, 2013

Hepatitis C: Phase III Data Show Boehringer Ingelheim's Faldaprevir* is Effective Even in Patients with Common Drug-Resistant Viral Variant

INGELHEIM, Germany - Monday, December 16th 2013 [ME NewsWire]

Summary: Naturally occurring mutations in the hepatitis C virus (HCV) are common and many lead to reduced efficacy of antiviral treatments. Faldaprevir* has now been shown to be effective even in patients with the common HCV Q80K variant,1 which affects an estimated 700,0002,3,4 patients in the USA alone. Faldaprevir* is being studied in combinations both with and without interferon. The EMA recently granted accelerated assessment for faldaprevir* as part of an interferon-based regimen and a decision on marketing authorisation is anticipated next year.5,6

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Data show that Boehringer Ingelheim’s second-generation protease inhibitor faldaprevir*, when used in combination with pegylated interferon and ribavirin, was effective even with the presence of naturally-occurring mutant variants of the hepatitis C virus (HCV), such as the NS3 Q80K polymorphism. The Q80K mutant was detected in 23% (49/127, STARTVerso™1) and 40% (159/398, STARTVerso™2) of genotype-1a infected patients. Its presence was found to have no effect on the chances of viral cure (SVR12) in genotype-1 infected hepatitis C patients treated with faldaprevir* plus pegylated interferon and ribavirin.1 These data were presented last week at HEP DART 2013, taking place in Big Island, Hawaii.

“These data are encouraging as they demonstrate that HCV genotype-1 infected patients irrespective of the presence of the common HCV Q80K variant may benefit from faldaprevir*,” said Christoph Sarrazin, M.D., Professor of Medicine at the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany. “In some parts of the world, the Q80K mutation is present in almost 50% of genotype-1a infected patients, who will potentially require additional screening prior to using some HCV protease inhibitors. With faldaprevir’s*efficacy against HCV Q80K, physicians should be able to avoid screening for this mutation prior to treatment of genotype-1a infected patients.”

The HCV NS3/4A protease is essential for viral replication and is a key target for direct acting antiviral (DAA) treatments such as faldaprevir*. The NS3 Q80K variant is the most commonly observed NS3 polymorphism in genotype-1a HCV and has been reported in up to 47% of genotype-1a infected patients. The variation in frequency is influenced by the geography, with the prevalence of Q80K being particularly high in the USA.4

Faldaprevir* is the core component of Boehringer Ingelheim’s investigational hepatitis C pipeline and is being studied in combinations both with and without interferon. Faldaprevir*was recently granted accelerated assessment by the European Medicines Agency. If approved by the European Commission, faldaprevir* could be available for marketing in the EU in the second half of 2014 as part of an interferon-based regimen. In addition, Boehringer Ingelheim aims to deliver one of the first interferon-free regimens for the treatment of hepatitis C infection. Pivotal Phase III HCVerso® data for the interferon-free regimen of faldaprevir*, deleobuvir* and ribavirin will be available in 2014.

Additional data from Boehringer Ingelheim at HEP DART

Data presented last week as part of the ‘oral abstract session II’ show a high rate of virologic response in patients treated with a 12 week all-oral combination of Boehringer Ingelheim’s faldaprevir* and deleobuvir* and Presidio’s PPI-668* with and without ribavirin.7 Results from the ongoing Phase II trial were recently presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).

*Faldaprevir, deleobuvir and PPI-668 are investigational compounds and not yet approved. Their safety and efficacy have not yet been fully established.



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1. Sarrazin et al. NS3/4A baseline polymorphisms and treatment-emergent variants in HCV genotype-1 infected, treatment-naïve patients from the Phase III STARTVerso1 and 2 clinical studies of faldaprevir plus pegylated interferon a-2A and ribavirin. Presented at HEP DART 2013.

2. Centers for Disease Control and Prevention. Hepatitis C FAQs for health professionals. [last accessed 03/12/13]

3. Theodore Sy, M. Mazen Jamal. Epidemiology of Hepatitis C Virus (HCV) Infection. Int J Med Sci 2006; 3(2):41-46.

4. Berger et al. Baseline HCV NS3 Polymorphisms and their Impact on Treatment Response in Clinical Studies of the HCV NS3 Protease Inhibitor Faldaprevir. Antimicrob Agents Chemother. 2013 Nov 11.

5. Boehringer Ingelheim Data on file. European Medicines Agency, Human Medicines Evaluation Division. (Faldaprevir Boehringer Ingelheim, Boehringer Ingelheim International GmbH). Submission validation, 21 November, 2013

6. Boehringer Ingelheim Data on file. European Medicines Agency, Human Medicines Evaluation Division. (Faldaprevir Boehringer Ingelheim, Boehringer Ingelheim International GmbH). Accelerated assessment acceptance, 12 November, 2013

7. Lalezari, et al. Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection. Presented at HEP DART 2013


Contact: Reinhard Malin

Boehringer Ingelheim

Corporate Communications

Media + PR

Reinhard Malin

Tel: +49 (6132) 77-90815



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