Date: 2013-01-17
Type of information: Initiation of patient enrollment
phase: 3
Announcement: enrolment of the first patients
Company: Boehringer Ingelheim (Germany)
Product: IFN-free investigational polymodal regimen combining faldaprevir (BI 201335), BI 207127 plus ribavirin.
Action
mechanism: Faldaprevir (BI 201335) is a next wave once-daily protease inhibitor, and BI 207127 is a non-nucleoside polymerase inhibitor.
Disease: hepatitis C
Therapeutic area: Infectious diseases
Country: US, Europe, Canada, and Australia
Trial
details: The HCVerso™ clinical trial programme includes two Phase III IFN-free clinical trials that will treat approximately 1,000 treatment-naïve HCV genotype-1b (GT-1b) patients. Trial sites are planned for many different countries around the world, including the US, Germany, Canada, and Australia.
HCVerso 1 1
In this Phase III study, more than 460 treatment-naïve GT-1b HCV patients will be treated. Patients will be randomised (1:1) into two treatment arms. A third, open label arm will treat up to 70 cirrhotic patients.
- Group 1: 24 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV
- Group 2: 16 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV followed by an additional 8 weeks of placebo
- Group 3 (patients with compensated liver cirrhosis): 24 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV (NCT01732796)
HCVerso 2 2
In this Phase III study, more than 490 treatment-naïve GT-1b HCV patients will be treated. This study includes patients who are eligible or ineligible for interferon. Patients will be randomised (1:1) into two treatment arms. A third, open-label arm will treat up to 70 cirrhotic patients.
- Group 1: 24 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV
- Group 2: 16 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV (initial 8 weeks of placebo)
- Group 3 (patients with compensated liver cirrhosis): 24 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV
Latest
news: * On June 20, 2014, Boehringer Ingelheim has re-evaluated its strategy in hepatitis C, and as a result the company has decided not to move forward in this therapeutic area. The HCV treatment environment has significantly and rapidly evolved since the submission of the faldaprevir marketing applications to regulatory bodies around the world. There are now several new treatment options available for patients and additional all-oral options are expected to be approved in 2014. This decision was taken as there is no longer an unmet medical need for the faldaprevir interferon-based regimen that was the subject of the application. Boehringer Ingelheim will withdraw all pending marketing applications for faldaprevir worldwide and is discontinuing further development. * On January 17, 2013, Boehringer Ingelheim announced that the first patients have been enrolled in the company’s pivotal Phase III interferon (IFN)-free hepatitis C (HCV) clinical trial programme, HCVerso™. Boehringer Ingelheim’s IFN-free investigational polymodal* regimen combines faldaprevir (BI 201335)+, a next wave once-daily protease inhibitor, and BI 207127+, a non-nucleoside polymerase inhibitor, plus ribavirin. The HCVerso™ clinical trial programme includes two Phase III IFN-free clinical trials that will treat approximately 1,000 treatment-naïve HCV genotype-1b (GT-1b) patients. The decision to focus the Phase III trials on this patient group follows positive Phase IIb trial data from the SOUND-C studies, where Boehringer Ingelheim’s IFN-free investigational polymodal* regimen showed high viral cure rates in patients with GT-1b HCV, the most prevalent type of HCV globally. Results from the SOUND-C2 study, which were presented in November 2012 at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), found that up to 85 percent of GT-1b HCV patients treated with different IFN-free regimens of faldaprevir, BI 207127 and ribavirin achieved viral cure at 12 and 24 weeks following treatment completion (SVR12 and SVR24)
New preliminary results from the SOUND-C3 trial show that 100 percent (n=20) of HCV patients with GT-1b achieved viral elimination when measured four weeks (SVR4) after completing a 16 week course of treatment. These data further support the choice of this patient population for Phase III. Full results from SOUND-C3 are expected in early 2013.
Data from the HCVerso studies are expected in late 2013.
