Following an assessment of the blinded Phase III trial patient disposition data from HCVerso 1 and 2 for the combination of deleobuvir, faldaprevir and ribavirin, Boehringer Ingelheim has decided to halt further development of deleobuvir containing hepatitis C regimens.
Compared to other therapies in development, the combination showed a higher rate of premature discontinuations which may result in a lower efficacy rate than anticipated. Boehringer Ingelheim has concluded that the expected therapeutic value of the deleobuvir containing regimen would not justify further development.
Faldaprevir, Boehringer Ingelheim’s investigational second generation hepatitis C protease inhibitor, has shown promising results in combination with pegylated interferon and ribavirin in the STARTverso trials. It was recently granted accelerated assessment by the European Medicines Agency, PMDA, Taiwan FDA, and Swiss Medic. Ongoing regulatory reviews of faldaprevir are not affected by the decision on the interferon free development projects and Boehringer Ingelheim will move forward with the submission process.