- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
Positive Phase II Results Reported for IFN-Free Regimen in Patients With Hepatitis C
Rapid virologic response in 97% of patients (October 8)
Positive interim data have been reported from an ongoing phase II study of an all-oral triple regimen of investigational compounds, consisting of the protease inhibitor faldaprevir (BI 201335, Boehringer Ingelheim) and the non-nucleoside NS5B polymerase inhibitor deleobuvir (BI 207127, Boehringer Ingelheim), in combination with an investigational pan-genotypic NS5A inhibitor, PPI-668 (Presidio Pharmaceuticals), with and without ribavirin, in patients with hepatitis C virus (HCV) infection.
The new data will be presented Nov. 4 at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Washington, D.C.
The ongoing study includes 29 patients with HCV infection. The study’s primary endpoint is viral cure 12 weeks after treatment completion (SVR12).
To date, 97% of the patients (28/29) have achieved undetectable levels of virus by week 4 of treatment, which qualifies as a rapid virologic response (RVR). In addition, all of the patients who have completed treatment (13/13) achieved nondetectable levels of virus at the end of therapy.
Faldaprevir is an investigational oral protease inhibitor that is specifically designed to target viral replication in the liver. Deleobuvir is an investigational NS5B non-nucleoside polymerase inhibitor that has shown the potential to eliminate interferon (IFN) from HCV treatment when combined in a regimen with faldaprevir and ribavirin.
Source: Boehringer Ingelheim; October 8, 2013.