Boehringer Ingelheim has completed patient enrollment for a phase IIa clinical trial (NCT01859962) investigating a new interferon-free, all-oral, direct-acting antiviral (DAA) combination treatment for patients with genotype-1a chronic hepatitis C virus (HCV) infection. This trial is conducted in collaboration with Presidio Pharmaceuticals and evaluates Boehringer Ingelheim’s investigational compounds, the protease inhibitor faldaprevir (BI 201335) and non-nucleoside NS5B polymerase inhibitor, deleobuvir (BI 207127), in combination with Presidio’s investigational pan-genotypic NS5A inhibitor, PPI-668, with and without ribavirin.
The trial includes 36 treatment-naïve genotype-1a infected patients treated for 12 weeks with the all-oral DAA regimen, with 24 weeks of post-treatment follow-up. The primary endpoint of the trial is sustained virologic response 12 weeks after treatment is completed (SVR12).
In March, the two companies entered a non-exclusive collaboration to evaluate the three DAAs in combination regimens.Both companies will retain all rights to their respective compounds.Presidio has operational responsibility for this collaborative trial, with oversight by an intercompany project team. Final results are expected in Q2 2014.
Eliminating injectable interferon from treatment regimens is a critical goal in hepatitis C management.Clinical studies have shown that up to 50% of patients may not be eligible for treatment with interferon due to contraindications. Patients may also find interferon challenging due to long treatment duration and side effects.These side effects commonly include fatigue, anxiety, depression, gastrointestinal and flu-like symptoms. More serious side effects may include heart failure, sepsis, leukopenia and vision loss.
Jacob Lalezari, M.D., director of Quest Clinical Research in San Francisco, Calif., said, “By treating patients with multiple compounds that attack the hepatitis C virus in different ways, we hope to be able to cure more patients in less time with fewer of the side-effects associated with existing treatment options.”