In September, Boehringer Ingelheim Pharmaceuticals, Inc., announced the completion of patient enrollment for a Phase 2a clinical trial investigating a new interferon-free, all-oral, direct-acting antiviral combination treatment for patients with genotype-1a chronic hepatitis C virus (HCV) infection.
The existing standard of treatment for HCV includes weekly injections of pegylated interferon (peg-IFN) and a daily ribavirin (RBV) oral pill. This regimen is not ideal, as nearly 50% of patients do not respond to it. In addition, those who do respond often experience debilitating side effects that can last the duration of the treatment—either 24 or 48 weeks. Pharmaceutical companies are experimenting with interferon-free regimens to eliminate some of the challenging side effects.
Conducted in collaboration with Presidio Pharmaceuticals, Inc., the trial will assess Boehringer Ingelheim’s investigational therapies used in combination with other therapies. The novel treatment regimen includes Boehringer’s 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 RBV.
The trial will include 36 previously untreated patients with genotype-1a HCV infection, the most common genotype. Subjects will receive the all-oral DAA regimen for 12 weeks, plus 24 weeks of post-treatment follow-up. The goal of the trial is to achieve sustained virologic response (SVR) 12 weeks after treatment is completed. SVR indicates that a patient has “cleared” the virus for at least six months after completing therapy. It is achieved when viral levels drop, becoming nearly undetectable. Patients who achieve SVR are considered cured of their HCV infection. Final results of the trial are expected in the second quarter of 2014.
“This further compliments our ongoing Phase 3 HCVerso® trial program, which aims to provide interferon-free treatment to genotype-1b patients,” said Peter Piliero, MD, Vice President, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Through the development of our own pipeline compounds and through new collaborations like this we aim to provide interferon- and ribavirin-free regimens for a wide range of patients and hepatitis C genotypes, including the most challenging types to cure.”
Source: Boehringer Ingelheim press release dated September 10, 2013