Interim data presented recently have shown that all patients ( 13/13 ) who reached their 4-weeks post-treatment follow-up have undetectable levels of hepatitis C virus ( SVR4 ) after completing a 12-week treatment with Faldaprevir, Deleobuvir, PPI-668 and Ribavirin.
Additional data from the trial have shown 100% of patients ( 12/12 ) treated with a Ribavirin-free regimen had hepatitis C virus ( HCV ) levels below the lower level of quantification at 4 weeks after initiation of treatment.
Safety and tolerability appears to be better in this Ribavirin-free treatment arm compared to those with Ribavirin.
The ongoing phase II trial features the 12-week regimen both with and without Ribavirin in 36 genotype-1a infected patients, one of the more difficult-to-cure types of HCV. In addition, more than half of the patients in the study ( 20/36 ) had pre-existing HCV mutations. This includes the Q80K variant, which is common in genotype-1a infected patients and has been associated with reduced responses to some HCV protease inhibitors.
Notably, all 12 patients in the study with pre-existing Q80K mutations are responding well to treatment with the Faldaprevir-based Interferon-free regimen.
To date, all patients in the study have received at least 4 weeks of treatment and 97% ( 35/36 ) achieved HCV levels below the lower limit of quantification at week 4. One patient had an initial virologic response but then exhibited viral breakthrough and was discontinued after 5 weeks of treatment.
Overall, adverse events in the study have been mild to moderate, with the incidence and severity of skin rashes and gastrointestinal side effects similar to those observed in previous trials studying Faldaprevir and Deleobuvir.
Faldaprevir, an investigational oral protease inhibitor, is specifically designed to target viral replication in the liver. Boehringer Ingelheim is developing Faldaprevir as a core component of both Interferon-based and Interferon-free hepatitis C treatment regimens.
Deleobuvir is an investigational non-nucleoside NS5B polymerase inhibitor to treat patients with genotype-1b hepatitis C virus. ( Xagena )
Source: 64th Annual Meeting of the American Association for the Study of Liver Diseases ( AASLD ), 2013