Boehringer Ingelheim has presented new data from a Phase III trial programme which shows that faldaprevir was highly effective in a broad range of patients with genotype-1 hepatitis C.
The study, the data from which were presented at the Liver Meeting in Washington DC, evaluated faldaprevir in combination with pegylated interferon and ribavirin in treatment-naive and experienced patients as well as in HIV co-infected participants.
Among the highlights of the data, in the STARTVerso 1 and 2 trials, 84% of treatment-naïve patients receiving faldaprevir were able to shorten the total time on treatment from 48 to 24 weeks and 83% of these patients achieved viral cure (SVR12). Interim results from STARTVerso 4 showed that 74% of patients with HCV/HIV co-infection had undetectable HCV four weeks after the conclusion of treatment.
Ira Jacobson of the Weill Cornell Medical College in New York said that “the broad populations studied in STARTVerso and the fact that very few patients discontinued treatment due to adverse events provides physicians with confidence in faldaprevir as an important potential addition to the available agents for the treatment of HCV”.
More than 2,200 patients have been studied in the STARTVerso programme and the results are “particularly promising given the inclusion of a broad range of patients and the similar success rates seen in both HCV mono and HCV/HIV co-infected patients”, said Klaus Dugi, Shead of medicine at Boehringer. He noted that these data will form the basis of regulatory submissions, adding that faldaprevir “may offer a simple and convenient option for patients, due to once-daily dosing and no food restrictions”.
Prof Dugi concluded by saying that the protease inhibitor “is the foundation of our HCV pipeline” and the company will present Phase III data using faldaprevir as part of an interferon-free regimen in 2014.
