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Positive Phase III Results With Faldaprevir-Based Regimen in Patients with Hepatitis C

80% of patients achieve sustained viral response at 3 months (Apr. 23)

Positive results have been announced from a pivotal phase III trial of faldaprevir (BI 201335; Boehringer Ingelheim) in combination with pegylated interferon (peg-IFN) and ribavirin in previously untreated patients with genotype-1 hepatitis C virus (HCV) infection.

A sustained viral response at 12 weeks (SVR12) was achieved by 79% and 80% of patients who received faldaprevir 120 mg and 240 mg once daily, respectively, plus peg-IFN and ribavirin compared with 52% of patients who received peg-IFN and ribavirin plus placebo (P < 0.0001).

In addition, protocol-defined early treatment success was achieved by 87% and 89% of patients treated with the faldaprevir-based regimen (120 mg and 240 mg, respectively), meaning that they were eligible for an overall shorter treatment duration of 12 weeks faldaprevir/24 weeks peg-IFN and ribavirin. Of the patients who completed treatment early, 86% and 89% (120 mg and 240 mg, respectively) went on to achieve viral cure (SVR12), thereby demonstrating that an overall treatment regimen of 24 weeks was sufficient to achieve viral cure in most patients.

The STARTVerso 1 trial was a double-blind, placebo-controlled phase III study of faldaprevir in combination with peg-IFN and ribavirin in 652 treatment-naïve patients in Europe and Japan who were infected with chronic genotype-1 HCV. The study enrolled a range of genotype-1a and -1b patients, including patients with compensated cirrhosis, who are challenging to treat and cure.

The findings will be presented April 27 at the European Association for the Study of Liver Disease’s (EASL) International Liver Conference, to be held in Amsterdam.

Serious adverse events (AEs) were experienced by 6% of placebo-treated patients and by 7% of patients receiving 120 mg or 240 mg of faldaprevir. Anemia, rash, and gastrointestinal events were the most common grade-2 to grade-4 AEs in the three treatment groups.

Source: Boehringer Ingelheim; April 23, 2013.

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