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Boehringer Ingelheim Enrolls First Patients in Pivotal Phase 3 Interferon-Free Hepatitis C Trial Program
Date:1/17/2013

to stay on treatment, which is imperative to achieve the ultimate goal of a virologic cure," said lead study investigator Christoph Sarrazin , M.D., Professor of Medicine at the Johann Wolfgang Goethe University Hospital in Frankfurt, Germany. "I'm pleased the trial design includes a diverse population of genotype-1b patients, particularly those with liver cirrhosis, reflecting the types of patients we see very frequently in clinical practice."

Boehringer Ingelheim Interferon-free Phase 3 Trial Designs
The Phase 3 trial program includes two pivotal studies:
HCVerso 1
This Phase 3 study will enroll treatment-naive patients infected with HCV GT-1b. Patients will be randomized (1:1) into two treatment arms. A third, open-label arm will enroll cirrhotic patients.

  • Group 1: 24 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV
  • Group 2: 16 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV followed by an additional 8 weeks of placebo
  • Group 3 (patients with compensated liver cirrhosis): 24 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV

HCVerso 2
This Phase 3 study will enroll treatment-naive patients infected with HCV GT-1b, and includes patients who are eligible or ineligible for interferon. Patients will be randomized (1:1) into two treatment arms. A third, open-label arm will enroll cirrhotic patients.

  • Group 1: 24 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV
  • Group 2: 8 weeks of placebo followed by 16 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV
  • Group 3 (patients with compensated liver cirrhosis): 24 weeks of BI 207127 600mg BID + faldaprevir 120mg QD + RBV

Data from the HCVers
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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