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Positive Interim Results from Interferon-Free Phase 2b SOUND-C2 Study with Boehringer Ingelheim's Two Investigational HCV Direct Acting Antivirals Presented at AASLD
Date:11/7/2011

I 201335, BI 207127 and RBV showed high virologic response rates through week 12 across treatment arms. Viral suppression also was observed in the RBV-sparing arm but was lower than in the other arms at week 12.

  • 76 percent of patients who received BI 201335 once daily (QD) plus BI 207127 twice daily (BID) with RBV achieved viral response through week 12.
  • 70 percent of patients who received BI 201335 QD plus BI 207127 three times daily (TID) with RBV achieved viral response through week 12.
  • 57 percent of patients who received BI 201335 QD plus BI 207127 TID without RBV achieved viral response through week 12.

Breakthrough occurred in 13 percent of patients in BI 201335 plus BI 207127 TID with RBV treatment groups (arms one – three) and in 21 percent of patients in the BI 201335 plus BI 207127 BID with RBV treatment group. Breakthrough occurred in 15 percent of patients in the group that did not receive RBV.

The most frequent adverse events (AEs) were asthenia, pruritus, rash, photosensitivity, jaundice, nausea, vomiting and diarrhea. Across all treatment groups, 6–12 percent of patients discontinued due to AEs.

Results from this open-label, randomized, Phase 2b study were presented as a late-breaking poster titled, "Virologic Response to an Interferon-Free Regimen of BI 201335 and BI 207127, with and Without Ribavirin, in Treatment-Naive Patients with Chronic Genotype-1 HCV Infection: Week 12 Interim Results of the SOUND-C2 Study," by Stefan Zeuzem. In the study, 362 treatment-naive GT1 HCV patients were randomized to receive either:

  • BI 201335 120 mg QD plus BI 207127 600 mg TID plus RBV for 16 weeks;
  • BI 201335 120 mg QD plus BI 207127 600 mg TID plus RBV for 28 weeks;
  • BI 201335 120 mg QD plus BI 207127 600 mg TID plus RBV for 40 weeks;
  • BI 201335 120 mg QD plus BI 207127 600 mg BID plus RBV f
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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