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Emergence and Persistence of NS5B Mutations Following Combination Treatment with Tegobuvir (GS-9190) plus Standard of Care--Long-Term follow-Up from the Phase 2b Study GS-US-196-0103
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Reported by Jules Levin
EASL 2011 Berlin March 31-Apr 2
C Hebner, J Harris, B Peng, K Ku, J Lee, D Oldach, MD Miller, H Mo
Gilead Sciences, Inc; Foster City, CA USA
Summary
· Baseline sequencing showed that C316N was the most abundant TGV-resistant variant found prior to treatment
- C316 status did not affect RVR or cEVR rates
· Y448H was the most abundant mutation associated with viral rebound in both genotype 1a and 1b patients
- Y448H was observed in single, double, and triple resistance mutation combinations in GT 1b
· Y448H was the most abundant mutation associated with relapse in both genotype 1a and 1b patients
- 63% of 1a patients and 57% of 1b patients had Y448H at relapse
- C445F occurred in 29% of GT1b patients, but was not observed in GT1a
· Long-term follow-up of patients with Y448H at on-treatment Week 12 showed that by 48 weeks after treatment discontinuation, 4/6 patients had maintained the Y448H mutation
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