H. Lewis, R. Igbe, M. Wilkinson
Apr 1, 2012
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Influential Citations
2
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Quality indicators
Journal
Journal of Hepatology
Abstract
the primary systemic metabolite of PSI-7977, PSI-6206, were determined following the first and 7th dose of PSI-7977. HCVRNA and safety were monitored throughout the study. All data were compared to that obtained from non-cirrhotic HCV-infected subjects receiving 7 days of PSI-7977 400mg QD in the NUCLEAR study (Cohort 3). Results: Nine moderately hepatic-impaired HCV-infected subjects were enrolled. One subject withdrew study consent without explanation or reported AEs and was replaced. Two AEs of nausea and diarrhea (single instances) were reported, with no severe AEs or SAEs reported. Geometric least squares mean ratios (90% CIs) for PSI-6206 Day 7 Cmax and AUCtau in subjects with moderate hepatic impairment relative to non-cirrhotic subjects were 0.94 (0.67, 1.31) and 1.18 (0.84, 1.64), respectively. Median baseline HCVRNA was 5.8 log10 IU/mL, and at Day 7, a median reduction in HCVRNA of 3.7 log10 IU/mL was observed (range 2.8–4.1). One subject achieved HCVRNA