ENTA—Nothing wrong with those phase-2 data from the PEARL-1 study! In the treatment-naïve GT1b cohort, SVR12 was 95% (20/22) on an ITT basis (and it would’ve been 100% excluding the 2 patients lost to follow-up). In the treatment-experienced GT1b cohort, SVR12 was 90% (36/40), also on an ITT basis.
Reminder: The PEARL-1 study is a phase-2 testing (among other things) the 2-DAA regimen of ABT-450 + ABT-267—without ABT-333 or ribavirin—in GT1b patients. This is the regimen ABBV/ENTA are taken into phase-3 for GT1b approval in Japan.
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