ABBV’s PR pertains to only one trial (GIFT-1: https://clinicaltrials.gov/ct2/show/NCT02023099 ). The PR is confusing because there was a pre-specified subgroup analysis that constituted the primary endpoint and a separate randomized “safety control” group that consisted of non-cirrhotic patients (some of whom were treatment-experienced) whose treatment start was deferred by 12 weeks in order to perform the safety comparison to the main (immediate treatment) group. It’s this control group that had an SVR12 rate of 98% on an ITT basis.
If one merges the 95% (106/112) subgroup for the primary endpoint and the 98% (104/106) control group, the result is an SVR12 rate of 96.3% (210/218).
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