Abstract
with 5% of patients who received the BAP placebo in the SOC arm. Lymphopenia was the most common reason for discontinuation of BAP. There were 2 deaths reported in the study (primary varicella and B-cell lymphoma) and these were considered related to study medication and a potential consequence of the lymphopenia. Conclusions: When combined with the SOC, BAP increased the rate of RVR and cEVR in genotype 1 patients; however, the drug did not confer an SVR advantage due in part to frequent safetyrelated dose reductions and discontinuations for both BAP and SOC. Further development of BAP has been halted because of the unfavourable benefit:risk ratio. Investigations are ongoing to explore the mechanism of BAP-related toxicity.
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