Clinical immunogenicity outcomes from GENEr8-1, a phase 3 study of valoctocogene roxaparvovec, an AAV5-vectored gene therapy for hemophilia A.

Compared with ELISpot-negative time points, ELISpot-positive time points showed a trend toward higher ALT levels, especially for the week-7-through-12 window, in which the mean ALT levels were 54.0 (SD, 77.6) U/L for ELISpot-positive samples and 34.0 (SD, 40.0) U/L for ELISpot-negative samples ( Figure 4 A).

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