Transient B cell depletion or improved transgene expression by codon optimization promote tolerance to factor VIII in gene therapy.

In summary, a highly significant 9–10-fold reduction in antibody response to hFVIII protein was achieved with the cohFVIII construct including a complete lack of response to hFVIII protein in 5/8 mice.

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This was somewhat reflected in adoptive transfer experiments, where CD4 + CD25 + cells from AAV8-F8-only treated mice showed a trend for greater suppression compared to cells from “AAV8-F8+αCD20” mice, although this did not reach significance.

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While this level of correction was not quite as good as for naïve mice, the difference did not reach statistical significance.

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