Table 2. Encapsidated vector DNA... | American Society of Hematology

Table 2.

Encapsidated vector DNA biodistribution and shedding following 6 × 10¹³ vg/kg valoctocogene roxaparvovec infusion

	Participants with detectable vector DNA, n (%)	Peak concentration, vg/mL	Time to peak concentration, wk	Time to last detectable sample, wk	Participants with 3 consecutive negative samples, n (%)	Time to first negative sample∗,†, wk
Plasma (n = 134)
Median	130 (97.0)	BLOQ	1.1	2.2	134 (100)	3.3
Min		BLOQ	0.9	0.9		1.3
Max		1.1 × 10⁷	4.1	10.0		10.1
Semen (n = 133)‡
Median	131 (98.5)	9.3 × 10⁵	0.6	1.9	131§ (98.5)	3.0
Min		BLOQ	0.1	0.1		0.4
Max		3.8 × 10⁸	4.0	8.1		12.1

	Participants with detectable vector DNA, n (%)	Peak concentration, vg/mL	Time to peak concentration, wk	Time to last detectable sample, wk	Participants with 3 consecutive negative samples, n (%)	Time to first negative sample∗,†, wk
Plasma (n = 134)
Median	130 (97.0)	BLOQ	1.1	2.2	134 (100)	3.3
Min		BLOQ	0.9	0.9		1.3
Max		1.1 × 10⁷	4.1	10.0		10.1
Semen (n = 133)‡
Median	131 (98.5)	9.3 × 10⁵	0.6	1.9	131§ (98.5)	3.0
Min		BLOQ	0.1	0.1		0.4
Max		3.8 × 10⁸	4.0	8.1		12.1

Confirmed by 2 consecutive negative or BLOQ samples.

FDA definition of time to clearance.

One participant did not provide semen shedding assessments.

Two participants had insufficient sample quantity for vector DNA assessment by iqPCR.