Methods: Pediatric and adult pts who received isolated LT and multi-organ transplantation including liver were identified from studies CMX001-304 [NCT02087306] and CMX001-350 [NCT01143181] (studies of ≥12 weeks treatment duration); and emergency INDs. Assessments included change from baseline AdV viral load (VL), time to nadir VL, and safety/tolerability.
Results: Thirteen LT recipients including 10 multi-organ pts received BCV for AdV infection. The majority (n=10) were pediatric pts with a median age of 21 months (range: 6 months, 13 years), and 9 (69%) were male. Three subjects (all female) were ≥15 years of age with a median age of 17 years (15, 31 years). Across the 13 pts, median baseline plasma AdV VL was 3.4 log10 c/mL (undetectable, 10.0 log10 c/mL). Median change from baseline in VL was -1.3 log10 c/mL (-8.0, -0.3 log10 c/mL) and median time to nadir VL was 15 d (4, 96 d). In subjects followed for >28 d (n=10), all were alive at time of evaluation, with median change in AdV VL of -1.1 log10c/mL. In subjects (n=3) followed for <28 d, one subject died. In one pt (out of 13 pts), treatment was discontinued due to a BCV-related adverse event (AE) (diarrhea). No BCV-related clinical hepatobiliary AEs were reported, with aminotransferase levels remaining stable or declining during treatment. Median change in ALT was +4 U/L (-507, +106 U/L), AST -1 U/L (-691, +35 U/L), bilirubin -0.05 mg/dL (-15.5, +4.1 mg/dL), and creatinine +0.1 mg/dL (-0.9, +2.5 mg/dL).
Conclusion: Preliminary pooled data from several LT patients with AdV infection suggest that treatment with BCV can reduce viral burden and is associated with favorable survival. BCV was tolerated, with no clinical hepatobiliary AEs reported in these LT patients.
D. F. Florescu,
E. Bourne, Chimerix: Employee and Shareholder , Salary
G. Chittick, Chimerix, Inc.: Employee and Shareholder , Salary
T. Brundage, Chimerix: Employee and Shareholder , Salary
H. Mommeja-Marin, Chimerix: Employee and Shareholder , Salary
G. Maron, None
See more of: Poster Abstract Session