Methods: A database of 364 LTR from 2011-2014 was accessed. Patients with retransplants, liver-kidney transplants, HIV, or those in whom CMV serostatus or duration of VGCV exposure could not be confirmed were excluded. Low-dose VGCV was defined as 450 mg/day adjusted for renal function. Prophylaxis duration was 3 months; patients treated for rejection received an additional 3 months. The primary endpoint was CMV disease at one year post-transplant. Breakthrough CMV disease was defined as disease occurring while on VGCV prophylaxis. Secondary endpoints were rejection and leukopenia on VGCV. With respect to leukopenia, patients receiving low-dose VGCV were compared to a group of D+R- patients from the database receiving high-dose VGCV. Univariable analyses were performed using chi-squared, Fisher’s exact, or Wilcoxon rank-sum tests.
Results: 200 R+ LTR met inclusion criteria. Median age was 60 (interquartile range [IQR], 54–66) years, with 125 (64%) male, median MELD score of 23 (IQR, 14–31), and 178 (89%) patients receiving deceased-donor transplants. HCC, HCV, HBV, and alcoholic cirrhosis were the most common indications for transplant. CMV disease occurred in 9 (4.5%) patients. Two cases of breakthrough CMV disease occurred. No CMV resistance testing was performed. 18 (9%) patients had biopsy-proven rejection. Patients received VGCV prophylaxis for a median 3.4 (IQR, 3.1–4.3) months. 156 (76%) patients receiving low-dose VGCV developed leukopenia compared to 20 (80%) patients receiving high-dose VGCV (p=0.66). Premature VGCV discontinuation and G-CSF use were rare and not significantly different between the two groups.
Conclusion: Low-dose VGCV was effective at preventing CMV disease in R+ LTR. Few patients developed biopsy-proven rejection. Leukopenia was common on both low-and high-dose VGCV but rarely clinically significant.
M. Ali, None
D. Dunn, None
G. Patel, None
S. Huprikar, None