LB21. Preemptive Therapy (PET) vs. Prophylaxis for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Donor Seropositive/Recipient Seronegative (D+R−) Liver Transplant Recipients (LTR): A NIH-Sponsored, Randomized, Controlled, Multicenter Trial

ABSTRACT: Abstract

Background

Current guidelines preferentially recommend valganciclovir (VGCV) prophylaxis over PET in most D+R− organ transplant populations, but adequately powered direct comparative clinical trials are lacking.

Methods

D+R− LTR were randomly assigned (1:1, stratified by site and T-cell depleting induction) to receive either PET (weekly plasma CMV DNAemia at central laboratory for 100 days, with VGCV 900 mg bid for DNAemia at any level, until two consecutive negative weekly tests) or prophy (VGCV 900 mg qd for 100 days). The primary outcome was CMV disease by 12 months as adjudicated by an independent, blinded, endpoint committee in ITT population. Secondary outcomes were opportunistic infections (OIs) (invasive fungal and bacterial), neutropenia (ANC < 1000/µL),

SUBMITTER: Singh N 

PROVIDER: S-EPMC6254092 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature