title: Treatment of cytomegalovirus infection and disease pre- and post-quantitative nucleic acid test standardization: does use of a more sensitive assay lead to longer treatment duration?
abstract: Quantitative cytomegalovirus (CMV) nucleic acid testing (NAT) has been standardized using the World Health Organization (WHO) international calibration standard. A new FDA-approved WHO-calibrated assay (CA) was found to be more sensitive than a laboratory-developed test (LDT). We hypothesized that monitoring therapeutic response using a more sensitive assay may lead to longer antiviral therapy in solid organ and hematopoietic stem cell transplant patients with CMV infection. We reviewed transplant patients with CMV disease retrospectively, and divided them into two groups: those diagnosed and managed based on LDT and those managed using WHO-CA. Compared to patients monitored by LDT, the time to reach an undetectable viral load was significantly longer in the group monitored by the WHO-CA. However, a trend toward shorter duration of antiviral treatment was observed (median, 34 vs. 41 d; p = 0.058), with earlier discontinuation of induction antiviral therapy upon reaching undetectable viral load using WHO-CA (11 vs. 18 d; p = 002). We concluded that despite using a more sensitive CMV NAT, the total duration of antiviral treatment was not significantly prolonged in transplant patients with CMV infection and disease. Relapse rates did not differ between the two groups.
authors.affiliation: Division of Infectious Diseases, Department of Medicine, Mayo Clinic, Rochester, MN, USA.
authors.forename: M Veronica
authors.initials: MV
authors.lastname: Dioverti
authors.affiliation: Biomedical Statistics and Informatics, Department of Biostatistics, Mayo Clinic, Rochester, MN, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Lahr
authors.affiliation: Division of Infectious Diseases, Department of Medicine, Mayo Clinic, Rochester, MN, USA.|Department of Health Sciences Research, The William J. Von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic, Rochester, MN, USA.
authors.forename: Raymund R
authors.initials: RR
authors.lastname: Razonable
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use; D003587:Cytomegalovirus / Q000235:genetics* / Q000302:isolation & purification; D003586:Cytomegalovirus Infections / Q000175:diagnosis* / Q000188:drug therapy / Q000821:virology; D004279:DNA, Viral / Q000235:genetics; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate; D006084:Graft Rejection / Q000175:diagnosis / Q000188:drug therapy / Q000821:virology; D006085:Graft Survival; D006801:Humans; D007676:Kidney Failure, Chronic / Q000601:surgery; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D021141:Nucleic Acid Amplification Techniques / Q000379:methods / Q000592:standards*; D011183:Postoperative Complications; D011379:Prognosis; D012189:Retrospective Studies; D012307:Risk Factors; D019562:Viral Load / Q000187:drug effects / Q000235:genetics*
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral
keywords: cytomegalovirus; nucleic acid testing; transplant