Format

Send to

Choose Destination
Antimicrob Agents Chemother. 2019 Feb 26;63(3). pii: e01855-18. doi: 10.1128/AAC.01855-18. Print 2019 Mar.

Relationship of Ganciclovir Therapeutic Drug Monitoring with Clinical Efficacy and Patient Safety.

Author information

1
Department of Pharmacy, Mayo Clinic, Rochester, Minnesota, USA ritchie.brianne@mayo.edu.
2
Department of Pharmacy, Mayo Clinic, Rochester, Minnesota, USA.
3
Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota, USA.
4
Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.
5
Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.
6
Division of Infectious Diseases, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.
7
William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic, Rochester, Minnesota, USA.

Abstract

The clinical utility of ganciclovir therapeutic drug monitoring (TDM) is unknown. We retrospectively analyzed adult patients treated for cytomegalovirus (CMV) infection with ganciclovir with TDM between 2005 and 2015. The primary outcome was an association between ganciclovir TDM and clinical efficacy endpoints within 30 days, defined by viral load and symptomatology. Secondary outcomes included safety endpoints, evaluated within 7 days of the last administered dose of ganciclovir. Of 175 patients evaluated, 82 patients with CMV infection were included in our analysis with a median (interquartile range) baseline CMV viral load of 5,500 (3,000 to 15,200) copies/ml. The majority achieved undetectable or reduced CMV viral load below the lower limit of quantification (74.4%) with improvement in symptomatology (70.7%) at 30 days. Among patients with detectable CMV viremia at 30 days, the viral load had declined to a median of 1,000 (1,000 to 3,090) copies/ml. We did not observe significant associations between the efficacy outcomes and ganciclovir trough (P = 0.20 and P = 0.20, respectively) or peak concentrations (P = 0.14 and P = 0.14, respectively). Similarly, there was no significant association between ganciclovir trough or peak concentrations and safety endpoints, including leukopenia (P = 0.48 and P = 0.69), neutropenia (P = 0.59 and P = 0.69), thrombocytopenia (P = 0.29 and P = 0.37), anemia (P = 0.51 and P = 0.35), nephrotoxicity (P = 0.41 and P = 0.57), and neurotoxicity (P = 0.22 and P = 0.48). We did not observe any associations between ganciclovir TDM and clinical efficacy or safety endpoints. Routine ganciclovir TDM may be of limited value. Future studies may be warranted to identify specific populations with unpredictable pharmacokinetic and pharmacodynamics profiles in whom ganciclovir TDM may be of benefit.

KEYWORDS:

antiviral therapy; ganciclovir; therapeutic drug monitoring; viral infections

PMID:
30602515
PMCID:
PMC6395929
[Available on 2019-08-26]
DOI:
10.1128/AAC.01855-18

Supplemental Content

Full text links

Icon for HighWire
Loading ...
Support Center