Efficacy of levofloxacin in the treatment of BK viremia: a multicenter, double-blinded, randomized, placebo-controlled trial.
OBJECTIVE
BK virus reactivation in kidney transplant recipients can lead to progressive allograft injury. Reduction of immunosuppression remains the cornerstone of treatment for active BK infection. Fluoroquinolone antibiotics are known to have in vitro antiviral properties, but the evidence for their use in patients with BK viremia is inconclusive. The objective of the study was to determine the efficacy of levofloxacin in the treatment of BK viremia.


METHODS
Enrollment in this prospective, multicenter, double-blinded, placebo-controlled trial occurred from July 2009 to March 2012. Thirty-nine kidney transplant recipients with BK viremia were randomly assigned to receive levofloxacin, 500 mg daily, or placebo for 30 days. Immunosuppression in all patients was adjusted on the basis of standard clinical practices at each institution. Plasma BK viral load and serum creatinine were measured monthly for 3 months and at 6 months.


RESULTS
At the 3-month follow-up, the percentage reductions in BK viral load were 70.3% and 69.1% in the levofloxacin group and the placebo group, respectively (P=0.93). The percentage reductions in BK viral load were also equivalent at 1 month (58% versus and 67.1%; P=0.47) and 6 months (82.1% versus 90.5%; P=0.38). Linear regression analysis of serum creatinine versus time showed no difference in allograft function between the two study groups during the follow-up period.


CONCLUSIONS
A 30-day course of levofloxacin does not significantly improve BK viral load reduction or allograft function when used in addition to overall reduction of immunosuppression.
Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
Belinda T
BT
Lee
Steven
S
Gabardi
Monica
M
Grafals
R Michael
RM
Hofmann
Enver
E
Akalin
Aws
A
Aljanabi
Didier A
DA
Mandelbrot
Deborah B
DB
Adey
Eliot
E
Heher
Pang-Yen
PY
Fan
Sarah
S
Conte
Christine
C
Dyer-Ward
Anil
A
Chandraker
D000890:Anti-Infective Agents / Q000627:therapeutic use*; D001739:BK Virus / Q000187:drug effects* / Q000472:pathogenicity; D015415:Biomarkers / Q000097:blood; D003404:Creatinine / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects; D016030:Kidney Transplantation / Q000009:adverse effects*; D064704:Levofloxacin / Q000627:therapeutic use*; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D027601:Polyomavirus Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014412:Tumor Virus Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology; D014481:United States; D019562:Viral Load; D014766:Viremia / Q000175:diagnosis / Q000188:drug therapy* / Q000821:virology
D000890:Anti-Infective Agents; D015415:Biomarkers; D007166:Immunosuppressive Agents; D064704:Levofloxacin; D003404:Creatinine