Ganciclovir treatment of symptomatic congenital cytomegalovirus infection: results of a phase II study. National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group.
Congenital cytomegalovirus (CMV) infection occurs in approximately 1% of newborns in the United States. A phase II evaluation was done of ganciclovir for the treatment of symptomatic congenital CMV infection. Daily doses of 8 or 12 mg/kg were administered in divided doses at 12-h intervals for 6 weeks. Clinical and laboratory evaluations sought evidence of toxicity, quantitative virologic responses in urine, plasma drug concentrations, and clinical outcome. A total of 14 and 28 babies received 8 and 12 mg/kg/day, respectively. Five additional babies received ganciclovir on a compassionate plea basis. Significant laboratory abnormalities included thrombocytopenia (< or = 50,000/mm3) in 37 babies and absolute neutropenia (< or = 500 mm3) in 29 babies. Quantitative excretion of CMV in the urine decreased; however, after cessation of therapy, viruria returned to near pretreatment levels. Hearing improvement or stabilization occurred in 5 (16%) of 30 babies at 6 months or later, indicating efficacy.
Whitley
R J
RJ
Department of Pediatrics, University of Alabama at Birmingham, 35233, USA.
Cloud
G
G
Gruber
W
W
Storch
G A
GA
Demmler
G J
GJ
Jacobs
R F
RF
Dankner
W
W
Spector
S A
SA
Starr
S
S
Pass
R F
RF
Stagno
S
S
Britt
W J
WJ
Alford
C
C
Soong
S
S
Zhou
X J
XJ
Sherrill
L
L
FitzGerald
J M
JM
Sommadossi
J P
JP
D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001219:Aspartate Aminotransferases / Q000097:blood; D001663:Bilirubin / Q000097:blood; D002493:Central Nervous System Diseases / Q000151:congenital / Q000188:drug therapy / Q000821:virology; D003587:Cytomegalovirus / Q000302:isolation & purification; D003586:Cytomegalovirus Infections / Q000151:congenital / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D015774:Ganciclovir / Q000009:adverse effects / Q000627:therapeutic use*; D005865:Gestational Age; D006529:Hepatomegaly; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D007234:Infant, Premature; D007958:Leukocyte Count; D008297:Male; D010976:Platelet Count; D013163:Splenomegaly; D013997:Time Factors; D014481:United States / Q000453:epidemiology; D014556:Urine / Q000821:virology
D000998:Antiviral Agents; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D015774:Ganciclovir; D001663:Bilirubin