Use of filgrastim as adjuvant therapy in patients with AIDS-related cytomegalovirus retinitis.
BACKGROUND
Neutropenia in AIDS predisposes to bacterial infection. Granulocyte colony-stimulating factor (filgrastim) can reverse neutropenia.


OBJECTIVE
To determine the effects of filgrastim on bacterial infections, hospitalization, and mortality in patients with cytomegalovirus retinitis and AIDS.


METHODS
Using a person-time analysis, a retrospective cohort study of filgrastim adjuvant therapy in three multicenter clinical trials of anti-cytomegalovirus therapy during the period 1990-1997 measured filgrastim use, bacterial infections, and mortality.


RESULTS
Of 719 patients, 379 patients used filgrastim for 31% of the follow-up time. There was an inverse relationship between the 389 confirmed bacterial infections, including 186 bacteremias, and absolute neutrophil counts. Before adjustment for CD4 T-cells counts and antibiotic/antiretroviral therapy, filgrastim was associated with reduced risk of catheter-related bacteremia [relative risk (RR), 0.52; P = 0.02] and repeat bacterial infection (RR, 0.41; P = < 0.01). After adjustment, the RR of catheter-related bacteremia with filgrastim use was decreased (RRadj, 0.69; P = 0.16) and the RR of repeat bacterial infection with filgrastim use was of marginal significance (RRadj, 0.57; P = 0.07), possibly due to the confounding effect of trimethoprim-sulfamethoxazole on all bacteremia (RRadj, 0.55; P = < 0.01). Unrelated to bacteremia, filgrastim use was associated with a 56% reduction in mortality (P < 0.01).


CONCLUSIONS
There was a large survival benefit associated with filgrastim use in this study but the reasons for this benefit are unclear. Although a reduction in crude risk of some bacterial infections with filgrastim use was detected, after adjustment for potentially confounding factors these risks were smaller and no longer statistically significant.
Davidson
Michael
M
Center for Clinical Trials, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
Min
Yuan-I
YI
Holbrook
Janet T
JT
Van Natta
Mark L
ML
Murphy
Robert
R
Jabs
Douglas A
DA
Welch
William
W
Meinert
Curtis L
CL
D017088:AIDS-Related Opportunistic Infections / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D001424:Bacterial Infections / Q000150:complications; D017024:Chemotherapy, Adjuvant; D017726:Cytomegalovirus Retinitis / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006760:Hospitalization; D006801:Humans; D008297:Male; D009503:Neutropenia / Q000188:drug therapy; D011994:Recombinant Proteins; D012189:Retrospective Studies; D012307:Risk Factors; D015996:Survival Rate
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim