Kuritzkes D, Parenti D, Ward D, Rachlis A, Jacobson M; Conference on Retroviruses and Opportunistic Infections.
Program Abstr 4th Conf Retrovir Oppor Infect Conf Retrovir Oppor Infect 4th 1997 Wash DC. 1997 Jan 22-26; 4th: 131 (abstract no. 365).
Univ Colorado, Denver, CO.
The effect of Filgrastim to prevent severe neutropenia (ANC less than 500/microliter) was studied in 258 moderately neutropenic (ANC 750-1000/microliter) HIV-infected individuals with CD4 less than 200/microliter. Pts were randomized to receive Filgrastim (n=172) titrated to maintain ANC between 2,000-10,000/microliter, or to an observational control group (n=86). If ANC less than 500/microliter, two consecutive times, control patients could cross over to Filgrastim. Baseline characteristics were well balanced, except for treated pts who had a higher number of prior opportunistic infections and lower CD4 counts compared with the control group (13 vs. 20 cells/microliter, respectively). Intent-to-treat analyses of clinical endpoints, both adjusted and unadjusted were performed. Incidence of severe neutropenia was significantly lower during the 24-week study period in the Filgrastim groups (1.7%) vs control (22%), (p is less than 0.001). The incidence of bacterial infections was 31% lower in the Filgrastim-treated groups (2.93 vs. 4.25/1000 pt days, p=0.07, p=0.03 adjusted). Filgrastim-treated pts also had 54% fewer severe bacterial infections (p=0.02, p=0.01 adjusted). As a result, Filgrastim-treated pts had 45% fewer hospital days for bacterial infections (8.1 vs. 14.8 days/1000 pt days, p=0.02, p=0.01 adjusted). No unexpected or new adverse events were observed. There were no differences in plasma HIV-1 RNA levels between groups. Filgrastim therapy is safe and effective in preventing severe neutropenia, and in reducing incidence of bacterial infections in HIV-infected individuals.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Anti-HIV Agents
- Bacterial Infections
- CD4 Lymphocyte Count
- Clinical Trials as Topic
- Filgrastim
- HIV
- HIV Infections
- HIV Seropositivity
- Health Personnel
- Humans
- Incidence
- Longitudinal Studies
- Methionine
- Neutropenia
- methods
- therapy
Other ID:
UI: 102225278
From Meeting Abstracts