title: Filgrastim: new indication. AIDS-associated neutropenia: another soft indication.
abstract: (1) Neutropenia is frequent in patients with AIDS and is an added risk factor for infection. There is no specific treatment, except, when feasible, the withdrawal of a suspected culprit drug. (2) Filgrastim, a granulocyte growth factor, has been granted a license extension to cover the treatment of persistent neutropenia in patients at an advanced stage of HIV infection. (3) Only one comparative, unblinded trial has been published in this setting. It involved 258 patients distributed into three groups, who received daily filgrastim, intermittent filgrastim, or no treatment. Six months after the beginning of the trial, filgrastim had not reduced the number of deaths, the number of hospital days, or the risk of bacterial or fungal infection. (4) The trial report fails to show whether filgrastim influences viral load or the CD4+ lymphocyte count. (5) In the absence of published dose-finding studies there is no proof that the dose regimen recommended in the licensing terms is the one with the best risk-benefit ratio. (6) Treatment with filgrastim is costly, especially as the available unit doses are unsuitable for this indication. (7) Patients at an advanced stage of HIV infection are already heavily medicated. There is no reason to add filgrastim, which has no proven clinical value.
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000150:complications; D002986:Clinical Trials as Topic; D003362:Cost-Benefit Analysis; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D009503:Neutropenia / Q000188:drug therapy* / Q000209:etiology; D011994:Recombinant Proteins; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim