Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.
PRNewswire - December 17, 2001
This multi-center study, which enrolled HIV-positive patients with hemoglobin(Hb) levels of <12 g/dL receiving antiretroviral therapy, compared the efficacy and tolerability of QW versus TIW subcutaneous administration of PROCRIT. Efficacy endpoints in this randomized, prospective study were Hb normalization and quality of life (QoL) assessments using the Linear Analog Scale Assessment (LASA) and HIV-MOS (Medical Outcomes study) Health Survey. Patients were randomized to receive either 100 U/kg epoetin alfa TIW or 40,000 U epoetin alfa QW for 16 weeks, both administered subcutaneously, with treatment aimed to normalize Hb levels.
An interim analysis of the 16-week data included 174 (91 QW; 83 TIW) HIV- positive patients with no significant differences in age, weight, viral load and CD4 cell count at baseline. The mean change in Hb from baseline to final in the QW group was 2.8 g/dL +/- 1.9 and 2.4 g/dL +/- 2.4 in the TIW group. A significant improvement was noted in Hb levels and QoL in both arms at week 8 (P<.05) that was maintained until the end of the study. There were no significant differences (P>.05) between the QW and TIW dosing arms in Hb levels and QoL at week 16 or at last measurement. Both QW and TIW administration of epoetin alfa were well tolerated in the trial.
"The preliminary data provide new information about epoetin alfa in treating anemia in HIV-positive patients on antiretroviral therapy," said Howard Grossman, M.D. of the Columbia University College of Physicians and Surgeons, the lead investigator of the study. These results warrant further investigation of once-weekly versus three-times-weekly dosing of PROCRIT in treating anemia in HIV-positive patients receiving antiretroviral therapy. The study was supported by Ortho Biotech Products, L.P.
PROCRIT is indicated for three-times-weekly dosing in the treatment of anemia related to therapy with zidovudine in HIV-positive patients. PROCRIT is generally well tolerated.
Any adverse experiences associated with PROCRIT were believed to be related to the disease process of acquired immunodeficiency syndrome (AIDS), not to therapy with PROCRIT. Adverse experiences did not occur with clinically significant greater incidence than those seen in placebo-treated patients.
PROCRIT stimulates red blood cell production and is the only therapy with the protein sequence identical to the body's naturally occurring erythropoietin, which is produced in healthy kidneys. When more red blood cells are produced, more oxygen is carried through the body, which may increase energy levels. PROCRIT has been used in more than one million people and is marketed by Ortho Biotech Products, L.P.
Please visit http://www.PROCRIT.com for full U.S. Prescribing Information and additional information on PROCRIT and anemia.
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