Once-weekly epoetin alfa dosing is as effective as three times-weekly dosing in increasing hemoglobin levels and is associated with improved quality of life in anemic HIV-infected patients.

Author(s): Grossman HA, Goon B, Bowers P, Leitz G, 010 Study Group

Affiliation(s): Columbia University College of Physicians and Surgeons, New York, New York, USA. hagdoc@polari.net

Publication date & source: 2003-12-01, J Acquir Immune Defic Syndr., 34(4):368-78.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

BACKGROUND: Anemia is prevalent in HIV-positive patients despite lower doses of zidovudine used in highly active antiretroviral therapy. Previously, epoetin alfa has been administered 3 times weekly (TIW). We compared the hematologic and quality of life (QOL) effects and tolerability of the more convenient once-weekly (QW) regimen with TIW epoetin alfa in anemic HIV-positive patients. METHODS: Two hundred eighty-five anemic (hemoglobin [Hb] <12 g/dL) HIV-positive adults receiving stable antiretroviral therapy were enrolled in this 16-week, randomized, multicenter study. Enrolled patients were randomized to receive epoetin alfa doses of 40,000 to 60,000 U QW or 100 to 300 U/kg TIW. RESULTS: Two hundred seventy-two patients were evaluable for efficacy. Both epoetin alfa dosing schedules produced significant Hb level increases by week 2 (mean Hb increase of 1.3 g/dL [QW] and 1.0 g/dL [TIW]; P < 0.0001) that continued to increase until week 8 and were maintained until study completion, with no significant difference between treatment groups at final Hb measurement (mean Hb increase of 2.9 g/dL [QW] and 2.5 g/dL [TIW]). All QOL parameters improved significantly (P < 0.05) from baseline by week 8 in both groups, with no significant differences between groups at week 16. Both dosing schedules were well tolerated. CONCLUSIONS: QW dosing of epoetin alfa is as effective as TIW dosing in increasing Hb levels, which was associated with improved QOL in anemic HIV-positive patients. QW dosing should also offer added convenience for patients and caregivers.