3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

CHARACTERIZATION OF ANEMIA IN HIV-INFECTED (HIV+) SUBJECTS TREATED WITH ANTIRETROVIRAL THERAPY (ART) WITH AND WITHOUT ZIDOVUDINE (±ZDV) IN 54 CLINICAL TRIALS

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. TuFo0106

Edwards M., Burkle W., Cutrell A., Liao Q., Brothers C., Hernandez J.
GlaxoSmithKline R&D, Research Triangle Park, North Carolina, United States of America

INTRODUCTION: Hematotoxicity (mainly anemia and neutropenia) is reported in HIV+ subjects, including those treated with ZDV. This ZDV-associated toxicity is considered dose related. Approximately 3% of subjects report moderate/severe anemia (DAIDS 1992 grades 2/4) at the currently approved dose. We performed an analysis of data from 54 trials (>12,000 subjects treated with ART ± ZDV) to evaluate the incidence and severity of anemia.

METHODS: All GSK-sponsored trials with ≥24 weeks of ART finished from January 1995 to January 2004 were analyzed. Anemia was identified by Hb levels <normal, and classified with the DAIDS scale. Descriptive statistics were summarized for naïve and experienced subjects treated ±ZDV.

RESULTS: Baseline demographics and characteristics were comparable between subjects treated with (5174 subjects) and without (7511 subjects) ZDV. 71% and 42% of subjects respectively were ART-naïve. The incidence of grade 2/4 anemia in naïve subjects was similar in those receiving ZDV (1.5%, 95%CI [1.1%,1.8%]) versus those not receiving ZDV (1.3%, 95%CI [0.9%,1.7%]). In experienced subjects, the incidence of anemia was higher, (p<0.01), in those receiving ZDV (1.7%, 95%CI [1.1%,2.4%]) than in those not receiving ZDV (0.8%, 95%CI [0.5%,1.1%]). When subjects receiving ZDV were classified as receiving ZDV as a separate drug vs. as part of a fixed combination tablet (Combivir [COM, ZDV 300mg/Lamivudine 150mg] or Trizivir [TZV, ABC 300mg/Lamivudine 150mg/ZDV 300mg]) incidences of anemia were 2.0% (95%CI [1.5%,2.6%]) for ZDV and 1.1% (95%CI [0.7%,1.5%]) for COM/TZV. Severe anemia (grade 3/4) was documented in 1.0% of naïve and in 1.0% of experienced subjects taking ZDV compared to 0.7% and 0.4% of subjects not taking ZDV.

CONCLUSIONS: The overall incidence of anemia in this cohort was low (1%). Subjects treated with ZDV had a higher incidence of anemia compared to subjects not treated with ZDV. This incidence, however, was low and appeared to be lower when COM/TZV were used.

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050724
TuFo0106
Complications of HIV therapy

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