By Rachel Parratt
SYDNEY, AUSTRALIA -- July 26, 2007 -- KivexaŽ (abacavir/lamivudine) met noninferiority criteria for virologic efficacy but not for treatment efficacy when compared with TruvadaŽ (tenofovir/emtricitabine).
Jose Gatell, MD, Professor of Medicine, University of Barcelona, and Head, Infectious Diseases Unit, University Hospital Clinic, Barcelona, Spain, presented these findings here at the 4th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention.
Truvada and Kivexa are fixed-dose combinations and the most commonly recommended and used nucleoside analogue backbone for initial antiretroviral therapy.
A total of 333 patients with virologic suppression for at least 6 months while on a lamivudine-containing highly active antiretroviral therapy regimen had their nucleoside reverse transcriptase inhibitor (NRTI) backbone switched to either Truvada or Kivexa.
Virologic suppression was defined as an HIV RNA level <200 copies/mL.
Treatment failure occurred in 13.3% of patients in the Truvada arm and 19.2% of patients in the Kivexa arm.
For treatment efficacy, the Kivexa arm did not meet the noninferiority endpoint compared with the Truvada arm. This difference was mainly driven by nine patients in the Kivexa arm who discontinued because of suspected abacavir hypersensitivity. Retrospective human leukocyte antigen (HLA) testing showed three out of the nine patients were HLA B5701 positive.
For virologic efficacy, Kivexa met the noninferiority endpoint compared with Truvada. However, there were more virologic failures in the Kivexa arm compared with the Truvada arm (2.4% vs 0%).
Dr. Gatell commented, "In patients switching the NRTI component to Kivexa versus Truvada, noninferiority was met for virologic efficacy, but not for treatment efficacy."
[Presentation title: Efficacy and Safety of NRTI's Switch to Tenofovir Plus Emtricitabine (TruvadaŽ) Vs. Abacavir Plus Lamivudine (KivexaŽ) in Patients With Virologic Suppression Receiving a Lamivudine Containing HAART: The BICOMBO Study. Late Breaker WESS102]
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