Washington DC, October 31,2004 GlaxoSmithKline (GSK) today announced that new information
from ongoing clinical trials investigating varied clinical applications for TRIZIVIR (abacavir sulfate, lamivudine
and zidovudine) were presented at the 44th annual meeting of the Interscience Conference on Antimicrobial
Agents and Chemotherapy (ICAAC).
TIMS - Quad Therapy TRIZIVIR + Tenofovir, Compared with Triple Therapy
COMBIVIR + Efavirenz
In an open-label study reported at ICAAC, 114 treatment-naove patients were randomized to receive the single-
class quad NRTI regimen of TRIZIVIR plus tenofovir disoproxil fumarate (TDF) or a regimen of a dual-class triple
regimen of two NRTIs (COMBIVIR) and the nonnucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV). |
These data were reported by Graeme Moyle, M.D., of Chelsea and Westminster Hospital, London.
At week 48 intent-to-treat analysis, 40 of 57 patients (70 percent) on the regimen containing TRIZIVIR plus TDF
and 39 of 57 patients (68 percent) on the regimen containing COMBIVIR plus EFV had undetectable viral loads
(VL) <50 copies/mL. Mean baseline (BL) VL was 5.13log(10) and mean CD4 cell count was 153 cells/mm(3) in
the group randomized to take TRIZIVIR plus TDF, and 5.26log(10) and 193 cells/mm(3), respectively, in the group
taking COMBIVIR plus EFV. In intent-to-treat analysis, results are included for all patients randomized to a
study, regardless of whether they actually completed the study protocol and patients with missing data are
considered treatment failures.
ESS30005 (ZIP) - Regimens for Patients with Early Virologic Failure
In a second study presented at ICAAC, 51 patients experiencing early virologic failure on a regimen of
RETROVIR(R) (zidovudine, ZDV) or stavudine (d4T) plus EPIVIR(R) (lamivudine, 3TC), combined with either a PI
or NNRTI were switched to open-label TRIZIVIR twice daily (BID) plus TDF once daily (QD). In a planned 24 week
interim analysis, proportions with HIV RNA <400 c/mL were 75 percent (ITT missing = failure). HIV RNA <50 c/mL
was achieved by 65 percent (ITT missing = failure) at week 24. No subject experienced confirmed virologic failure
through week 24. At BL, media VL was 1,972 copies/mL and median CD4 was 436 cells/mm(3).
"Patients with early virologic failure on an NNRTI-based or PI-based regimen may be appropriate candidates for a
quad regimen containing TRIZIVIR,"said Allan Rodriguez, M.D., associate professor of medicine, division of
infectious diseases, University of Miami School of Medicine.
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