New information on TRIZIVIR presented at conference.

2004 DEC 1 - (NewsRx.com & NewsRx.net) -- GlaxoSmithKline (GSK) 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).

TRIZIVIR, the first tablet to combine three medications for HIV, is a fixed-dose-combination tablet containing three nucleoside reverse transcriptase inhibitors (NRTIs).

"These data help demonstrate the versatility of TRIZIVIR as a treatment for HIV in different clinical situations, and illustrate GSK's ongoing commitment to simplify HIV treatment regimens for many patients," said Doug Manion, MD, vice president for HIV Clinical Research for the Infectious Diseases Medicines Development Center (MDC) at GSK.

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, MD, of Chelsea and Westminster Hospital, London.

At week 48 intent-to-treat analysis, 40 of 57 patients (70%) on the regimen containing TRIZIVIR plus TDF and 39 of 57 patients (68%) on the regimen containing COMBIVIR plus EFV had undetectable viral loads (VL)

In a second study presented at ICAAC, 51 patients experiencing early virologic failure on a regimen of RETROVIR (zidovudine, ZDV) or stavudine (d4T) plus EPIVIR (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

"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, MD, associate professor of medicine, division of infectious diseases, University of Miami School of Medicine.