Interim analysis comparing TDF to EFV in combination with...( both K65R and MI84V mutations in 23 of ...),Health

both K65R and MI84V mutations in 23 of 36 patients (64 percent) of patients experiencing virologic non-response in the TDF group at 12 weeks. The K65R mutation was much more common in patients failing this combination than has been reported with failure of other tenofovir-containing regimens," said Joel Gallant, M.D., MPH, associate professor of medicine and epidemiology, Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.

"This study is part of GlaxoSmithKline's ongoing effort to provide options that fit the needs of individual patients by exploring fixed dose co-formulations that provide flexibility while reducing pill burden and dosing frequency," said Doug Manion, M.D., vice president of clinical development, GSK. "The study arm using the investigational co-formulation of ABC/3TC with EFV showed good virologic responses and it is continuing unchanged. GSK is committed to pursuing this further to better understand the findings of ESS30009." Abacavir is currently approved for BID dosing and lamivudine is approved for both QD and BID dosing. GSK is developing a co-formulation of lamivudine and abacavir for once daily dosing. This co-formulation is in late-stage clinical development.

Product Information

HIV medicines do not cure HIV infection/AIDS or prevent passing HIV to others. Ziagen Tablets and Oral Solution, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection. This indication is based on two controlled trials of 16 and 48 weeks duration that evaluated suppression of plasma HIV-1 RNA and changes in CD4+ cell count. At present, there are no results from controlled trials evaluating the effect of Ziagen on clinical progression of HIV.

When used as part of a combination regimen, abacavir is a potent nucleoside reverse transcriptase inhibitor (NRTI). The most serious adverse event associated with abacavir administ
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Contact: Elaine Salewske
esalewske@pcipr.com
312-558-1770
Public Communications Inc.
16-Sep-2003

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