Study assessing once daily Abacavir (ABC) in a once daily A...( The geometric mean ABC terminal ha...),Health

The geometric mean ABC terminal half-life in plasma was 2.59 hours; the geometric mean CBV-TP terminal half-life in PBMCs was 20.64 hours.

"The short plasma half-life of ABC and the long terminal half-life of CBV-TP in blood cells suggests that there is accumulation of one of the precursors of carbovir triphosphate within the cell," said Dr. Manion. "These findings are of interest as we continue to evaluate the use of ABC as a 600mg dose taken once a day."

Abacavir is currently approved for BID dosing and lamivudine is approved for both QD and BID dosing.

Based on these studies, CNA10905 and CNA30021, and other information, GSK is developing a co-formulation of lamivudine and abacavir that is intended 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. Epivir in combination with other antiretroviral agents is indicated for the treatment of HIV infection.

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 administration is a hypersensitivity reaction occurring in approximately 5 percent of patients and which can be life threatening and has been fatal in some cases. It is characterized by fever, skin rash, fatigue and gastrointestinal symptoms, such as nausea, vomiting, diarrhea or abdominal pain. Respiratory symptoms such as dyspnea, pharyngitis or cough may al
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Contact: Elaine Salewske
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312-558-1770
Public Communications Inc.
16-Sep-2003