CNA30021 Studies QD Regimen

A multicenter, randomized study of HIV-infected ART nave adults compared the virologic response of 600mg QD and 300mg twice daily (BID) regimens of abacavir (in a double-blind manner), each in combination with open-label Epivir (lamivudine) (3TC) 300mg QD and efavirenz (EFV) 600mg QD.

The ABC QD dosing regimen provided an antiretroviral response over 48 weeks that was shown to be non-inferior to the approved ABC BID dosing regimen, according to study results.

"There are a number of antiretroviral drugs that have now received FDA approval to be dosed once a day, but because of drug interactions or food requirements, finding a combination that is 'truly' QD with a patient taking all his ART medications at one time, once a day has been daunting," said Doug Manion, M.D., GSK vice president of clinical development. "It has been GSK's goal to test our established drugs to determine if the data would support their use QD, providing greater flexibility for patients and physicians. Epivir is already approved to be dosed once a day and the data from the two studies being presented at ICAAC this week provide additional insight into QD dosing of Ziagen. If you add in efavirenz, which is also given once daily, a true QD regimen appears possible with patients being able to take three ART pills once a day."

In the study of 770 individuals, 66 percent in the ABC QD group versus 68 percent in the ABC BID group achieved and maintained plasma HIV-1 RNA of <50 copies/mL through 48 weeks. Virologic failure was infrequent and similar between the treatment groups (10 percent in the QD group versus 8 percent in the BID group). Patients at basel
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Contact: Elaine Salewske
esalewske@pcipr.com
312-558-1770
Public Communications Inc.
16-Sep-2003