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Study evaluates Abacavir, Lamivudine and Efavirenz versus Zidovudine, Lamivudine and Efavirenz

Chicago, Sept. 14, 2003 A treatment regimen of Ziagen (abacavir sulfate) (ABC), Epivir (lamivudine) (3TC) and efavirenz (EFV) has been shown to be non-inferior to the often prescribed regimen of Retrovir (zidovudine) (ZDV) and 3TC and EFV in a large Phase III clinical trial comparing virologic response in treatment-nave HIV+ adults. The 48-week data from the trial (CNA30024) were reported here today at the 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

Study CNA30024 enrolled therapy-nave adults and randomized them to treatment with (1) ABC 300mg twice daily plus 3TC 150mg twice daily plus EFV 600mg once daily or (2) ZDV 300mg twice daily plus 3TC 150 mg twice daily plus EFV 600mg once daily. Abacavir is currently approved for twice daily dosing and lamivudine is approved for both once daily and twice daily dosing.

CNA30024 Results

Virologic failure was infrequent and similar between the treatment groups at 48-weeks, but subjects in the ABC/3TC/EFV group had a significantly better immunologic response (+209 CD4+cells/mm3) compared to subjects in the ZDV/3TC/EFV group (+155 CD4+cells/mm3). Safety profiles were comparable and both regimens were generally well tolerated over 48 weeks of randomized treatment.

"In this study, the three-drug combination of abacavir, lamivudine and efavirenz provided a potent antiretroviral response over 48 weeks and was shown to be non-inferior to zidovidine, lamivudine and efavirenz," said Edwin DeJesus, M.D., Infectious Disease Consultants, Altamonte Springs, Fla., lead investigator on the study.

In the international, multicenter trial of 649 patients, 70 percent of subjects in the ABC/3TC/EFV group and 69 percent of subjects in the ZDV/3TC/EFV group achieved an undetectable viral load (VL) level below 50 copies/mL at 48 weeks. Among all the patients, median VL at baseline was approximately 62,000 copies/mL and 39 percent had baseline VL >100,000 copies/mL. Me
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Contact: Elaine Salewske
esalewske@pcipr.com
312-558-1770
Public Communications Inc.
15-Sep-2003


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