Boston (Feb. 14, 2003) Final 48-week results from the NEAT trial, an open-label, multi-center study evaluating the safety and efficacy of the investigational protease inhibitor (PI) GW433908 (908) in antiretroviral therapy-nave HIV+ patients versus nelfinavir (NFV/Viracept), were presented here today. In the trial, 66 percent of 166 HIV+ patients (n=109) achieved an undetectable viral load (vRNA) with 908, compared to 51 percent of 83 patients (n=42) taking nelfinavir. The 908 compound was co-discovered by GlaxoSmithKline (GSK) and Vertex Pharmaceuticals (Nasdaq: VRTX).

These results come from the final analysis of 48-week data from the NEAT study in which patients were randomized to receive either 1400 mg of 908 (2 tablets) twice daily (BID) or 1250 mg of nelfinavir (5 tablets) BID. 908 was taken without food or fluid restrictions. Both groups took these medications in combination with 300 mg BID of abacavir (ABC) and 150 mg BID of lamivudine (3TC). ABC and 3TC are nucleoside analogue reverse transcriptase inhibitors (NRTIs).

"These 48-week data on the safety and efficacy of the investigational agent 908 in a relatively advanced and diverse treatment-nave patient population demonstrate that, once approved, 908 will be a promising new addition to current therapy options for individuals infected with HIV," said Doug Manion, M.D., vice president of Clinical Development, GSK.

Efficacy Results from NEAT

"At 48 weeks, 66 percent of 166 HIV-positive patients taking 908 achieved undetectable viral load (<400 copies/mL), compared to 51 percent of 83 patients taking nelfinavir. More subjects on the NFV group, 28 percent, were considered virologic failures compared to those subjects receiving 908, 14 percent," said Jeffrey P. Nadler, M.D., University of South Florida College of Medicine, Tampa, a NEAT trial investigator. Further, 55 percent (n=92) of patients in the 908 arm achieved a viral load <50 copies/mL, compared to 41 percent (n=
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Contact: Amy Kling
akling@pcipr.com
312-558-1770
Public Communications Inc.
14-Feb-2003

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