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48-week results for the SOLO trial comparing GW433908/r QD to nelfinavir BID

Glasgow, United Kingdom (Nov. 21, 2002)- Results of the SOLO trial, an open-label, multi-center study evaluating the safety and efficacy of once-a-day (QD) dosing of the investigational protease inhibitor (PI) GW433908 (908) boosted with ritonavir (908/r) QD in antiretroviral therapy-nave patients versus twice-a-day (BID) nelfinavir (NFV, Viracept), were presented today at a late breaker session at the 6th International Congress on Drug Therapy in HIV Infection. SOLO is one of the first pivotal studies to investigate the potential of QD dosing of an HIV protease inhibitor. Both drug arms were administered as part of combination therapy that included abacavir (ABC) and lamivudine (3TC).

In the final analysis of this 48-week trial data, 68 percent of HIV+ patients achieved undetectable viral load with 908/r compared to 65 percent of patients taking NFV BID in this open label study. The 908 compound was co-discovered by GlaxoSmithKline (GSK) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX).

At a Glance

  • 68% of HIV+ patients achieved undetectable viral load (VL) with the investigational protease inhibitor 908/r compared to 65% of patients taking nelfinavir (NFV) BID in this open label study.

  • 71% of patients in the 908/r arm with high VL (>500,000 copies/mL) at baseline achieved undetectable VL compared to 53% of patients with high VL at baseline in NFV arm.

  • Virologic failure at 48 weeks was seen in 4% of patients in the 908/r QD arm and 15% of patients in the NFV BID arm.

  • The SOLO study population was treatment-naive, ethnically and gender diverse, with a high proportion of patients with advanced disease.

  • The most significant adverse event was diarrhea, which occurred in 16% in the NFV BID arm and 9% in the 908/r QD arm.

Efficacy Results from SOLO
In the SOLO study, 660 patients (649 treated) were randomized to receive either 1400 mg of 9
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Contact: Amy Kling
akling@pcipr.com
312-558-1770
Public Communications Inc.
21-Nov-2002


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