Sixth International Congress

Drug Therapy in HIV Infection


17-21 November, 2002
Glasgow, UK

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Efficacy and safety of GW433908/ritonavir once daily in therapy naïve subjects, 48 week results: the SOLO Study

D Schürmann1, J Gathe2, I Sanne3, R Wood on behalf of the SOLO Study Team4
Int Cong Drug Therapy HIV 2002 Nov 17-21;6:Abstract No. PL14.4

GW433908 (908) is a new protease inhibitor, with a well characterised distinct resistance profile, and the potential for once daily dosing (QD) when combined with low dose ritonavir (RTV). SOLO is a randomised, open-label study in ART-naïve subjects comparing the efficacy and safety of 908/RTV QD vs nelfinavir (NFV) BID over 48 weeks. 660 subjects (649 treated) with plasma HIV-1 RNA (vRNA) = 1000 c/mL were randomised 1:1 to 908 1400mg/RTV 200mg QD or NFV 1250mg BID in combination with ABC and 3TC BID, and were stratified at entry on vRNA. Subjects generally had advanced HIV disease at baseline: median vRNA 4.8 log10 c/mL, 43% had vRNA >100,000c/mL; median CD4 170 cells/ mm3, 20% had <50 cells/mm3; 22% had a history of CDC Class C events.

908/RTV QD NFV BID Stratified Δ
n = 322 n = 327 (95% CI)
Virological failure at Week 48 7% 17% -
Week 48 vRNA <400 c/mL (ITT M=F) 68% 65% 3%
220/322 213/327 (-4, 10)
Week 48 vRNA <400 c/mL (Per Protocol) 95% 91% 4%
215/226 215/237 (0, 9)
Week 48 vRNA <50 c/mL (ITT M=F) 56% 52% 3%
179/322 171/327 (-5, 11)
Week 48 vRNA <50 c/mL (Per Protocol) 78% 72% 6%
176/226 171/237 (-2, 13)

Diarrhea was significantly lower in the 908/RTV group (9% v 16%, p=0.008), but the incidence of other drug-related AEs (≥Grade 2) was comparable. Incidences of Grade 3/4 lipid abnormalities were low despite the use of low dose RTV (triglycerides: 6% v 2%; cholesterol: 1% v 0; 908/RTV NFV respectively). These results demonstrate the potency, durability and tolerability of 908/ RTV QD in therapy-naïve subjects, with the added benefit of a low pill burden.

Presenting author: D Schürmann

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1 Charité University Hospital, Berlin, Germany

2 Therapeutic Concepts, Houston, Texas, USA

3 Infectious Diseases Clinical Trial Unit, Parktown, South Africa

4 Somerset Hospital, Cape Town, South Africa

2002-11-17
PL14-4

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