AEGiS-Glasgow [PL3.2] Phase 3 comparison of lopinavir/ritonavir vs. investigator-selected protease inhibitors in single PI-experienced , NNRTI-naïve patients: 48-week results of study M98-888

Seventh International Congress on Drug Therapy in HIV Infection

Glasgow, UK - 14-17 November 2004

[PL3.2] Phase 3 comparison of lopinavir/ritonavir vs. investigator-selected protease inhibitors in single PI-experienced, NNRTI-naïve patients: 48-week results of study M98-888

Int Cong Drug Therapy HIV 2004 Nov 14-18;7:Abstract No. PL3.2

R.B. Pollard¹ , M.A. Thompson², C.B. Hicks³, B. Grinsztejn⁴, A. Horban⁵, M.S. King⁶, M. Norton⁶, P.A. Cernohous⁶, S.C. Brun⁶, J.H. Omachi⁶
¹UC-Davis Med Ctr., Sacramento; ²ARCA, Atlanta; ³Duke U Med Ctr., Durham, USA; ⁴Hospital Evandro Chagas-Fiocruz, Rio De Janeiro, Brazil; ⁵Center of AIDS Diagnosis and Treatment, Warsaw, Poland; ⁶Abbott Laboratories, Abbott Park, USA

Phase 2 trial in single PI-experienced patients (pts), LPV/r plus nevirapine (NVP) and 2 NRTIs demonstrated durable antiviral activity through 3 years.

Phase 3, randomized, open-label, 48-wk trial, 288 NNRTI-naïve pts failing an initial PI-based regimen received LPV/r 400/100 mg BID (n=148) or ISPIs (n=140). Allowed control-arm PIs were any single PI, RTV/SQV (400/400), RTV/IDV (400/400), or NFV/SQV (1250/1200). All pts received NVP and 2 NRTIs.

Pts were primarily male (86%) and Caucasian (80%). Mean baseline HIV RNA and CD4 count were 4.1 log₁₀c/mL and 322 cells/mm³. Most common prior PIs: NFV (43%), IDV (42%). ISPIs regimens: RTV/SQV (44%), RTV/IDV (21%), NFV (21%). Discontinuation through 48 wks was 43% for ISPIs (14% AE, 13% virologic failure (VF), 16% other) and 24% for LPV/r (5% AE, 2% VF, 17% other), p<0.001. By intent-to-treat analysis, 57% (LPV/r) and 33% (ISPIs) had HIV RNA <400 c/mL at 48 wks (FDA TLOVR algorithm, p<0.001). Mean 48-wk CD4 increases were 111 (LPV/r) and 112 (ISPIs) cells/mm³. Most common moderate/severe, drug-related AEs and grade 3 lab elevations: nausea (7% LPV/r, 16% ISPIs), vomiting (4%, 12%), diarrhea (7%, 9%), total cholesterol (>300 mg/dL, 20% LPV/r, 21% ISPIs) and triglycerides (>750 mg/dL, 25% LPV/r, 21% ISPIs).

A LPV/r-based regimen demonstrated superior virologic efficacy and better tolerability in single PI-experienced pts, vs. a regimen based on investigator-selected PIs.

SESSION 3

2004-11-14
PL3.2

Copyright © 2004 - Thomson ACUMED® All rights reserved. Thomson ACUMED® is an intelligent and innovative medical marketing and communications agency – a new division of The Gardiner-Caldwell Group Ltd, part of The Thomson Corporation, located in Tytherington, UK.

Reproduction of this abstract (other than one copy for personal reference) must be cleared through the authors.