Ritonavir (RTV)-saquinavir (SQV) in protease inhibitor-naïve patients after 72 weeks.
Originally Published on January 1, 1998
John Mellors, A.J. Japour, J.Leonard, E. Sun, Y. Xu, M. Salgo. M97-462 Study Groups.
The 12th World AIDS Conference. 28 June-3 July 1998, Geneva, Switzerland. Abstract 12295.
ABSTRACT: Objectives: Summarize the safety and efficacy of RTV-SQV regimens through 72 wks in protease inhibitor naïve HIV-positive pts with CD4 counts of 100-500/mL.
Design: Prospective, open-label randomized study with four RTV-SQV dose regimens. RTIs were added for pts whose viral load did not reach or maintain <200 copies/mL after 12 wks. After wk 48 all pts were allowed to dose reduce to 400-400 mg BID and add up to two additional RTIs (nucleoside or non-nucleoside) for any reason.
Results: The baseline plasma HIV RNA was 4.63 log10 copies/mL and CD4 count was 273/mL. 73% (103/141) remain on study at Wk 72 of follow-up. Wk 72 data is available from 93% (96/103). Overall, 90% (86/96) have plasma HIV RNA <200 copies/mL More than half had been dose reduced to RTV-SQV 400-400 mg BID by 24 wks. Median CD4 cell increase was 188/mL at Wk 72. Thirty-three pts had RTIs added to their regimen after a median of 186 days; three of these pts discontinued the study. Twenty-seven pts added RTI for HIV RNA >200 copies/mL. In 85% (23/27) HIV RNA decreased to <200 copies/mL at wk 72 (preliminary data). Updated safety data will be presented. There have been no reported CDC-defined AIDS events and no deaths reportedthrough Wk 72.
