Durability of response of efavirenz (SUSTIVATM, EFV)-containing regimens: Report of the post-control period results of studies with EFV.
authors
Manion DJ, Faulkner E, Saxton TD, Labriola DF, Ruiz NM.
publication
6th Conference on Retroviruses and Opportunistic Infections. 31 Jan-4 Feb, 1999, Chicago, IL. Abstract 382.
ABSTRACT
Background: Efavirenz (EFV) is a once daily NNRTI that has demonstrated equal to superior efficacy and superior tolerability to a protease inhibitor containing standard of care regimen when used with ZDV and 3TC (Study 006, 36 weeks).
Objectives: Assess long term safety and efficacy of several EFV-containing regimens.
Studies: 003 EFV+IDV (cohort IV, N=59), 005 EFV+ZDV+3TC(N=34), 020 EFV+IDV+NRTIs (N=136). Treatment assignments were blinded for 12, 16 and 24 weeks for studies 003, 005, and 020.
Methodology; Analyses: observed data (OBS, "on-treatment" analysis), intent-to-treat(ITT): last observation carried forward (LOCF), and ITT: non-completer equals failure (NC=F).
Preliminary Results:
% PTS HIV-RNA <400 copies/mL
%PTS HIV-RNA <50 copies/mL
Wk
OBS
LOCF
NC=F
Wk
OBS
LOCF
NC=F
003
84
84.1
69.5
64.9
60
76.2
73.6
69.6
005
48
90.5
76.5
59.9
16
66.7
52.9
52.9
Conclusions: Early efficacy and safety results from studies of EFV have indicated that it is well tolerated and highly effective. The data presented here suggest that this effectiveness is maintained for as long as 84 weeks with little late onset toxicity.
