Efficacy of efavirenz (SUSTIVATM) containing regimens in patients with baseline plasma HIV-RNA viral loads exceeding 100,000 copies/mL.
authors
DJ MANION, DF LABRIOLA, NM RUIZ.
publication
6th Conference on Retroviruses and Opportunistic Infections. 31 Jan-4 Feb, 1999, Chicago, IL. Abstract 383.
ABSTRACT
Efavirenz (EFV) is a once-daily NNRTI. The antiretroviral activity of the NNRTI class in patients with high baseline plasma HIV-RNA levels has been questioned. Clinical data of EFV was reanalyzed to investigate whether the efficacy demonstrated for the entire cohorts were similar to those of patients with baseline viral loads above 100,000 copies/mL (105 log10 copies/mL).
Methods: HIV-RNA was assessed by Roche Amplicor(r), primary endpoint was the percentage of patients below quantifiable levels (BQL, <400 or <50 copies/mL) by on-treatment (observed) data analysis.
% <400copies/mL
% <50 copies/mL
Study
EFV+
Wk
Entire cohort
>105/mL
Wk
Entire cohort
>105/mL
003
IDV
84
82%
N=45
76%
N=29
60
77%
N=43
74%
N=27
006
IDV
48
83%
N=88
62%
N=29
48
74%
N=88
55%
N=29
006
ZDV+3TC
48
98%
N=103
100%
N=30
48
90%
N=103
97%
N=30
020
IDV+ NRTI
36
77%
N=56
71%
N=7
24
74%
N=72
75%
N=8
Conclusions: ARV combinations containing EFV (with or without a PI) demonstrate similarly high levels of efficacy in individuals with baseline plasma HIV-RNA levels above 100,000 copies/mL when compared to the general study population and support the use of EFV-containing regimens in patients with high baseline viral loads.
