-- Significantly greater mean increase in CD4+ cell count from baseline;
mean increase of 81 vs. 64 cells/mm(3)[p=0.0022]
The results of DUET-1 and DUET-2 were published separately in two
articles in the July 7, 2007 issue of The Lancet, and the pooled analysis
from the DUET studies was presented at the 47th Interscience Conference on
Antimicrobial Agents and Chemotherapy (ICAAC) in September 2007.
DUET-1 and -2 Resistance
-- The presence of K103N, which was the most prevalent NNRTI substitution
in DUET-1 and -2 studies at baseline, did not affect the response in
the INTELENCE arm.
-- The presence at baseline of the substitutions V179D, V179F, V179T,
Y181V, or G190S was associated with a decreased virologic response to
-- In the DUET-1 and -2 studies, the presence at baseline of three or more
2007 IAS-USA-defined NNRTI substitutions (V90I, A98G, L100I, K101E/P,
K103N, V106A/I/M, V108I, V179D/F, Y181C/I/V, Y188C/H/L, G190A/S, P225H)
resulted in a decreased virologic response to INTELENCE.
-- For patients in the DUET-1 and -2 studies experiencing virologic
failure on an INTELENCE-containing regimen, the substitutions that
occurred most commonly were V179F, V179I, Y181C, and Y181I which
usually emerged in a background of multiple other NNRTI
resistance-associated substitutions. Other NNRTI resistance-associated
substitutions which emerged in patients on INTELENCE treatment in
< 10 percent of the virologic failure isolates included K101E, K103N,
V106I/M, V108I, Y188L, V189I, G190S/C and R356K.
-- Cross-resistance to delavirdine, efavirenz, and/or nevirapine is
expected after virologic failure with an INTELENCE-containing regimen.
DUET-1 and -2 Tolerability
In the DUET-1 and -2 studies, the most common adverse events (> 10
|SOURCE Tibotec Therapeutics|
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