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Purpose:
To
examine the efficacy in sub-populations of study 903
which was
designed to evaluate the efficacy and safety of TDF as part of a fixed ART
regimen in antiretroviral-naive patients over 144
weeks.
Methods:
Phase
III, multicentre, randomized, double-blind,
active-controlled trial in patients with HIV-1 RNA >5000 copies/ml with no
minimum entry requirement for CD4+ lymphocyte cell count. Patients were
randomized to receive either TDF or d4T plus 3TC and EFV. Patients randomized to
TDF received d4T placebo bid while
those randomized to d4T
received TDF placebo once daily.
Results:
The intent-to-treat (ITT) population included 600 patients with the following
baseline characteristics: mean age 36 years, 26% female,36%
non-Caucasian, mean HIV-1 RNA 4.9 log10 c/ml; mean CD4 count 279 cells/mm3.
Using ITT, missing=failure analysis through
week 96, the
proportion of patients in the entire study achieving <400 c/ml was similar in
both groups (TDF 82% (244/299), d4T 78% (235/301)). Using the same analysis (ITT
M=F, % < 400 c/ml), the results for the subpopulations are as follows: baseline
HIV RNA >100,000 c/ml [TDF 82% (113/138), d4T 79% (102/129)], baseline CD4 cell
count <200 [TDF 79% (93/118), d4T 75% (85/113)], baseline CD4 cell count <50
[TDF 73% (37/51), d4T 74% (32/43)],non-clade B HIV [TDF 89% (24/27), d4T 91%
(21/23)], men (TDF84% (185/220), d4T 80% (179/225)), women (TDF 75% (59/79),d4T
74% (56/76)), black (TDF 75% (48/64), d4T 62% (33/53)),hispanic [TDF 67%
(14/21), d4T 70% (16/23)] and those patients who substituted nevirapine for
efavirenz, per protocol [TDF 70%
(14/20), d4T 70% (16/23)].
Conclusions:
Through
96 weeks, combination
therapy with TDF was comparable to d4T
for efficacy regardless of baseline characteristic variable in ART-naive
patients.
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