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Background:
Suppression of plasma HIV-1 viral load (VL) to <50
copies/ml
by HAART has been associated with long-term efficacy and a low incidence of
treatment failure. Previous studies have demonstrated that HIV-infected
patients with high pre-treatment VL may have a decreased likelihood of
suppression to <50 copies/ml. This finding suggests that the potency of a
HAART regimen is an important factor to consider for patients with VL
>100000 copies/ml. FTC is a new, potent once-daily (QD) NRTI in development
for HIV and
HBV infection.
in vitro,
FTC is up to 10-fold more potent than
lamivudine (3TC) and stavudine (d4T). A 14-day monotherapy study of FTC 200
mg QD demonstrated a 1.92 log10 reduction in VL.
Methods:
The
antiviral efficacy of FTC 200 mg QD was compared to
3TC 150
mg BID and d4T BID in a subset analysis from two doubleblind, randomized
clinical trials of treatment-naive HIV-infected patients with VL >100000
copies/ml. In study FTC301, FTC 200 mg QD
was compared to d4T BID in a background of didanosine QD and efavirenz (EFV)
QD. In study FTC-302, FTC 200 mg QD was compared to 3TC 150 mg BID in
a background of d4T BID and EFV QD. For this analysis, virologic failure
(VF) was defined as never achieving <50 copies/ml or >50 copies/ml on two
consecutive visits after achieving success. The Kaplan-Meier (KM)
probability of VF was compared between FTC and control arms using a log-rank
test.
Results:
Study FTC-301 enrolled 571 patients, 230 (117 FTC; 113
d4T) had
entry VL >100000 copies/ml. Study FTC-302 enrolled 468 patients, 74 (36 FTC;
38 3TC) had entry VL >100000 copies/ml. The KM probability of VF at W48 was
8.5% (FTC) and 23.6% (d4T) in study FTC-301, and 6.5% (FTC) and 11.0% (3TC)
in study FTC-302. Overall, FTC was statistically superior to the combined
control
arms (P=0.01).
Conclusions:
FTC is a potent, once-daily NRTI that
provided
significant efficacy within a HAART regimen in treatment naive HIV-infected
patients with viral load >100000 copies/ml.Paris,
13–16 July 2003
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