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Background:
Emtricitabine (FTC) is a new once-daily NRTI in development
with potent activity against HIV and HBV. Abacavir (ABC),a NRTI, has
demonstrated suppression of HIV when used in combination with other
antiretroviral agents. The study was designed to compare the effectiveness
of once-daily FTC to twice-daily ABC when
used within a HAART
regimen.
Methods:
This was a randomized,
open-label pilot study in
treatment-naive HIV-1-infected patients with plasma HIV-1 RNA (VL)
=5000
copies/ml. Patients were randomized in a 1:1 ratio to receive FTC (200 mg
QD) or ABC (300 mg BID) in a background of stavudine and efavirenz. Patients
were evaluated at baseline (BL) and every 4 weeks for adverse events (AEs)
and every 12 weeks for VL through week 48. The primary efficacy comparison
was the proportion of randomized and treated patients with VL
=50copies/ml
at week 24 using an intent-to-treat (ITT), non-completer
equals failure analysis.
Results:
A total of 37 patients (18 FTC, 19
ABC) were
enrolled across nine clinical sites. At BL the median VL(4.6
log10) and median CD4+ cell percent (19%) were comparable
between the two treatment arms. The majority of patients were male (>90%)
and Caucasian (51%). Median exposure to study drug wasn 36 weeks in the ABC
arm and 40 weeks in the FTC arm. At week 24, a greater proportion of
patients in the FTC arm (83.3%) had VL
=50
copies/ml compared with the ABC arm (63.2%), however, this difference was
not statistically significant due to the small sample size.
Persistent suppression of the VL was maintained in both treatment arms after
week 24. The CD4+ cell percent increased in both treatment groups, with a
median increase from BL at 24 weeks of 6.4% in the ABC arm and 7.6% in
the FTC arm. Two patients from each
treatment arm
discontinued study drug due to an AE.
Conclusions:
The antiviral efficacy and tolerability of once-daily emtricitabine compares
favorably to twice-daily abacavir when used with stavudine and efavirenz. |
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