final program.qxd - Parallels Plesk Panel

PP 4.26
Cell-cycle independent antiretroviral therapy: combination of nevirapine,
emtricitabine, and tenofovir
Charles Davis, Anthony Amoroso, Bruce Gilliam, Derek Spencer, Becky Boyce,
Shannon Berg, Joyelle Dominique, Sandy Zaremba, Robert Redfield
Institute of Human Virology Baltimore, Maryland, USA
Background
Published data demonstrates differential anti-viral activity of specific reverse transcriptase
(RT) inhibitors in resting and activated PBMCs, however, Abacavir, Tenofovir (TDF),
Emtricitabine (FTC), and NNRTIs inhibit RT independent of cell cycle. We hypothesized a
cell cycle independent RT based regimen would be potent and demonstrate durable viral
suppression.
Methods
This is an open-labeled, 96 week clinical trial evaluating the efficacy of TDF 300 mg qd,
FTC 200 mg qd, and Nevirapine (NVP) 200 mg b.i.d. Entry criteria included: >18 y.o. with
established HIV; ARV-naive; CD4 count of 5,000 c/mL.
Results
Thirty (70% male, 97% African American) volunteers have enrolled to date. The mean
HIV-1 RNA and CD4 count at baseline (BL) were 5.15 log10 (47% with viral loads
> 100,000) and 149 cells/mL, respectively. The mean decline in RNA at Week 2 was 2.09
log10. Week 24 analysis (ITT and OT) showed 73% and 96% < 400 c/mL, and 70% and
91% < 50 c/mL. The mean increase in CD4 count from BL was 109 cells/mL (OT). Twenty
two subjects have completed 48 weeks: 16/22 (73%) and 16/16 (100%) had HIV-1 RNA
< 400 c/mL and 15/22 (68%) and 15/16 (94%) < 50 c/mL, ITT and OT, respectively; the
mean increase in CD4 cell count was 186 cells/mL. A transient self-limited mild rash not
requiring therapy interruption occurred in 4 subjects. Two volunteers developed grade
4 LFT elevation and 1 volunteer developed grade 4 neutropenia: all resolved with
discontinuation of the ARVs.
POSTERS
Conclusion
The combination of TDF, FTC, and NVP appears very potent, safe, and well tolerated,
even at high viral loads. This study provides evidence-based data to support the use of
TDF, FTC and NVP in patients with CD4 cell counts < 250, including in resource-limited
settings, and warrants further evaluation.
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