 |
|
|
| |
Induction/Maintenance-Simplification: Sustained Virologic Efficacy of Atazanavir (ATV) Versus Atazanavir/Ritonavir (ATV/r), each in Combination with Abacavir/Lamivudine (ABC/3TC) over 120 Weeks: the ARIES Trial
|
| |
| |
Reported by Jules Levin
ICAAC Boston Sept 13 2010
K. SQUIRES1, E. DEJESUS2, N. BELLOS3, D. WARD4, D. MURPHY5, B. YOUNG6, H. ZHAO7, L. PATEL7, L. ROSS7, P. WANNAMAKER7, M. SHAEFER8
1Thomas Jefferson Univ., Philadelphia, PA;2Orlando Immunology Ctr., Orlando, FL; 3SW Infectious Disease Assoc., Dallas, TX 4Dupont Circle Physicians Group, Washington DC, 5Clinique MedicaleL'Actuel, Montreal, Quebec; 6Rocky Mountain CARES/DIDC, Denver, CO 7GlaxoSmithKline, RTP, NC; 8ViiV Healthcare, RTP, NC
INTRODUCTION
Treatment simplification strategies involving induction with a ritonavir-boosted protease inhibitor regimen followed by simplification (discontinuing ritonavir) are appealing because they may result in sustained virologic suppression while minimizing potential long-term ritonavir-associated adverse effects. While atazanavir drug levels can be reduced when co-administered with some ART, ABC/3TC is approved for use with unboosted ATV. The ARIES trial demonstrated the non-inferiority of ATV to ATV/r, both with ABC/3TC over 84 weeks after induction with ATV/r + ABC/3TC.1,2
An extension of the study from 84 to 144 weeks was added to assess long-term efficacy. and safety.
METHODS
As shown in Fig. 1, ART-naïve subjects received ABC/3TC + ATV/r followed by randomization (1:1) at week 36 to maintain or discontinue RTV to 84 weeks; eligible subjects could continue to 144 weeks. Randomization criteria were as follows: confirmed RNA <50 c/mL prior to Week 36; RNA <50 c/mL immediately preceding Week 36, and no protocol defined virologic failure
The objectives of this study extension were to collect extended treatment data in subjects who had completed 84 weeks of study, and evaluate the proportion of subjects with HIV RNA <50 and 400 c/mL (TLOVR) at Weeks 120 and 144. Additionally , the change from baseline in HIV RNA and CD4+ cell count, resistance in subjects with virologic failure and safety endpoints were examined.
Results of a planned analysis at 120 weeks are presented. Protocol defined virologic failure (VF) after Week 36 was defined as a confirmed HIV-1 RNA (RNA) ≥400 copies/mL.
RESULTS
Of 419 randomized subjects who were included in the Week 84 analysis, 369 (88%) participated in the extension phase (ITT-Extension population) (Table 1) which continued post Week 84 through 144 weeks. Five subjects in each treatment arm did not enroll in the extension phase. Extension subjects were demographically similar to the randomized population1and between arms (Table 1): mean age 39 yrs; 85% male; 64% white; median baseline RNA and CD4+ count were 5.06 log10 c/mL, 198 cells/mm3,respectively.
|
| |
|
|
|
|
|
