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Abstract
Efficacy and safety of atazanavir (ATV) based HAART in virologically suppressed subjects switched from lopinavir/ritonavir (LPV/RTV) Treatment
J.M. Gatell1, T. Branco2, L. Sasset3, F. Pulido4, A. Macor5, S. Gothelf6, C. Gruber7, L. Odeshoo8, V. Wirtz8, E. Ledesma9
Background: BMS097 (SWAN) study demonstrated that simplification from stable PI ± ritonavir (RTV)-containing to unboosted ATV-containing regimens maintained virologic suppression with lipid improvements through 48 weeks. This analysis reports the safety and efficacy of subjects on LPV/RTV at enrollment.
Methods: Subjects on PI containing regimens with RNA <50c/mL without prior virologic failure on PIs were randomized 2:1 in the SWAN study to ATV 400 mg QD (nucleosides unchanged) or unmodified therapy. Fifty-four percent of subjects were on a boosted PI regimen at entry; of those, 68% on LPV/RTV are included in this post-hoc analysis.
Results: 153 subjects with a mean prior exposure to LPV/RTV of 79 weeks were included. Baseline characteristics of subjects on LPV/RTV at entry were similar to the overall study population.
Efficacy Results
48 weeks
| Switch to ATV** | Continue LPV/RTV | | Viral rebound | 11% (11/100) | 9% (5/53) | | Treatment failure for any reason* | 26% (26/100) | 28% (15/53) | | *Viral rebound, discontinuation for any reason before Week 48 or never treated. | | **18 subjects received RTV (concomitant use of TDF). |
New onset gastrointestinal symptoms of any grade were reported in 2% of subjects on ATV, 13% on LPV/RTV (p<0.01), with 3% and 8% using antidiarrheals, respectively (p=NS). Improvements in lipid parameters were observed on ATV (non-HDL-C ¯17% vs ¯4%; p<0.0001) with less use of lipid lowering agents (8% vs 21%; p<0.05). Comparable rates of SAEs (12% vs 11%), discontinuations (17% vs 19%), discontinuations for AEs (6% both) and grade 3/4 ALT elevations (3% vs 2%) were observed. 1% of subjects on ATV discontinued due to jaundice.
Conclusions: Simplification to an unboosted ATV-based regimen provided comparable antiretroviral efficacy and improvements in plasma lipids, compared to subjects who continued on LPV/RTV. Both treatment arms were generally safe and well tolerated, with subjects on ATV reporting less gastrointestinal symptoms.
AIDS 2006 - XVI International AIDS Conference
Abstract no.
THPE0123
Suggested Citation
"J.M.Gatell, et al.
Efficacy and safety of atazanavir (ATV) based HAART in virologically suppressed subjects switched from lopinavir/ritonavir (LPV/RTV) Treatment.
Oral abstract session:
AIDS 2006 - XVI International AIDS Conference:
Abstract no.
THPE0123"
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