3rd IAS Conference on HIV Pathogenesis and Treatment
July 24 - 27, 2005, Rio de Janerio, Brazil
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Switching to Atazanavir from Other PI-based HAART Maintains Suppression, Results in Fewer Viral Rebounds and Improves Lipids and GI Tolerance: The SWAN Study In the SWAN study, researchers at multiple medical centers evaluated the effectiveness and safety of switching to the protease inhibitor (PI) atazanavir (Reyataz) compared to continuing unmodified therapy in patients on a stable PI-based HAART regimen. PI-treated subjects with RNA <50 c/mL, no previous PI virologic failure were randomized 2:1 to either change PI(s) to ATV (ATV/r if combined with tenofovir (Viread) or continued therapy (CTD). Primary endpoint: proportion of viral rebounds (VReb) (twice >50 c/mL) at 48 weeks. Results · The 419 randomized (407 treated, 274 ATV, 133 CTD) subjects had comparable baseline AIDS (28%), co-infection HBV and/or HCV (31%), CD4 (491 cells/mm3), PI/r use at screening (overall 54%; LPV/r 37%) and previous mean time on ARV (weeks): 175 PI, 202 NRTI, 70 NNRTI. · Similar discontinuation rates through week 24 were observed (8% vs 6%), but switching to ATV led to fewer VReb at w24: 3% vs 8% and reduced proportion of overall failures with higher rate of <50 c/mL. · For those on PI/r at screening (n=226), comparable VReb rates (4% vs 5%) were observed. · Comparable rates of death (0% vs 4%), other serious adverse events (SAEs) (8% vs 6%) or discontinuations for AEs (6% vs 5%) were reported. · Scleral icterus and/or jaundice occurred in 10% (1% grade 3-4, 1% discontinued) on ATV. · Gastrointestinal toxicity was less frequent on ATV (6% vs 11%; p<0.05) and lipid parameters (Total-C, LDL-C, TGL, non-HDL-C) improved significantly (for example non-HDL-C -22% vs 0%; p<0.0001). · No differences in grade 3-4 ALT/AST elevations were observed between arms overall (4% vs 5%) or in those without (both 0%) or with (14% vs 11%) hepatitis C and/or B co-infection. Based on these results, the authors conclude, “Switching to ATV maintained antiviral suppression and resulted in fewer viral rebounds with comparable overall safety, improved GI tolerance and significant lipid improvements compared with continued therapy. Incidence of scleral icterus/jaundice on ATV was low.” Additional analyses through week 48 will be conducted to confirm these results, according to the authors. Hospital Clinic i Provincial, Barcelona SP, Group Hospitalier Cochin, Paris FR, Ospedale San Raffaele, Milano IT, Univ Ziekenhuizen Leuven Gasthuisberg, Leuven BE, Hospital de Santa Maria, Lisboa PO, Western General Hospital, Edinburgh UK, Wojewódzki Szpital Zakaźny, Warsaw PO, Bristol-Myers Squibb, Pharmaceutical Research Institute, Wallingford CT, US, Bristol-Myers Squibb, Pharmaceutical Research Institute, Braine l’Alleud BE. 07/29/05 Reference |
