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1 June 2007

Volume 44, Number 11
Clinical Infectious Diseases 2007;44:1484–1492
1058-4838/2007/4411-0015$15.00
DOI: 10.1086/517497
HIV/AIDS MAJOR ARTICLE

Efficacy and Safety of Atazanavir‐Based Highly Active Antiretroviral Therapy in Patients with Virologic Suppression Switched from a Stable, Boosted or Unboosted Protease Inhibitor Treatment Regimen: The SWAN Study (AI424‐097) 48‐Week Results

Jose Gatell,1

Dominique Salmon‐Ceron,2

Adriano Lazzarin,3

Eric Van Wijngaerden,4

Francisco Antunes,6

Clifford Leen,7

Andrzej Horban,8

Victoria Wirtz,9

Linda Odeshoo,9

Monique Van den Dungen,5

Claudia Gruber,5 and

Emilio Ledesma,9,a for the

SWAN Study Groupb

1Hospital Clinic–IDIBAPS, University of Barcelona, Barcelona, Spain; 2Hospitalier Cochin, Paris, France; 3San Raffaele Turro, Milan, Italy; 4Universitaire Ziekenhuizen, Leuven, and 5Pharmaceutical Research Institute, Braine l’Alleud, Belgium; 6Instituto Bento da Rocha Cabral, Lisbon, Portugal; 7University of Edinburgh, Scotland; 8Wojewodzki Hospital, Warsaw, Poland; and 9Bristol‐Myers Squibb, Pharmaceutical Research Institute, Wallingford, Connecticut

Background.Atazanavir is a once‐daily protease inhibitor (PI) for the treatment of human immunodeficiency virus (HIV) infection that has previously been studied in cohorts of treatment‐naive and treatment‐experienced patients. Limited data are available on the usefulness of switching from a PI‐based regimen to a regimen based on a different PI, such as atazanavir, in HIV‐infected patients experiencing virologic suppression but seeking regimen simplification.

Methods.The Switch to Another Protease Inhibitor (SWAN) study was a 48‐week, open‐label trial involving HIV‐positive patients with virologic suppression who were receiving stable PI‐based regimens (with or without ritonavir). Patients were randomized 2:1 to switch to atazanavir (400 mg per day)—or, if they were receiving tenofovir, to atazanavir‐ritonavir (300/100 mg per day)—or to continue to receive their existing PI. The proportion of patients who experienced virologic rebound (defined as an HIV RNA load 50 copies/mL) was compared through study week 48.

Results.Patients either received an atazanavir‐containing regimen (278 patients) or continued to receive a comparator PI‐containing regimen (141 patients). The proportion of patients who experienced virologic rebound was significantly lower among those who switched to an atazanavir‐containing regimen (19 [7%] of 278) than it was among those who continued to receive a comparator PI regimen (22 [16%] of 141; ). Patients who switched to atazanavir therapy experienced significantly fewer total cholesterol, fasting triglyceride, and non–high density lipoprotein cholesterol elevations than did patients in the comparator PI group ( ); patients receiving atazanavir had comparable rates of adverse event–related discontinuation and serious adverse events.

Conclusions.In patients with virologic suppression who were receiving other PIs, switching to a once‐per‐day regimen containing atazanavir provided better maintenance of virologic suppression (as demonstrated by significantly lower rates of virologic rebound and treatment failure than those observed with continued unmodified therapy), a comparable safety profile, and improved lipid parameters, compared with those for patients who continued their prior PI‐based regimen through 48 weeks.

Received 19 September 2006; accepted 12 February 2007; electronically published 25 April 2007.

Reprints or correspondence: Dr. Jose Gatell, Infectious Diseases Unit, Hospital Clinic–IDIBAPS, University of Barcelona, Villarroel, 170.08036, Barcelona, Spain ().

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  • Present affiliation: Sanofi Pasteur, Lyon, France.

  • Members of the study group are listed at the end of the text.

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