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, Dominique Salmon-Ceron, Adriano Lazzarin, Eric Van Wijngaerden, Francisco Antunes, Clifford Leen, Andrzej Horban, Victoria Wirtz, Linda Odeshoo, Monique Van Den Dungen, Claudia Gruber, Emilia Ledesma

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Abstract

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 (denned 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; P = .004). 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 (P <.001); 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.

Original languageEnglish
Pages (from-to)1484-1492
Number of pages9
JournalClinical Infectious Diseases
Volume44
Issue number11
DOIs
Publication statusPublished - Jun 1 2007

ASJC Scopus subject areas

  • Immunology

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    Gatell, J., Salmon-Ceron, D., Lazzarin, A., Van Wijngaerden, E., Antunes, F., Leen, C., Horban, A., Wirtz, V., Odeshoo, L., Van Den Dungen, M., Gruber, C., & Ledesma, E. (2007). 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. Clinical Infectious Diseases, 44(11), 1484-1492. https://doi.org/10.1086/517497