Efavirenz versus Boosted Atazanavir or Zidovudine and Abacavir in Antiretroviral Treatment-Naive, HIV-Infected Subjects: Week 48 Data from the Altair Study
Identifieur interne : 002B07 ( Istex/Curation ); précédent : 002B06; suivant : 002B08Efavirenz versus Boosted Atazanavir or Zidovudine and Abacavir in Antiretroviral Treatment-Naive, HIV-Infected Subjects: Week 48 Data from the Altair Study
Auteurs : Rebekah L. Puls [Australie] ; Preeyaporn Srasuebkul [Australie] ; Kathy Petoumenos [Australie] ; Christoph Boesecke [Australie] ; Chris Duncombe [Thaïlande] ; Waldo H. Belloso [Argentine] ; Jean-Michel Molina [France] ; Lin Li [Singapour] ; Anchalee Avihingsanon [Thaïlande] ; Brian Gazzard [Royaume-Uni] ; David A. Cooper [Australie] ; Sean Emery [Australie]Source :
- Clinical Infectious Diseases [ 1058-4838 ] ; 2010-10-01.
Abstract
Background. Antiretroviral therapy is complicated by drug interactions and contraindications. Novel regimens are needed. Methods. This open label study randomly assigned treatment-naive, human immunodeficiency virus (HIV)—infected subjects to receive tenofovir-emtricitabine with efavirenz (Arm I), with ritonavir-boosted atazanavir (Arm II), or with zidovudine/abacavir (Arm III). Pair-wise comparisons of differences in time-weighted mean change from baseline plasma HIV-RNA to week 48 formed the primary analysis. Treatment arms were noninferior if the upper limit of the 95% confidence interval (CI) was <0.5 log10 copies/mL. Secondary objectives included virologic, immunologic and safety end points. Results. The intention-to-treat population comprised 322 patients (Arm I, n = 114; Arm II, n = 105; and Arm III, n = 103). Noninferiority for the primary end point was established. Analysis for superiority showed that Arm III was significantly less potent than Arm I (−0.20 log10 copies/mL; 95% CI, −0.39 to −0.01 log10 copies/mL; P = .038). The proportions of patients on each of Arm I (95%) and Arm II (96%) with <200 copies/mL were not different (P = .75), but the percentage of patients in Arm III with <200 copies/mL (82%) was significantly lower (P = .005). CD4+ cell counts did not differ. Serious adverse events were more frequent in Arm III (n = 30) than in Arm I or Arm II (n = 15 for each; P = .062). Conclusions. A novel quadruple nucleo(t)side combination demonstrated significantly less suppression of HIV replication, compared with the suppression demonstrated by standard antiretroviral therapy regimens, although it did meet the predetermined formal definition of noninferiority. Secondary analyses indicated statistically inferior virologic and safety performance. Efavirenz and ritonavir-boosted atazanavir arms were equivalent in viral suppression and safety.
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DOI: 10.1086/656363
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Puls</name><affiliation wicri:level="1"><mods:affiliation>Coogee Campus, Coogee, Australia</mods:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Coogee Campus, Coogee</wicri:regionArea></affiliation></author><author><name sortKey="Srasuebkul, Preeyaporn" sort="Srasuebkul, Preeyaporn" uniqKey="Srasuebkul P" first="Preeyaporn" last="Srasuebkul">Preeyaporn Srasuebkul</name><affiliation wicri:level="1"><mods:affiliation>Coogee Campus, Coogee, Australia</mods:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Coogee Campus, Coogee</wicri:regionArea></affiliation></author><author><name sortKey="Petoumenos, Kathy" sort="Petoumenos, Kathy" uniqKey="Petoumenos K" first="Kathy" last="Petoumenos">Kathy Petoumenos</name><affiliation wicri:level="1"><mods:affiliation>Coogee Campus, Coogee, Australia</mods:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Coogee Campus, Coogee</wicri:regionArea></affiliation></author><author><name sortKey="Boesecke, Christoph" sort="Boesecke, Christoph" uniqKey="Boesecke C" first="Christoph" last="Boesecke">Christoph Boesecke</name><affiliation wicri:level="1"><mods:affiliation>Coogee Campus, Coogee, Australia</mods:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Coogee Campus, Coogee</wicri:regionArea></affiliation></author><author><name sortKey="Duncombe, Chris" sort="Duncombe, Chris" uniqKey="Duncombe C" first="Chris" last="Duncombe">Chris Duncombe</name><affiliation wicri:level="1"><mods:affiliation>HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand</mods:affiliation><country xml:lang="fr">Thaïlande</country><wicri:regionArea>HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok</wicri:regionArea></affiliation></author><author><name sortKey="Belloso, Waldo H" sort="Belloso, Waldo H" uniqKey="Belloso W" first="Waldo H." last="Belloso">Waldo H. 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Puls</name><affiliation wicri:level="1"><mods:affiliation>Coogee Campus, Coogee, Australia</mods:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Coogee Campus, Coogee</wicri:regionArea></affiliation></author><author><name sortKey="Srasuebkul, Preeyaporn" sort="Srasuebkul, Preeyaporn" uniqKey="Srasuebkul P" first="Preeyaporn" last="Srasuebkul">Preeyaporn Srasuebkul</name><affiliation wicri:level="1"><mods:affiliation>Coogee Campus, Coogee, Australia</mods:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Coogee Campus, Coogee</wicri:regionArea></affiliation></author><author><name sortKey="Petoumenos, Kathy" sort="Petoumenos, Kathy" uniqKey="Petoumenos K" first="Kathy" last="Petoumenos">Kathy Petoumenos</name><affiliation wicri:level="1"><mods:affiliation>Coogee Campus, Coogee, Australia</mods:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Coogee Campus, Coogee</wicri:regionArea></affiliation></author><author><name sortKey="Boesecke, Christoph" sort="Boesecke, Christoph" uniqKey="Boesecke C" first="Christoph" last="Boesecke">Christoph Boesecke</name><affiliation wicri:level="1"><mods:affiliation>Coogee Campus, Coogee, Australia</mods:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Coogee Campus, Coogee</wicri:regionArea></affiliation></author><author><name sortKey="Duncombe, Chris" sort="Duncombe, Chris" uniqKey="Duncombe C" first="Chris" last="Duncombe">Chris Duncombe</name><affiliation wicri:level="1"><mods:affiliation>HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand</mods:affiliation><country xml:lang="fr">Thaïlande</country><wicri:regionArea>HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok</wicri:regionArea></affiliation></author><author><name sortKey="Belloso, Waldo H" sort="Belloso, Waldo H" uniqKey="Belloso W" first="Waldo H." last="Belloso">Waldo H. Belloso</name><affiliation wicri:level="1"><mods:affiliation>Hospital Italiano de Buenos Aires, Buenos Aires, Argentina</mods:affiliation><country xml:lang="fr">Argentine</country><wicri:regionArea>Hospital Italiano de Buenos Aires, Buenos Aires</wicri:regionArea></affiliation></author><author><name sortKey="Molina, Jean Michel" sort="Molina, Jean Michel" uniqKey="Molina J" first="Jean-Michel" last="Molina">Jean-Michel Molina</name><affiliation wicri:level="1"><mods:affiliation>Department of Infectious Diseases, Saint Louis Hôpital, Paris, France</mods:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Infectious Diseases, Saint Louis Hôpital, Paris</wicri:regionArea></affiliation></author><author><name sortKey="Li, Lin" sort="Li, Lin" uniqKey="Li L" first="Lin" last="Li">Lin Li</name><affiliation wicri:level="1"><mods:affiliation>Infectious Diseases Research Centre, Tan Tock Seng Hospital, Singapore</mods:affiliation><country xml:lang="fr">Singapour</country><wicri:regionArea>Infectious Diseases Research Centre, Tan Tock Seng Hospital</wicri:regionArea></affiliation></author><author><name sortKey="Avihingsanon, Anchalee" sort="Avihingsanon, Anchalee" uniqKey="Avihingsanon A" first="Anchalee" last="Avihingsanon">Anchalee Avihingsanon</name><affiliation wicri:level="1"><mods:affiliation>HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand</mods:affiliation><country xml:lang="fr">Thaïlande</country><wicri:regionArea>HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok</wicri:regionArea></affiliation></author><author><name sortKey="Gazzard, Brian" sort="Gazzard, Brian" uniqKey="Gazzard B" first="Brian" last="Gazzard">Brian Gazzard</name><affiliation wicri:level="1"><mods:affiliation>Department of HIV/GUM Medicine, St. Stephen's Centre, Chelsea and Westminster Hospital, London, United Kingdom</mods:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of HIV/GUM Medicine, St. Stephen's Centre, Chelsea and Westminster Hospital, London</wicri:regionArea></affiliation></author><author><name sortKey="Cooper, David A" sort="Cooper, David A" uniqKey="Cooper D" first="David A." last="Cooper">David A. Cooper</name><affiliation wicri:level="1"><mods:affiliation>Coogee Campus, Coogee, Australia</mods:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Coogee Campus, Coogee</wicri:regionArea></affiliation><affiliation wicri:level="1"><mods:affiliation>St Vincent's Centre for Applied Medical Research, Darlinghurst, National Centre in HIV Epidemiology and Clinical Research, Faculty of Medicine, University of New South Wales, Australia</mods:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>St Vincent's Centre for Applied Medical Research, Darlinghurst, National Centre in HIV Epidemiology and Clinical Research, Faculty of Medicine, University of New South Wales</wicri:regionArea></affiliation></author><author><name sortKey="Emery, Sean" sort="Emery, Sean" uniqKey="Emery S" first="Sean" last="Emery">Sean Emery</name><affiliation wicri:level="1"><mods:affiliation>Coogee Campus, Coogee, Australia</mods:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Coogee Campus, Coogee</wicri:regionArea></affiliation></author></analytic><monogr></monogr><series><title level="j">Clinical Infectious Diseases</title><title level="j" type="abbrev">Clinical Infectious Diseases</title><idno type="ISSN">1058-4838</idno><idno type="eISSN">1537-6591</idno><imprint><publisher>The University of Chicago Press</publisher><date type="published" when="2010-10-01">2010-10-01</date><biblScope unit="volume">51</biblScope><biblScope unit="issue">7</biblScope><biblScope unit="page" from="855">855</biblScope><biblScope unit="page" to="864">864</biblScope></imprint><idno type="ISSN">1058-4838</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1058-4838</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract">Background. Antiretroviral therapy is complicated by drug interactions and contraindications. Novel regimens are needed. Methods. This open label study randomly assigned treatment-naive, human immunodeficiency virus (HIV)—infected subjects to receive tenofovir-emtricitabine with efavirenz (Arm I), with ritonavir-boosted atazanavir (Arm II), or with zidovudine/abacavir (Arm III). Pair-wise comparisons of differences in time-weighted mean change from baseline plasma HIV-RNA to week 48 formed the primary analysis. Treatment arms were noninferior if the upper limit of the 95% confidence interval (CI) was <0.5 log10 copies/mL. Secondary objectives included virologic, immunologic and safety end points. Results. The intention-to-treat population comprised 322 patients (Arm I, n = 114; Arm II, n = 105; and Arm III, n = 103). Noninferiority for the primary end point was established. Analysis for superiority showed that Arm III was significantly less potent than Arm I (−0.20 log10 copies/mL; 95% CI, −0.39 to −0.01 log10 copies/mL; P = .038). The proportions of patients on each of Arm I (95%) and Arm II (96%) with <200 copies/mL were not different (P = .75), but the percentage of patients in Arm III with <200 copies/mL (82%) was significantly lower (P = .005). CD4+ cell counts did not differ. Serious adverse events were more frequent in Arm III (n = 30) than in Arm I or Arm II (n = 15 for each; P = .062). Conclusions. A novel quadruple nucleo(t)side combination demonstrated significantly less suppression of HIV replication, compared with the suppression demonstrated by standard antiretroviral therapy regimens, although it did meet the predetermined formal definition of noninferiority. Secondary analyses indicated statistically inferior virologic and safety performance. Efavirenz and ritonavir-boosted atazanavir arms were equivalent in viral suppression and safety.</div></front></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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