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Randomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT study

dc.contributor.authorPost, F
dc.contributor.authorMoyle, G
dc.contributor.authorStellbrink, H
dc.contributor.authorDomingo, P
dc.contributor.authorPodzamczer, D
dc.contributor.authorFisher, M
dc.contributor.authorNorden, A
dc.contributor.authorCavassini, M
dc.contributor.authorRieger, A
dc.contributor.authorKhuong-Josses, MA
dc.contributor.authorBranco, T
dc.contributor.authorPearce, H
dc.contributor.authorGivens, N
dc.contributor.authorVavro, C
dc.contributor.authorLim, M
dc.date.accessioned2011-08-30T12:59:51Z
dc.date.available2011-08-30T12:59:51Z
dc.date.issued2010
dc.description.abstractBACKGROUND: Abacavir/lamivudine and tenofovir/emtricitabine fixed-dose combinations are commonly used first-line antiretroviral therapies, yet few studies have comprehensively compared their safety profiles. METHODS: Forty-eight-week data are presented from this multicenter, randomized, open-label study comparing the safety profiles of abacavir/lamivudine and tenofovir/emtricitabine, both administered with efavirenz, in HLA-B*5701-negative HIV-1-infected adults. RESULTS: Three hundred eighty-five subjects were enrolled in the study. The overall rate of withdrawal was high (28%). Changes in estimated glomerular filtration rate from baseline were similar between arms [difference 0.953 mL.min.1.73 m (95% confidence interval: -1.445 to 3.351), P = 0.435]. Urinary excretion of retinol-binding protein and beta-2 microglobulin increased significantly more in the tenofovir/emtricitabine arm (+50%; +24%) compared with the abacavir/lamivudine arm (no change; -47%) (P < 0.0001). A lower proportion achieved viral load <50 copies per milliliter in the abacavir/lamivudine arm (114 of 192, 59%) compared with the tenofovir/emtricitabine arm (137 of 193, 71%) [difference 11.6% (95% confidence interval: 2.2 to 21.1)]. The overall virological failure rate was low. The adverse event rate was similar between arms (except drug hypersensitivity, reported more in the abacavir/lamivudine arm). CONCLUSIONS: The study showed no difference in estimated glomerular filtration rate between the arms, however, increases in markers of tubular dysfunction were observed in the tenofovir/emtricitabine arm, the long-term consequence of which is unclear. A significant difference in efficacy favoring tenofovir/emtricitabine was observed.por
dc.identifier.citationJ Acquir Immune Defic Syndr. 2010 Sep 1;55(1):49-57por
dc.identifier.issn1525-4135
dc.identifier.urihttp://hdl.handle.net/10400.10/412
dc.language.isoengpor
dc.peerreviewedyespor
dc.publisherLippincott Williams & Wilkinspor
dc.subjectInfecção por HIVpor
dc.subjectAntiretroviraispor
dc.subjectHIV-1por
dc.subjectASSERT Studypor
dc.titleRandomized comparison of renal effects, efficacy, and safety with once-daily abacavir/lamivudine versus tenofovir/emtricitabine, administered with efavirenz, in antiretroviral-naive, HIV-1-infected adults: 48-week results from the ASSERT studypor
dc.typejournal article
dspace.entity.typePublication
oaire.citation.conferencePlaceHagerstown, MDpor
oaire.citation.endPage57por
oaire.citation.startPage49por
oaire.citation.titleJournal of Acquired Immune Deficiency Syndromespor
rcaap.rightsopenAccesspor
rcaap.typearticlepor

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