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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.author | Post, F | |
dc.contributor.author | Moyle, G | |
dc.contributor.author | Stellbrink, H | |
dc.contributor.author | Domingo, P | |
dc.contributor.author | Podzamczer, D | |
dc.contributor.author | Fisher, M | |
dc.contributor.author | Norden, A | |
dc.contributor.author | Cavassini, M | |
dc.contributor.author | Rieger, A | |
dc.contributor.author | Khuong-Josses, MA | |
dc.contributor.author | Branco, T | |
dc.contributor.author | Pearce, H | |
dc.contributor.author | Givens, N | |
dc.contributor.author | Vavro, C | |
dc.contributor.author | Lim, M | |
dc.date.accessioned | 2011-08-30T12:59:51Z | |
dc.date.available | 2011-08-30T12:59:51Z | |
dc.date.issued | 2010 | |
dc.description.abstract | BACKGROUND: 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.citation | J Acquir Immune Defic Syndr. 2010 Sep 1;55(1):49-57 | por |
dc.identifier.issn | 1525-4135 | |
dc.identifier.uri | http://hdl.handle.net/10400.10/412 | |
dc.language.iso | eng | por |
dc.peerreviewed | yes | por |
dc.publisher | Lippincott Williams & Wilkins | por |
dc.subject | Infecção por HIV | por |
dc.subject | Antiretrovirais | por |
dc.subject | HIV-1 | por |
dc.subject | ASSERT Study | por |
dc.title | 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 | por |
dc.type | journal article | |
dspace.entity.type | Publication | |
oaire.citation.conferencePlace | Hagerstown, MD | por |
oaire.citation.endPage | 57 | por |
oaire.citation.startPage | 49 | por |
oaire.citation.title | Journal of Acquired Immune Deficiency Syndromes | por |
rcaap.rights | openAccess | por |
rcaap.type | article | por |
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