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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EThe Single Tablet Regimen (STaR) head-to-head comparison of anti-HIV-1 formulations has established the noninferiority of rilpivirine\/emtricitabine\/tenofovir DF (RPV\/FTC\/TDF) versus efavirenz\/emtricitabine\/tenofovir DF (EFV\/FTC\/TDF) in HIV-1 virologic outcomes at weeks 48 and 96. The RPV\/FTC\/TDF combination was superior to EFV\/FTC\/TDF in terms of adverse effects and patient-reported outcomes.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EHIV \u0026amp; AIDS\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInfectious Disease Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EInfectious Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EHIV \u0026amp; AIDS\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EInfectious Disease Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThe Single Tablet Regimen (STaR) head-to-head comparison of anti-HIV-1 formulations has established the noninferiority of rilpivirine\/emtricitabine\/tenofovir DF (RPV\/FTC\/TDF) versus efavirenz\/emtricitabine\/tenofovir DF (EFV\/FTC\/TDF) in HIV-1 virologic outcomes at weeks 48 and 96. The RPV\/FTC\/TDF combination was superior to EFV\/FTC\/TDF in terms of adverse effects and patient-reported outcomes. The findings were presented by Calvin Cohen, MD, MSc, Community Research Initiative of New England, Boston, Massachusetts, USA.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe RPV\/FTC\/TDF combination for treatment of HIV-1 has been established as noninferior to EFV\/FTC\/TDF in patients na\u00efve to antiretroviral therapy in 2 prior blinded placebo-controlled trials. However, the previous study regimens involved multiple pills and twice-daily dosing. STaR was a head-to-head comparison of single-tablet formulations of both drug combinations.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EAntiretroviral-na\u00efve patients (N = 786) with HIV-1 RNA \u2265 2500 copies\/mL and sensitivity to the study drugs were randomized to the single-tablet formulations of RPV\/FTC\/TDF (n = 394) or EFV\/FTC\/TDF (n = 392) for 96 weeks (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/28\/8\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Design of the STaR Trial\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-940880243\u0022 data-figure-caption=\u0022Design of the STaR Trial\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/28\/8\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/28\/8\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/28\/8\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11856\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-5\u0022 class=\u0022first-child\u0022\u003EDesign of the STaR Trial\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EARV, antiretroviral; EFV, efavirenz; FTC, emtricitabine; RPV, rilpivirine; STaR, single-tablet regimen; TDF, tenofovir.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from C Cohen, MD, MSc.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-6\u0022\u003EThe primary end point was virologic success (reduction of HIV-1 RNA to \u0026lt; 50 copies\/mL) at week 48. Secondary end points included proportion of subjects displaying virologic success at week 48; CD4 count at weeks 48 and 96; genotypic\/phenotypic resistance at the time of virologic failure (rebound in HIV-1 RNA to \u2265 50 copies\/mL); and subject-completed questionnaire-rated HIV symptoms, quality of life, and treatment satisfaction.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EBaseline demographics, mean CD4 count, mean HIV-1 RNA, and proportion of coinfection with hepatitis B and\/or C virus were similar between the groups. \u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E summarizes the virologic outcomes and CD4 change. The RPV\/FTC\/TDF combination produced slightly greater virologic success than the EFV\/FTC\/TDF combination at weeks 48 and 96. Virologic failure was low and similar for both formulations at weeks 48 and 96. The mean CD4 count increase at weeks 48 and 96 was greater but not statistically significant for the RPV\/FTC\/TDF formulation, with the overall change in CD4 counts favoring this formulation.\u003C\/p\u003E\u003Cdiv id=\u0022F2\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/28\/8\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Virologic Outcomes and CD4 Change at Weeks 48 and 96\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-940880243\u0022 data-figure-caption=\u0022Virologic Outcomes and CD4 Change at Weeks 48 and 96\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 2.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/28\/8\/F2.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/28\/8\/F2.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 2.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/28\/8\/F2.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11857\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 2.\u003C\/span\u003E \n            \u003Cp id=\u0022p-8\u0022 class=\u0022first-child\u0022\u003EVirologic Outcomes and CD4 Change at Weeks 48 and 96\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-3\u0022\u003EARV, antiretroviral; EFV, efavirenz; FTC, emtricitabine; RPV, rilpivirine; TDF, tenofovir; W, week.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-4\u0022\u003EReproduced with permission from C Cohen, MD, MSc.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-9\u0022\u003EQuestionnaires completed at baseline and week 96 revealed that nervous system, psychiatric, gastrointestinal\/related, and constitutional\/other symptoms had developed less often and, when present, had resolved to a greater extent for those receiving the RPV\/FTC\/TDF formulation. The difference was statistically significant for pain\/tingling in hands\/feet (26% of RPV\/FTC\/TDF vs 40% of EFV\/FTC\/TDF), difficulty with sleep (37% vs 47%), depression (38% vs 49%), fatigue (38% vs 49%), fever (18% vs 27%), cough (17% vs 25%), hair loss (18% vs 27%), and sexual problems (26% vs 39%).\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EA battery of quality-of-life parameters were higher at week 96 compared to baseline in those receiving RPV\/FTC\/TDF than those receiving EFV\/FTC\/TDF, but the differences were not statistically significant. The mental health composite score (2.9 and 0.6 for RPV\/FTC\/TDF and EFV\/FTC\/TDF, respectively) favored the former drug combination, with significant differences in the RPV\/FTC\/TDF group between baseline and week 96 and as compared to the EFV\/FTC\/TDF group. The physical health composite score (0.7 and 1.7 for RPV\/FTC\/TDF and EFV\/FTC\/TDF, respectively) favored the latter group; the difference between the 2 groups was not significant.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EThe RPV\/FTC\/TDF combination was better tolerated, with fewer adverse effects, and was associated with significantly fewer adverse effect-related discontinuations (RPV\/FTC\/TDF, n = 10, 3%; EFV\/FTC\/TDF, n = 34, 9%; \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .001). The RPV\/FTC\/TDF combination was judged noninferior to EFV\/FTC\/TDF through week 96.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/28\/8.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzm17d\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzm17d\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}