This study will compare the antiretroviral activity of MK-1439A, a single-tablet, once-daily (q.d.) fixed-dose combination (FDC) containing MK-1439 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, with ATRIPLA\u2122, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg, in treatment-naive participants infected with HIV<\/p>\n\n\n\n
Brief summary: <\/strong>Doravirine (DOR), a novel non-nucleoside\nreverse-transcriptase inhibitor (NNRTI), is active against wild-type Human\nImmunodeficiency Virus (HIV)-1 and the most common NNRTI-resistant variants,\nand has a favorable and unique in vitro resistance profile. <\/p>\n\n\n\n DRIVE-AHEAD is a phase 3, double-blind, non-inferiority trial. Antiretroviral treatment-naive adults with \u2265 1000 HIV-1 RNA copies\/mL were randomized (1:1) to once-daily, fixed-dose DOR at 100 mg, lamivudine at 300 mg, and tenofovir disoproxil fumarate (TDF) at 300 mg (DOR\/3TC\/TDF) or to efavirenz at 600 mg, emtricitabine at 200 mg, and TDF at 300 mg (EFV\/FTC\/TDF) for 96 weeks. The primary efficacy endpoint was the proportion of participants with < 50 HIV-1 RNA copies\/mL at week 48 (Food and Drug Administration snapshot approach; non-inferiority margin 10%). <\/p>\n\n\n\n Of the 734 participants randomized, 728 were treated (364 per group) and included in the analyses. At week 48, 84.3% (307\/364) of DOR\/3TC\/TDF recipients and 80.8% (294\/364) of EFV\/FTC\/TDF recipients achieved < 50 HIV-1 RNA copies\/mL (difference 3.5%, 95% CI, -2.0, 9.0). DOR\/3TC\/TDF recipients had significantly lower rates of dizziness (8.8% vs 37.1%), sleep disorders\/disturbances (12.1% vs 25.2%), and altered sensorium (4.4% vs 8.2%) than EFV\/FTC\/TDF recipients. Mean changes in fasting low-density lipoprotein cholesterol (LDL-C) and non-high-density lipoprotein cholesterol (non-HDL-C) (-3.83 vs +13.26 mg\/dL) were significantly different between DOR\/3TC\/TDF and EFV\/FTC\/TDF (-1.6 vs +8.7 mg\/dL and -3.8 vs +13.3 mg\/dL, respectively). <\/p>\n\n\n\n In HIV-1\ntreatment-naive adults, DOR\/3TC\/TDF demonstrated non-inferior efficacy to\nEFV\/FTC\/TDF at week 48 and was well tolerated, with significantly fewer\nneuropsychiatric events and minimal changes in LDL-C and non-HDL-C compared\nwith EFV\/FTC\/TDF. <\/p>\n","protected":false},"excerpt":{"rendered":" \t\t\t\tThis study will compare the antiretroviral activity of MK-1439A, a single-tablet, once-daily (q.d.) fixed-dose combination (FDC) containing MK-1439 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, with ATRIPLA\u2122, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg, in treatment-naive participants infected with HIV\t\t<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[24],"tags":[],"class_list":["post-1853","post","type-post","status-publish","format-standard","hentry","category-studies"],"_links":{"self":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/1853","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/comments?post=1853"}],"version-history":[{"count":1,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/1853\/revisions"}],"predecessor-version":[{"id":3335,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/posts\/1853\/revisions\/3335"}],"wp:attachment":[{"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/media?parent=1853"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/categories?post=1853"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hivnat.org\/en\/wp-json\/wp\/v2\/tags?post=1853"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}