{"id":3352,"date":"2012-10-28T11:36:54","date_gmt":"2012-10-28T15:36:54","guid":{"rendered":"http:\/\/blogs.nejm.org\/?p=3352"},"modified":"2017-03-23T13:36:11","modified_gmt":"2017-03-23T17:36:11","slug":"dolutegravir-and-the-88-rule","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/dolutegravir-and-the-88-rule\/2012\/10\/28\/","title":{"rendered":"Dolutegravir and the 88% Rule"},"content":{"rendered":"<p><a href=\"http:\/\/blogs.nejm.org\/wp-content\/uploads\/2012\/10\/paganini.jpeg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright wp-image-3355\" title=\"paganini\" src=\"http:\/\/blogs.nejm.org\/wp-content\/uploads\/2012\/10\/paganini.jpeg\" alt=\"\" width=\"135\" height=\"183\" \/><\/a>In the latest treatment-naive trials of elvitegravir and dolutegravir, there&#8217;s a striking consistency in the results of the &#8220;test&#8221; regimen. Here are the studies, with the percentage of responders by treatment arm:<\/p>\n<ul>\n<li><a href=\"http:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(12)60917-9\/abstract\" target=\"_blank\">Study 102:<\/a> \u00a0TDF\/FTC\/EFV (84%) vs. TDF\/FTC\/EVG\/c <strong>(88%)<\/strong> &#8212; non-inferior<\/li>\n<li><a href=\"http:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(12)60918-0\/abstract\" target=\"_blank\">Study 103<\/a>: \u00a0TDF\/FTC + ATV\/r (87%) vs. TDF\/FTC\/EVG\/c <strong>(90%)<\/strong> &#8212; non-inferior<\/li>\n<li><a href=\"http:\/\/pag.aids2012.org\/abstracts.aspx?aid=20990\" target=\"_blank\">SPRING-2:<\/a>\u00a0 TDF\/FTC or ABC\/3TC + RAL (85%) vs. DTG <strong>(88%)<\/strong> &#8212; non-inferior<\/li>\n<li><a href=\"http:\/\/www.natap.org\/2012\/ICAAC\/ICAAC_06.htm\" target=\"_blank\">SINGLE<\/a>: \u00a0TDF\/FTC\/EFV (81%) vs. ABC\/3TC + DTG <strong>(88%)<\/strong> &#8212; ABC\/3TC + DTG &#8212; superior<\/li>\n<\/ul>\n<p>The last of these, the SINGLE study, is the only one where there&#8217;s superiority in the primary outcome for the experimental arm, here ABC\/3TC + dolutegravir. As the lead investigator Sharon Walmsley note, this favorable result was largely due to a significantly higher proportion of subjects in the TDF\/FTC\/EFV group discontinuing therapy for adverse events (10% vs 2%), as rates of virologic failure were similar between arms. ABC\/3TC + dolutegravir also was better than TDF\/FTC\/EFV from both the immunologic and resistance perspective.<\/p>\n<p>And though cross study comparisons are frowned upon by purists, we can&#8217;t resist. Just a quick\u00a0glance at all four of the EVG and DTG arms, and you can easily see that an 88% response rate is the new price of admission for any treatment-naive regimen.<\/p>\n<p>Anything shy of the high 80s, and there has to be something else <em>very special<\/em> about the treatment &#8212; for example, better tolerability, much lower cost, better long-term safety, it helps you become a\u00a0virtuoso\u00a0violinist &#8212; to make it compete with options for therapy we already have, or will have soon.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In the latest treatment-naive trials of elvitegravir and dolutegravir, there&#8217;s a striking consistency in the results of the &#8220;test&#8221; regimen. Here are the studies, with the percentage of responders by treatment arm: Study 102: \u00a0TDF\/FTC\/EFV (84%) vs. TDF\/FTC\/EVG\/c (88%) &#8212; non-inferior Study 103: \u00a0TDF\/FTC + ATV\/r (87%) vs. TDF\/FTC\/EVG\/c (90%) &#8212; non-inferior SPRING-2:\u00a0 TDF\/FTC or [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,4,8,10],"tags":[87,284,307,316,779],"class_list":["post-3352","post","type-post","status-publish","format-standard","hentry","category-health-care","category-hiv","category-patient-care","category-research","tag-atazanavir","tag-dolutegravir","tag-efavirenz","tag-elvitegravir","tag-raltegravir"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/3352","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/comments?post=3352"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/3352\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/media?parent=3352"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/categories?post=3352"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/tags?post=3352"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}