{"id":5385,"date":"2014-08-24T08:00:13","date_gmt":"2014-08-24T12:00:13","guid":{"rendered":"http:\/\/blogs.nejm.org\/?p=5385"},"modified":"2015-06-04T14:32:08","modified_gmt":"2015-06-04T18:32:08","slug":"combination-abc3tcdtg-approved-fourth-one-pill-a-day-hiv-treatment","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/combination-abc3tcdtg-approved-fourth-one-pill-a-day-hiv-treatment\/2014\/08\/24\/","title":{"rendered":"Combination ABC\/3TC\/DTG Approved &#8212; Fourth One Pill a Day HIV Treatment"},"content":{"rendered":"<p><a href=\"http:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2014\/08\/cy-young1.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright size-medium wp-image-5387\" src=\"http:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2014\/08\/cy-young-213x3001.jpg\" alt=\"cy young\" width=\"212\" height=\"300\" \/><\/a>As expected, there&#8217;s a new single pill regimen for HIV, this one containing abacavir (ABC)\/lamivudine (3TC)\/dolutegravir (DTG), and it&#8217;s called <em>Triumeq<\/em>.<\/p>\n<p>(Where oh where do companies\u00a0get these names?)<\/p>\n<p>A few thoughts\/comments:<\/p>\n<ul>\n<li>The most important study for this combination was\u00a0<strong><a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa1215541\" target=\"_blank\">the SINGLE study<\/a>,<\/strong> which showed\u00a0that ABC\/3TC + DTG (given as two pills) was\u00a0superior to TDF\/FTC\/EFV (given as one), the difference based primarily on tolerability advantage of the former. It was a novel double-blind study, as all three drugs were different in each\u00a0treatment arm.<\/li>\n<li>Another benefit DTG-based regimens &#8212; whether given with ABC\/3TC or TDF\/FTC as separate pills &#8212; is that to date, no treatment-naive patient with virologic failure has developed resistance to DTG. I suspect it\u00a0will happen one of these days, but the data thus far suggest at the very least DTG resistance\u00a0will be a rare event.<\/li>\n<li>Needless to say, but will say it anyway for emphasis, all patients starting this regimen will need to be tested for HLA-B*5701 and found to be negative. Wonder\u00a0if\u00a0pharmacies will enforce this, or whether it will be left up to the prescribers. Here&#8217;s <a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa0706135\" target=\"_blank\">t<strong>he landmark study<\/strong><\/a> that proved this testing essentially excludes severe hypersensitivity to ABC, quite an amazing story in pharmacogenomics.<\/li>\n<li>An unresolved question is whether ABC is associated with an increased risk of cardiovascular disease. <strong><a href=\"http:\/\/journals.lww.com\/jaids\/Abstract\/2012\/12010\/No_Association_of_Abacavir_Use_With_Myocardial.5.aspx\" target=\"_blank\">This FDA meta analysis<\/a><\/strong>\u00a0of randomized clinical trials\u00a0didn&#8217;t think so, but around half of the observational studies did, including <a href=\"http:\/\/www.aidsmap.com\/Heart-attack-link-to-abacavir-persists-in-DAD-study\/page\/2835318\/\" target=\"_blank\"><strong>the updated DAD study<\/strong>.<\/a>\u00a0NA-ACCORD data will be of great interest, whenever they appear.<\/li>\n<li>As of Sunday, August 24, the price of ABC\/3TC\/DTG is not known (at least to me) &#8212; and it could be a real game changer, since both ABC and 3TC are already\u00a0generic. Says Ben Young over on <strong><a href=\"http:\/\/www.thebodypro.com\/content\/74896\/triumeq-tivicay--epzicom-becomes-newest-single-pil.html\" target=\"_blank\">TheBody<\/a><\/strong>: &#8220;<span style=\"color: #000000\">If ViiV Healthcare manages to set the price of Triumeq in accordance with the generic status of abacavir and lamivudine, the cost should be substantially lower than the price of the other single-tablet regimens that contain all on-patent components.&#8221; Yep.<\/span><\/li>\n<li>I suspect people will call it &#8220;Trii&#8221; (rhymes with &#8220;Cy&#8221;, as in &#8220;Cy Young&#8221;) for a while, just like they called TDF\/FTC\/EVG\/COBI &#8220;Quad&#8221;.<\/li>\n<\/ul>\n<p>So what are some upcoming\u00a0single-tablet regimens? Tenofovir\u00a0alafenamide (TAF) with FTC\/EVG\/COBI. TAF\/FTC\/DRV\/COBI. DTG\/rilpivirine. And inevitably,\u00a0generic TDF\/3TC\/EFV, <a href=\"http:\/\/www.who.int\/hiv\/pub\/guidelines\/keypopulations\/en\/\" target=\"_blank\">which is widely available globally.<\/a><\/p>\n<p>Regardless, sure beats <a href=\"http:\/\/www.thebody.com\/Forums\/AIDS\/Simplification\/Q49632.html\" target=\"_blank\">the old days.<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>As expected, there&#8217;s a new single pill regimen for HIV, this one containing abacavir (ABC)\/lamivudine (3TC)\/dolutegravir (DTG), and it&#8217;s called Triumeq. (Where oh where do companies\u00a0get these names?) A few thoughts\/comments: The most important study for this combination was\u00a0the SINGLE study, which showed\u00a0that ABC\/3TC + DTG (given as two pills) was\u00a0superior to TDF\/FTC\/EFV (given as [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,8],"tags":[],"class_list":["post-5385","post","type-post","status-publish","format-standard","hentry","category-hiv","category-patient-care"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/5385","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=5385"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/5385\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/media?parent=5385"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/categories?post=5385"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/tags?post=5385"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}