{"id":8028,"date":"2016-03-09T02:58:46","date_gmt":"2016-03-09T07:58:46","guid":{"rendered":"http:\/\/blogs.nejm.org\/hiv-id-observations\/?p=8028"},"modified":"2016-03-09T14:26:48","modified_gmt":"2016-03-09T19:26:48","slug":"approval-of-tafftcrpv-another-single-pill-hiv-treatment-option","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/approval-of-tafftcrpv-another-single-pill-hiv-treatment-option\/2016\/03\/09\/","title":{"rendered":"Approval of TAF\/FTC\/RPV, Another Single Pill HIV Treatment Option"},"content":{"rendered":"<p><a href=\"http:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2016\/03\/2001-yellow-suit.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright wp-image-8029\" src=\"http:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2016\/03\/2001-yellow-suit.jpg\" alt=\"2001-yellow-suit\" width=\"272\" height=\"177\" srcset=\"https:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2016\/03\/2001-yellow-suit.jpg 551w, https:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2016\/03\/2001-yellow-suit-300x195.jpg 300w\" sizes=\"auto, (max-width: 272px) 100vw, 272px\" \/><\/a><a href=\"http:\/\/www.gilead.com\/news\/press-releases\/2016\/3\/us-food-and-drug-administration-approves-gileads-second-tafbased-single-tablet-regimen-odefsey-emtricitabine-rilpivirine-tenofovir-alafenamide-for-the-treatment-of-hiv1-infection\" target=\"_blank\">The approval last week of TAF\/FTC\/RPV<\/a>\u00a0&#8212; that&#8217;s coformulated\u00a0tenofovir alafenamide, emtricitabine, and rilpivirine\u00a0&#8212; brings us another one-pill, once-daily option for HIV treatment.<\/p>\n<p>It&#8217;s essentially the same as the\u00a0existing TDF\/FTC\/RPV, with similar pros\/cons, but with three notable differences coming with\u00a0the substitution of TAF for TDF.<\/p>\n<p>Specifically:<\/p>\n<ol>\n<li><strong>Likely reduced renal and bone toxicity.<\/strong>\u00a0Since approval was based on bioequivalnce, this hasn&#8217;t (yet) been proven in clinical trials &#8212; switch-studies are ongoing, comparing TAF\/FTC\/RPV to both TDF\/FTC\/RPV, and TDF\/FTC\/EFV. Note that this might end up being a more relevant consideration with TDF\/FTC\/RPV than TDF\/FTC\/EFV, since the former is taken with food and hence leads to higher tenofovir levels.<\/li>\n<li><strong>A smaller tablet\u00a0size.<\/strong> TDF\/FTC\/RPV was already\u00a0the smallest coformulated pill for complete HIV treatment, and with 25 mg of TAF replacing 300 mg of TDF, the new pill is quite a bit smaller. For some patients, this matters a lot.<\/li>\n<li><strong>A weird new brand name.<\/strong> It&#8217;s called Odefsey, which sounds kind of like <strong><a href=\"http:\/\/www.imdb.com\/title\/tt0062622\/\" target=\"_blank\">the famous Stanley Kubrick film<\/a>, <\/strong>without the &#8220;2001: \u00a0A Space &#8230;&#8221;<\/li>\n<\/ol>\n<p>We can assume (for now) that carried over\u00a0from TDF\/FTC\/RPV is\u00a0the generally well-tolerated profile (low risk of rash, GI side effects, metabolic abnormalities). As with TDF\/FTC\/RPV, TAF\/FTC\/RPV should be taken with food and without concomitant PPIs to maximize RPV absorption. It is not intended for treatment-naive patients who have HIV RNA &gt; 100,000 copies\/mL.<\/p>\n<p>So this is a nice advance, especially for those patients at risk for renal and\/or bone disease. Little reason not to switch existing TDF\/FTC\/RPV-treated patients to this new formulation, at least once payers add it to their formularies. (As with ECF-TAF, the listed price of TAF\/FTC\/RPV is the same as TDF\/FTC\/RPV.)<\/p>\n<p>Note that arguably a bigger TAF-related approval &#8212; the TAF\/FTC pill, already nicknamed &#8220;TAF-ada&#8221; &#8212; is expected next month.<\/p>\n<p>[youtube http:\/\/www.youtube.com\/watch?v=KliLsBSo-J4]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The approval last week of TAF\/FTC\/RPV\u00a0&#8212; that&#8217;s coformulated\u00a0tenofovir alafenamide, emtricitabine, and rilpivirine\u00a0&#8212; brings us another one-pill, once-daily option for HIV treatment. It&#8217;s essentially the same as the\u00a0existing TDF\/FTC\/RPV, with similar pros\/cons, but with three notable differences coming with\u00a0the substitution of TAF for TDF. Specifically: Likely reduced renal and bone toxicity.\u00a0Since approval was based on bioequivalnce, [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,5,8,10],"tags":[423,814,1095],"class_list":["post-8028","post","type-post","status-publish","format-standard","hentry","category-hiv","category-infectious-diseases","category-patient-care","category-research","tag-hiv","tag-rilpivirine","tag-taf"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/8028","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=8028"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/8028\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/media?parent=8028"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/categories?post=8028"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/tags?post=8028"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}