{"id":893,"date":"2015-11-17T18:13:47","date_gmt":"2015-11-17T18:13:47","guid":{"rendered":"http:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/?p=893"},"modified":"2017-08-21T11:16:14","modified_gmt":"2017-08-21T11:16:14","slug":"primary-care-corner-with-geoffrey-modest-md-new-hiv-1-drug-approved-by-fda","status":"publish","type":"post","link":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2015\/11\/17\/primary-care-corner-with-geoffrey-modest-md-new-hiv-1-drug-approved-by-fda\/","title":{"rendered":"Primary Care Corner With Geoffrey Modest MD: New HIV-1 Drug Approved by FDA"},"content":{"rendered":"<p><strong>By Dr. Geoffrey Modest<\/strong><\/p>\n<p>The FDA just approved a new single pill for the treatment of HIV-1. Genvoya (the new drug)\u00a0is basically the same drug as Stribild (elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg and tenofovir disoproxil fumarate,\u00a0or TDF,\u00a0 300mg), but changes the TDF to tenofovir alafenamide 10mg (TAF). This is really a good evolution, since data over the last few years has confirmed that TAF has similar antiviral efficacy to TDF but much less renal toxicity and bone loss. The current FDA approval is\u00a0for HIV-1 patients who are treatment-naive, over 12 years old, weighing more than 35 kg, as well as for adults with suppressed viral loads (&lt;50 copies\/ml) on a stable antiretroviral regimen. TAF has\u00a0a much lower tenofovir\u00a0dose than\u00a0TDF, has lower blood levels, but higher intracellular levels (where the HIV-1 replicates). There is an accompanying\u00a0boxed-warning that it can cause lactic acidosis and severe hepatomegaly with steatotosis, either of\u00a0which can be fatal, and that it is not approved to treat\u00a0hepatitis B infection. Common side effect is nausea.\u00a0Genvoya is not recommended for patients with\u00a0severe renal impairment (undefined), though can be used in those with moderate renal impairment.\u00a0The European Union also approved its use in September. For the full but brief FDA press release, see\u00a0<a href=\"http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm471300.htm\">http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm471300.htm<\/a>\u200b .<\/p>\n<p>A couple of comments:<\/p>\n<ul>\n<li>Though the FDA warned against using Genvoya for hepatitis B,\u00a0there are actually some small studies finding TAF is as good as TDF for treating hepatitis B (see\u00a0Journal of Hepatology, 2015-03-01, Volume 62, Issue 3, Pages 533-540). \u00a0I.e., my guess is that they mean\u00a0that we should not use Genvoya for sole\u00a0hepatitis B infections, though it does sound reasonable to me to use Genvoya for those with a combo of HIV and hepatitis B (as I have been doing with prior HIV\u00a0regimens\u00a0that\u00a0have TDF\/FTC as a component). But I would follow the hepatitis B viral load closely, just to be sure.<\/li>\n<li>My understanding is that the FDA approval was based on a few studies, including a non-inferiority study\u00a0just released in\u00a0the Lancet Infectious Diseases journal. There they looked at 1443 patients who were\u00a0on one of 4 TDF-based regimens, were virologically suppressed, and had eGFR &gt;50 ml\/min, then randomized them to either the combo of elvitegravir\/cobicistat\/emtricitabine\/TAF (i.e. Genvoya) vs\u00a0continuing their prior meds\u00a0(see<a href=\"http:\/\/dx.doi.org\/10.1016\/S1473-3099(15)00348-5\">org\/10.1016\/S1473-3099(15)00348-5<\/a>). Bottom line: at 48 weeks, viral suppression with Genvoya was 97%, vs 93% if continued their old meds. Hip and spine bone mineral density, as well as GFR and proteinuria, were better with TAF (Genvoya) than in those on the TDF-based meds, though there were more adverse events in the TAF group (mostly not related to the drug, such as URIs, with somewhat fewer Grade 3\u00a0or 4 adverse events &#8212; 9% vs 11% with TDF). Nausea was present in 5% of those on Genvoya.<\/li>\n<li>So, finally, TAF will be hitting the approved-drug lists. Hopefully in other forms as well (e.g., just replacing the\u00a0TDF in\u00a0Truvada, which is TDF and emtricitabine, with TAF).\u00a0We&#8217;ll see what the cost will be&#8230;.\u200b<\/li>\n<\/ul>\n<p>For other blogs on tenovofir in HIV,\u00a0see:<\/p>\n<p><a href=\"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2015\/04\/17\/primary-care-corner-with-geoffrey-modest-md-updated-hiv-guidelines-2015\/\">https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2015\/04\/17\/primary-care-corner-with-geoffrey-modest-md-updated-hiv-guidelines-2015\/<\/a> which reviews the current guidelines and highlights stribild as one of the preferred initial drugs<\/p>\n<p><a href=\"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2015\/07\/23\/primary-care-corner-with-geoffrey-modest-md-tenofovir-nephrotoxicity\/\">https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2015\/07\/23\/primary-care-corner-with-geoffrey-modest-md-tenofovir-nephrotoxicity\/<\/a> which comments on how best to screen for tenofovir nephrotoxicity<\/p>\n<p>\u200b<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Primary Care Corner With Geoffrey Modest MD: New HIV-1 Drug Approved by FDA [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2015\/11\/17\/primary-care-corner-with-geoffrey-modest-md-new-hiv-1-drug-approved-by-fda\/\">Read More&#8230;<\/a><\/p>\n","protected":false},"author":148,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[14283],"tags":[],"class_list":["post-893","post","type-post","status-publish","format-standard","hentry","category-archive"],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/posts\/893","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/users\/148"}],"replies":[{"embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/comments?post=893"}],"version-history":[{"count":0,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/posts\/893\/revisions"}],"wp:attachment":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/media?parent=893"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/categories?post=893"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/tags?post=893"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}