{"id":29870,"date":"2016-03-22T09:25:43","date_gmt":"2016-03-22T09:25:43","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=29870"},"modified":"2016-03-22T14:33:07","modified_gmt":"2016-03-22T14:33:07","slug":"48-week-results-for-nnrti-doravirine-compared-to-efavirenz","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/29870","title":{"rendered":"48-week results for NNRTI doravirine compared to efavirenz"},"content":{"rendered":"<p><img loading=\"lazy\" decoding=\"async\" class=\"alignright wp-image-29668\" src=\"https:\/\/i-base.info\/htb\/wp-content\/uploads\/2016\/02\/CROI-logo2-no-key.png\" alt=\"CROI logo2 no key\" width=\"200\" height=\"202\" \/><\/p>\n<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>Phase 2 results in treatment naive patients using doravirine (MK-1439) &#8211; an NNRTI in development with Merck &#8211; were presented in a poster from Jos\u00e9 Gatell from Barcelona Hospital and colleagues.<\/strong> [1]<\/p>\n<p>This was a randomised, double-blind, placebo controlled phase 2 dose finding study in two parts. In part 2, new patients started using the selected 100 mg doravirine dose. All participants were treatment naive and used tenofovir DF\/FTC as background NRTIs.<\/p>\n<p>Combined 48 week data included 42 people randomised to the 100 mg once-daily dose in part one of the study plus 66 participants who were added in part two (n=108), compared with 109 control patients randomised to efavirenz.<\/p>\n<p>Baseline demographics included ~90% men, 75% white, with mean age 35 (range 19-67) years and median CD4 count and viral load of approximately 425 cells\/mm<sup>3<\/sup> (range 92 to 1121) and 2.6 log copies\/mL (range 2.6 to 6.7).<\/p>\n<p>At week 48, viral suppression to &lt;40 copies\/mL was reported for 77.8% vs 78.7% of the doravirine vs efavirenz groups respectively, (difference -1.1%; 95%CI -12.2 to +10.0). There were slightly fewer discontinuations in the doravirine group (12% vs 14.7%) which included fewer discontinuations related to side effects (2.8% vs 5.5%).<\/p>\n<p>In patients with baseline viral load &lt;100,000 copies\/mL approximately 87% in each group reached &lt;40 copies\/mL at week 48 but greater suppression was reported for the efavirenz group for those starting with viral load &gt;100,000 copies\/mL (74% vs 84%). Both groups reported 91% rates using a &lt;200 copies\/mL test.<\/p>\n<p>There were few laboratory abnormalities greater than grade 2 but lipids, liver enzymes and lipase generally favoured the doravirine group and abnormal glucose fasted occured slightly more in the doravirine group (3.2 % va 1.1%).<\/p>\n<p>Ongoing studies include as part of a single tablet, fixed dose combination with generic NRTIs: doravirine\/tenofovirDF\/3TC. [2]<\/p>\n<p>References:<\/p>\n<ol>\n<li>Gatell JM et al. Doravirine 100mg QD vs efavirenz +TDF\/FTC in ART-naive HIV+ patients: week 48 results. 23rd CROI, 22 &#8211; 25 February 2016, Boston. Poster abstract 470.<br \/>\n<a href=\"http:\/\/www.croiconference.org\/sessions\/doravirine-100mg-qd-vs-efavirenz-tdfftc-art-naive-hiv-patients-week-48-results\">http:\/\/www.croiconference.org\/sessions\/doravirine-100mg-qd-vs-efavirenz-tdfftc-art-naive-hiv-patients-week-48-results<\/a>\u00a0(Abstract)<br \/>\n<a href=\"http:\/\/www.croiconference.org\/sites\/default\/files\/posters-2016\/470.pdf \">http:\/\/www.croiconference.org\/sites\/default\/files\/posters-2016\/470.pdf <\/a>(PDF poster)<\/li>\n<li>Clinicaltrials.gov listing. Effects of switching from ATRIPLA (efavirenz, tenofovir, emtricitabine) to MK-1439A (doravirine, tenofovir, lamivudine) in virologically-suppressed participants (MK-1439A-028)<br \/>\n<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02652260\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02652260<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base Phase 2 results in treatment naive patients using doravirine (MK-1439) &#8211; an NNRTI in development with Merck &#8211; were presented in a poster from Jos\u00e9 Gatell from Barcelona Hospital and colleagues. [1] This was a randomised, &hellip;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3],"tags":[217],"class_list":["post-29870","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-croi-2016"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/29870","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=29870"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/29870\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=29870"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=29870"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=29870"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}