{"id":5567,"date":"2014-10-30T12:30:58","date_gmt":"2014-10-30T16:30:58","guid":{"rendered":"http:\/\/blogs.nejm.org\/?p=5567"},"modified":"2015-05-18T11:13:47","modified_gmt":"2015-05-18T15:13:47","slug":"why-ipergay-yes-thats-its-name-study-results-could-substantially-increase-use-of-prep","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/why-ipergay-yes-thats-its-name-study-results-could-substantially-increase-use-of-prep\/2014\/10\/30\/","title":{"rendered":"Why the IPERGAY (Yes, That&#8217;s Its Name) Study Could Substantially Increase Use of PrEP"},"content":{"rendered":"<p>Yesterday, the French IPERGAY study of intermittent pre-exposure prophylaxis (PrEP) was stopped early by the Data Safety Monitoring Board, and for the best reason &#8212;\u00a0the evidence demonstrating that it prevented HIV was overwhelming.<\/p>\n<p>For those who read French, here&#8217;s <a href=\"http:\/\/www.ipergay.fr\/un-grand-succes-dans-la-lutte-contre-le-vih-sida.html\" target=\"_blank\">the official announcement.<\/a>\u00a0(Scroll down for the English.) And for those who can&#8217;t believe the name, it stands for\u00a0&#8220;Intervention Prophylactique pour Et avec les Gays&#8221;. Of course.<\/p>\n<p>Here&#8217;s a short English version of the study: IPERGAY was\u00a0a randomized\u00a0trial of intermittent, &#8220;on demand&#8221; PrEP vs placebo done in high risk, HIV negative, men who have sex with men (MSM) in France and Canada. The specific strategy tested was:<\/p>\n<ul>\n<li>Two tablets of tenofovir\/emtricitabine (Truvada) from 2-24 hours before sex<\/li>\n<li>One tablet 24 hours later<\/li>\n<li>Another tablet 24 hours after that one<\/li>\n<\/ul>\n<p>So a total of 4 tablets over 3 days for episodic\u00a0sexual activity, with an option for daily use for more frequent\u00a0exposures.<\/p>\n<p>We saw the pharmacokinetic\u00a0data from\u00a0IPERGAY in Melbourne, which showed that this strategy generated blood levels of tenofovir highly predictive\u00a0of protection, and that appears to be\u00a0borne out in these results.\u00a0The full study detail are not yet available, but encouragingly they are reported to be better than iPrEx (the first study of PrEP in MSM). These results, along with\u00a0the PROUD trial\u00a0done in Britain &#8212; <a href=\"http:\/\/www.proud.mrc.ac.uk\/PDF\/PROUD%20Statement%20161014.pdf\" target=\"_blank\">also stopped early for efficacy<\/a> &#8212; substantially\u00a0strengthen the data for PrEP in MSM.<\/p>\n<p>So will the results\u00a0increase the prescribing of PrEP? Even though the FDA has only approved \u00a0tenofovir\/FTC for <em>daily<\/em> use for prevention? I say\u00a0it will, and here&#8217;s why:<\/p>\n<ol>\n<li>Patients have been asking about intermittent &#8220;on demand&#8221; dosing\u00a0since the first day\u00a0people were even thinking about PrEP.<\/li>\n<li>Even though iPrEx was a study of daily PrEP, it appears\u00a0that many study subjects were taking it intermittently &#8212; and still were protected if they got drug levels <a href=\"http:\/\/pag.aids2014.org\/abstracts.aspx?aid=11143\">correlating with 4 or more pills\/week.<\/a><\/li>\n<li>Compared with daily dosing, this IPERGAY strategy will cost less.<\/li>\n<li>It will also reduce drug exposure, and hence likely toxicity.<\/li>\n<li>No one can say &#8220;IPERGAY&#8221; without smiling. Said with a French accent, of course.<\/li>\n<\/ol>\n<p>Just like this film clip (it&#8217;s Monty Python week). Roll &#8217;em!<\/p>\n<p><center><iframe loading=\"lazy\" src=\"\/\/www.youtube.com\/embed\/A8yjNbcKkNY\" width=\"420\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><\/iframe><\/center><br \/>\n<em>(Hat tip to the <a href=\"http:\/\/www.thebodypro.com\/content\/75162\/on-demand-prep-may-significantly-reduce-hiv-risk-i.html\" target=\"_blank\">excellent Myles Helfand<\/a> for alerting me to the results.)<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Yesterday, the French IPERGAY study of intermittent pre-exposure prophylaxis (PrEP) was stopped early by the Data Safety Monitoring Board, and for the best reason &#8212;\u00a0the evidence demonstrating that it prevented HIV was overwhelming. For those who read French, here&#8217;s the official announcement.\u00a0(Scroll down for the English.) And for those who can&#8217;t believe the name, it [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,4,5,8,10],"tags":[525,527,748],"class_list":["post-5567","post","type-post","status-publish","format-standard","hentry","category-health-care","category-hiv","category-infectious-diseases","category-patient-care","category-research","tag-ipergay","tag-iprex","tag-prep"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/5567","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=5567"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/5567\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/media?parent=5567"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/categories?post=5567"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/tags?post=5567"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}