{"id":1193,"date":"2010-11-23T08:20:09","date_gmt":"2010-11-23T13:20:09","guid":{"rendered":"http:\/\/blogs.nejm.org\/?p=1193"},"modified":"2015-06-04T15:24:22","modified_gmt":"2015-06-04T19:24:22","slug":"iprex-first-ever-prep-efficacy-study-published","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/iprex-first-ever-prep-efficacy-study-published\/2010\/11\/23\/","title":{"rendered":"iPrEx:  First-Ever PrEP Efficacy Study Published"},"content":{"rendered":"<p><img loading=\"lazy\" decoding=\"async\" class=\"alignright size-full wp-image-1194\" title=\"prexie stamp\" src=\"http:\/\/blogs.nejm.org\/hiv-id-observations\/wp-content\/uploads\/sites\/2\/2010\/11\/prexie-stamp1.jpg\" alt=\"prexie stamp\" width=\"225\" height=\"255\" \/>It&#8217;s been quite the year (plus a month) for HIV prevention research.<\/p>\n<p>That glimmer of hope from the <a href=\"http:\/\/blogs.nejm.org\/index.php\/well-that-was-fast-hiv-vaccine-trial-published\/2009\/10\/20\/\" target=\"_blank\">Thai vaccine trial<\/a>. \u00a0The striking effect of <a href=\"http:\/\/blogs.nejm.org\/index.php\/hiv-treatment-is-prevention\/2010\/05\/27\/\" target=\"_blank\">HIV-treatment as prevention<\/a>.\u00a0\u00a0The positive results of the <a href=\"http:\/\/blogs.nejm.org\/index.php\/vienna-ias-first-really-positive-microbicide-study\/2010\/07\/19\/\" target=\"_blank\">CAPRISA vaginal microbicide study<\/a>, which were\u00a0presented to rapturous applause this summer in Vienna.<\/p>\n<p>And today, <a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa1011205\" target=\"_blank\">the iPrEx study is published<\/a>, which shows that giving TDF\/FTC to HIV-negative, high-risk men who have sex with men (MSM) reduces their risk of acquiring HIV by 44%. \u00a0It&#8217;s the first efficacy study of pre-exposure prophylaxis (PrEP) and will undoubtedly generate plenty of discussion.<\/p>\n<p>For a detailed scientific analysis of the trial, two HIV prevention experts have already provided their commentary, Nelson Michael in <a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMe1012929\"><em>NEJM<\/em><em> <\/em><\/a>and Raphy Landovitz in\u00a0<em><a href=\"http:\/\/aids-clinical-care.jwatch.org\/cgi\/content\/full\/2010\/1123\/1\" target=\"_blank\">Journal Watch AIDS Clinical Care<\/a><\/em>. \u00a0I highly recommend both.<\/p>\n<p>But every HIV specialist\/Infectious\u00a0Disease doctor will have thoughts on this important study, so in no particular order, here are mine:<\/p>\n<ul>\n<li>A few doctors (mostly those with patient panels with large numbers of MSM) anecdotally have already been prescribing PrEP, at least to a limited extent. If this practice expands, will insurance cover it? Like virtually everything else in our patchwork healthcare &#8220;system&#8221;, I suspect this will vary widely from plan to plan and from state to state. \u00a0And you can be sure that for the time being this will\u00a0<em>not <\/em>be covered under the state-based AIDS Drug Assistance Programs (ADAPs). <!--more--><\/li>\n<li>Aside from those providers, what other clinicians will actually prescribe PrEP? ID docs? Primary care providers? Many HIV specialists don&#8217;t follow HIV-negative patients; providers who work in clinics that focus on treatment of sexually transmitted infections generally don&#8217;t follow patients longitudinally; and non-HIV specialists have little familiarity with antiretrovirals.<\/li>\n<li>Would intermittent PrEP with TDF\/FTC work just as well as continuous therapy? \u00a0How intermittent? Again, anecdotally, this appears to be how most clinicians who have been prescribing PrEP have been using it.<\/li>\n<li>The intervention clearly worked in preventing HIV infection &#8212; at least in those who took it. \u00a0In fact, if you believe the pharmocology sub-group analysis, compliance was pretty lousy, with detectable drug levels found in only 9% of those acquiring HIV and 51% of those remaining HIV negative. \u00a0Since this was in a research study setting, where compliance is usually <em>better <\/em>than in clinical practice, I&#8217;m not optimistic that the highest risk patients &#8212; some of whom have significant drug-dependency and psychiatric disease &#8212; are going to do very well with this.<\/li>\n<li>No drug is 100% safe, and the burden of proof for safety is greater when something is used as prevention rather than treatment. How safe does it have to be? I would say a good goal would be comparable safety to a widely adopted vaccine, a very high bar indeed.<\/li>\n<li>Two stylistic oddballs in the study: \u00a0How does &#8220;iPrEx&#8221; stand for &#8220;Preexposure Prophylaxis Initiative&#8221;? What&#8217;s with the funky capitalization scheme? An iPrEx sounds like a gizmo you plug into an iPhone. And why was coformulated tenofovir-emtricitabine abbreviated &#8220;FTC-TDF&#8221;, when virtually every other mention of this product in the HIV universe does it in the other direction (i.e., TDF-FTC)?<\/li>\n<\/ul>\n<p>Weird spelling notwithstanding, iPrEx is the first of several studies of PrEP, and its publication is a landmark event. \u00a0The study continues with all subjects now receiving TDF\/FTC (or FTC-TDF, grrr); hence there are more data to come &#8212; not only from iPrEx but from the multiple other ongoing HIV prevention studies .<\/p>\n<p>In fact, this\u00a0<a href=\"http:\/\/www.avac.org\/ht\/d\/Contents\/contenttype_id\/18\/order\/date\/direction\/asc\/pid\/1891\/displaytype\/iframe\/afterdays\/1390\/beforedays\/-1215\/TPL\/Timeline\/cfs\/1\/\/?\" target=\"_blank\">timeline<\/a> of HIV prevention research suggests that the next few years could, amazingly, be even more exciting than this past one.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>It&#8217;s been quite the year (plus a month) for HIV prevention research. That glimmer of hope from the Thai vaccine trial. \u00a0The striking effect of HIV-treatment as prevention.\u00a0\u00a0The positive results of the CAPRISA vaginal microbicide study, which were\u00a0presented to rapturous applause this summer in Vienna. And today, the iPrEx study is published, which shows that [&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],"tags":[],"class_list":["post-1193","post","type-post","status-publish","format-standard","hentry","category-health-care"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/1193","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=1193"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/1193\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/media?parent=1193"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/categories?post=1193"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/tags?post=1193"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}