{"id":1548,"date":"2011-04-25T06:52:26","date_gmt":"2011-04-25T10:52:26","guid":{"rendered":"http:\/\/blogs.nejm.org\/?p=1548"},"modified":"2011-04-25T06:52:26","modified_gmt":"2011-04-25T10:52:26","slug":"fem-prep-a-set-back-in-hiv-prevention-research","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/fem-prep-a-set-back-in-hiv-prevention-research\/2011\/04\/25\/","title":{"rendered":"FEM-PrEP: A Set Back in HIV Prevention Research"},"content":{"rendered":"<p>HIV prevention has been on such a roll recently that the <a href=\"http:\/\/www.fhi.org\/en\/AboutFHI\/Media\/Releases\/FEM-PrEP_statement041811.htm\" target=\"_blank\">recent negative news<\/a> from the FEM-PrEP study came as something of a surprise.\u00a0 Bottom line:<\/p>\n<blockquote><p>Following a scheduled interim review of the FEM-PrEP study data, the  Independent Data Monitoring Committee (IDMC) advised that the FEM-PrEP  study will be highly unlikely to be able to demonstrate the  effectiveness of Truvada [emtricitabine (FTC) and tenofovir disoproxil  fumarate (TDF)] in preventing HIV infection in the study population,  even if it continued to its originally planned conclusion. FHI  subsequently concurred and has therefore decided to initiate an orderly  closure of the study over the next few months.<\/p><\/blockquote>\n<p>When studies are stopped early by a data and safety monitoring board, the investigators are of course as taken by surprise as the rest of us, and hence <em>lots<\/em> of details from this study are still not available.<\/p>\n<p>As a result,\u00a0 we can only speculate why TDF\/FTC (Truvada) worked for prevention of HIV among gay men, but not among heterosexual women.\u00a0 Some (unofficial) thoughts thoughts from my friend\/colleague Raphy Landovitz, who does research in HIV prevention:<\/p>\n<blockquote><p>I\u2019m  willing to bet it all comes down to adherence, with the proof  to come in the drug-level analyses.\u00a0 As iPrEx showed, self report of 95% in both arms is  meaningless.\u00a0 One also wonders if there was more condom non-adherence as part of  fertility goals.<\/p><\/blockquote>\n<p>Regardless of the cause, these negative results underscore one of the most important specific items in the CDC &#8220;<a href=\"http:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/mm6003a1.htm?s_cid=mm6003a1_w\" target=\"_blank\">Guidance<\/a>&#8221; on use of PrEP:\u00a0 that for now, if it&#8217;s prescribed, the only appropriate recipients are high-risk MSM.<\/p>\n<p>[Edit: \u00a0Nice summary of the FEM-PrEP study findings and implications over <a href=\"http:\/\/aids-clinical-care.jwatch.org\/cgi\/content\/full\/2011\/425\/1?q=featured_ac\" target=\"_blank\">here<\/a> in <em>Journal Watch HIV\/AIDS Clinical Care.<\/em>]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>HIV prevention has been on such a roll recently that the recent negative news from the FEM-PrEP study came as something of a surprise.\u00a0 Bottom line: Following a scheduled interim review of the FEM-PrEP study data, the Independent Data Monitoring Committee (IDMC) advised that the FEM-PrEP study will be highly unlikely to be able to [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,4,8,10],"tags":[354,423,748],"class_list":["post-1548","post","type-post","status-publish","format-standard","hentry","category-health-care","category-hiv","category-patient-care","category-research","tag-fem-prep","tag-hiv","tag-prep"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/1548","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=1548"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/1548\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/media?parent=1548"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/categories?post=1548"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/tags?post=1548"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}