{"id":3146,"date":"2012-08-31T08:52:10","date_gmt":"2012-08-31T12:52:10","guid":{"rendered":"http:\/\/blogs.nejm.org\/?p=3146"},"modified":"2015-06-04T15:14:03","modified_gmt":"2015-06-04T19:14:03","slug":"pearls-study-a-massive-impressive-accomplishment","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/pearls-study-a-massive-impressive-accomplishment\/2012\/08\/31\/","title":{"rendered":"“PEARLS” Study a Massive, Impressive Accomplishment"},"content":{"rendered":"

\"\"<\/a>One of the most frequent criticisms of randomized clinical trials of HIV therapy is\u00a0that certain patient groups — in particular gay men — are over represented compared to the HIV population as a whole. For example, in the recently published and presented clinical trials of the Quad<\/a> and dolutegravir<\/a>, women accounted for < 20% of the study population, despite representing approximately 50% of those living with HIV worldwide.<\/p>\n

Now along comes the\u00a0The Prospective Evaluation of Antiretrovirals in Resource Limited Settings (PEARLS) study,<\/a> and let no one\u00a0<\/em>criticize this trial as not being representative! \u00a0Conducted in\u00a0Brazil, Haiti, India, Malawi, Peru, South Africa, Thailand, the United States, and Zimbabwe, the study enrolled\u00a01,571 HIV-1-infected treatment-naive patients, of whom 47% were women. They were randomized to one of three treatments:<\/p>\n

    \n
  1. ZDV\/3TC + EFV<\/li>\n
  2. TDF\/FTC\/EFV<\/li>\n
  3. ddI + FTC + ATV<\/li>\n<\/ol>\n

    50% were African race, 23% Asian, and 20% Hispanic — remarkably diverse demographics.<\/p>\n

    A DSMB stopped the study early after observing a greater number of virologic failures in the ATV arm, and a lower than expected number of failures with the other two regimens. Furthermore, while the two EFV arms were comparably effective from a virologic perspective — a finding similar to the prior 934 study<\/a>, where virologic failures were not significantly different\u00a0— the safety of TDF\/FTC\/EFV was significantly better than ZDV\/3TC + EFV, particularly in women. Interestingly, women also did better than men on the atazanavir regimen; the reason for this difference is being investigated, and may be related to fact that levels of PIs can be higher in women than men.<\/p>\n

    The importance of this study is that it\u00a0greatly strengthens the evidence that TDF\/FTC\/EFV is truly our gold standard for HIV treatment across a broad range of patients and in multiple settings. It also demonstrates a research collaboration on a massive scale, involving the NIH, several pharmaceutical companies, literally hundreds of investigators at dozens of study sites, and 9 countries!<\/p>\n

    Additional analyses from this impressive trial are eagerly awaited.<\/p>\n

     <\/p>\n

     <\/p>\n","protected":false},"excerpt":{"rendered":"

    One of the most frequent criticisms of randomized clinical trials of HIV therapy is\u00a0that certain patient groups — in particular gay men — are over represented compared to the HIV population as a whole. For example, in the recently published and presented clinical trials of the Quad and dolutegravir, women accounted for < 20% of […]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,4,10],"tags":[87,307,322,423,552,704,908,1005],"class_list":["post-3146","post","type-post","status-publish","format-standard","hentry","category-health-care","category-hiv","category-research","tag-atazanavir","tag-efavirenz","tag-emtricitabine","tag-hiv","tag-lamivudine","tag-pearls-study","tag-tenofovir","tag-zidovudine"],"post_mailing_queue_ids":[],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/3146","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=3146"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/posts\/3146\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/media?parent=3146"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/categories?post=3146"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/hiv-id-observations\/index.php\/wp-json\/wp\/v2\/tags?post=3146"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}