{"id":222,"date":"2014-05-30T10:04:46","date_gmt":"2014-05-30T10:04:46","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=222"},"modified":"2014-08-31T16:29:22","modified_gmt":"2014-08-31T20:29:22","slug":"hiv-therapy-guidance-recommendations-diverge-show-us-bias","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2014\/05\/30\/222\/hiv-therapy-guidance-recommendations-diverge-show-us-bias\/","title":{"rendered":"HIV Therapy Guidance Recommendations Diverge, Show US Bias"},"content":{"rendered":"<p>US doctors seem to be very willing to start drugs earlier in disease, while their EU colleagues are slower and more conservative.\u00a0 Recent examples: the ever-wider indication for statins, the disproportionate uptake of drugs for attention-deficit \/ hyperactivity and opioids for pain relief.\u00a0 The new US HIV treatment guidelines are following this same trend.<!--more--><\/p>\n<p>The April 2014 HIV Guidelines[1]\u00a0recommend that all HIV infected patients receive treatment <em>regardless<\/em> of CD4 count.\u00a0 While there is fairly solid data for situations when the CD4 count is &lt; 350, it becomes less convincing for patients with CD4 counts above this cut-off.\u00a0 Indeed, when the CD4 counts are &gt; 500 this is admittedly a \u201cB\u201d recommendation i.e., only a \u2018moderately strong\u2019 endorsement.\u00a0 What is bothering is the fact that it is actually a \u201cB III\u201d recommendation which is not based on data but reflects expert opinion.\u00a0 The reason given by the Advisory Panel is to \u2018reduce the risk of disease progression\u2019.\u00a0 Their EU counterparts beg to differ.<\/p>\n<p>The European AIDS Clinical Society (EACS) Guideline[2]\u00a0from Oct. 2013 takes a more nuanced approach.\u00a0 For patients with asymptomatic HIV infection, treatment is a \u2018consideration\u2019.\u00a0 The risk of drug side effects is mentioned by the experts who feel that the risk \/ benefit ratio is unclear.\u00a0 Even the risk of cardiovascular disease with long-standing HIV infection (an argument for early treatment by US guideline authors) does not sway these experts: ART is a \u2018consideration\u2019, not a recommendation in this population as well.<\/p>\n<p>It does not come as a surprise when recommendations diverge that have no basis in fact.\u00a0 In a 2010 article, Khan (Clin Inf Dis 2010; 51:1147) reported an analysis of IDSA guidelines.\u00a0 A stunning 55% of \u2018recommendations\u2019 were solely based on expert opinions, not controlled trial information.\u00a0 Clearly, a lot of guideline ink is spilled on expert belief systems.<\/p>\n<p>In this age of evidence-based medicine, why even have \u201cB III\u201d opinion pieces in a Guidance? \u00a0For the newly diagnosed HIV patient the decision when to start and commit to ART for the rest of his life is monumental.\u00a0 Without demonstration of benefit, there is no justification in pushing drugs.<\/p>\n<p>[1] http:\/\/aidsinfo.nih.gov\/ContentFiles\/AdultandAdolescentGL.pdf<br \/>\n[2] http:\/\/www.eacsociety.org\/Portals\/0\/Guidelines_Online_131014.pdf<\/p>\n","protected":false},"excerpt":{"rendered":"<p>US doctors seem to be very willing to start drugs earlier in disease, while their EU colleagues are slower and more conservative.\u00a0 Recent examples: the ever-wider indication for statins, the disproportionate uptake of drugs for attention-deficit \/ hyperactivity and opioids for pain relief.\u00a0 The new US HIV treatment guidelines are <a class=\"more-link\" href=\"https:\/\/allphasepharma.com\/dir\/2014\/05\/30\/222\/hiv-therapy-guidance-recommendations-diverge-show-us-bias\/\">Continue reading <span class=\"screen-reader-text\">  HIV Therapy Guidance Recommendations Diverge, Show US Bias<\/span><span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[18],"tags":[6,51,50,52,54,23,49,27,55],"class_list":["post-222","post","type-post","status-publish","format-standard","hentry","category-the_viewpoint","tag-advisory-board","tag-art","tag-cd4-count","tag-eacs","tag-grading","tag-guidelines","tag-hiv","tag-idsa","tag-strength-of-evidence"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-3A","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":1859,"url":"https:\/\/allphasepharma.com\/dir\/2015\/08\/12\/1859\/the-beauty-of-science-no-need-to-think-about-costs-when-you-live-in-an-ivory-tower\/","url_meta":{"origin":222,"position":0},"title":"The Beauty of Science: No Need to Think About Costs When You Live in An Ivory Tower","author":"Harald","date":"August 12, 2015","format":false,"excerpt":"The recently published INSIGHT trial showed that starting HIV therapy earlier rather than later has benefit for patients 1. This should not come as a surprise considering the excellent suppressive power of current triple regimens.\u00a0 The trial which enrolled 4685 HIV infected patients was stopped prematurely when an interim analysis\u2026","rel":"","context":"In &quot;Did you know...?&quot;","block_context":{"text":"Did you know...?","link":"https:\/\/allphasepharma.com\/dir\/category\/interesting_facts\/"},"img":{"alt_text":"Instight NEJM blog","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/Instight-NEJM-blog.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/Instight-NEJM-blog.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/08\/Instight-NEJM-blog.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":2285,"url":"https:\/\/allphasepharma.com\/dir\/2016\/02\/07\/2285\/mister-s-goes-to-washington\/","url_meta":{"origin":222,"position":1},"title":"Mister S. Goes To Washington","author":"Harald","date":"February 7, 2016","format":false,"excerpt":"Let\u2019s just assume that Mr. Martin Shkrely had provided full testimony at the Congressional\u00a0hearing, this is what it might\u00a0have said: Read my lips: NO MORE REBATES ! It\u2019s time to give Shkrely a break \u2013 he has been maligned too much. The media already made him into the new Gordon\u2026","rel":"","context":"In &quot;The News&quot;","block_context":{"text":"The News","link":"https:\/\/allphasepharma.com\/dir\/category\/the_news\/"},"img":{"alt_text":"Shrely-slider NEW copy","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/02\/Shrely-slider-NEW-copy.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/02\/Shrely-slider-NEW-copy.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2016\/02\/Shrely-slider-NEW-copy.jpg?resize=525%2C300 1.5x"},"classes":[]},{"id":407,"url":"https:\/\/allphasepharma.com\/dir\/2014\/06\/25\/407\/should-efavirenz-remain-a-tier-1-art-drug\/","url_meta":{"origin":222,"position":2},"title":"Should Efavirenz Remain a Tier 1 ART Drug?","author":"Harald","date":"June 25, 2014","format":false,"excerpt":"In a recent publication Raffi et al. suggest that\u00a0it may be time to drop efavirenz (Sustiva\u00ae) from 1st line HIV treatment recommendations [1]. \u00a0The authors\u00a0make the\u00a0claim that efavirenz was inferior to rilpivirin (Edurant\u00ae) and dolutegravir (Tivicay\u00ae) in a total of 3 recent controlled studies. \u00a0They review\u00a0the CNS side effect profile\u2026","rel":"","context":"In &quot;Recent Literature&quot;","block_context":{"text":"Recent Literature","link":"https:\/\/allphasepharma.com\/dir\/category\/recent_literature\/"},"img":{"alt_text":"JAC","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/06\/JAC-190x300.jpg?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":182,"url":"https:\/\/allphasepharma.com\/dir\/2014\/04\/24\/182\/so-many-hcv-guidelines-cant-we-wait-till-the-dust-has-settled\/","url_meta":{"origin":222,"position":3},"title":"So Many HCV \u201cGuidelines\u201d: Can\u2019t We Wait Till the Dust Has Settled?","author":"Harald","date":"April 24, 2014","format":false,"excerpt":"It was clear from the outset that the new roster of HCV drugs would change the playing field. Gilead\u2019s NS5B polymerase inhibitor sofosbuvir and J&J\u2019s NS3\/4A protease inhibitor simeprevir have already revolutionized the treatment paradigm, pushing telaprevir and boceprevir, the first-generation PIs, to the sidelines. For treatment-na\u00efve patients with GT1,\u2026","rel":"","context":"In &quot;The Viewpoint&quot;","block_context":{"text":"The Viewpoint","link":"https:\/\/allphasepharma.com\/dir\/category\/the_viewpoint\/"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":1112,"url":"https:\/\/allphasepharma.com\/dir\/2014\/11\/08\/1112\/2014-the-year-that-changed-the-landscape-of-hcv-therapy\/","url_meta":{"origin":222,"position":4},"title":"2014: The Year That Changed The Landscape of HCV Therapy","author":"Harald","date":"November 8, 2014","format":false,"excerpt":"It was d\u00e9j\u00e0 vu all over again, albeit compressed in time: when the race started to replace PegIFN+RBV\u00a0for the treatment of HCV infection, the learnings from HIV drug development and the lessons with HAART provided an excellent template for quick and efficient development. There was early consensus that a search\u2026","rel":"","context":"In &quot;The News&quot;","block_context":{"text":"The News","link":"https:\/\/allphasepharma.com\/dir\/category\/the_news\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/11\/All-New-HCV-slider.jpg?fit=640%2C200&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/11\/All-New-HCV-slider.jpg?fit=640%2C200&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/11\/All-New-HCV-slider.jpg?fit=640%2C200&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":1741,"url":"https:\/\/allphasepharma.com\/dir\/2015\/07\/17\/1741\/does-the-taxpayer-get-rewarded-for-funding-studies\/","url_meta":{"origin":222,"position":5},"title":"Does The Taxpayer Get Rewarded For Funding Such Studies?","author":"Harald","date":"July 17, 2015","format":false,"excerpt":"Cabotegravir (S-1265744) is an integrase inhibitor similar to dolutegravir. \u00a0When formulated as a long-acting drug using crystalline nanoparticle technology it is called GSK'744 LAP.\u00a0 When injected intramuscularly, '744 LAP it has a half-life of >1 month which makes it ideally suited for PrEP\u00a0of HIV for high-risk patients who nowadays are\u2026","rel":"","context":"In &quot;Did you know...?&quot;","block_context":{"text":"Did you know...?","link":"https:\/\/allphasepharma.com\/dir\/category\/interesting_facts\/"},"img":{"alt_text":"LAP HIV Drugs - slider copy","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/07\/LAP-HIV-Drugs-slider-copy.jpg?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/07\/LAP-HIV-Drugs-slider-copy.jpg?resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/07\/LAP-HIV-Drugs-slider-copy.jpg?resize=525%2C300 1.5x"},"classes":[]}],"jetpack_likes_enabled":true,"_links":{"self":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/222","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/comments?post=222"}],"version-history":[{"count":8,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/222\/revisions"}],"predecessor-version":[{"id":828,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/posts\/222\/revisions\/828"}],"wp:attachment":[{"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/media?parent=222"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/categories?post=222"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/allphasepharma.com\/dir\/wp-json\/wp\/v2\/tags?post=222"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}