{"id":1279,"date":"2015-02-23T14:58:28","date_gmt":"2015-02-23T19:58:28","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=1279"},"modified":"2015-02-24T03:19:50","modified_gmt":"2015-02-24T08:19:50","slug":"discontinued-but-not-forgotten-hcv-drugs-that-did-not-make-it","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2015\/02\/23\/1279\/discontinued-but-not-forgotten-hcv-drugs-that-did-not-make-it\/","title":{"rendered":"Discontinued But Not Forgotten: HCV Drugs That Did Not Make It"},"content":{"rendered":"<p>I find it useful to look back and review drug candidates that were stopped in development.\u00a0 In case of insufficient efficacy, i.e., not enough of a VL reduction or early viral rebound, everyone can sympathize with the decision to discontinue a drug.<\/p>\n<p>More importantly, we want to learn about the safety problems of abandoned drug candidates.\u00a0 However, here we hit a road block:\u00a0 sadly this particular information is often withheld for competitive reasons.<\/p>\n<p>Gentile gives us a nice summary of the 2012-2013 HCV drug &#8216;grave yard&#8217;\u00a0<a href=\"#_ftn1\" name=\"_ftnref1\">[1]<\/a>.\u00a0 Instructive examples of late-stage disappointments include:<\/p>\n<ul>\n<li>filibuvir, a non-nucleosidic NS5B drug which had a high propensity for VL rebound after drug discontinuation<\/li>\n<li>several guanidine nucleoside NS5B inhibitors: BMS-986094, which was associated with rare cases of heart failure and kidney toxicity, IDX-184 because of concerns for similar cardiac toxicity, and PSI-938 for reasons of hepatotoxicity<\/li>\n<li>VX-222, yet another NS5B inhibitor which was associated with a higher than expected rate of virologic break-throughs<\/li>\n<\/ul>\n<p>Obviously, certain viral targets are quite a bit more difficult to tackle than others.\u00a0 Case in point: the NS5B polymerase inhibitor group of drugs.\u00a0 They had the highest attrition rate and ended up on the \u00a0\u2018cemetery\u2019 disproportionately often.<a href=\"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/02\/Commandments.jpg?ssl=1\"><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" class=\"alignright  wp-image-1280\" src=\"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/02\/Commandments.jpg?resize=262%2C263&#038;ssl=1\" alt=\"Commandments\" width=\"262\" height=\"263\" \/><\/a><\/p>\n<p>The authors mention that the true reasons why drugs were stopped in development are often not provided. \u00a0Too frequently,\u00a0reference is made to \u2018strategic decisions\u2019 which really is another way of saying \u201cwe\u2019ll keep you guessing\u201d.<\/p>\n<p>Bottom line: Besides company insiders, only Health Authorities know the true story, but they won\u2019t tell.<\/p>\n<p>So, where are the patient advocate groups that demand that this information be made public, as part of the patient-sponsor agreement that is the basic covenant of all clinical trials?<\/p>\n<p><strong>Reference:<\/strong><\/p>\n<p><a href=\"#_ftnref1\" name=\"_ftn1\">[1]<\/a> Gentile.\u00a0 Expert Opin. Investig. Drugs (2015) 24(2):239-251<\/p>\n","protected":false},"excerpt":{"rendered":"<p>I find it useful to look back and review drug candidates that were stopped in development.\u00a0 In case of insufficient efficacy, i.e., not enough of a VL reduction or early viral rebound, everyone can sympathize with the decision to discontinue a drug. More importantly, we want to learn about the <a class=\"more-link\" href=\"https:\/\/allphasepharma.com\/dir\/2015\/02\/23\/1279\/discontinued-but-not-forgotten-hcv-drugs-that-did-not-make-it\/\">Continue reading <span class=\"screen-reader-text\">  Discontinued But Not Forgotten: HCV Drugs That Did Not Make It<\/span><span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":1282,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_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},"jetpack_post_was_ever_published":false},"categories":[227],"tags":[360,403,844,838,842,845,836,24,841,839,847,129,846,835,840,843,65,837],"class_list":["post-1279","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-recent_literature","tag-adverse-events","tag-antibiotic-blog","tag-attrition-rate","tag-bms-986094","tag-cardiac-toxicity","tag-development-stop","tag-filibuvir","tag-hcv","tag-hepatotoxicity","tag-idx-184","tag-lack-of-transparency-in-reporting","tag-ns5b","tag-nucleoside-ns5b-inhibitor","tag-polymerase-inhibitors","tag-psi-938","tag-renal-toxicity","tag-reporting-bias","tag-vx-222"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Discontinued But Not Forgotten: HCV Drugs That Did Not Make It - Allphase Pharma Consulting, LLC<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/allphasepharma.com\/dir\/2015\/02\/23\/1279\/discontinued-but-not-forgotten-hcv-drugs-that-did-not-make-it\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Discontinued But Not Forgotten: HCV Drugs That Did Not Make It - Allphase Pharma Consulting, LLC\" \/>\n<meta property=\"og:description\" content=\"I find it useful to look back and review drug candidates that were stopped in development.\u00a0 In case of insufficient efficacy, i.e., not enough of a VL reduction or early viral rebound, everyone can sympathize with the decision to discontinue a drug. 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More importantly, we want to learn about the Continue reading  Discontinued But Not Forgotten: HCV Drugs That Did Not Make It&rarr;","og_url":"https:\/\/allphasepharma.com\/dir\/2015\/02\/23\/1279\/discontinued-but-not-forgotten-hcv-drugs-that-did-not-make-it\/","og_site_name":"Allphase Pharma Consulting, LLC","article_published_time":"2015-02-23T19:58:28+00:00","article_modified_time":"2015-02-24T08:19:50+00:00","og_image":[{"width":640,"height":180,"url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/02\/Cemetery-slider.jpg?fit=640%2C180&ssl=1","type":"image\/jpeg"}],"author":"Harald","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Harald","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/allphasepharma.com\/dir\/2015\/02\/23\/1279\/discontinued-but-not-forgotten-hcv-drugs-that-did-not-make-it\/#article","isPartOf":{"@id":"https:\/\/allphasepharma.com\/dir\/2015\/02\/23\/1279\/discontinued-but-not-forgotten-hcv-drugs-that-did-not-make-it\/"},"author":{"name":"Harald","@id":"https:\/\/allphasepharma.com\/dir\/#\/schema\/person\/b577474473153b47f4bf5b4cc676a2ee"},"headline":"Discontinued But Not Forgotten: HCV Drugs That Did Not Make It","datePublished":"2015-02-23T19:58:28+00:00","dateModified":"2015-02-24T08:19:50+00:00","mainEntityOfPage":{"@id":"https:\/\/allphasepharma.com\/dir\/2015\/02\/23\/1279\/discontinued-but-not-forgotten-hcv-drugs-that-did-not-make-it\/"},"wordCount":302,"commentCount":0,"publisher":{"@id":"https:\/\/allphasepharma.com\/dir\/#organization"},"image":{"@id":"https:\/\/allphasepharma.com\/dir\/2015\/02\/23\/1279\/discontinued-but-not-forgotten-hcv-drugs-that-did-not-make-it\/#primaryimage"},"thumbnailUrl":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2015\/02\/Cemetery-slider.jpg?fit=640%2C180&ssl=1","keywords":["adverse events","antibiotic blog","attrition rate","BMS-986094","cardiac toxicity","development stop","filibuvir","HCV","hepatotoxicity","IDX-184","lack of transparency in reporting","NS5B","nucleoside NS5B inhibitor","polymerase inhibitors","PSI-938","renal toxicity","reporting bias","VX-222"],"articleSection":["Recent Literature"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/allphasepharma.com\/dir\/2015\/02\/23\/1279\/discontinued-but-not-forgotten-hcv-drugs-that-did-not-make-it\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/allphasepharma.com\/dir\/2015\/02\/23\/1279\/discontinued-but-not-forgotten-hcv-drugs-that-did-not-make-it\/","url":"https:\/\/allphasepharma.com\/dir\/2015\/02\/23\/1279\/discontinued-but-not-forgotten-hcv-drugs-that-did-not-make-it\/","name":"Discontinued But Not Forgotten: HCV Drugs That Did Not Make It - 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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":313,"url":"https:\/\/allphasepharma.com\/dir\/2014\/06\/18\/313\/snapshot-hcv-drugs-in-development\/","url_meta":{"origin":1279,"position":1},"title":"Snapshot: HCV Drugs in Development","author":"Harald","date":"June 18, 2014","format":false,"excerpt":"It's becoming a daunting task to follow the field given the rapid-fire release of study results and the many recent submissions of new direct-acting antiviral (DAA) drugs. All will be given as cocktails, with or without interferon or ribavirin, and for various durations\u00a0depending on genotype (GT) and other factors. \u00a0How\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":"","width":0,"height":0},"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":1279,"position":2},"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":1146,"url":"https:\/\/allphasepharma.com\/dir\/2014\/11\/23\/1146\/after-harvoni-whats-still-left-to-improve-besides-the-price-tag\/","url_meta":{"origin":1279,"position":3},"title":"After Harvoni: What\u2019s Still Left to Improve (Besides the Price Tag)?","author":"Harald","date":"November 23, 2014","format":false,"excerpt":"SVR rates in recent DAA combination trials are really impressive.\u00a0 Hardly a month goes by without yet another trial showing excellent efficacy in populations so far considered \u2018difficult to treat\u2019, like cirrhotics or post-liver transplant patients on immunosuppressive therapies.\u00a0 This begs the question: is there still room for improvement?\u00a0 Why\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-Menu-copy-e1431668358188.jpg?fit=1200%2C1150&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-Menu-copy-e1431668358188.jpg?fit=1200%2C1150&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/11\/All-New-HCV-Menu-copy-e1431668358188.jpg?fit=1200%2C1150&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/11\/All-New-HCV-Menu-copy-e1431668358188.jpg?fit=1200%2C1150&ssl=1&resize=700%2C400 2x, 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