{"id":1039,"date":"2010-11-05T12:24:00","date_gmt":"2010-11-05T12:24:00","guid":{"rendered":"https:\/\/blogs.nature.com\/spoonful\/2010\/11\/comparison-of-hepatitis-drugs-zeros-in-on-null-responders.html"},"modified":"2010-11-05T12:24:00","modified_gmt":"2010-11-05T12:24:00","slug":"use_caution_when_comparing_new","status":"publish","type":"post","link":"https:\/\/blogs.nature.com\/spoonful\/2010\/11\/use_caution_when_comparing_new.html","title":{"rendered":"Comparison of hepatitis drugs zeros in on null responders"},"content":{"rendered":"<p><img loading=\"lazy\" decoding=\"async\" alt=\"zero.jpg\" src=\"https:\/\/blogs.nature.com\/spoonful\/files\/zero.jpg\" width=\"150\" height=\"150\" border=\"0\" hspace=\"10px\" vspace=\"5px\" align=\"right\"\/>The current standard-of-care treatment for hepatitis C is interferon treatments, which aim to inhibit the ability of cells to host the virus. Studies have shown that certain ethnic groups like African-Americans and Hispanics are <a href=\"https:\/\/journals.lww.com\/jcge\/pages\/articleviewer.aspx?year=2010&#038;issue=02000&#038;article=00015&#038;type=abstract\">less likely to respond<\/a> to interferon treatments.<\/p>\n<p>Drug giants Vertex and Merck are now jockeying to assume market supremacy in a new class of hepatitis drugs.  Both companies are currently developing protease inhibitors that directly target the hepatitis C virus.<\/p>\n<p>But when comparing the two companies&#8217; compounds, the devil is in the details. An &#8216;apples and oranges&#8217;  problem was highlighted on the pharmaceutical blog <em><a href=\"https:\/\/invivoblog.blogspot.com\/2010\/11\/notes-from-aasld-apples-and-oranges-and.html\">In Vivo<\/a><\/em>. In its <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT00708500\"><span class=\"caps\">RESPOND<\/span>-2<\/a> study, Merck defines a <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/16566033\">null responding patient<\/a> \u2014 someone who is faring the worst under the current standard of care \u2014 as a patient whose viral load decreased less than 1 log after four weeks of standard treatment. That&#8217;s a considerably different criteria from the US Food and Drug Administration, which defines null responders as &#8216;less than a 2 log10 reduction in <span class=\"caps\">HCV<\/span> <span class=\"caps\">RNA<\/span> at week 12&#8217;. Vertex used the FDA&#8217;s definition of null responder in its study, <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/study\/NCT00627926\"><span class=\"caps\">REALIZE<\/span><\/a>. Since both companies are trying to show that their protease inhibitor works better for patients for whom current options have failed, there is a remote chance that Merck&#8217;s numbers might paint an artificially rosier picture.<\/p>\n<p><em><a href=\"https:\/\/commons.wikimedia.org\/wiki\/File:Cc-zero.svg\">Image<\/a> via Wikimedia Commons<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The current standard-of-care treatment for hepatitis C is interferon treatments, which aim to inhibit the ability of cells to host the virus. Studies have shown that certain ethnic groups like African-Americans and Hispanics are less likely to respond to interferon treatments.&nbsp; <a href=\"https:\/\/blogs.nature.com\/spoonful\/2010\/11\/use_caution_when_comparing_new.html#wpn-more-1039\" class=\"more-link\">Read more<\/a> <a href=\"https:\/\/blogs.nature.com\/spoonful\/2010\/11\/use_caution_when_comparing_new.html\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":167,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-1039","post","type-post","status-publish","format-standard","hentry","category-drugs-drugs-and-more-drugs"],"_links":{"self":[{"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/posts\/1039","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/users\/167"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/comments?post=1039"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/posts\/1039\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/media?parent=1039"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/categories?post=1039"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nature.com\/spoonful\/wp-json\/wp\/v2\/tags?post=1039"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}