{"id":238260,"date":"2010-01-27T18:19:06","date_gmt":"2010-01-27T23:19:06","guid":{"rendered":"http:\/\/blogs.jwatch.org\/hiv-id-observations\/?p=687"},"modified":"2010-01-27T18:19:06","modified_gmt":"2010-01-27T23:19:06","slug":"no-vicriviroc-%e2%80%94%c2%a0yet","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/238260","title":{"rendered":"No Vicriviroc \u2014\u00a0Yet"},"content":{"rendered":"

\"ccr5lrg\"Apparently, Merck — taking over for Schering-Plough — will not seek approval for vicriviroc<\/a> in treatment-experienced patients:<\/p>\n

\n

In two Phase III studies in this patient population, vicriviroc did not meet the primary efficacy endpoint. These studies enrolled a high percentage of patients who had three or more active drugs in their optimized background therapy regimen.<\/p>\n<\/blockquote>\n

The report goes on to say that the results of these studies will be presented at CROI next month<\/a>, and that other studies of vicriviroc in treatment-naive patients will continue.<\/p>\n

Even though we don’t know the details yet, it’s understandable how this trial didn’t show any benefit for vicriviroc.\u00a0 With the “optimized background therapy” having 3 or more active drugs, how could it?\u00a0 We’re a long way from the TORO\/T-20<\/a> days, when such “OBT” led to virologic suppression in < 10% of patients.<\/p>\n

The control arms in these studies now just do too<\/em> well.\u00a0 Progress!<\/p>\n

Still, given the checkered history of this particular CCR5 antagonist — including a failed phase II study<\/a> in treatment-naive patients and a possible signal of increased malignancies<\/a> in another trial — the FDA approval for any indication might be a long hill to climb.<\/p>\n

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

Apparently, Merck — taking over for Schering-Plough — will not seek approval for vicriviroc in treatment-experienced patients: In two Phase III studies in this patient population, vicriviroc did not meet the primary efficacy endpoint. These studies enrolled a high percentage of patients who had three or more active drugs in their optimized background therapy regimen. […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-238260","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/238260","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/comments?post=238260"}],"version-history":[{"count":0,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/238260\/revisions"}],"wp:attachment":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/media?parent=238260"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/categories?post=238260"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/tags?post=238260"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}