{"id":6972,"date":"2005-04-18T09:44:44","date_gmt":"2005-04-18T08:44:44","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=6972"},"modified":"2014-05-21T18:27:37","modified_gmt":"2014-05-21T18:27:37","slug":"24-week-efficacy-of-tmc114-in-pi-experienced-patients","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/6972","title":{"rendered":"24-week efficacy of TMC114 in PI-experienced patients"},"content":{"rendered":"

Graham McKerrow, HIV i-Base<\/strong><\/p>\n

An interim 24-week analysis of data from 497 patients in a multinational study of the new protease inhibitor TMC114 with ritonavir, demonstrated exciting efficacy in three-class-experienced patients with limited treatment options and was presented as an oral late-breaker session.<\/strong><\/p>\n

Four different dosing regimens were generally safe and well tolerated and the researchers concluded by recommending a dose of 600\/100mg twice a day for further clinical development in treatment experienced patients because on a series of measures that dose was as potent or more potent than others and produced comparable or fewer side effects.<\/p>\n

TMC114 had previously shown potent activity in protease inhibitor (PI) resistant patients in a 14-day trial. The new study looked at its effect in people who had experienced at least 3 classes of antiretrovirals with prior use of at least 1 PI, had at least one primary PI mutation, and viral load >1,000 copies\/mL.<\/p>\n

Patients were randomised to receive optimal background therapy (OBR, at least 2 NRTIs with or without T-20) and one of 4 doses of TMC114\/r (400\/100mg once a day, 800\/100mg once a day, 400\/100mg BD or 600\/100mg BD) or chosen PI (CPI).<\/p>\n

Baseline median CD4 count and viral load were 141 cells\/mm3 and 4.6 log10 copies\/mL respectively.<\/p>\n

Interim week 24 interim results (intent to treat) are shown in the table below. The TMC-144\/r dose 600\/100mg twice-daily dosing produced a greater mean change in viral load, a greater percentage of subjects with 1log or more reduction, a marginally greater percentage with fewer than 400 copies\/mL, and a greater percentage with fewer that 50 copies\/mL than any other group, while at the same time having the same or only a slightly higher percentage of subjects with grade 3 and 4 adverse events and a lower or comparable percentage of severe adverse events.<\/p>\n

Mean change in CD4 was +75 cells\/mm3<\/sup> for TMC114\/r 600\/100 twice-daily vs +15 cells\/mm3<\/sup> for CPI. See Table 1 below.<\/p>\n

Table 1: 24-week interim results of TMC114 vs comparitor PI<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n
TMC114\/r<\/th>\n400\/100 once- daily<\/th>\n800\/100 once-daily<\/th>\n400\/100 twice-daily<\/th>\n600\/100 twice-daily<\/th>\nCPI<\/th>\n<\/tr>\n
<\/td>\nN=100<\/td>\nN=100<\/td>\nN=98<\/td>\nN=99<\/td>\nN=100<\/td>\n<\/tr>\n
Mean HIV RNA change<\/td>\n-1.28<\/td>\n-1.43<\/td>\n-1.47<\/td>\n-1.85<\/td>\n-0.27<\/td>\n<\/tr>\n
% > 1 log reduction<\/td>\n55<\/td>\n56<\/td>\n58<\/td>\n72<\/td>\n16<\/td>\n<\/tr>\n
% < 400 copies\/mL<\/td>\n46<\/td>\n48<\/td>\n58<\/td>\n72<\/td>\n16<\/td>\n<\/tr>\n
% < 50 copies\/mL<\/td>\n30<\/td>\n31<\/td>\n38<\/td>\n47<\/td>\n10<\/td>\n<\/tr>\n
% grade 3 and 4 ae\u2019s<\/td>\n23<\/td>\n26<\/td>\n26<\/td>\n26<\/td>\n23<\/td>\n<\/tr>\n
% severe ae\u2019s<\/td>\n10<\/td>\n17<\/td>\n16<\/td>\n9<\/td>\n11<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Reference:<\/p>\n

Katlama C, Berger D, Bellos N et al. Efficacy of TMC114\/r in 3-class experienced patients with limited treatment options: 24-week planned interim analysis of 2 96-week multinational dose-finding trials. 12th CROI, Boston, 2005.
\nAbstract 164LB<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

Graham McKerrow, HIV i-Base An interim 24-week analysis of data from 497 patients in a multinational study of the new protease inhibitor TMC114 with ritonavir, demonstrated exciting efficacy in three-class-experienced patients with limited treatment options and was presented as an …<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3],"tags":[59],"class_list":["post-6972","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-croi-2005"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/6972","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=6972"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/6972\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=6972"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=6972"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=6972"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}