{"id":324,"date":"2008-12-26T20:29:32","date_gmt":"2008-12-26T19:29:32","guid":{"rendered":"http:\/\/localhost\/new\/htb\/?p=324"},"modified":"2013-08-23T12:49:35","modified_gmt":"2013-08-23T12:49:35","slug":"48-week-data-for-darunavirritonavir-drvr-in-treatment-experienced-children-and-adolescents","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/324","title":{"rendered":"48-week data for darunavir\/ritonavir (DRV\/r) in treatment-experienced children and adolescents"},"content":{"rendered":"<p><strong>Polly Clayden, HIV i-Base<\/strong><\/p>\n<p><strong>48-week data was presented from the DELPHI (TMC114-C212) study. DELPHI is a multi site open-label, two-part Phase II study assessing the safety and efficacy of DRV\/r plus OBR in treatment-experienced children and adolescents.<\/strong><\/p>\n<p>Children were dosed according to body weight for &gt;\/=48 weeks: 20-&lt;30kg, 375\/50mg bid (20 patients); 30-&lt;40kg, 450\/60mg bid (24 patients); &gt;\/=40kg, 600\/100mg bid (36 patients). PK, safety and efficacy (viral load, CD4 % and CD4 counts) were evaluated throughout the study.<\/p>\n<p>80 children with a median age of 14 years (range: 6-17 years) of which 71% were male received DRV\/r. At baseline their mean viral load was 4.64 log, median CD4 was 330 cells\/mm3 and CD4 % was 17%. They had a median of 3 primary PI mutations, 11 PI RAMs (65% had &gt;\/=10 PI RAMs), 2 NNRTI and 4 NRTI RAMs.<\/p>\n<p>The investigators reported that target DRV PK concentrations for treatment-experienced adults were achieved across all ages and weight bands, which confirmed the dose selection.<\/p>\n<p>The majority of patients (74, 93%) experienced one AE. The most frequently reported were: fever, cough, upper respiratory tract infection and diarrhea. Most were grade 1\/2. 21 (26%) patients had grade 3\/4 AEs but most were considered to be unrelated to DRV\/r. 11 (14%) of patients (14%) experienced serious AEs but there were no deaths. One patient discontinued the study because of grade 3 anxiety but this was not considered to be DRV\/r related. 6 pts (8%) had grade 2-4 AEs possibly related to DRV\/r.<\/p>\n<p>At week 48, 65% of patients had =1.0 log10 viral load reduction (TLOVR); 59% and 48% were undetectable to &lt;400 and &lt;50 copies\/mL (TLOVR), respectively. Their mean CD4 increase was 147 cells\/mm3.<\/p>\n<p>The investigators noted that predictive analyses will be performed to evaluate the contribution of the OBR to response rates in this population.<\/p>\n<p>Reference:<\/p>\n<p>Blanche S, Bologna R, Cahn P et al. 48-wk safety and efficacy of Darunavir\/ritonavir (DRV\/r) in treatment-experienced children and adolescents in DELPHI. 48th ICAAC, 25-28 October 2008. Washington. Abstract H-894.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Polly Clayden, HIV i-Base 48-week data was presented from the DELPHI (TMC114-C212) study. DELPHI is a multi site open-label, two-part Phase II study assessing the safety and efficacy of DRV\/r plus OBR in treatment-experienced children and adolescents. Children were dosed &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,32],"tags":[102],"class_list":["post-324","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-paediatric-care","tag-icaac-48th-2008"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/324","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=324"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/324\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=324"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=324"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=324"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}