{"id":36116,"date":"2019-05-20T08:26:51","date_gmt":"2019-05-20T08:26:51","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=36116"},"modified":"2019-05-20T11:34:56","modified_gmt":"2019-05-20T11:34:56","slug":"b-f-taf-suitable-for-children-from-six-years-of-age","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/36116","title":{"rendered":"B\/F\/TAF suitable for children from six years of age"},"content":{"rendered":"

\"\"Polly Clayden, HIV i-Base<\/strong><\/p>\n

The adult fixed dose combination formulation of bictegravir, emtricitabine, and tenofovir alafenamide (B\/F\/TAF) is appropriate for the treatment of adolescents and children 6 to 18 years of age and weighing 25 kg and above.<\/strong><\/p>\n

Week 48-week efficacy, safety, acceptability, and palatability data presented at CROI 2019 (combined with previously reported PK data), support the use of adult strength B\/F\/TAF (50\/200\/25 mg) in this paediatric population.<\/p>\n

The study was sequential in age descending cohorts. Virologically suppressed adolescents (12 to <18 years) weighing ><\/u>35 kg (cohort 1) and children (6 to <12 years) weighing ><\/u>25 kg (cohort 2) with viral load <50 copies\/mL for ><\/u>6 months and CD4 ><\/u>200 cells\/mm3<\/sup>were switched to B\/F\/TAF once daily.<\/p>\n

Fifty adolescents and 50 children were enrolled. Sites were in South Africa, Thailand, Uganda and US.<\/p>\n

For cohort 1, at baseline, median age was 15 years (range: 12 to 17), weight 45 kg (IQR: 40 to 56), 64% girls, 65% black, and median CD4 count 751 cells\/mm3<\/sup>.<\/p>\n

For cohort 2, median age was 10 years (range: 6 to 11), median weight 29 kg (IQR: 27 to 33), 54% girls, 72% black, and median CD4 count 930 cells\/mm3<\/sup>.<\/p>\n

Population pharmacokinetics showed bictegravir exposure to be similar to adults in both children and adolescents. Bictegravir trough levels was lower in adolescents than adults but remained >11-fold above paEC50; but similar to adults in children. Exposures of FTC and TAF were in the range of historical adult data and for children\/adolescents treated with elvitegravir\/cobicistat\/F\/TAF.<\/p>\n

All 100 participants had viral load <50 copies\/mL at week 24 and 98% (74\/75) at week 48 (US FDA snapshot). No participant had treatment-emergent resistance.<\/p>\n

One child discontinued after week 16 due to an adverse event (grade 2 insomnia and anxiety).<\/p>\n

All participants reported B\/F\/TAF size (15 x 8 mm) and shape as acceptable and taste as palatable. Median percent adherence (pill counts) to study drug was high at 98.9% (range: 80% to 100%).<\/p>\n

comments<\/h3>\n

Further investigations (by the originator manufacturer Gilead) with reduced strength, paediatric B\/F\/TAF 30\/120\/15 mg FDC in 2 years of age and above and weight 14 to <25 kg are ongoing.<\/strong><\/p>\n

Reference\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Gaur A et al. Bictegravir\/FTC\/TAF single-tablet regimen in adolescents and children: week 48 results. CROI 2019. Seattle. 4\u20137 March 2019. Oral abstract 46.
\nhttps:\/\/www.croiconference.org\/sessions\/bictegravirftctaf-single-tablet-regimen-adolescents-children-week-48-results\u00a0<\/a>(abstract)
\nhttp:\/\/www.croiwebcasts.org\/p\/2019croi\/46\u00a0<\/a>(webcast)<\/p>\n","protected":false},"excerpt":{"rendered":"

Polly Clayden, HIV i-Base The adult fixed dose combination formulation of bictegravir, emtricitabine, and tenofovir alafenamide (B\/F\/TAF) is appropriate for the treatment of adolescents and children 6 to 18 years of age and weighing 25 kg and above. Week 48-week …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,32],"tags":[264],"class_list":["post-36116","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-paediatric-care","tag-croi-2019"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36116","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=36116"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36116\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=36116"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=36116"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=36116"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}