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Polly\u00a0Clayden,\u00a0HIV\u00a0i-Base<\/b><\/p>\nPolly\u00a0Clayden,\u00a0HIV\u00a0i-Base<\/b><\/p>\n
Pharmacokinetics, safety and efficacy of tenofovir alafenamide (TAF) in adolescents receiving the coformulation with emtricitabine (FTC\/TAF) was similar to adults at 24 weeks, according to data presented at CROI 2018. [1]<\/strong><\/p>\n Coformulated FTC\/TAF is approved for adolescents aged 12 to 18 years in the US and EU and is a recommended first-line NRTI backbone for adolescents in the US.<\/p>\n FTC\/TAF was developed with two versions: 200\/10 mg and 200\/25 mg for administration with boosted and unboosted agents respectively. FTC\/TAF 200\/25 mg is the only dose strength approved by the FDA.<\/p>\n Safety and efficacy of TAF in adolescents has been shown in studies of elvitegravir\/cobicistat\/FTC\/TAF and bictegravir\/FTC\/TAF. Safety, pharmacokinetics (PK), and efficacy of other FTC\/TAF-containing regimens in adolescents have not been reported. These data are the first to be presented on FTC\/TAF with other\u00a0 with non-Gilead third agents in HIV positive adolescents.<\/p>\n This was a phase 2\/3, open-label, multicentre, single arm switching study in 28 virologically suppressed adolescents aged 12 to 18 years weighing at least 35 kg.<\/p>\n Participants were a median age 14 years (range: 12 to 17) and weight 45 kg (range: 35 to 62): 57% male and 43% black. Median CD4 count was 909 cells\/mm3<\/sup>. Third agent was efavirenz or lopinavir\/ritonavir.<\/p>\n Exposures of TAF and TFV were consistent with those of adults regardless of third agent.<\/p>\n Most common adverse event (AE) was viral upper respiratory infection (32%) followed by headache (25%). Two participants had serious, unrelated AEs. Five had TAF-related AEs; no participant discontinued study drug due to an AE.<\/p>\n Mean % change from baseline in BMD at week 24 was +3.56% for spine and +1.57% for total body less head (TBLH). Mean change in BMD height-age adjusted z-score was 0.00 for spine and \u20130.03 for TBLH. Mean (SD) estimated change in glomerular filtration rate was 2.0 (20.95) mL\/min\/1.73 m2<\/sup>.<\/p>\n The majority of participants (92.9%, 26\/28) maintained viral load <50 copies\/mL. Mean reductions in CD4 count and CD4% from baseline were \u2013130 cells\/mm3<\/sup> and \u20130.2%.<\/p>\n CROI 2018 also showed the first data from the fixed dose combination of bictegravir\/FTC\/TAF in 24 virologically suppressed adolescents. [2]<\/b><\/p>\n At week 24 PK, safety and efficacy of all the component agents were also similar to those reported in phase 3 trials in adults.<\/b><\/p>\n There were no grade 3\/4 AEs. One participant experienced grade 1 vomiting, judged related to study drug that resolved on the same day with no adjustment to the regimen.<\/b><\/p>\n This fixed dose combination is a considerably smaller tablet than those currently most commonly prescribed (as will generic versions of dolutegravir\/FTC\/TAF for low- and middle-income countries) \u2013 its shape and size were reported to be acceptable.<\/b><\/p>\n References<\/p>\n Polly\u00a0Clayden,\u00a0HIV\u00a0i-Base Pharmacokinetics, safety and efficacy of tenofovir alafenamide (TAF) in adolescents receiving the coformulation with emtricitabine (FTC\/TAF) was similar to adults at 24 weeks, according to data presented at CROI 2018. [1] Coformulated FTC\/TAF is approved for adolescents aged 12 …<\/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":[251],"class_list":["post-33884","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-paediatric-care","tag-croi-2018"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/33884","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=33884"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/33884\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=33884"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=33884"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=33884"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}comment<\/b><\/h3>\n
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\nhttp:\/\/www.croiconference.org\/sessions\/safety-pk-efficacy-ftctaf-hiv-infected- adolescents-12-18-yrs<\/a> (abstract and poster)<\/li>\n
\nhttp:\/\/www.croiconference.org\/sessions\/bictegravirftctaf-single-tablet-regimen-adolescents-week-24-results<\/a> (Poster and abstract)<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"