{"id":3426,"date":"2026-09-04T18:30:58","date_gmt":"2026-09-04T18:30:58","guid":{"rendered":"https:\/\/allesleypharmacy.co.uk\/pharmacy\/?p=3426"},"modified":"2026-09-04T18:30:58","modified_gmt":"2026-09-04T18:30:58","slug":"fda-approves-first-hiv-treatment-for-newborns-weighing-just-2-kg","status":"publish","type":"post","link":"https:\/\/allesleypharmacy.co.uk\/pharmacy\/fda-approves-first-hiv-treatment-for-newborns-weighing-just-2-kg\/","title":{"rendered":"FDA Approves First HIV Treatment for Newborns Weighing Just 2 kg"},"content":{"rendered":"

ViiV Healthcare has received approval from the U.S. Food and Drug Administration (FDA<\/a>) for a new version of the HIV medication Tivicay called Tivicay PD. This medication can now be used alongside other HIV drugs to treat children living with HIV-1 who weigh at least 2 kilograms (about 4.4 pounds). This approval makes Tivicay PD the first second-generation integrase inhibitor\u2014a type of HIV medicine<\/a>\u2014approved for use in eligible newborns.<\/p>\n

Diana F. Clarke, an Assistant Professor of Pediatrics at Boston University School of Medicine and the lead researcher of the IMPAACT 2023 study, shared her thoughts on this development. She explained that for a long time, newborns with HIV have had very few treatment options designed specifically for their needs, even though starting treatment as soon as possible is critical for their health. She said, ‘With the approval of Tivicay PD, babies born at full term and weighing at least 2 kg can now start dolutegravir-based therapy right after birth. This is a major step forward because early treatment with the most effective medicines leads to the best outcomes for these babies.’<\/p>\n

Without early diagnosis and treatment, HIV can progress very quickly in infants. In fact, about half of untreated infants with HIV do not survive past the age of two. This new approval means more babies will have access to modern, age-appropriate HIV medicines, which is especially important for this vulnerable group.<\/p>\n

Jean van Wyk, the Chief Medical Officer at ViiV Healthcare, emphasized the significance of this approval. He said, ‘Today\u2019s approval of Tivicay PD gives doctors and families in the U.S. more options for treating HIV in children from the very beginning of life.’ He also highlighted that this achievement reflects ViiV Healthcare\u2019s commitment to bringing innovative HIV treatments to children and addressing gaps in care. This progress was made possible through collaboration with the HIV community, which shares a common goal: ensuring that children living with HIV are not overlooked.<\/p>\n

The FDA\u2019s approval of Tivicay PD came after a Priority Review, which means the agency fast-tracked the review process due to the urgent need for this medication. The approval is supported by data from the NIH-funded IMPAACT 2023 study and pharmacokinetic modeling, which showed that dolutegravir\u2014a key ingredient in Tivicay PD\u2014reaches effective levels in full-term newborns and has a safety profile similar to that seen in older children and adults.<\/p>\n","protected":false},"excerpt":{"rendered":"

ViiV Healthcare has received approval from the U.S. Food and Drug Administration (FDA) for a new version of the HIV […]<\/p>\n","protected":false},"author":0,"featured_media":3427,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[543],"tags":[],"class_list":["post-3426","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-news"],"_links":{"self":[{"href":"https:\/\/allesleypharmacy.co.uk\/pharmacy\/wp-json\/wp\/v2\/posts\/3426","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/allesleypharmacy.co.uk\/pharmacy\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/allesleypharmacy.co.uk\/pharmacy\/wp-json\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/allesleypharmacy.co.uk\/pharmacy\/wp-json\/wp\/v2\/comments?post=3426"}],"version-history":[{"count":1,"href":"https:\/\/allesleypharmacy.co.uk\/pharmacy\/wp-json\/wp\/v2\/posts\/3426\/revisions"}],"predecessor-version":[{"id":3435,"href":"https:\/\/allesleypharmacy.co.uk\/pharmacy\/wp-json\/wp\/v2\/posts\/3426\/revisions\/3435"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/allesleypharmacy.co.uk\/pharmacy\/wp-json\/wp\/v2\/media\/3427"}],"wp:attachment":[{"href":"https:\/\/allesleypharmacy.co.uk\/pharmacy\/wp-json\/wp\/v2\/media?parent=3426"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/allesleypharmacy.co.uk\/pharmacy\/wp-json\/wp\/v2\/categories?post=3426"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/allesleypharmacy.co.uk\/pharmacy\/wp-json\/wp\/v2\/tags?post=3426"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}