{"id":54109,"date":"2026-07-01T09:43:25","date_gmt":"2026-07-01T09:43:25","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=54109"},"modified":"2026-07-01T09:56:58","modified_gmt":"2026-07-01T09:56:58","slug":"updated-us-paediatric-hiv-guidelines-include-dolutegravir-from-birth","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/54109","title":{"rendered":"Updated US paediatric HIV guidelines include dolutegravir from birth"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>On 1 July 2026, the US HHS guidelines released several updates to these important guidelines. [1]<\/strong><\/p>\n<p>Changes to the previous guidelines cover five main sections summarised below are cross-posted from: <a href=\"https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/whats-new\" rel=\"noopener\"><em>clinicalinfo.hiv.gov<\/em><\/a><\/p>\n<p>Changes to the previous edition are highlighted online and in the fill PDF version.<\/p>\n<h2>Preventing HIV Transmission During Infant Feeding<\/h2>\n<p><a href=\"https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/preventing-transmission-infant-feeding\">https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/preventing-transmission-infant-feeding<\/a><\/p>\n<ul>\n<li data-list-item-id=\"ec91d7e51ee79be59e0e609b7703535b2\">If antiretroviral therapy (ART) is taken consistently and the viral load is maintained at a level of &lt;50 copies\/mL (i.e., undetectable viral load) for at least 3 months prior to delivery, the Panels recommend counseling about the options of formula feeding, use of banked donor milk, or breastfeeding.<\/li>\n<li data-list-item-id=\"e39d47ee1811251e6cfaa1203db361116\">The Panel notes there is no evidence that formula supplementation increases the risk of HIV acquisition in the breastfed infant in the context of parental ART and viral suppression.<\/li>\n<li data-list-item-id=\"e60946ee5d5970a6319f8744f96d7286a\">The Panel recommends that women with HIV with mastitis or other unilateral breast pathology stop breastfeeding on the affected breast and feed on the contralateral (or unaffected) breast; when symptoms resolve, women can again feed from both breasts.<\/li>\n<\/ul>\n<h2>Diagnosis of HIV Infection in Infants and Children<\/h2>\n<p><a href=\"https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/diagnosis-hiv-infection-infants-and-children\">https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/diagnosis-hiv-infection-infants-and-children<\/a><\/p>\n<ul>\n<li data-list-item-id=\"e07324dbd1d23c7aab32bb6c7d360c2de\">Non-subtype B HIV-1 is no longer a diagnostic concern. All recommendations and text referencing non-subtype B HIV-1 have been removed.<\/li>\n<li data-list-item-id=\"e2c50bafbd5d89691b2ea03c6f79f26eb\">The Panels revised the recommended timing of virologic diagnostic testing for infants with perinatal HIV exposure who are being breastfed. The last test should be performed 3 months after cessation of breastfeeding.<\/li>\n<li data-list-item-id=\"e5eafb2ea3db8f78da3160d245ef1229e\">The HIV RNA Assays subsection has been updated to include a sensitive HIV-1\/HIV-2 RNA assay that can be used for infant diagnosis.<\/li>\n<li data-list-item-id=\"e0e2cf1f1b5463bf36d2df2ca8d4fbdfc\"><a href=\"https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/diagnosis-hiv-infection-infants-and-children#table-virologic-testing\" rel=\"noopener\">Table 3. Recommended Virologic Testing Schedules for Infants With Perinatal and Breastfeeding Exposure to HIV<\/a> has been simplified and restructured.<\/li>\n<\/ul>\n<h2>What to Start: Antiretroviral Treatment Regimens Recommended for Initial Therapy in Infants and Children With HIV<\/h2>\n<p><a href=\"https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/regimens-recommended-initial-therapy-antiretroviral-naive-children\">https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/regimens-recommended-initial-therapy-antiretroviral-naive-children<\/a><\/p>\n<ul>\n<li data-list-item-id=\"eafd275f6943fcdd8326078af3c0d309c\">The preferred regimen for initial ART in full-term infants from birth to age &lt;30 days and who weigh \u22652 kg is now the second-generation integrase inhibitor dolutegravir (DTG) in combination with a nucleoside reverse transcriptase inhibitor backbone of zidovudine (ZDV) plus either lamivudine (3TC) or emtricitabine (FTC).<\/li>\n<li data-list-item-id=\"e8afddd0f8795c8aaca310df4567edeae\">Studies have established dosing guidelines for DTG pediatric dispersible tablets in neonates.<\/li>\n<li data-list-item-id=\"ea8f1a233c3a5d513abd69a52a074dec3\">The What Not to Start section has been discontinued as a separate document and has been incorporated into this section for brevity and clarity.<\/li>\n<\/ul>\n<h2>Antiretroviral Management of Infants With\u202f<em>In Utero,<\/em>Intrapartum, or Breastfeeding Exposure to HIV<\/h2>\n<p><a href=\"https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/management-infants-utero-intrapartum-breastfeeding-hiv-exposure\">https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/management-infants-utero-intrapartum-breastfeeding-hiv-exposure<\/a><\/p>\n<ul>\n<li data-list-item-id=\"e1239923fc8c194f43e907d4244397077\">Three-drug presumptive treatment for infants with high risk of HIV acquisition now consists of ZDV\/3TC plus nevirapine (NVP) or DTG.<\/li>\n<li data-list-item-id=\"e3df11e5e6d41d831aff5cc92f85e6122\">The Panel recommends performing a birth HIV nucleic acid test in all scenarios except for those in which infants are at low risk for HIV acquisition.<\/li>\n<li data-list-item-id=\"ed8eca1c92bcfd506d8bc896659feb1eb\">The Panel recommends that extended antiretroviral (ARV) prophylaxis during breastfeeding, when used, be continued until either 4 weeks after the last exposure to breast milk or 4 weeks after concerns about maternal virologic suppression have resolved <strong>(BIII).<\/strong> If extended prophylaxis with NVP is planned, it should ideally be initiated from birth, replacing ZDV as the initial prophylaxis; alternatively, extended prophylaxis with 3TC should be initiated after the completion of initial ZDV prophylaxis.<\/li>\n<li data-list-item-id=\"e0d4af5afe2cafb2fccb1ac2ea02b3f7b\">If a maternal HIV RNA level of \u2265200 copies\/mL (viremia) develops or there is presumed viremia (e.g., reports of nonadherence to ARVs) during breastfeeding, the Panels recommend cessation of breastfeeding. If the infant had not been receiving ARV prophylaxis, a three-drug ARV regimen should be given for 4 weeks. If the infant had been receiving ARV prophylaxis with 3TC or NVP, the decision to either continue the single-drug prophylaxis or initiate treatment with a three-drug regimen should be based on maternal RNA level and other factors <strong>(AII).<\/strong><\/li>\n<\/ul>\n<h2>Appendix A: Pediatric Antiretroviral Drug Information<\/h2>\n<p><a href=\"https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/overview-0?view=full\">https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/overview-0?view=full<\/a><\/p>\n<ul>\n<li data-list-item-id=\"e54fc1083330289f9bdc9c1de9939cc18\">Drug sections and fixed-dose combination (FDC) tables\u2014<a href=\"https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/appendix-table-1-antiretrovirals-available-fixed-dose-combination-tablets-full\" rel=\"noopener\">Table 1. Antiretrovirals Available in Fixed-Dose Combination Tablets or as a Co-packaged Formulation, by Drug Class<\/a>\u202fand\u202f<a href=\"https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/appendix-a-table-2-antiretroviral-fixed-dose-combination-tablets-and-copackaged-formulations?view=full\" rel=\"noopener\">Table 2. Antiretroviral Fixed-Dose Combination Tablets and Co-packaged Formulations: Minimum Body Weights and Considerations for Use in Children and Adolescents<\/a>\u2014in this appendix were reviewed and updated to include recent pediatric data, dosing and safety information, and U.S. Food and Drug Administration (FDA) approvals of new formulations and FDCs. Significant changes are summarized below:\n<ul>\n<li data-list-item-id=\"e44a235b114394ba82f84f19e9ff97c79\">The FDA approved use of darunavir (DRV) and cobicistat (COBI) (Prezcobix PED) tablets for oral suspension for children aged \u22653 years and weighing \u226515 kg to &lt;25 kg for use in combination with other ARV drugs (see <a href=\"https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/cobicistat\" rel=\"noopener\">Cobicistat<\/a>).<\/li>\n<li data-list-item-id=\"e0cb217992bdb00daf02921802405ec86\">COBI alone (as Tybost) has been discontinued, and there is no generic standalone tablet formulation of COBI available (see <a href=\"https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/cobicistat\" rel=\"noopener\">Cobicistat<\/a>).<\/li>\n<li data-list-item-id=\"e7dad3ce3399a371c256d8e19c546f6d8\">The Panel supports the use of DTG dispersible tablets (Tivicay PD) in neonates (gestational age \u226537 weeks to age &lt;4 weeks and weighing \u22652 kg) based on available pharmacokinetic (PK) modeling and simulation and clinical trial data; this dosing strategy is not currently approved by the FDA.<\/li>\n<li data-list-item-id=\"e4af6bf038817935c4af9813bb11b67ae\">The Panel supports the use of abacavir (ABC)\/DTG\/3TC (Triumeq PD) dispersible tablets in children aged \u22654 weeks, HLA-B*5701 negative, and weighing \u22653 kg to &lt;25 kg based on available PK modeling and simulation and clinical trial data; this dosing strategy is not currently approved by the FDA.<\/li>\n<\/ul>\n<\/li>\n<li data-list-item-id=\"e67d582455aea6eddc16e2dd5999fa176\">The recent FDA approval of doravirine and islatravir tablets (Idvynso) will be addressed in the next update of the <a href=\"https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/pediatric-arv\/doravirine\" rel=\"noopener\">Doravirine<\/a> section.<\/li>\n<\/ul>\n<h3>comment<\/h3>\n<p><strong>The inclusion of the recommendation to include earlier used of second-generation integrase inhibitors (dolutegravir) is \u00a0notable for comming before the FDA have approved this indication. [2]<\/strong><\/p>\n<p>Reference<\/p>\n<ol>\n<li>Update to the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV. (30 June 2026).<br \/>\n<a href=\"https:\/\/www.hiv.gov\/blog\/update-to-the-guidelines-for-the-use-of-antiretroviral-agents-in-pediatric-hiv-infection-062926\">https:\/\/www.hiv.gov\/blog\/update-to-the-guidelines-for-the-use-of-antiretroviral-agents-in-pediatric-hiv-infection-062926<\/a><\/li>\n<li>FDA and EMA applications to expand dolutegravir indication to newborns from birth. HTB (23 June 2026).<br \/>\n<a href=\"https:\/\/i-base.info\/htb\/54097\">https:\/\/i-base.info\/htb\/54097<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 1 July 2026, the US HHS guidelines released several updates to these important guidelines. [1] Changes to the previous guidelines cover five main sections summarised below are cross-posted from: clinicalinfo.hiv.gov Changes to the previous edition &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[32,23],"tags":[],"class_list":["post-54109","post","type-post","status-publish","format-standard","hentry","category-paediatric-care","category-guidelines"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/54109","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=54109"}],"version-history":[{"count":3,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/54109\/revisions"}],"predecessor-version":[{"id":54112,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/54109\/revisions\/54112"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=54109"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=54109"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=54109"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}