{"id":54573,"date":"2026-08-28T08:41:10","date_gmt":"2026-08-28T08:41:10","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=54573"},"modified":"2026-08-29T10:20:16","modified_gmt":"2026-08-29T10:20:16","slug":"us-fda-approves-once-daily-oral-bictegravir-lenacapavir-as-simplified-hiv-combination","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/54573","title":{"rendered":"US FDA approves once-daily oral bictegravir\/lenacapavir as simplified HIV combination (Bixlenvo)"},"content":{"rendered":"

Simon Collins, HIV i-Base<\/strong><\/p>\n

\"\"<\/a>

BIC\/LEN – Biktarvy – Triumeq (cms)<\/p><\/div>\n

On 27 August 2026 the US FDA approved a once-daily single tablet regimen (STR) of bictegravir 75 mg\/lenacapavir 50 mg as a simplification option for people currently on complex combinations.<\/strong><\/p>\n

Approval was based on results from the phase 3 ARTISTRY-1 and -2 studies presented at CROI earlier this year and previously reported in HTB. [2]<\/p>\n

BIC\/LEN was developed by Gilead Sciences and is marketed under the trade name Bixlenvo.<\/p>\n

comment<\/h3>\n

This important new STR will safely and effectively offer a new option for people on complex multi-tablet combinations.<\/strong><\/p>\n

Access in Europe though will depend on price.<\/strong><\/p>\n

Although lenacapavir was approved as a treatment for multi-drug resistance, in 2022 in the UK, NHS England took four years to make the drug available. [3]<\/strong><\/p>\n

References<\/p>\n

    \n
  1. US FDA Approves Gilead\u2019s Bixlenvo a New Once-Daily Single Tablet Option for Virologically Suppressed Adults With HIV Including Those on Complex Regimens. (27 August 2026).
    \n    https:\/\/www.gilead.com\/news\/news-details\/2026\/u-s–fda-approves-gileads-bixlenvo-a-new-once-daily-single-tablet-option-for-virologically-suppressed-adults-with-hiv-including-those-on-complex-regimens<\/a><\/li>\n
  2. CROI 2026: Once-daily oral BIC\/LEN simplifies ART for those on complex combinations. HTB (25 February 2026).
    \n    https:\/\/i-base.info\/htb\/53317<\/a><\/li>\n
  3. NHS England finally approves lenacapavir for ART. HTB (28 August 2026),.
    \n    https:\/\/i-base.info\/htb\/54565<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 27 August 2026 the US FDA approved a once-daily single tablet regimen (STR) of bictegravir 75 mg\/lenacapavir 50 mg as a simplification option for people currently on complex combinations. Approval was based on results from …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,38],"tags":[],"class_list":["post-54573","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals","category-treatment-access"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/54573","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=54573"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/54573\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=54573"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=54573"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=54573"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}