{"id":46813,"date":"2023-12-01T07:36:38","date_gmt":"2023-12-01T07:36:38","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=46813"},"modified":"2024-12-29T20:19:19","modified_gmt":"2024-12-29T20:19:19","slug":"switching-to-daily-fixed-dose-doravirine-islatravir-96-week-results","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/46813","title":{"rendered":"EACS 2023: Switching to daily fixed-dose doravirine\/islatravir: 96-week results"},"content":{"rendered":"

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

\"\"EACS 2023 included 96-week results from a phase 3 study that randomised 641 participants with undetectable viral load on current ART to either switch to daily DOR\/ISL (100 mg \/ 0.76 mg) or continue on B\/F\/TAF (Biktarvy). [1]<\/strong><\/p>\n

This was a double-blinded placebo-controlled study for the first 96 weeks and continues for a further 48 weeks using open-label fixed dose combinations.<\/p>\n

Baseline characteristics included mean age 47.8 years (SD: \u00b112.2), 72% male, 75% white.<\/p>\n

At week 96, viral load was <50 copies\/mL in 84.8% vs 90.9% in people taking DOR\/ISL vs B\/F\/TAF (difference \u20136.1% [95% CI \u201311.3 to \u20131.1]). However, when excluding 13 participants from the DOR\/ISL arm due to protocol-defined CD4 decreases >30% (introduced at week 72), results were 88.3% vs 90.9% respectively (difference \u20132.6% [95% CI: \u20137.5 to +2.2]).<\/p>\n

Two participants taking DOR\/ISL had viral failure (confirmed >200 copies\/mL) at roughly 800 and 14,000 copies\/mL, both with no detectable islatravir levels suggesting non-adherence. A single blip to 70 copies\/mL in the B\/F\/TSF arm resuppressed without any changes.<\/p>\n

Mean CD4 count changes were lower with DOR\/ISL vs B\/F\/TAF (+6 vs +60 cells\/mm3<\/sup>).<\/p>\n

Adverse events, including infections, were comparable in each arm. More discontinuations on DOR\/ISL were linked to the decline in CD4 counts.<\/p>\n

Note: these results have since been published in Lancet HIV. [2]<\/p>\n

Reference<\/p>\n

    \n
  1. Paredes R et al. Switch to fixed-dose doravirine\/islatravir (100\/0.75 mg) once daily in adults with HIV-1 virologically suppressed on bictegravir\/emtricitabine\/tenofovir alafenamide: week 96 results of a phase 3, randomized, double-blind, non-inferiority trial. 19th EACS, 18\u201321 October 2023, Warsaw, Poland. Oral presentation PS 1.01.
    \nhttps:\/\/eacs2023.abstractserver.com\/program\/#\/details\/presentations\/396<\/a> (abstract)
    \n    https:\/\/live.allintheloop.net\/Agenda\/EACS\/EACS2023\/greenLiveStream\/444748\/2<\/a> (webcast with login)<\/li>\n
  2. Molina JM et al.Switch to fixed-dose doravirine (100 mg) with islatravir (0\u00b775 mg) once daily in virologically suppressed adults with HIV-1 on antiretroviral therapy: 48-week results of a phase 3, randomised, open-label, non-inferiority trial. The Lancet HIV, Volume 11, Issue 6, e369 – e379.
    \n    https:\/\/www.thelancet.com\/journals\/lanhiv\/article\/PIIS2352-3018(24)00031-6\/abstract<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base EACS 2023 included 96-week results from a phase 3 study that randomised 641 participants with undetectable viral load on current ART to either switch to daily DOR\/ISL (100 mg \/ 0.76 mg) or continue on B\/F\/TAF …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3],"tags":[330],"class_list":["post-46813","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-eacs-19-2023"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/46813","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=46813"}],"version-history":[{"count":14,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/46813\/revisions"}],"predecessor-version":[{"id":49808,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/46813\/revisions\/49808"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=46813"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=46813"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=46813"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}