{"id":44427,"date":"2022-12-01T07:44:01","date_gmt":"2022-12-01T07:44:01","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=44427"},"modified":"2022-12-21T09:31:06","modified_gmt":"2022-12-21T09:31:06","slug":"glasgow-2022-islatravir-studies-to-use-0-25-mg-daily-dose-to-overcome-risk-of-reducing-cd4-and-total-lymphocytes-2","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/44427","title":{"rendered":"Glasgow 2022: Impact of islatravir on lymphocyte counts in a dose-ranging study: a post-hoc analysis"},"content":{"rendered":"
Kirk Taylor, HIV i-Base<\/strong><\/div>\n
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\"\"<\/span><\/strong>HIV Glasgow included a late-breaking post-hoc analysis of islatravir (ISL) dose-ranging studies (0.25 mg, 0.75 mg and 2.25 mg) that led to most clinical studies being stopped last December due to safety concerns over a decline of CD4 counts. [1, 2]<\/b><\/p>\n<\/div>\n

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Total lymphocyte, CD4 and B cell counts were reduced by the greatest extent at the highest dose of ISL (2.25 mg). A 3-fold dose reduction from 2.25 to 0.75 mg improved cell counts. Changes in total lymphocyte and CD4 cell counts were comparable for 0.25 mg ISL and standard ART.<\/p>\n<\/div>\n

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Other haematological parameters (haemoglobin, platelets, and neutrophils) were not affected.<\/p>\n<\/div>\n

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Post-hoc analysis was performed for protocol 11, which included participants that received either ISL (0.25, 0.75 or 2.25 mg) plus DOR\/3TC or DOR\/3TC\/TDF. ISL was standardised to 0.75 mg at week 60, and all participants were switched to ISL\/DOR (0.75\/100 mg) at week 144 and followed for a year.<\/p>\n<\/div>\n

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At week 72, total lymphocytes counts were +20.5%, \u20130.4% and \u201315.9% compared to baseline for 0.25, 0.75 and 2.25 mg ISL, respectively. CD4 counts changed by +24.0% (2.25 mg ISL), +47.1% (0.75 mg ISL), +79.8% (0.25 mg ISL) and 60.1% (DOR\/3TC\/TDF).<\/p>\n<\/div>\n

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A 3-fold reduction of ISL from 2.25 mg to 0.75 mg increased lymphocyte (21.2%) and CD4 (28%) counts. Conversely, a 3-fold increase of ISL (0.25 mg to 0.75 mg) led to reduced lymphocyte (10.8%) and CD4 (1.8%) counts.<\/p>\n<\/div>\n

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Adverse events relating to other infections were common across all arms of the study with prevalence rates of 71% (DOR\/3TC\/TDF), 58.1% (2.25 mg ISL), 73.3% (0.75 mg ISL) and 65.5% (0.25 mg ISL).<\/p>\n<\/div>\n

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There were two AIDS-defining events that were not linked to ISL.<\/p>\n<\/div>\n

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References<\/span><\/p>\n<\/div>\n

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  1. Correll T et al. Total lymphocyte and lymphocyte subset changes in participants receiving islatravir (0.25, 0.75 and 2.25mg QD) and doravirine (DOR) +\/- lamivudine (3TC): post-hoc analysis from a phase 2b dose-ranging study (P011). Oral 46. HIV Glasgow, 23 to 26 October 2022.
    \n<\/span>https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jia2.26009<\/a> (abstract)
    \n<\/span>    https:\/\/virtual.hivglasgow.org\/programme\/late-breakers-hot-topics<\/a> (webcast)<\/li>\n
  2. Collins S. FDA further limit use of islatravir in ongoing studies. HTB (20December 2021).
    \n    https:\/\/i-base.info\/htb\/41866<\/a><\/li>\n<\/ol>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    Kirk Taylor, HIV i-Base HIV Glasgow included a late-breaking post-hoc analysis of islatravir (ISL) dose-ranging studies (0.25 mg, 0.75 mg and 2.25 mg) that led to most clinical studies being stopped last December due to safety concerns over a decline …<\/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":[],"class_list":["post-44427","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/44427","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=44427"}],"version-history":[{"count":2,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/44427\/revisions"}],"predecessor-version":[{"id":44611,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/44427\/revisions\/44611"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=44427"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=44427"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=44427"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}