{"id":41599,"date":"2021-11-30T07:37:54","date_gmt":"2021-11-30T07:37:54","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=41599"},"modified":"2021-12-03T15:04:43","modified_gmt":"2021-12-03T15:04:43","slug":"islatravir-plus-doravirine-dual-art-144-week-follow-up-from-phase-2-study","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/41599","title":{"rendered":"Islatravir plus doravirine dual ART: 144 week follow-up from phase 2 study"},"content":{"rendered":"
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\"\"Simon Collins, HIV i-Base<\/strong><\/p>\n<\/div>\n

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Extended results from the early phase 2 study daily oral islatravir plus doravirine were presented at EACS 2021 in an oral presentation. This dual combination is already in phase 3 development. [1]<\/span><\/strong><\/p>\n<\/div>\n

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This was initially a randomised dose-finding study in 120 treatment naive participants with 30 people in each of the <\/span>0.25, 0.75, and 2.25 mg groups (used with 3TC\/TDF) and a control arm of doravirine\/3TC\/TDF.<\/span><\/p>\n<\/div>\n

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Several efficacy and safety results at 96-week were presented at Glasgow 2020, CROI 2021 and IAS 2021 and generally were similar at 144 weeks (when participants had received 60-84 weeks on dual islatravir + doravirine). <\/span><\/p>\n<\/div>\n

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By snapshot analysis, 72% (65\/90) of the combined islatravir participants had viral suppression <50 copies\/mL, with 83% (25\/30) in the original dose-selected 75 mg islatravir arm, compared to 77% (24\/30) in the control arm.<\/span><\/p>\n<\/div>\n

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Viral failure was rare, with viral load >50 copies\/mL in 7 vs 1 participants in the combined vs control arms. Approximately 20% in each group (18\/90 vs 6\/30) had missing data at week 144, with most of those in the islatravir arms not related to study drug.<\/span><\/p>\n<\/div>\n

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Of the 7 who discontinued with protocol defined viral failure (confirmed VL >50 copies\/mL), all had viral load < 80 copies\/mL. Of these 5\/7 had baseline viral load >100,000 copies\/mL. There was only one non-responder (in the higher dose islatravir arm).<\/span><\/p>\n

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comment<\/h3>\n
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A recent safety analysis of ongoing islatravir studies has reported reductions in mean total lymphocyte counts (and sometimes CD4 counts), although these are still within normal ranges. <\/span><\/strong><\/p>\n<\/div>\n

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Limited details are available, but this also included PrEP studies using islatravir monotherapy in HIV negative people. [2]<\/span><\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n

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

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  1. Molina J-M. Efficacy and safety of islatravir in combination with doravirine through 144 weeks for treatment-na\u00efve adults with HIV-1 infection in a phase 2b trial. EACS 2021, oral abstract session, 28 October 2021, 3-4 pm. Oral abstract OS1\/5.
    \n<\/span>https:\/\/eacs2021.abstractserver.com\/program\/#\/details\/presentations\/410<\/a> (abstract)<\/li>\n
  2. MSD\/Merck stop once-weekly NNRTI MK-8507: islatravir studies continue with closer monitoring. HTB (19 November 2021).
    \n    https:\/\/i-base.info\/htb\/41647<\/a><\/li>\n<\/ol>\n

    This report was first posted on 14 November 2021. It was updated on 26 November to include the comments.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base Extended results from the early phase 2 study daily oral islatravir plus doravirine were presented at EACS 2021 in an oral presentation. This dual combination is already in phase 3 development. [1] This was initially a …<\/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":[315],"class_list":["post-41599","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-eacs-18th-2021"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/41599","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=41599"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/41599\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=41599"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=41599"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=41599"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}