{"id":48337,"date":"2024-08-10T11:10:44","date_gmt":"2024-08-10T11:10:44","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=48337"},"modified":"2024-08-12T17:56:22","modified_gmt":"2024-08-12T17:56:22","slug":"switching-to-daily-oral-bictegravir-and-lenacapavir-dual-therapy-to-simplify-art-in-artistry-1-study","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/48337","title":{"rendered":"Switching to daily oral bictegravir and lenacapavir dual therapy to simplify ART in ARTISTRY-1 study"},"content":{"rendered":"

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

\"\"<\/a><\/strong>Impressive 48-week data were presented from a switch study in 128 highly treatment-experienced people with long treatment histories, common age and HIV-related comorbidities and who were on multiple complex combinations.<\/p>\n

Participants were randomised to a new dual combination of oral bictegravir and lenacapavir compared to continuing on their current ART.<\/p>\n

Participants were randomised 2:2:1 to a new dual combination of oral bictegravir and lenacapavir \u2013 BIC (75 mg) + LEN (25 mg) or BIC (75 mg) + LEN (50 mg) or continued on current ART. [1]<\/p>\n

Results at week 48 were broadly similar to earlier week 24 results presented earlier this year at CROI 2024. [2]<\/p>\n

Baseline characteristics included median age 60 (IQR: 56 to 65) and CD4 count 610 (435 to 766) cells\/mm3<\/sup>. Overall, 19% were women, 64% white, 31% Black and 16% were Hispanic\/Latinx.<\/p>\n

Participants had been on ART for a median 27 years (IQR: 19 to 32), used a median of 6 previous combinations (range 3 to 11), and 52%, 64% and 35% had previous resistance to NNRTIs, NRTIs and PIs respectively. Current ART included a median of 3 (range: 2 to 9) daily pills.<\/p>\n

Common comorbidities included dyslipidemia 75%, diabetes mellitus 68%, hypertension (60%) and chronic kidney disease (22%).<\/p>\n

Viral efficacy, CD4 responses and tolerability were similar and not statistically different between the three arms including between those using 25 mg and 50 mg lenacapavir.<\/p>\n

Although viral efficacy <50 copies\/mL was 93% vs 90% vs 100% in the 25 mg, 50 mg and control arms respectively, this was due to 4 participants in the 25 mg arm and 5 in the 50 mg arm with no data, largely due to leaving the study early for reasons other than viral failure, when viral load was <50 copies\/mL. None of the 7 serious events were related to treatment.<\/p>\n

This study rolls over into a larger phase 3 study using fixed-dose BIC\/LEN using the 50 mg dose. [3]<\/p>\n

References<\/p>\n

    \n
  1. Segal-Maurer S et al. Efficacy and safety of bictegravir plus lenacapavir: 48-week outcomes in virologically suppressed people with HIV-1 on complex antiretroviral regimens at baseline. AIDS 2024, 22\u201326 July 2024, Munich. Oral abstract OAB2602.
    \n<\/span>    https:\/\/programme.aids2024.org\/Abstract\/Abstract\/?abstractid=1<\/a> (abstract)
    \n<\/span>    https:\/\/presentations.gilead.com\/item\/5717531250<\/a> (slides)<\/span><\/li>\n
  2. Mounzer K, Slim J, Ramgopal M, et al. Phase 2 study of switch to daily BIC + LEN in individuals on a complex HIV treatment regimen. CROI 2024, Denver.
    \n<\/span>    https:\/\/www.croiconference.org\/abstract\/phase-ii-study-of-switch-to-daily-bic-len-in-individuals-on-a-multitablet-hiv-treatment-regimen\/<\/a> (abstract)
    \n    https:\/\/www.croiconference.org\/wp-content\/uploads\/sites\/2\/posters\/2024\/642.pdf<\/a> (poster)<\/span><\/li>\n
  3. clinicaltrials.gov. Study to compare bictegravir\/\u200blenacapavir versus current therapy in people with HIV-1 who are successfully treated with a complicated regimen (ARTISTRY-1).
    \n<\/span>    https:\/\/clinicaltrials.gov\/study\/NCT05502341<\/span><\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base Impressive 48-week data were presented from a switch study in 128 highly treatment-experienced people with long treatment histories, common age and HIV-related comorbidities and who were on multiple complex combinations. Participants were randomised to a new …<\/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":[335],"class_list":["post-48337","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-aids-25th-munich-2024"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/48337","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=48337"}],"version-history":[{"count":9,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/48337\/revisions"}],"predecessor-version":[{"id":48405,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/48337\/revisions\/48405"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=48337"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=48337"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=48337"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}