{"id":49517,"date":"2024-11-21T22:47:44","date_gmt":"2024-11-21T22:47:44","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=49517"},"modified":"2024-12-29T18:33:54","modified_gmt":"2024-12-29T18:33:54","slug":"glasgow-2024-dolutegravir-lamivudine-vs-triple-art-in-advanced-hiv-infection","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/49517","title":{"rendered":"Dolutegravir\/lamivudine vs triple ART have similar efficacy in advanced HIV infection with CD4 <200 and viral load >100,000"},"content":{"rendered":"

\"A<\/strong><\/p>\n

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

The dual combination of dolutegravir\/lamivudine is already included as one of the four recommended as first-line ART in UK guidelines. <\/strong><\/p>\n

This is based on several randomised studies (including GEMINI) showing similar efficacy to triple combinations based on second-generation integrase inhibitors.<\/strong><\/p>\n

However, current UK guidelines do not recommend dolutegravir\/lamividine if baseline CD4 and viral load are <200 cells\/mm3<\/sup> or higher than 500,000 copies\/mL.<\/strong><\/p>\n

An oral presentation at HIV Glasgow 2024 added further data supporting similar efficacy and safety results to triple therapy in participants with advanced HIV and CD4 counts <200 cells\/mm3<\/sup>, irrespective of baseline CD4 and viral load.<\/p>\n

Week 48 results from the open-label DOLCE study in 230 treatment-naive participants in Brazil and Argentina with advanced HIV were presented by Pedro Cahn from Fundacion Huesped, Buenos Aires.<\/p>\n

Participants were randomised 2:1 to DTG\/3TC (single pill) or DTG + TDF\/XTC (two pills) and results were stratified by baseline viral load >100,000 copies\/mL.<\/p>\n

Baseline characteristics included median CD4 count and viral load of 116 cells\/mm3<\/sup> (IQR: 53 to 188) and 151,000 copies\/mL (IQR: 49,027\u2013446,947), respectively. Notably, 22% (n=35) had baseline viral load >500,000 and 10% (n=16) were >1 million copies\/mL.<\/p>\n

Median age was 35 years (IQR: 28 to 47), 77% male\/23% female, and just under half were gay and bisexual men. Approximately 17% were Black, 8% Indigenous South American, 43% Spanish\/Latino and 34% white.<\/p>\n

At week 48, the primary analysis of viral load <50 copies\/mL by ITT analysis was 82% (125\/152) vs 80% (62\/77), in the dual vs triple ART arms, adjusted difference: 2% (95% CI \u22128.7 to +12.8%). These results suggested non-inferiority in an exploratory post-hoc analysis (p=0.016), but were not presented as a formal conclusion.<\/p>\n

Times taken to become undetectable were also superimposable.<\/p>\n

Similar responses were reported in participants with baseline viral load ><\/em>100,000 copies\/mL: 80% vs 76%, adj. difference 5.1% (95% CI: \u221210.1 to +20.3%). Overall suppression rates were lower in participants with the highest baseline levels: 72% when >500,000 and 61% when >1 million \u2013 although these were reported as being close to <50 copies\/mL.<\/p>\n

Protocol defined failures (7% vs 8%, with median viral load at 144 copies\/mL) and missing data (11% vs 12%) were also similar. No resistance was detected in the 11 participants with protocol defined failure.<\/p>\n

CD4 count increases were +200 vs +177 cells\/mm3<\/sup> in the dual vs triple ART arms, respectively, also superimposable.<\/p>\n

IRIS was reported in 10 participants: 6\/153 (3.9%) vs 4\/77 (5.2%) and severe adverse events (n=27) were reported in 17\/153 (11.1%) vs 10\/77 (12.9%) participants, both in the dual vs triple ART arms respectively.<\/p>\n

References<\/p>\n

Cahn P et al. Comparable efficacy and safety of dolutegravir\/lamivudine to a three-drug regimen amongst ARV naive people living with HIV with CD4 <200\/mm3<\/sup>: the DOLCE study. HIV Glasgow 2024, 10\u201313 November 2024. Oral abstract O24.
\nhttps:\/\/onlinelibrary.wiley.com\/toc\/17582652\/2024\/27\/S6<\/a> (abstract book)
\nhttps:\/\/virtual.hivglasgow.org\/programme\/antiretroviral-treatment-strategies<\/a> (webcast)<\/p>\n","protected":false},"excerpt":{"rendered":"

Simon Collins, HIV i-Base The dual combination of dolutegravir\/lamivudine is already included as one of the four recommended as first-line ART in UK guidelines. This is based on several randomised studies (including GEMINI) showing similar efficacy to triple combinations based …<\/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":[337],"class_list":["post-49517","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-hiv-17-glasgow-2024"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/49517","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=49517"}],"version-history":[{"count":23,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/49517\/revisions"}],"predecessor-version":[{"id":49792,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/49517\/revisions\/49792"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=49517"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=49517"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=49517"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}