{"id":43042,"date":"2022-06-01T06:43:48","date_gmt":"2022-06-01T06:43:48","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=43042"},"modified":"2022-09-12T07:23:35","modified_gmt":"2022-09-12T07:23:35","slug":"croi-2022-switching-to-dolutegravir-for-adults-on-stable-pi-based-second-line-art","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/43042","title":{"rendered":"CROI 2022: Switching to dolutegravir for adults on stable PI-based second-line ART"},"content":{"rendered":"

Polly Clayden, HIV i-Base<\/strong><\/p>\n

\"CROISwitching from a boosted protease inhibitor to dolutegravir appears safe and effective for HIV treatment-experienced adults with undetectable viral load and no previous exposure to integrase inhibitors.<\/strong><\/p>\n

This is based on findings from the Second-line Switch to DTG (2SD) study presented at CROI 2022. <\/strong><\/p>\n

This study is an open-label, randomised, controlled, non-inferiority trial, conducted at four sites in Kenya. Eligible participants were 18 years of age and above, virally suppressed for at least 12 weeks before enrolment and on a second-line regimen of a ritonavir-boosted protease inhibitor (PI\/r) plus two nucleoside reverse transcriptase inhibitors (NRTIs) for at least 24 weeks, and with no previous integrase inhibitor exposure.<\/p>\n

Participants were randomised (1:1) to switch to DTG or continue on their PI\/r. Both arms remained on their NRTIs. The primary endpoint was proportion of participants with viral load above 50 copies\/mL at week 48 (intention-to-treat-exposed [ITT-E] population; non-inferiority margin of 4%).<\/p>\n

Between February and September 2020, 795 participants were randomised and 791 were treated and included in the analysis: 397 in the DTG arm and 394 in the PI\/r arm. All were black African and a median of 46 years of age, 524 (66%) were women. They had been on a PI\/r for about five and a half years \u2013 the majority (approximately 80%) received boosted atazanavir. Baseline characteristics were similar in both arms. Participants were not assessed for prior resistance.<\/p>\n

At week 48, the proportion with viral load above 50 copies\/mL was 5.0% (20\/397) and 5.1% (20\/394) in the DTG and PI\/r arms, respectively: difference \u20130.04% (95% CI: \u20133.09 to +3.02). This met the study non-inferiority criteria.<\/p>\n

No participants with virological failure had detectable genotypic resistance to either DTG or PI\/r.<\/p>\n

Treatment-related adverse events (AE) occurred in 92 (23.2%) participants on DTG and 78 (19.8%) participants on PI\/r. Grade 3 or 4 AEs were similar (5.8% vs 6.9% for DTG vs PI\/r), with no treatment-related serious AEs in either arm. One (0.3%) in the DTG and 3 (0.8%) in the\u00a0 PI\/r arm discontinued study drug for any AE. There were no significant differences between arms in any AE comparisons.<\/p>\n

There was greater weight gain in the DTG vs PI\/r arm: 2.1 vs 1.3% change from baseline (p=0.02).<\/p>\n

comment<\/h3>\n

Switching people who are virally suppressed from PI\/r-based second-line to DTG has not previously been investigated.<\/strong><\/p>\n

The shortcomings of PI\/r-containing regimens (particularly for low- and middle-income countries) have been well-documented: high pill-burden, tolerability, toxicity, drug interactions (including with TB treatment) and cost.<\/strong><\/p>\n

So these results are welcome and might offer a useful option \u2013 even without knowledge of prior resistance.<\/strong><\/p>\n

No data was presented comparing NRTI backbones and just over half of the participants received tenofovir and 3TC in this cohort.<\/strong><\/p>\n

Reference<\/p>\n

Ombajo L et al. A randomized trial of switching treatment-experienced adults from PI\/r to DTG. CROI 2022. 12\u201316 February. Virtual. Oral abstract 136.
\nhttps:\/\/www.croiconference.org\/abstract\/a-randomized-trial-of-switching-treatment-experienced-adults-from-pi-r-to-dtg\/<\/a> (abstract)
\nhttp:\/\/www.croiwebcasts.org\/p\/2022croi\/croi\/136<\/a> (webcast)<\/p>\n\n","protected":false},"excerpt":{"rendered":"

Polly Clayden, HIV i-Base Switching from a boosted protease inhibitor to dolutegravir appears safe and effective for HIV treatment-experienced adults with undetectable viral load and no previous exposure to integrase inhibitors. This is based on findings from the Second-line Switch …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,41],"tags":[318],"class_list":["post-43042","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-treatment-strategies","tag-croi-2022"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/43042","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=43042"}],"version-history":[{"count":1,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/43042\/revisions"}],"predecessor-version":[{"id":44032,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/43042\/revisions\/44032"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=43042"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=43042"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=43042"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}