{"id":36450,"date":"2019-07-24T15:28:22","date_gmt":"2019-07-24T15:28:22","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=36450"},"modified":"2019-07-26T04:12:46","modified_gmt":"2019-07-26T04:12:46","slug":"switching-to-dolutegravir-lamivudine-dual-therapy-is-non-inferior-at-week-48-to-taf-based-triple-thereapy-in-tango-study","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/36450","title":{"rendered":"Switching to dolutegravir\/lamivudine dual therapy is non-inferior to TAF-based triple therapy at week-48 in TANGO study"},"content":{"rendered":"

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

Results from a international phase 3 study using the dual fixed dose combination (FDC) dolutegravir\/lamivudine (DTG\/3TC) as a switch option in treatment experienced participants was presented in a late-breaking oral presentation at IAS 2019.<\/strong><\/p>\n

Although already approved for first-line therapy, the phase 3 TANGO study is the first large randomised study to look at this in treatment-experienced participants.<\/p>\n

This study randomised 741 people (1:1) with viral load <50 copies\/mL for > 6 months on current TAF-based ART to either switch to DTG\/3TC or remain on their current therapy. Entry criteria included not having hepatitis B or prior virologic failure or document major resistance to NRTIs or integrase inhibitors.<\/p>\n

The primary endpoint of this ongoing phase 3, non-inferiority trial \u00a0is viral suppression at week-48, with results stratified by baseline third drug (PI, NNRTI or INSTI), with follow-up out to week 196.<\/p>\n

Approximate baseline characteristics included median (range) age 40 years (18 to 74), which 20% older than 50; 8% were women and 20% were defined as \u201cnon-white\u201d. Baseline median (range) CD4 was about 700 cells\/mm3 (119 to 1904) with 9% having a CD4 count <350 cells\/mm3.<\/p>\n

Most participants were using an integrase inhibitor (79%, mainly elvitegravir), with 14% using an NNRTI (mainly rilpivirine) and 7% were using a boosted PI (mainly boosted darunavir).<\/p>\n

Participants had been on ART for a median (range) of 34 months (range: 7 to 201 months).<\/p>\n

At week 48, 0.3% vs 0.5% (n=1 and 2) participants had viral load >50 copies\/mL in the dual vs triple arms respectively (difference: 0.3: 95%CI: 1.2 to +0.7), meeting criterion for non-inferiority for this primary endpoint, based on 4% margin. The single case in the DTG\/3TC arm was a protocol violation before taking study drugs.<\/p>\n

Results were very similar for secondary endpoint of suppression < 50 copies\/mL: 93% in each arm, again meeting non-inferiority (difference: 0.2; 95%CI: \u20133.4 to +3.9, margin 8%). Also, 6.5% in each group had no data for this time point. See Table 1.<\/p>\n

Adverse events were similar between groups: with 80% reporting any AE, but 12% vs 1% reported drug-related AEs, in the dual vs TDF arms, with 4% (n=13) vs 1% (n=2) discontinuing because of side effects. These were mainly anxiety (n=3), insomnia (n=3), weight gain (n=2) or fatigue (n=2) in the DTG\/3TC arm (all (<1%). Serious AEs (SAEs) were report by 6% (n=21) vs 4% (n=16). The single death in the study \u00a0was due to gunshot wounds and unrelated to HIV treatment.<\/p>\n

Small differences in bone and renal markers, and lipid profiles, were unlikely to have clinical significance but continued follow-up to 96- and 148 weeks will provide information about longer-term results.<\/p>\n

At week 48, similar weight gains were reported for each group (approximately +0.8 kg).<\/p>\n

Table 1: Week 48 study outcome by snapshot analysis<\/strong><\/p>\n\n\n\n\n\n\n\n\n
\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <\/strong><\/td>\nDTG\/3TC
\n(n=369)<\/td>\n		TAF-based ART (n=372)<\/td>\n<\/tr>\n
VL <50 c\/mL, n (5)<\/td>\n344 (93%)<\/td>\n346 (93%)<\/td>\n<\/tr>\n
VL <50 c\/mL, n (5)<\/td>\n1* (0.3%)<\/td>\n\u00a02\u00a0(0.5%)<\/td>\n<\/tr>\n
No VL data<\/td>\n24 (6.5%)<\/td>\n24 (6.5%)<\/td>\n<\/tr>\n
Discontinue (AE or death)<\/td>\n12 (3.3%)<\/td>\n1 (0.3%)<\/td>\n<\/tr>\n
Discontinue other reasons (VL >50 c\/mL<\/td>\n24 (6.5%)<\/td>\n22 (5.9%)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

* Discontinued unrelated to treatment.<\/p>\n

References<\/p>\n

van Wyk J et al. Switching to DTG+3TC fixed dose combination (FDC) is non-inferior to continuing a TAF-based regimen (TBR) in maintaining virologic suppression through 24 weeks (TANGO Study). 10th IAS Conference on HIV Science (IAS 2019), 21-24 July 2019, Mexico City. Late-breaker oral abstract WEAB0403LB.
\nhttp:\/\/programme.ias2019.org\/Abstract\/Abstract\/4903<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Simon Collins, HIV i-Base Results from a international phase 3 study using the dual fixed dose combination (FDC) dolutegravir\/lamivudine (DTG\/3TC) as a switch option in treatment experienced participants was presented in a late-breaking oral presentation at IAS 2019. Although already …<\/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":[273],"class_list":["post-36450","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-ias-10-mexico-city-2019"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36450","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=36450"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/36450\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=36450"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=36450"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=36450"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}