![\"15th](\"https:\/\/i-base.info\/simoncollins\/wp-content\/uploads\/2015\/10\/15th-EACS-graphic.png\")
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Simon Collins, HIV i-Base<\/strong><\/p>\n EACS 2105 also included studies of dolutegravir-based dual therapy.<\/strong><\/p>\n Early results were presented from an ongoing pilot study using dolutegravir plus lamivudine (3TC) as first-line ART. Participants became undetectable within four weeks and remained suppressed for six months. [1]<\/p>\n These early results from a pre-planned analysis of a secondary endpoint were presented at EACS 2015 by Pedro Cahn from Fundacion HUESPED, Buenos Aires.<\/p>\n This was a single arm, open label study in 20 HIV positive treatment-naive adults. Entry criteria included CD4 count >200 cells\/mm3 and viral load <100,000 copies\/mL and being HB(s)Ag negative. Dolutegravir (50 mg) and 3TC (300 mg) were taken together, once daily.<\/p>\n Given the preliminary nature of this strategy, the study was carefully designed to ensure that intensive viral monitoring would detect any early signal of sub-optimal therapy.<\/p>\n Viral load was monitored at baseline, at days 2, 4, 7, 19 and 14 and then at weeks 4, 8, 12 and 24. The primary endpoint was viral suppression <50 copies\/mL at week 48 (by FDA snapshot ITT analysis). Enrolment was in two stages, dependent on successful viral outcomes at week 8 for the first ten participants, with predetermined discontinuation rules for the study based on suboptimal viral responses.<\/p>\n Median (IQR) approximate baseline characteristics of the 19 men and one woman included age 34 years (IQR: 31 to 43), CD4 count 507 cells\/mm3 (IQR: 296 to 517) and viral load 24,000 copies\/mL (IQR: 12,000 to 37,000).<\/p>\n By day 14, mean (+\/ SD) viral load dropped by 2.54 log\/copies\/mL (+\/\u2013 0.27).<\/p>\n All participants had viral load <50 copies\/mL by week 12 that was sustained to week 24.<\/p>\n Although the entry criteria excluded high baseline viral load, four participants had viral load increases to >100,000 copies\/mL (range 105,000 to 273,000) between screening and baseline. Although these four people took slightly longer to suppress viral load, 3\/4 reached <50 copies by week 4 and the fourth by week 8.<\/p>\n CD4 changes were reported as mean increase of 194 cells\/mm3 (+\/\u2013 160) by week 12 that remained stable out to week 24.<\/p>\n The only side effects were generally mild with single reports of somnolence, epigastric pain, headache, diarrhoea and nausea (all grade 1) and one report of grade 2 headache. There were no serious side effects or grade 3\/4 laboratory abnormalities.<\/p>\n Planned follow up will continue until week 96.<\/p>\n The inclusion of 20% people during likely primary infection (in this otherwise very well-designed study) could perhaps have been detected with exposure risk history, with or without symptoms.\u00a0<\/b><\/p>\n However, in a question after the presentation, the results from the four cases >100,000 copies\/mL were used to suggest that future studies might not require an upper viral load exclusion criteria.<\/b><\/p>\n Clearly these results need to be confirmed in larger randomised studies, several of which are either ongoing or due to start shortly. <\/b>[2, 3, 4, 5]<\/p>\n Several switch studies in treatment-experienced participants were also presented at EACS with similar virological results\u00a0 using dolutegravir as monotherapy. <\/b>[6, 7]<\/p>\n The low toxicity and cost of 3TC has also been used in dual therapy to overcome the lower rates of virological efficacy from studies of boosted-PI monotherapy. The 96-week results of the GARDEL study showed that dual therapy with lopinavir\/r plus 3TC was non-inferior to lopinavir\/r plus two NRTIs were also reported by Pedro Cahn at EACS 2015. <\/b>[8]<\/p>\n The data supporting safety for a French study switching people to maintenance therapy with only tenofovir DF\/FTC is unclear given the history of early dual-NRTI being suboptimal treatment<\/b>.<\/strong> [9]<\/p>\n References:<\/p>\n Unless stated otherwise, references are to the programme and abstracts of the 15th European AIDS Conference (EACS), 21-24 October 2015, Barcelona.<\/p>\n http:\/\/www.professionalabstracts.com\/eacs2015\/iplanner<\/a><\/p>\n Simon Collins, HIV i-Base EACS 2105 also included studies of dolutegravir-based dual therapy. Early results were presented from an ongoing pilot study using dolutegravir plus lamivudine (3TC) as first-line ART. Participants became undetectable within four weeks and remained suppressed for …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3,41],"tags":[213],"class_list":["post-29212","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","category-treatment-strategies","tag-eacs-15-barcelona-2015"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/29212","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=29212"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/29212\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=29212"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=29212"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=29212"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Comment<\/h3>\n
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\nhttps:\/\/clinicaltrials.gov\/ct2\/show\/NCT02491242<\/a><\/li>\n
\nhttps:\/\/clinicaltrials.gov\/ct2\/show\/NCT02582684<\/a><\/li>\n
\nhttps:\/\/clinicaltrials.gov\/ct2\/show\/NCT02527096<\/a><\/li>\n
\nhttps:\/\/clinicaltrials.gov\/ct2\/show\/NCT02263326<\/a><\/li>\n
\nhttps:\/\/clinicaltrials.gov\/ct2\/show\/NCT02302547<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"