![\"AIDS](\"https:\/\/i-base.info\/htb\/wp-content\/uploads\/2016\/07\/AIDS-2016-combined-logo-211x300.png\"){kind=logo}
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Simon Collins, HIV i-Base<\/strong><\/p>\n After many years of research, Merck now have a once-daily formulation of raltegravir – though it requires two tablets and a higher milligram daily dose.<\/strong><\/p>\n In addition to developing the new raltegravir formulation, non-inferiority needed to be shown in a randomised, double-blind placebo controlled phase 3 study, rather than relying on pharmacokinetic bioequivalence studies. The original raltegravir 400 mg twice-daily version was compared to the new 2 x 600 mg once-daily formulation, with background NRTIs tenofovir DF + FTC for all participants.<\/p>\n Results of this study were presented as a late-breaker oral abstract at AIDS 2016 by Pedro Cahn from Fundaci\u00f3n Huesped, Buenos Aires.<\/p>\n Of the 802 participants randomised 2:1 to the once- vs twice-daily formulations, 797 received study drug and 732 (92%) completed follow-up to week 48.<\/p>\n Baseline characteristics overall included a study population that was 85% male, 59% white and mean age 36. Mean CD4 and viral load were 415 cells\/mm3<\/sup> and 4.6 log copies\/mL respectively, with 28% having viral load >100,000 copies\/mL.<\/p>\n At the primary endpoint at week 48, viral suppression to <40 copies\/mL was reported by 88% of each arm with no significant differences related to efficacy or tolerability between arms. The once-daily formulation has slightly fewer serious side effects (5.8% vs 9.4%; difference \u20133.6% [95%CI: \u20138.0 to +0.2]) and discontinuations due to side effects (0.8% vs 2.3%; difference \u20131.5 [95%CI: \u20134.1 to + 0.1]), though neither difference was statistically significant.<\/p>\n Viral failure during the study (defined as non-suppression by week 24 or more than one consecutive blip >40 copies\/mL) was reported in 7% of each group. Of these, approximately half resuppressed by week 48 without changing treatment: 20\/26 vs 8\/18 in the once-vs twice-daily arms groups respectively.<\/p>\n Of the 5\/14 with drug resistance in the once-daily arm, 4\/5 (0.9%) had resistance to raltegravir. Of the three people tested in the twice-daily arm, 2\/3 had no resistance and 1\/3 failed testing.<\/p>\n The study will continue until week 96 for secondary endpoint analyses.<\/p>\n Although raltegravir was the first integrase inhibitor to be approved – the results of more than a decade of commitment to this new class – the higher price compared to existing combinations meant that many people who could have benefitted were not able to access this drug.<\/strong><\/p>\n As newer integrase inhibitors became available, the twice-daily formulation meant that even after lowering the price, raltegravir had a limited market.<\/strong><\/p>\n In the meantime, some doctors reported switching the twice-daily 400 mg formulation to 800 mg once-daily after viral load was suppressed to <50 copies\/mL. While these reports were largely positive this off-label use had limited uptake.<\/strong><\/p>\n Reference<\/p>\n Cahn P et al. Raltegravir (RAL) 1200 mg once daily (QD) is non-inferior to RAL 400 mg twice daily (BID), in combination with tenofovir\/emtricitabine, in treatment-na\u00efve HIV-1-infected subjects: week 48 results. AIDS 2016, 18-22 July 2016, Durban. Oral late breaker abstract FRAB0103LB. Simon Collins, HIV i-Base After many years of research, Merck now have a once-daily formulation of raltegravir – though it requires two tablets and a higher milligram daily dose. In addition to developing the new raltegravir formulation, non-inferiority needed to …<\/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":[224],"class_list":["post-30382","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-aids-21st-2016-durban"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/30382","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=30382"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/30382\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=30382"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=30382"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=30382"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Comment<\/h3>\n
\nhttp:\/\/programme.aids2016.org\/Abstract\/Abstract\/10312<\/a>\u00a0(Abstract)
\nhttp:\/\/www.natap.org\/2016\/IAC\/IAC_91.htm<\/a>\u00a0(Slides online thanks to natap.org)<\/p>\n","protected":false},"excerpt":{"rendered":"