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Simon Collins, HIV i-Base<\/strong><\/p>\n Results from the first proof-of-principle for injection only antiretroviral treatment (ART) was presented as an oral late breaker by David Margolis from ViiV Healthcare.<\/strong><\/p>\n This phase 2 study required an induction period using oral drugs and compared monthly and two-monthly intramuscular injections to a control group that remained on oral drugs throughout.<\/p>\n The was an open-label phase 2b study in 301 treatment-naive participants, randomised 2:2:1 to 4-weekly (4W) or 8-weekly (8W) injections or to oral ART (cabotegravir plus abacavir\/3TC).<\/p>\n The 20-week induction phase used cabotegravir (30 mg once-daily) plus abacavir\/3TC once-daily, adding in oral rilpivirine (25 mg once-daily) for the last four weeks. After induction, 91% (n=286) of participants continued into the randomised phase because their viral load was <50 copies\/mL. The primary analysis at week 32 of the main study (ie starting after the induction period) was presented at CROI 2016 earlier this year – and these data were used to select the 4-weekly dose for phase 3 studies. [2]<\/p>\n At week 32, viral suppression to <50 copies\/mL was achieved in 94%, 95% and 91% of the 4W, 8W and oral arms respectively, which met pre-specified criteria for showing each intramuscular injection (IM) arm was not worse than the oral treatment group. Virologic non-response rates were slightly lower in the 4W arm (<1% v 4% in the other arms) with lower non-virologic reasons for discontinuation in the 8W arm (vs 5% in each of the other two arms).<\/p>\n By week 48, the percentage with <50 copies\/mL dropped slightly to 91%, 92% and 89% of the 4W, 8W and oral arms respectively. Virologic non-response was greater in the 8W vs 4W arms (7% vs <1%) but this lead to few discontinuations (<1% vs 0). Discontinuations due to side effects or death was lower in the 8W group (0 vs 5%).<\/p>\n Tolerability at 48 weeks – mainly linked to injection site reactions (ISRs) – was similar to the 32 week results. Slightly higher rates of ISRs in the 8W group levels out to approximately 30% of participants by week 48. Of these, 82% were mild and 17% were moderate: 90% resolved within 7 days. The most common symptoms were pain (67%, nodules (7%) and swelling (6%). Only 2\/230 participants (<1%) discontinued due to ISRs.<\/p>\n Other side effects generally occurred at low levels and were similar between injection groups: fever 5% vs 3% vs 0; fatigue 4% vs 2% vs 1%; flu-like symptoms 2% vs 3% vs 0; in the 4W, 8W and oral arms respectively, with headache reported by 2% in all arms.<\/p>\n Virological failure only occurred in two people in the 8W arm and 1 person in the oral group. Mutations associated with drug resistance to integrase inhibitors (Q148R) were only reported in one person in the 8W group.<\/p>\n In a patient survey, participants reported higher rates of satisfaction with injections compared to oral drugs and higher preference for continuing with current combination.<\/p>\n Even with the potential obstacles and disadvantages of intramuscular injections with very long half-lives, the option to not take daily pills has always been seen as exciting by many people – even now once-daily single pill formulations are available.<\/strong><\/p>\n Injectable long-acting ART is steadily getting closer, with phase 3 studies now planned using 4-weekly injections.<\/strong><\/p>\n Long-acting cabotegravir injections are also being studied at PrEP in a phase2b\/3 study in HIV negative men and transgender women, compared to a control arm of daily oral tenofovir\/FTC. <\/strong>[3]<\/p>\n A poster at AIDS 2016 from a phase 2 study of cabotegravir LA PrEP reported preference over daily oral PrEP.<\/strong> [4]<\/p>\n References:<\/p>\n Simon Collins, HIV i-Base Results from the first proof-of-principle for injection only antiretroviral treatment (ART) was presented as an oral late breaker by David Margolis from ViiV Healthcare. This phase 2 study required an induction period using oral drugs and …<\/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-30384","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\/30384","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=30384"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/30384\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=30384"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=30384"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=30384"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Comment<\/h3>\n
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\nhttp:\/\/programme.aids2016.org\/Abstract\/Abstract\/10517<\/a>\u00a0(Abstract)
\nhttp:\/\/www.natap.org\/2016\/IAC\/IAC_48.htm<\/a>\u00a0(Slides online thanks to natap.org)<\/li>\n
\nhttp:\/\/www.croiconference.org\/sessions\/cabotegravirrilpivirine-long-acting-maintenance-therapy-latte-2-week-32-results<\/a>\u00a0(Abstract)
\nhttp:\/\/www.croiwebcasts.org\/console\/player\/29459<\/a>\u00a0(Webcast)<\/li>\n
\nhttps:\/\/clinicaltrials.gov\/ct2\/show\/NCT02720094<\/a><\/li>\n
\nhttp:\/\/programme.aids2016.org\/Abstract\/Abstract\/5405<\/a>\u00a0(Abstract)
\nhttp:\/\/programme.aids2016.org\/PAGMaterial\/eposters\/0_5405.pdf<\/a>\u00a0(Poster PDF)<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"