{"id":32214,"date":"2017-08-10T12:18:35","date_gmt":"2017-08-10T12:18:35","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=32214"},"modified":"2017-08-15T08:11:16","modified_gmt":"2017-08-15T08:11:16","slug":"continued-viral-suppression-with-long-acting-cabotegravirrilpivirine-injections-96-week-latte-results","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/32214","title":{"rendered":"Continued viral suppression with long-acting cabotegravir\/rilpivirine injections: 96-week LATTE-2 results"},"content":{"rendered":"

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

Longer follow-up results from using the first coformulated injectable ART were presented from the phase 2b LATTE study.<\/strong> [1]<\/p>\n

Following a lead period that included using oral formulations of cabotegravir and rilpivirine, 286 treatment-naive participants were randomised (2:2:1) to either 8-weekly (8W) or 4-weekly (4W) injections, or to oral cabotegravir plus abacavir\/3TC.<\/p>\n

Approximate baseline characteristics have been previously described and include 92% men, 80% white, CD4 489 cells\/mm3<\/sup> with 18% of participants having viral load >100,000 copies\/mL.<\/p>\n

The 96-week results presented at IAS 2017 maintained high levels of viral suppression to <50 copies\/mL in 94%, 87% and 84% of participants in the 8W, 4W and oral groups respectively. Viral suppression with both injection schedules were non-inferior to oral dosing: 8W: difference +10.0% (95%CI: \u20130.6% to +20.5%) and 4W: +3.0% (95%CI: \u20138.4% to +14.4%). This compared to viral suppression rates at week-48 of 92%, 91% and 89%, respectively. [2]<\/p>\n

Viral non-responses were more frequent in the 8W group (n=5 vs 0 vs 1) with only one case of viral failure in each of the 8W and oral arms.<\/p>\n

Non-virological discontinuations occurred more frequently in the 4W group, with n=2, n=15 and n=8 in the 8W, 4W and oral groups respectively. The discontinuations in the 4W group included five drug-related causes: rash, QT prolongation, tachycardia, depression and psychosis and five non-drug related events.<\/p>\n

Serious adverse events occurred in 10%, 10% and 13% in the 8W, 4W and oral groups respectively, but none were judged drug-related.<\/p>\n

Injection site reactions (ISRs) were common (>80% at day 1 and at ~30 to 40% in injection arms throughout follow-up, occurring slightly more in the 8W group, but 84% overall were mild and 15% were moderate. Most common ISR events were pain (66%), nodules (8%), swelling (6%), and pruritus (6%). Median duration of ISRs was 3 days, with 89% resolving in <7 days. Only two participants (both in the 8W group) discontinued due to ISRs.<\/p>\n

Participant\u00a0satisfaction continued to be highest in the injection arms (99% rating 5\/6 out of 6 to continue on present dosing, compared to 78% with the oral group).<\/p>\n

The 96-week results were also published in the Lancet. [3]<\/p>\n

comment<\/h3>\n

Phase 3 studies are currently ongoing using the 4W schedule selected based on week-48 results and all participants have the option to change to this dose after week 96. <\/strong><\/p>\n

Only one phase 3 study will continue to evaluate 8W dosing.<\/strong><\/p>\n

References:<\/p>\n

    \n
  1. Eron J et al. Safety and efficacy of long-acting CAB and RPV as two drug IM maintenance therapy: LATTE-2 week 96 results. IAS 2017, Paris. Late breaker oral abstract MOAX0205LB.
    \nhttp:\/\/programme.ias2017.org\/Abstract\/Abstract\/5628<\/a><\/li>\n
  2. Margolis D et al. Cabotegravir + rilpivirine as long-acting maintenance therapy: LATTE-2 week 48 results. AIDS 2016, 18-22 July 2016, Durban. Oral late breaker abstract THAB0206LB.
    \n    http:\/\/programme.aids2016.org\/Abstract\/Abstract\/10517<\/a><\/li>\n
  3. Margolis D et al. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial. The Lancet (24 July 2017). http:\/\/dx.doi.org\/10.1016\/S0140-6736(17)31917-7.
    \n    http:\/\/www.thelancet.com\/journals\/lancet\/article\/PIIS0140-6736(17)31917-7\/fulltext<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base Longer follow-up results from using the first coformulated injectable ART were presented from the phase 2b LATTE study. [1] Following a lead period that included using oral formulations of cabotegravir and rilpivirine, 286 treatment-naive participants were …<\/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":[243],"class_list":["post-32214","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-ias-9-paris-2017"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/32214","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=32214"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/32214\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=32214"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=32214"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=32214"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}