{"id":33755,"date":"2018-03-30T11:40:20","date_gmt":"2018-03-30T11:40:20","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=33755"},"modified":"2018-11-02T16:11:13","modified_gmt":"2018-11-02T16:11:13","slug":"ibalizumab-phase-3-results-and-susceptibility-to-drug-resistant-hiv","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/33755","title":{"rendered":"Ibalizumab 24-week phase 3 results and susceptibility to drug-resistant HIV"},"content":{"rendered":"

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

CROI 2018 included a poster on the most recent HIV drug, ibalizumab, which was given FDA approval in the US during the conference week. <\/strong><\/p>\n

Ibalizumab is a monoclonal antibody that post-attachment, blocks HIV entry into cells while preserving normal CD4 functions. After an initial loading dose, it is given by infusion every two weeks.<\/p>\n

Baseline susceptibility data was presented for 38\/40 highly treatment-experienced participants in the 24-week, single arm, phase 3 TBM-301 study. At baseline, 50% of participants had resistance to at least three classes, with major mutations to NRTIs, NNRTIs, PIs and INIs on 93%, 85%, 83% and 61%, respectively.<\/p>\n

Results from the main study were previously reported in HTB last year, but in summary, include 83% of participants meeting the primary endpoint of >0.5 log reduction in viral load seven days after adding a single dose as virtual monotherapy to the background failing combination and mean viral load reduction of 1.1 log copies\/mL. Background ART was then optimised with 24-week follow-up. [3]<\/p>\n

At week 24, viral load was <50 copies\/mL in 43% (50% < 200 c\/mL) with median viral load reductions of 1.6 log at week 24.<\/p>\n

The poster at CROI presented results of in vitro analysis showing that ibalizumab retained sensitivity irrespective of baseline resistance to NRTIs, NNRTIs, PIs and INSTIs.<\/p>\n

comment<\/h3>\n

Although ibalizumab is not currently approved in the EU, the company are actively pursuing the regulatory pathway in Europe.<\/strong><\/p>\n

References<\/p>\n

    \n
  1. Weinheimer S et al. Ibalizumab susceptibility in patient HIV isolates resistant to antiretrovirals.\u00a025th CROI, 4 \u2013 7 March 2018, Boston. Poster abstract 561.
    \nwww.croiconference.org\/sessions\/ibalizumab-susceptibility-patient-hiv-isolates-resistant-antiretrovirals<\/a> (abstract and poster)<\/li>\n
  2. HTB. FDA approves ibalizumab in the US to treat multidrug HIV resistance. (06 March 2018).
    \n    https:\/\/i-base.info\/htb\/33659<\/a><\/li>\n
  3. HTB. Ibalizumab infusion reduces viral load in people with HIV multi-drug resistance. HTB (29 November 2017).
    \n    https:\/\/i-base.info\/htb\/30877<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base CROI 2018 included a poster on the most recent HIV drug, ibalizumab, which was given FDA approval in the US during the conference week. Ibalizumab is a monoclonal antibody that post-attachment, blocks HIV entry into cells …<\/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":[251],"class_list":["post-33755","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-croi-2018"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/33755","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=33755"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/33755\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=33755"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=33755"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=33755"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}