{"id":1570,"date":"2018-05-11T08:33:13","date_gmt":"2018-05-11T13:33:13","guid":{"rendered":"https:\/\/blog.unmc.edu\/infectious-disease\/?p=1570"},"modified":"2018-05-08T22:29:59","modified_gmt":"2018-05-09T03:29:59","slug":"pharm-to-exam-table-ibalizumab-monoclonal-antibodies-make-their-way-into-hiv-treatment","status":"publish","type":"post","link":"https:\/\/blog.unmc.edu\/infectious-disease\/2018\/05\/11\/pharm-to-exam-table-ibalizumab-monoclonal-antibodies-make-their-way-into-hiv-treatment\/","title":{"rendered":"Pharm to Exam Table: Monoclonal Antibodies Make Their Way into HIV Treatment"},"content":{"rendered":"

Pharm to Exam Table: Clinical Pharmacology\/Antimicrobial Updates \u2013\u00a0Trogarzo<\/strong>\u00ae (ibalizumab-uiyk), a new monoclonal antibody treatment approved for multi-drug resistant HIV-1<\/strong><\/p>\n

\u00a0<\/strong>On March 6th 2018, the Food and Drug Administration approved a new monoclonal antibody called ibalizumab-uiyk, marketed under the tradename Trogarzo\u00ae. Ibalizumab-uiyk (IBA) is an intravenous treatment administered every two weeks. It is intended for use in combination with other antiretrovirals (in an optimized background regimen),\u00a0for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection, failing their current antiretroviral regimen<\/span>.(1)<\/sup><\/em><\/p>\n

\"\"IBA is a humanized long-acting IgG4 monoclonal antibody that prevents attachment of the HIV-1 molecule to CD4+ T cells by changing the conformation of the CD4+ T cell receptor while preserving the function of the cell.\u00a0 These functions\u00a0classify IBA as an entry inhibitor<\/a>.(1,3,4)\u00a0<\/sup>Other previous entry inhibitors are enfurvitide (fusion inhibitor) and maraviroc (CCR5 antagonist).\u00a0\"\"<\/p>\n

The FDA approval was based on results of study TMB-301<\/a> (N=40), an open-label study that investigated the antiviral activity and safety of IBA when administered with an optimized background regimen (OBR) in treatment-experienced patients with multi-drug resistant HIV-1. The study followed patients prospectively over 24 weeks after dosing them with IBA and their OBR.\u00a0 At day 14, 83% of patients achieved at least a 0.5 log10 (roughly 70%) viral load reduction from baseline seven days after receiving the IBA loading dose. By week 25, the mean change from baseline viral load was -1.6 log10<\/a> with 55% of participants having a \u22651 log10 reduction in viral load. The most common drug-related adverse reactions (incidence \u2265 5%) were diarrhea (8%), dizziness (8%), nausea (5%) and rash (5%). Serious adverse events were reported in 23% (9\/40) of participants and of these only one was considered drug-related (immune reconstitution inflammatory syndrome, IRIS).(1,2,4)<\/sup><\/p>\n

IBA is the first monoclonal antibody entry\u00a0 inhibitor approved for HIV infection. Given its unique properties, tolerable safety profile, lack of drug-drug interactions or antiretroviral cross-resistance, IBA offers an attractive antiretroviral option for adjunct<\/em> treatment of multi-drug resistant HIV-1 infection in combination with an Optimized Background Regimen.<\/p>\n

References<\/strong>
\n1 Trogarzo \u00ae [package insert].<\/em> TaiMed Biologics USA Corp., Irvine, California; 2018\u00a0<\/em>
\n2 TaiMed Biologics Inc. Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV. Available from: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02475629<\/em>
\n3 Iacob S A, Iacob D G. Ibalizumab targeting CD4 receptors, an emerging molecule in HIV therapy[J]. Frontiers in microbiology, 2017, 8: 2323.<\/em>
\n4 Lewis S et al. Long-acting ibalizumab in patients with multi-drug resistant hiv-1: a 24-week study. CROI, 2017 (Poster).<\/em><\/p>\n

Images courtesy the Department of Health and Human Services AidsInfo website HIV\/AIDS glossary on CCR5 Antagonists<\/a> and Fusion Inhibitors<\/a>.<\/p>\n

Thanks to Chao Fu, UNMC PharmD candidate 2018 for providing concept for content.<\/em><\/p>\n<\/div><\/div>","protected":false},"excerpt":{"rendered":"

Pharm to Exam Table: Clinical Pharmacology\/Antimicrobial Updates \u2013\u00a0Trogarzo\u00ae (ibalizumab-uiyk), a new monoclonal antibody treatment approved for multi-drug resistant HIV-1 \u00a0On March 6th 2018, the Food and Drug Administration approved a new monoclonal antibody called ibalizumab-uiyk, marketed under the tradename Trogarzo\u00ae. Ibalizumab-uiyk (IBA) is an intravenous treatment administered every two weeks. It is intended for use […]<\/p>\n","protected":false},"author":562,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_s2mail":"yes","footnotes":""},"categories":[64,69,34,57],"tags":[58,70],"class_list":["post-1570","post","type-post","status-publish","format-standard","hentry","category-hiv-aids","category-id-pharmacy","category-medical-education","category-unmc-scc","tag-hiv","tag-pharmtoexamtable"],"_links":{"self":[{"href":"https:\/\/blog.unmc.edu\/infectious-disease\/wp-json\/wp\/v2\/posts\/1570","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blog.unmc.edu\/infectious-disease\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blog.unmc.edu\/infectious-disease\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blog.unmc.edu\/infectious-disease\/wp-json\/wp\/v2\/users\/562"}],"replies":[{"embeddable":true,"href":"https:\/\/blog.unmc.edu\/infectious-disease\/wp-json\/wp\/v2\/comments?post=1570"}],"version-history":[{"count":10,"href":"https:\/\/blog.unmc.edu\/infectious-disease\/wp-json\/wp\/v2\/posts\/1570\/revisions"}],"predecessor-version":[{"id":1636,"href":"https:\/\/blog.unmc.edu\/infectious-disease\/wp-json\/wp\/v2\/posts\/1570\/revisions\/1636"}],"wp:attachment":[{"href":"https:\/\/blog.unmc.edu\/infectious-disease\/wp-json\/wp\/v2\/media?parent=1570"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blog.unmc.edu\/infectious-disease\/wp-json\/wp\/v2\/categories?post=1570"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blog.unmc.edu\/infectious-disease\/wp-json\/wp\/v2\/tags?post=1570"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}