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Ibalizumab: A Review in Multidrug-Resistant HIV-1 Infection

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Abstract

Ibalizumab (Trogarzo®; ibalizumab-uiyk) is the first monoclonal antibody to be approved for the treatment of HIV-1 infection. As a CD4-directed post-attachment inhibitor, ibalizumab blocks HIV-1 entry into CD4 cells while preserving normal immune function. Ibalizumab, in combination with other antiretroviral(s), is indicated in the USA for the treatment of heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen, and in the EU for the treatment of adults infected with multidrug-resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen. In the pivotal phase III TMB-301 trial, ibalizumab significantly reduced the viral load 7 days after being added to a failing antiretroviral regimen. Almost half of all patients achieved an undetectable viral load after 24 weeks of treatment with ibalizumab plus an optimized background regimen, with virological suppression maintained over the longer term (up to 96 weeks) in an expanded access protocol. The drug was generally well tolerated in clinical trials. Although additional studies and long-term post-marketing data are needed to fully determine its efficacy and safety, ibalizumab represents a valuable and much needed treatment option for patients with multidrug-resistant HIV-1 infection.

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Acknowledgements

During the review process, the manufacturer of ibalizumab was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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  1. Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand

    Hannah A. Blair

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  1. Hannah A. Blair
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Correspondence to Hannah A. Blair.

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The preparation of this review was not supported by any external funding.

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Hannah Blair is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.

Additional information

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for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.11540427.

The manuscript was reviewed by:A. Calmy, Infectious Disease Division, Geneva University Hospitals, Geneva, Switzerland; O. Kirk, Department of Infectious Diseases, University of Copenhagen, Copenhagen, Denmark; M. Liedtke, University of Oklahoma, College of Pharmacy, Oklahoma City, OK, USA.

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Blair, H.A. Ibalizumab: A Review in Multidrug-Resistant HIV-1 Infection. Drugs 80, 189–196 (2020). https://doi.org/10.1007/s40265-020-01258-3

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