Media Advisory

Wednesday, April 17, 2019

NIH researchers and international collaborators report findings from small open study

What

According to a report published online today, regular infusion of an antibody blocking HIV binding site on human immune cells can result in suppression of HIV levels for up to four months at home. people who take a short break in their antiretroviral regimen (ART). in The New England Medical Journal. The results of the open-label phase 2 study indicate that the antibody, known as UB-421, was safe and did not induce the production of antibody-resistant HIV. The study was funded in part by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health, and United Biopharma, Inc.

The study was conducted in Taiwan and led by Chang Yi Wang, Ph.D., Scientific Director and President of United BioPharma, Inc. Twenty-nine well-controlled HIV volunteers have stopped their standard daily oral antiretroviral therapy regimen at the time of their first infusion or a week later, depending on their antiretroviral regimen. Fourteen study participants received eight weekly weekly infusions of UB-421, while 15 received eight higher-dose infusions every two weeks. At the end of the eight or 16 week treatment period, all volunteers resumed their previous antiretroviral therapy and were evaluated at follow-up visits up to eight weeks later. Aside from a single participant who discontinued the study because of a mild rash, volunteers from both groups maintained the suppression of HIV (plasma levels of HIV RNA less than 20 copies / ml) throughout the course of treatment in the absence of antiretroviral therapy.

Previous experimental infusions of largely neutralizing antibodies, or bNAb, have inhibited HIV for about two weeks by targeting proteins to the virus itself, but the rapid mutation rate of HIV induces antibody-resistant strains that render ineffective treatment. UB-421 theoretically avoids this possibility by blocking a stable human protein that HIV uses to infect T cells. Indeed, no resistance to UB-421 was observed in this study. Since the small study did not include a comparison group receiving a placebo infusion, further studies were planned in Taiwan and Thailand to assess the safety and efficacy of the study. 39, efficacy of UB-421 as a treatment for HIV. In a related study, NIAID researchers are currently evaluating the safety of regular infusions of two highly potent bNAb bacteria that can prevent the development of resistant HIV strains by targeting two distinct areas of the virus.

article

C Wang et al. Effect of anti-CD4 antibody UB-421 on the rebound of HIV-1 after discontinuation of treatment. New England Journal of Medicine DOI: 10.1056 / NEJMoa1802264 (2019).

who

Anthony S. Fauci, Director of NIAID, is available for comment.

Contact

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NIAID conducts and supports research – at NIH, in the United States, and around the world – to investigate the causes of infectious and immune-mediated diseases and to develop better ways to prevent, diagnose and treat these diseases. NIAID press releases, fact sheets and other documents are available on the NIAID website.

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