A report published in The New England Journal of Medicine and brief by the National Institutes of Health, which funded the research, shows regular infusions of an antibody that blocks the HIV binding site on human immune cells may have suppressed levels of HIV for up to four months in people undergoing a short-term pause in their antiretroviral therapy (ART) regimens.
NIH said Results of the Phase 2, open-label study indicates the antibody, known as UB-421, was safe and did not induce the production of antibody-resistant HIV. Previous experimental infusions of broadly neutralizing antibodies, or bNAbs, have suppressed HIV for about two weeks by targeting proteins on the virus itself, but the rapid mutation rate of HIV induces antibody-resistant strains that render the treatment ineffective.
UB-421 theoretically avoids this possibility by blocking a stable human protein that HIV uses to infect T cells. Indeed, resistance to UB-421 was not seen in this study. Because the small study did not include a comparator group receiving a placebo infusion, further studies have been planned in Taiwan and Thailand to evaluate the safety and efficacy of UB-421 as a treatment for HIV. In a related study, NIAID investigators currently are evaluating the safety of regular infusions of two highly potent bNAbs that may prevent the development of resistant HIV strains by targeting two distinct areas of the virus.
The study was conducted in Taiwan and led by Chang Yi Wang, Ph.D., Chief Scientific Officer and Chairperson of United BioPharma, Inc. Visit NIH for more study details.
In other HIV news, earlier in April the FDA approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to the individual components of Dovato, manufactured by ViiV Healthcare. It is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received treatment for HIV.
