Viral suppression with anti-HIV-1 antibody - Phase 1b 3BNC117 & 10-1074

[Jim Allen]

Phase 1b study of the safety, tolerability and anti-viral activity of the combination of two broad and potent anti-HIV-1 antibodies, 3BNC117 and 10-1074


April 13th 2022

In Full: https://doi.org/10.1038/s41586-022-04597-1 Gaebler, C., Nogueira, L., Stoffel, E. et al. Prolonged viral suppression with anti-HIV-1 antibody therapy. Nature (2022).

In Brief:

Study eligibility criteria included ongoing ART and viral suppression with plasma HIV-1 RNA levels of less than 50 copies per ml for at least 12 months (with one blip of fewer than 500 copies per ml allowed), fewer than 20 copies per ml at screening, and CD4+ T cell counts above 500 cells

Participants in the treatment groups received up to seven infusions of 30 mg kg−1 of each antibody over the course of 20 weeks at 2-week (infusions 1–3) and 4-week intervals

26 enrolled participants were randomized to group 1 and eight were randomized to group 2

Participants in group 1 were asked to discontinue their ART 2 days after the first 3BNC117 and 10-1074 infusions, whereas participants in group 2 remained on ART before discontinuing the antiretrovirals after 26 weeks

Thirteen out of seventeen (76%) evaluable group 1 participants maintained viral suppression for at least 20 weeks after ART discontinuation

The participants in group 2 maintained viral suppression for a median of 7 weeks (4–9 weeks) after ART was discontinued 13 weeks (range 10–15 weeks) after the last bNAb infusion.

There was no statistically significant difference in time to viral rebound after ART interruption between group 1 and group 2 participants

We conclude that repeated infusions of two anti-HIV-1 bNAbs can maintain viral suppression for longer periods of time than previously reported as long as bNAb levels remain therapeutic. Similar results were observed in a parallel placebo-controlled clinical trial—sponsored by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIAID/NIH)—in which people living with HIV who started ART during the early phase of infection received eight doses of the same antibody combination over a 24-week period in the absence of ART

Past coverage of 3BNC117 & 10-1074

3BNC117

2015 - new antibody therapy shows promise in suppressing HIV infection
https://forums.poz.com/index.php?topic=58406.ms

2016 - HIV Antibody 3BNC117 Delays Viral Rebound
https://www.poz.com/article/hiv-antibody-3bnc117-delays-viral-rebound-component-cure


10-1074

2017 - Antibody (10-1074) trial in PLHIV.
https://forums.poz.com/index.php?topic=65324.msg