Author
Listed:
- Michael C. Sneller
(National Institutes of Health (NIH))
- Jana Blazkova
(National Institutes of Health (NIH))
- J. Shawn Justement
(National Institutes of Health (NIH))
- Victoria Shi
(National Institutes of Health (NIH))
- Brooke D. Kennedy
(National Institutes of Health (NIH))
- Kathleen Gittens
(NIH)
- Jekaterina Tolstenko
(National Institutes of Health (NIH))
- Genevieve McCormack
(National Institutes of Health (NIH))
- Emily J. Whitehead
(National Institutes of Health (NIH))
- Rachel F. Schneck
(National Institutes of Health (NIH))
- Michael A. Proschan
(NIH)
- Erika Benko
(Maple Leaf Medical Clinic)
- Colin Kovacs
(Maple Leaf Medical Clinic)
- Cihan Oguz
(NIH
Frederick National Laboratory for Cancer Research)
- Michael S. Seaman
(Harvard Medical School)
- Marina Caskey
(The Rockefeller University)
- Michel C. Nussenzweig
(The Rockefeller University
The Rockefeller University)
- Anthony S. Fauci
(National Institutes of Health (NIH))
- Susan Moir
(National Institutes of Health (NIH))
- Tae-Wook Chun
(National Institutes of Health (NIH))
Abstract
Antiretroviral therapy is highly effective in suppressing human immunodeficiency virus (HIV)1. However, eradication of the virus in individuals with HIV has not been possible to date2. Given that HIV suppression requires life-long antiretroviral therapy, predominantly on a daily basis, there is a need to develop clinically effective alternatives that use long-acting antiviral agents to inhibit viral replication3. Here we report the results of a two-component clinical trial involving the passive transfer of two HIV-specific broadly neutralizing monoclonal antibodies, 3BNC117 and 10-1074. The first component was a randomized, double-blind, placebo-controlled trial that enrolled participants who initiated antiretroviral therapy during the acute/early phase of HIV infection. The second component was an open-label single-arm trial that enrolled individuals with viraemic control who were naive to antiretroviral therapy. Up to 8 infusions of 3BNC117 and 10-1074, administered over a period of 24 weeks, were well tolerated without any serious adverse events related to the infusions. Compared with the placebo, the combination broadly neutralizing monoclonal antibodies maintained complete suppression of plasma viraemia (for up to 43 weeks) after analytical treatment interruption, provided that no antibody-resistant HIV was detected at the baseline in the study participants. Similarly, potent HIV suppression was seen in the antiretroviral-therapy-naive study participants with viraemia carrying sensitive virus at the baseline. Our data demonstrate that combination therapy with broadly neutralizing monoclonal antibodies can provide long-term virological suppression without antiretroviral therapy in individuals with HIV, and our experience offers guidance for future clinical trials involving next-generation antibodies with long half-lives.
Suggested Citation
Michael C. Sneller & Jana Blazkova & J. Shawn Justement & Victoria Shi & Brooke D. Kennedy & Kathleen Gittens & Jekaterina Tolstenko & Genevieve McCormack & Emily J. Whitehead & Rachel F. Schneck & Mi, 2022.
"Combination anti-HIV antibodies provide sustained virological suppression,"
Nature, Nature, vol. 606(7913), pages 375-381, June.
Handle:
RePEc:nat:nature:v:606:y:2022:i:7913:d:10.1038_s41586-022-04797-9
DOI: 10.1038/s41586-022-04797-9
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Cited by:
- Mathilde Foglierini & Pauline Nortier & Rachel Schelling & Rahel R. Winiger & Philippe Jacquet & Sijy O’Dell & Davide Demurtas & Maxmillian Mpina & Omar Lweno & Yannick D. Muller & Constantinos Petrov, 2024.
"RAIN: machine learning-based identification for HIV-1 bNAbs,"
Nature Communications, Nature, vol. 15(1), pages 1-16, December.
- Jun Niu & Qi Wang & Wenwen Zhao & Bing Meng & Youwei Xu & Xianfang Zhang & Yi Feng & Qilian Qi & Yanling Hao & Xuan Zhang & Ying Liu & Jiangchao Xiang & Yiming Shao & Bei Yang, 2023.
"Structures and immune recognition of Env trimers from two Asia prevalent HIV-1 CRFs,"
Nature Communications, Nature, vol. 14(1), pages 1-18, December.
- Miriam Rosás-Umbert & Jesper D. Gunst & Marie H. Pahus & Rikke Olesen & Mariane Schleimann & Paul W. Denton & Victor Ramos & Adam Ward & Natalie N. Kinloch & Dennis C. Copertino & Tuixent Escribà & An, 2022.
"Administration of broadly neutralizing anti-HIV-1 antibodies at ART initiation maintains long-term CD8+ T cell immunity,"
Nature Communications, Nature, vol. 13(1), pages 1-12, December.
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