1. Infusion Reactions After Receiving the Broadly Neutralizing Antibody VRC01 or Placebo to Reduce HIV-1 Acquisition: Results From the Phase 2b Antibody-Mediated Prevention Randomized Trials
- Author
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Takuva, Simbarashe, Karuna, Shelly T., Juraska, Michal, Rudnicki, Erika, Edupuganti, Srilatha, Anderson, Maija, Grecca, Robert De La, Gaudinski, Martin R., Sehurutshi, Alice, Orrell, Catherine, Naidoo, Logashvari, Valencia, Javier, Villela, Larissa M., Walsh, Stephen R., Andrew, Philip, Karg, Carissa, Randhawa, April, Hural, John, Gomez Lorenzo, Margarita M., Burns, David N., Ledgerwood, Julie, Mascola, John R., Cohen, Myron, Corey, Lawrence, Mngadi, Kathy, and Mgodi, Nyaradzo M.
- Subjects
Male ,Infectious Diseases ,HIV-1 ,Antibodies, Monoclonal ,Humans ,Female ,HIV Infections ,Pharmacology (medical) ,HIV Antibodies ,Antibodies, Neutralizing ,Article ,Broadly Neutralizing Antibodies ,Randomized Controlled Trials as Topic - Abstract
BACKGROUND: The AMP studies (HVTN 703/HPTN 081 and HVTN 704/HPTN 085) are harmonized Phase 2b trials to assess HIV prevention efficacy and safety of intravenous infusion of anti-gp120 broadly neutralizing antibody VRC01. Antibodies for other indications can elicit infusion-related reactions (IRRs), often requiring pre-medication and limiting their application. We report on AMP study IRRs. METHODS: From 2016–2018, 2,699 HIV-uninfected, at-risk men and transgender adults in the Americas and Switzerland (704/085) and 1,901 at-risk heterosexual women in sub-Saharan Africa (703/081) were randomized 1:1:1 to VRC01 10 mg/kg, 30 mg/kg, or placebo. Participants received infusions every 8 weeks (n=10/participant) over 72 weeks, with 104 weeks of follow-up. Safety assessments were conducted pre- and post-infusion and at non-infusion visits. A total of 40,674 infusions were administered. RESULTS: Forty-seven participants (1.7%) experienced 49 IRRs in 704/085; 93 (4.8%) experienced 111 IRRs in 703/081 (p
- Published
- 2022