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Safety, Tolerability, and Pharmacokinetics of a Long-Acting Broadly Neutralizing Human Immunodeficiency Virus Type 1 (HIV-1) Monoclonal Antibody VRC01LS in HIV-1–Exposed Newborn Infants
- McFarland, Elizabeth J;
- Cunningham, Coleen K;
- Muresan, Petronella;
- Capparelli, Edmund V;
- Perlowski, Charlotte;
- Morgan, Patricia;
- Smith, Betsy;
- Hazra, Rohan;
- Purdue, Lynette;
- Harding, Paul A;
- Theron, Gerhard;
- Mujuru, Hilda;
- Agwu, Allison;
- Purswani, Murli;
- Rathore, Mobeen H;
- Flach, Britta;
- Taylor, Alison;
- Lin, Bob C;
- McDermott, Adrian B;
- Mascola, John R;
- Graham, Barney S;
- Rossouw, Magdel;
- Rossouw, Lindie;
- Louw, Jeanne;
- Vhembo, Tichaona;
- Mhembere, Tsungai Patience;
- Matibe, Petronella;
- Mahmoudi, Saniyyah;
- Maldonado, Alexandrea;
- Maraqa, Nizar;
- Baig, Mahboobullah M;
- Rogo, Tanya;
- Cavallo, Martha;
- Collinson-Streng, Aleisha;
- Anderson, Thuy;
- Golden, W Christopher;
- Persaud, Deborah;
- Puga, Ana M;
- Robinson, Lisa-Gaye;
- Eysallenne, Zulma;
- Leon, Dayana;
- Paul, Mary E;
- McMullen-Jackson, Chivon;
- Buschur, Shelley;
- Pontifes, Mariam;
- Sung, Joyce;
- Glenny, Carrie;
- Dunn, Jennifer;
- Navarro, Kacey
Published Web Location
https://doi.org/10.1093/infdis/jiab229Abstract
Background
Perinatal human immunodeficiency virus type 1 (HIV-1) continues to occur due to barriers to effective antiretroviral prevention that might be mitigated by long-acting broadly neutralizing monoclonal antibodies (bNAbs).Methods
An extended half-life bNAb, VRC01LS, was administered subcutaneously at 80 mg/dose after birth to HIV-1-exposed, nonbreastfed (cohort 1, n = 10) and breastfed (cohort 2, n = 11) infants. Cohort 2 received a second dose (100 mg) at 12 weeks. All received antiretroviral prophylaxis. VRC01LS levels were compared to VRC01 levels determined in a prior cohort.Results
Local reactions (all grade ≤2) occurred in 67% and 20% after dose 1 and dose 2, respectively. The weight-banded dose (mean 28.8 mg/kg) of VRC01LS administered subcutaneously achieved a mean (standard deviation) plasma level of 222.3 (71.6) µg/mL by 24 hours and 44.0 (11.6) µg/mL at week 12, prior to dose 2. The preestablished target of ≥50 µg/mL was attained in 95% and 32% at weeks 8 and 12, respectively. The terminal half-life was 37-41 days. VRC01LS level after 1 dose was significantly greater (P <.002) than after a VRC01 dose (20 mg/kg). No infants acquired HIV-1.Conclusions
VRC01LS was well tolerated with pharmacokinetics that support further studies of more potent long-acting bNAbs as adjunct treatment with antiretrovirals to prevent infant HIV-1 transmission.Many UC-authored scholarly publications are freely available on this site because of the UC's open access policies. Let us know how this access is important for you.
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