References
- World Health Organization. HIV/AIDS Fact Sheet. 2016 Jul. [accessed 2016 Jul 22]. http://www.who.int/mediacentre/factsheets/fs360/en/
- Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011; 365:493-505; PMID:21767103; https://doi.org/10.1056/NEJMoa1105243
- Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 2010; 363:2587-99; PMID:21091279; https://doi.org/10.1056/NEJMoa1011205
- National Institutes of Health. Guidelines for the use of antiretroviral agents in HIV-1-Infected adults and adolescents: Limitations to treatment safety and efficacy: Adverse effects of antiretroviral agents. 2014 May 1. [accessed 2015 Feb 17]. http://aidsinfo.nih.gov/guidelines
- van der Straten A, Van Damme L, Haberer JE, Bangsberg DR. Unraveling the divergent results of pre-exposure prophylaxis trials for HIV prevention. AIDS 2012; 26:F13-9; PMID:22333749; https://doi.org/10.1097/QAD.0b013e3283522272
- Voronin Y, Mofenson LM, Cunningham CK, Fowler MG, Kaleebu P, McFarland EJ, Safrit JT, Graham BS, Snow W. HIV monoclonal antibodies: A new opportunity to further reduce mother-to-child HIV transmission. PLoS Med 2014; 11:e1001616; PMID:24714363; https://doi.org/10.1371/journal.pmed.1001616
- Nakamura KJ, Cerini C, Sobrera ER, Heath L, Sinkala M, Kankasa C, Thea DM, Mullins JI, Kuhn L, Aldrovandi GM. Coverage of primary mother-to-child HIV transmission isolates by second-generation broadly neutralizing antibodies. AIDS 2013; 27:337-46; PMID:23296195; https://doi.org/10.1097/QAD.0b013e32835cadd6
- Russell ES, Ojeda S, Fouda GG, Meshnick SR, Montefiori D, Permar SR, Swanstrom R. Short communication: HIV type 1 subtype C variants transmitted through the bottleneck of breastfeeding are sensitive to new generation broadly neutralizing antibodies directed against quaternary and CD4-binding site epitopes. AIDS Res Hum Retroviruses 2013; 29:511-5; PMID:23075434; https://doi.org/10.1089/aid.2012.0197
- Zhou T, Georgiev I, Wu X, Yang ZY, Dai K, Finzi A, Kwon YD, Scheid JF, Shi W, Xu L, et al. Structural basis for broad and potent neutralization of HIV-1 by antibody VRC01. Science 2010; 329:811-7; PMID:20616231; https://doi.org/10.1126/science.1192819
- Wu X, Yang ZY, Li Y, Hogerkorp CM, Schief WR, Seaman MS, Zhou T, Schmidt SD, Wu L, Xu L, et al. Rational design of envelope identifies broadly neutralizing human monoclonal antibodies to HIV-1. Science 2010; 329:856-61; PMID:20616233; https://doi.org/10.1126/science.1187659
- Pegu A, Yang ZY, Boyington JC, Wu L, Ko SY, Schmidt SD, McKee K, Kong WP, Shi W, Chen X, et al. Neutralizing antibodies to HIV-1 envelope protect more effectively in vivo than those to the CD4 receptor. Sci Transl Med 2014; 6:243ra88; PMID:24990883; https://doi.org/10.1126/scitranslmed.3008992
- Saunders KO, Pegu A, Georgiev IS, Zeng M, Joyce MG, Yang ZY, Ko SY, Chen X, Schmidt SD, Haase AT, et al. Sustained delivery of a broadly neutralizing antibody in nonhuman primates confers long-term protection against simian/human immunodeficiency virus infection. J Virol 2015; 89:5895-903; PMID:25787288; https://doi.org/10.1128/JVI.00210-15
- Gautam R, Nishimura Y, Pegu A, Nason MC, Klein F, Gazumyan A, Golijanin J, Buckler-White A, Sadjadpour R, Wang K, et al. A single injection of anti-HIV-1 antibodies protects against repeated SHIV challenges. Nature 2016; 533:105-9; PMID:27120156; https://doi.org/10.1038/nature17677
- Gilbert PB, Juraska M, deCamp AC, Karuna S, Edupuganti S, Mgodi N, Donnell DJ, Bentley C, Sista N, Andrew P. Basis and statistical design of the passive HIV-1 Antibody Mediated Prevention (AMP) test-of-concept efficacy trials. Stat Commun Infect Dis In press.
- Qin L, Gilbert PB, Corey L, McElrath MJ, Self SG. A framework for assessing immunological correlates of protection in vaccine trials. J Infect Dis 2007; 196:1304-12; PMID:17922394; https://doi.org/10.1086/522428
- Plotkin SA, Gilbert PB. Nomenclature for immune correlates of protection after vaccination. Clin Infect Dis 2012; 54:1615-7; PMID:22437237; https://doi.org/10.1093/cid/cis238
- Lynch RM, Boritz E, Coates EE, DeZure A, Madden P, Costner P, Enama ME, Plummer S, Holman L, Hendel CS, et al. Virologic effects of broadly neutralizing antibody VRC01 administration during chronic HIV-1 infection. Sci Transl Med 2015; 7:319ra206; PMID:26702094; https://doi.org/10.1126/scitranslmed.aad5752
- Ledgerwood JE, Coates EE, Yamshchikov G, Saunders JG, Holman L, Enama ME, DeZure A, Lynch RM, Gordon I, Plummer S, et al. Safety, pharmacokinetics and neutralization of the broadly neutralizing HIV-1 human monoclonal antibody VRC01 in healthy adults. Clin Exp Immunol 2015; 182:289-301; PMID:26332605; https://doi.org/10.1111/cei.12692
- European Medicines Agency. Guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms. 2013 Feb 21. [accessed 2016 Feb 28]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/03/WC500140482.pdf
- IMpact Study Group-RSV. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. Pediatrics 1998; 102:531-7; PMID:9738173; https://doi.org/10.1542/peds.102.3.531
- Homaira N, Rawlinson W, Snelling TL, Jaffe A. Effectiveness of palivizumab in preventing RSV hospitalization in high risk children: A Real-World perspective. Int J Pediatr 2014; 2014:571609; PMID:25548575; https://doi.org/10.1155/2014/571609
- Wang DD, Zhang S, Zhao H, Men AY, Parivar K. Fixed dosing versus body size-based dosing of monoclonal antibodies in adult clinical trials. J Clin Pharmacol 2009; 49:1012-24; PMID:19620385; https://doi.org/10.1177/0091270009337512
- Davda JP, Dodds MG, Gibbs MA, Wisdom W, Gibbs J. A model-based meta-analysis of monoclonal antibody pharmacokinetics to guide optimal first-in-human study design. MAbs 2014; 6:1094-102; PMID:24837591; https://doi.org/10.4161/mabs.29095
- Bai S, Jorga K, Xin Y, Jin D, Zheng Y, Damico-Beyer LA, Gupta M, Tang M, Allison DE, Lu D, et al. A guide to rational dosing of monoclonal antibodies. Clin Pharmacokinet 2012; 51:119-35; PMID:22257150; https://doi.org/10.2165/11596370-000000000-00000
- Lowy I, Molrine DC, Leav BA, Blair BM, Baxter R, Gerding DN, Nichol G, Thomas WD, Jr., Leney M, Sloan S, et al. Treatment with monoclonal antibodies against Clostridium difficile toxins. N Engl J Med 2010; 362:197-205; PMID:20089970; https://doi.org/10.1056/NEJMoa0907635
- Chung RT, Gordon FD, Curry MP, Schiano TD, Emre S, Corey K, Markmann JF, Hertl M, Pomposelli JJ, Pomfret EA, et al. Human monoclonal antibody MBL-HCV1 delays HCV viral rebound following liver transplantation: a randomized controlled study. Am J Transplant 2013; 13:1047-54; PMID:23356386; https://doi.org/10.1111/ajt.12083
- Moir S, Fauci AS. B cells in HIV infection and disease. Nat Rev Immunol 2009; 9:235-45; PMID:19319142; https://doi.org/10.1038/nri2524
- Schoofs T, Klein F, Braunschweig M, Kreider EF, Feldmann A, Nogueira L, Oliveira T, Lorenzi JC, Parrish EH, Learn GH, et al. HIV-1 therapy with monoclonal antibody 3BNC117 elicits host immune responses against HIV-1. Science 2016; 352:997-1001; PMID:27199429; https://doi.org/10.1126/science.aaf0972
- Lindbom L, Ribbing J, Jonsson EN. Perl-speaks-NONMEM (PsN)–a Perl module for NONMEM related programming. Comput Methods Programs Biomed 2004; 75:85-94; PMID:15212851; https://doi.org/10.1016/j.cmpb.2003.11.003