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J Infect Dis. 2015 Sep 1;212(5):754-9. doi: 10.1093/infdis/jiv110. Epub 2015 Feb 23.

Antibody Maturation in Women Who Acquire HIV Infection While Using Antiretroviral Preexposure Prophylaxis.

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Laboratory of Immunoregulation Department of Medicine.
Biostatistics Research Branch, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health.
Laboratory of Immunoregulation.
Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban.
Department of Pathology, Johns Hopkins University, Baltimore, Maryland.
Department of Clinical Epidemiology, Columbia University Department of Medicine, Cornell University, New York, New York Ragon Institute, Boston, Massachusetts Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban.


The CAPRISA 004 preexposure prophylaxis (PrEP) randomized trial demonstrated that women who used a vaginal gel containing the antiretroviral drug tenofovir (TFV) had a 39% lower risk of acquiring human immunodeficiency virus (HIV). It is not known whether topical TFV alters the antibody response to breakthrough HIV infection. In this study, antibody maturation was evaluated using 3 serologic assays: the BED capture enzyme immunoassay (CEIA), the Bio-Plex (Luminex) assay, and the Bio-Rad avidity assay. Tests were performed using serum samples collected 3, 6, 9, 12, 24, 36, 48, and >48 months after seroconversion from 95 women in the CAPRISA 004 trial (35 in the TFV gel arm and 60 in the placebo arm). For the BED CEIA and Luminex assay, linear mixed effects models were used to examine test results by study arm. Cox proportional hazard analysis was used to examine time to avidity cutoff. Anti-HIV antibody titers did not differ between study arms. Women assigned to TFV gel demonstrated slower antibody avidity maturation, as determined by the Bio-Rad (P = .04) and gp120 Bio-Plex (P = .028) assays. Women who were assigned to receive topical TFV but became infected had slower antibody avidity maturation, with potential implications for diagnosis and antibody-based incidence assays as access to antiretroviral therapy-based PrEP is increased.


HIV; antibody maturation; incidence assay; preexposure prophylaxis

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