Novel Strategies in HIV Prevention-Development of Topical Microbicides

Author(s):  
Brigitte E. Beer ◽  
James E. Cummins
2020 ◽  
Vol 71 (1) ◽  
pp. 361-377 ◽  
Author(s):  
Jared M. Baeten ◽  
Craig W. Hendrix ◽  
Sharon L. Hillier

HIV topical microbicides are products with anti-HIV activity, generally incorporating a direct-acting antiretroviral agent, that when applied to the vagina or rectum have the potential to prevent the sexual acquisition of HIV in women and men. Topical microbicides may meet the prevention needs of individuals and groups for whom oral daily forms of pre-exposure prophylaxis (PrEP) have not been acceptable. Microbicides can provide personal control over HIV prevention and offer the possibility of discreet use, qualities that may be particularly important for receptive partners in sexual relationships such as women and transgender women and men, who together account for the clear majority of new HIV infections worldwide. Although the promise of such a product emerged nearly three decades ago, proof of concept has been demonstrated only within the last decade. A robust pipeline of microbicidal gels, films, inserts, and rings has been evaluated in multiple studies among at-risk women and men, and refinement of products for ease of use, reversibility, and high safety is the priority for the field.


2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Terry A. Jacot ◽  
Meredith R. Clark ◽  
Oluwatosin E. Adedipe ◽  
Susan Godbout ◽  
Tina Cunningham ◽  
...  

Abstract Background Strict adherence to antiretroviral-based microbicide use is important for effective HIV prevention. We previously developed a composite measure of product adherence, protocol compliance, and semen exposure for determining vaginal use of tenofovir (TFV) 1% gel applicators through biomarkers and residual drug analyses. In this study, we tested the ability of the composite measure in vaginally used TFV gel applicators from a Phase III HIV prevention clinical trial. Methods Used vaginal gel applicators from the FACTS 001 study were swabbed for detection of vaginal bacterial markers (vaginal insertion), semen DNA markers (semen exposure), and residual TFV gel (product use). Results Of 1,098 evaluable TFV and placebo applicators, 80% had detectable vaginal insertion biomarkers and 52% had semen biomarkers. Ninety-nine percent of vaginally inserted applicators TFV applicators had detectable residual TFV as measured by liquid chromatography with tandem mass spectroscopy (LC–MS/MS). Residual TFV levels were also successfully detected using Fourier Transform Infrared (FTIR)-based spectroscopy. Conclusions Vaginal insertion and semen exposure biomarkers were detectable on used TFV 1% gel applicators. Residual TFV on these gel applicators was detectable by LC–MS/MS and FTIR-based spectroscopy, which has potential to be a more convenient and quicker method for detecting drug use. With continual improvements, this composite measure of product adherence, protocol compliance, and semen exposure has potential to assess use of not only TFV gel but also other topical microbicides or products.


2015 ◽  
Vol 113 ◽  
pp. 33-48 ◽  
Author(s):  
Javier Sánchez-Rodríguez ◽  
Enrique Vacas-Córdoba ◽  
Rafael Gómez ◽  
F. Javier De La Mata ◽  
Ma Ángeles Muñoz-Fernández

2010 ◽  
Vol 43 (1) ◽  
pp. 56
Author(s):  
SHERRY BOSCHERT
Keyword(s):  

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