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Testing of viscous anti-HIV microbicides using Lactobacillus.

B J Moncla¹, K Pryke, L C Rohan

¹Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA 15213, USA. bjm4@pitt.edu

Journal of Microbiological Methods

|January 10, 2012

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Topical microbicides for HIV prevention must be safe for vaginal Lactobacillus. While most tested drugs were safe, PSC-RANTES showed toxicity. A new Lactobacillus toxicity test was developed to assess product safety.

Area of Science:

Microbiology
Pharmacology
Infectious Diseases

Background:

Topical microbicides are crucial for HIV prevention.
Vaginal Lactobacillus species are essential for maintaining vaginal health.
Assessing the safety of microbicides on Lactobacillus is vital for product development.

Purpose of the Study:

To evaluate the toxicity of anti-HIV drugs and microbicide formulations on vaginal Lactobacillus species.
To develop and validate a new assay, the Lactobacillus toxicity test, for assessing product safety.

Main Methods:

Exposure of Lactobacillus species to pure drugs (dapivirine, tenofovir, UC781, PSC-RANTES) and formulated products (films, gels).
Development of the Lactobacillus toxicity test involving vortex mixing and assessment of bacterial viability.

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Evaluation of protective agents (serum, albumin, glycerol) and formulation excipients.

Main Results:

Dapivirine, tenofovir, and UC781 were not toxic to Lactobacillus.
PSC-RANTES demonstrated toxicity to Lactobacillus jensenii strains.
Vortex mixing significantly reduced Lactobacillus viability, but this was mitigated by serum or albumin.
Formulation excipients and films offered protection against vortex-induced killing.

Conclusions:

Most tested anti-HIV drugs are safe for vaginal Lactobacillus.
PSC-RANTES poses a potential risk to the vaginal microbiome.
The developed Lactobacillus toxicity test is relevant for evaluating the safety of viscous microbicide products.