Journal Article

Repeated rectal application of a hyperosmolar lubricant is associated with microbiota shifts but does not affect Pr EP drug concentrations: results from a randomized trial in men who have sex with men

Dinh, Chuong, Hart, Clyde E, Haaland, Richard E, Hall, LaShonda, Heeke, Sheila, Xu, Jiahui, Kelley, Colleen F, Hu, Yingtian, Pescatore, Nicole A, Fountain, Jeffrey, Holder, Angela, Hu, Yi‐Juan

2018

Overview

IntroductionOral pre‐exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) is highly effective in preventing HIV infection among men who have sex with men (MSM). The effects of consistent personal lubricant use in the rectum on tissue PrEP drug concentrations and the rectal microbiota are unknown. We investigated rectal PrEP drug concentrations and the microbiota in MSM before and after repeated rectal application of a hyperosmolar lubricant.MethodsWe randomized 60 HIV‐negative MSM to apply 4 mL of hyperosmolar rectal lubricant daily (n = 20), take daily oral TDF/FTC (n = 19), or both (n = 21) for seven days. Blood, rectal biopsies and rectal secretions were collected via rigid sigmoidoscopy before and on day 8 after product use. Tenofovir (TFV) and FTC as well as their intracellular metabolites tenofovir‐diphosphate (TFV‐DP), FTC‐triphosphate (FTC‐TP) were measured by HPLC‐mass spectrometry. Rectal mucosal microbiota was sequenced with 16S rRNA sequencing using Illumina MiSeq.ResultsSeven days of lubricant application was not associated with differences in PrEP drug concentrations in rectal tissue or secretions. Lubricant use was associated with a decrease in the relative abundance of the Bacteroides genus (p = 0.01) and a non‐significant increase in the Prevotella genus (p = 0.09) in the rectum. PrEP drug concentrations in rectal tissue and secretions were not associated with microbiota composition or diversity either before or after lubricant use.ConclusionsRepeated rectal application of a hyperosmolar lubricant does not affect mucosal PrEP drug concentrations but is associated with changes in the rectal microbiome.

• Publisher: John Wiley & Sons, Inc
• Subject: Acquired immune deficiency syndrome / AIDS / Antiretroviral drugs / Biopsy / Clinical trials / Disease control / Disease prevention / Drug dosages / HIV / Human immunodeficiency virus / Infections / Inflammation / Lubricants & lubrication / Mass spectrometry / Metabolites / Microbiota / Relative abundance / Scientific imaging / Sexually transmitted diseases / STD / Studies