Rectal Microbiome Alterations Associated With Oral Human Immunodeficiency Virus Pre-Exposure Prophylaxis.

BACKGROUND

Oral daily tenofovir (TFV) disoproxil fumarate/emtricitabine (TDF/FTC) for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) is highly effective for HIVprevention, yet long-term effects are not fully understood. We investigated the effects of PrEP on the rectal microbiome in a cohort of men who have sex with men (MSM).

METHODS

This cross-sectional analysis included HIV-negative MSM either on PrEP (n = 37) or not (n = 37) selected from an ongoing cohort using propensity score matching. Rectal swabs were used to examine microbiome composition using 16S ribosomal ribonucleic acid gene sequencing, and associations between PrEP use and microbiota abundance were examined. Hair specimens were used to quantify TFV and FTC exposure over the past 6 weeks on a subset of participants (n = 15).

RESULTS

Pre-exposure prophylaxis use was associated with a significant increase in abundance (adjusted = .015). Similar associations were identified using least absolute shrinkage and selection operator (LASSO) regression, confirming the increase in and also showing increased , , and decreased . Increased was significantly associated with increasing TFV exposure.

CONCLUSIONS

Oral TDF/FTC for PrEP is associated with rectal microbiome changes compared to well matched controls, specifically increased and abundance. This study highlights the need for future investigations of the role of microbiome changes on HIV susceptibility and effectiveness of PrEP.