Open AccessRepeated 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
Author(s) -
Haaland Richard E,
Fountain Jeffrey,
Hu Yingtian,
Holder Angela,
Dinh Chuong,
Hall LaShonda,
Pescatore Nicole A,
Heeke Sheila,
Hart Clyde E,
Xu Jiahui,
Hu YiJuan,
Kelley Colleen F
Publication year - 2018
Publication title -
journal of the international aids society
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.724
H-Index - 62
ISSN - 1758-2652
DOI - 10.1002/jia2.25199
Subject(s) - medicine , rectum , prevotella , randomized controlled trial , drug , gastroenterology , pharmacology , physiology , biology , bacteria , genetics
Oral pre‐exposure prophylaxis (Pr EP ) 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 Pr EP drug concentrations and the rectal microbiota are unknown. We investigated rectal Pr EP drug concentrations and the microbiota in MSM before and after repeated rectal application of a hyperosmolar lubricant. Methods We 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. Results Seven days of lubricant application was not associated with differences in Pr EP 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. Pr EP drug concentrations in rectal tissue and secretions were not associated with microbiota composition or diversity either before or after lubricant use. Conclusions Repeated rectal application of a hyperosmolar lubricant does not affect mucosal Pr EP drug concentrations but is associated with changes in the rectal microbiome.