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AIDS. 2018 Aug 24;32(13):1891-1898. doi: 10.1097/QAD.0000000000001922.

Tenofovir and tenofovir-diphosphate concentrations during pregnancy among HIV-uninfected women using oral preexposure prophylaxis.

Author information

1
Department of Epidemiology.
2
Department of Global Health.
3
Department of Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora.
4
Department of Medicine (Clinical Pharmacology), Johns Hopkins University, Baltimore.
5
Massachusetts General Hospital Global Health and Harvard Medical School.
6
Department of Medicine, Harvard Medical School, Boston.
7
Department of Medicine.
8
Vaccine and Infection Diseases and Public Health Science Division, Fred Hutchinson Cancer Research Center, Seattle, USA.
9
Department of Obstetrics and Gynecology, University of Washington, Seattle.
10
Kenya Medical Research Institute (KEMRI).
11
Kabwohe Clinical Research Center.
12
Infectious Disease Institute, Makerere University, Uganda.

Abstract

OBJECTIVES:

Pregnancy is a time of increased HIV acquisition risk and pregnancy reduces concentrations of antiretrovirals used for treatment. We assessed whether pregnancy lowers concentrations of tenofovir (TFV) and tenofovir-diphosphate (TFV-DP) among HIV-uninfected women using oral preexposure prophylaxis (PrEP).

METHODS:

We analyzed data from an open-label PrEP study, comparing concentrations of TFV in plasma and TFV-DP in dried blood spots (DBS) among 37 pregnant women and 97 nonpregnant women. Analyses controlled for adherence from daily electronic monitoring.

RESULTS:

The average plasma concentration of TFV among pregnant women was 34.7 ng/ml with 22.2 average recorded doses over the prior month versus 86.5 ng/ml with 23.1 doses among nonpregnant women. After controlling for adherence, TFV concentrations were 58% lower among pregnant women, a statistically significant difference of -50.4 ng/ml (95% CI -68.3 to -32.5). The average TFV-DP concentration was 450.3 fmol/punch among pregnant women and 636.7 fmol/punch among nonpregnant women. This difference was not statistically significant after adjusting for adherence; however, among those with quantifiable TFV-DP, concentrations were 27% lower during pregnancy [-202 fmol/punch (95% CI -384 to -19)]. Among participants with samples before and during pregnancy, there were significant decreases during pregnancy, controlling for adherence: -28.1 ng/ml TFV (95% CI -52.3 to -4.0) and -289.2 fmol/punch TFV-DP (95% CI -439.0 to -139.3).

CONCLUSION:

Consistent with studies among HIV-infected women on ART, we found TFV and TFV-DP concentrations were lower during pregnancy. There is no established TFV concentration threshold to achieve HIV prevention. Additional pharmacokinetic studies and studies of PrEP efficacy in pregnancy are needed.

PMID:
29894385
PMCID:
PMC6061961
DOI:
10.1097/QAD.0000000000001922
[Indexed for MEDLINE]
Free PMC Article

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