Tenofovir Disoproxil Fumarate (TDF) and tenofovir Alafenamide (TAF) are prodrugs of
tenofovir and have excellent long-term efficacy and tolerability for the treatment of HIV. An
objective marker of adherence to tenofovir-based therapy could be clinically useful in supporting
adherence to TDF-based HIV pre-Exposure Prophylaxis (PrEP) in populations in whom, self-report
has been shown to be unreliable, and could play a role in resource-limited settings to support HIV
and hepatitis B treatment adherence. A semi-quantitative high-performance liquid chromatographymass
spectrometry method for tenofovir quantification of urine samples was developed. This assay
detects tenofovir concentration in log10 levels between 1 and 10,000 ng/mL, and was shown to
distinguish between recent adherence and low/non-adherence to both TDF and TAF, with a
concentration of >1000 ng/mL, highly predictive of medication ingestion in the last 24-48 hours.
This assay was validated relative to other markers of adherence including dried blood spot and selfreport
in a highly adherent population of PrEP patients, and tenofovir was shown to be stable at
room temperature in urine for at least 14 days. The assay was successfully used in a clinical setting
to maintain high PrEP adherence and retention in care of 50 young men who have sex with men
(MSM) over 48 weeks, to assess PrEP adherence in youth with mental health conditions, and to
monitor drug levels relative to plasma levels in a case study of chewed TDF/FTC
(tenofovir/emtricitabine) for PrEP. Further studies are underway to implement the tenofovir urine
assay to monitor adherence and pre-exposure prophylaxis, nationally and internationally.
Retention in care outcomes for HIV pre-exposure prophylaxis implementation programmes among men who have sex with men in three US cities
