Validation of a Urine Assay to Measure Tenofovir Levels in Patients Taking Tenofovir Alafenamide

Summary

Pre-exposure prophylaxis (PrEP) with Truvada™ (tenofovir/emtricitabine), in which an HIV-uninfected individual at high risk for contracting HIV takes antiretroviral medications (one pill daily) to maintain blood and genital drug levels sufficient to prevent HIV-1 acquisition, has been validated in several large international trials that have included men who have sex with men and transgender women, heterosexual men and women, and people who use injection drugs, as a potential HIV-1 prevention strategy. HIV prevention interventions such as this, if adequately disseminated and implemented broadly, may help to curb new HIV infections, reduce HIV-associated morbidity and mortality, and reduce health disparities in HIV rates among the most at-risk individuals. Assuring adherence to a daily dose of PrEP is critical for effective protection against HIV infection. A urine-based test to measure PrEP medication levels in the body represents a non-invasive technique to assess adherence and ultimately improve PrEP's protective ability. TAF/FTC (Descovy™) is a new medication under study for HIV prevention to see if it is as effective as Truvada™. This study is testing whether a urine test can detect this medication in urine.

Timeline

Start

2017-11-16

Primary completion

2018-03-29

Completion

2018-05-01

Publications

• Results Lalley-Chareczko L, Hiserodt E, Moorthy G, Zuppa A, Mounzer K, Koenig H. Urine Assay to Measure Tenofovir Concentrations in Patients Taking Tenofovir Alafenamide. Front Pharmacol. 2020 Mar 19;11:286. doi: 10.3389/fphar.2020.00286. eCollection 2020.

Drugs

Indications