A Real-Time Urine Tenofovir Assay Improves Drug Adherence Among People With HIV With Prior Virologic Failure in a Randomized Controlled Trial.

Abstract

Scalable strategies to detect and address inadequate adherence to antiretroviral therapy (ART) are a high priority towards meeting UNAIDS 95-95-95 targets. A urine tenofovir rapid assay (UTRA) at the point-of-care improves adherence among pre-exposure prophylaxis recipients and virologic suppression (VS) in a pre-post study of people with HIV (PWH). Here, we conducted the first randomized trial of UTRA-enhanced adherence support vs standard of care among PWH. Participants receiving dolutegravir (DTG)- or protease inhibitor (PI)-based ART were randomized to UTRA-enhanced adherence support (n = 100) vs standard of care (n = 100). The primary outcome was VS, HIV-1 RNA <50 copies/mL, at 12-months and secondary outcome was VS at 6 months. To explore ART adherence over the preceding 6-8 weeks, tenofovir diphosphate (TFV-DP) in dried blood spots (DBS) was quantified. C-reactive protein (CRP) was measured as an inflammatory marker. At the 12-month visit, 59/80 (74%) in the intervention and 48/75 (64%) in the control arm achieved VS (the same proportion as at 6 months; P = .2); TFV-DP concentrations (median, IQR) in DBS were significantly higher in the intervention arm: 884 (491-1296) vs 598 (239-964) fmol/3-mm DBS punch in the control arm (P < .01). Higher TFV-DP DBS concentrations correlated with a slight decrease in CRP (Spearman's rho = -0.19; P = .02). UTRA-enhanced adherence support did not result in a significantly higher VS rate but was associated with increased TFV-DP in DBS-in turn, associated with lower CRP levels-suggesting that UTRA-enhanced adherence support improves long-term drug exposure and could also reduce HIV-associated inflammation. clinicaltrials.gov (https://clinicaltrials.gov/study/NCT05333679).