Higher medication complexity in persons with HIV is associated with lower tenofovir diphosphate in dried blood spots.

Study Objective: To assess the association between tenofovir diphosphate (TFV-DP) in dried blood spots (DBS), a measure of cumulative tenofovir-based antiretroviral (ART) adherence, with medication regimen complexity in persons with human immunodeficiency virus (PWH).

Design: Prospective clinical cohort (up to three visits over 48 weeks).

Setting: Academic-based HIV clinic.

Patients: PWH receiving tenofovir disoproxil fumarate (TDF)-based ART.

Measurements: DBS for TFV-DP were collected at every study visit. Baseline patient-level medication regimen complexity index (pMRCI) scores were calculated and categorized into three sub-scores (disease-specific [ART], non-ART, and over-the-counter [OTC]). The pMRCI scores were evaluated to assess the association with TFV-DP in DBS <350 fmol/punch after adjusting for clinical covariates. pMRCI scores were also categorized to estimate the adjusted relative risk (aRR) of having a TFV-DP <350 fmol/punch between pMRCI quartiles.

Main Results: Data from 525 participants (1,146 person-visits) were analyzed. Baseline median (interquartile range [IQR]) pMRCI scores for participants with TFV-DP in DBS <350 vs. ≥350 fmol/punch were 4 (3, 8) vs. 4 (2, 6) for ART, 27 (12, 31) vs. 12 (5, 22) for non-ART, and 0 (0, 1) vs. 0 (0, 2) for OTC, respectively. For the non-ART scores, the aRR for having a TFV-DP in DBS <350 fmol/punch was 6.4 (95% CI: 2.0, 20.6; P=0.002) when comparing participants in the highest pMRCI quartile with those in the lowest quartile.

Conclusions: Higher pMRCI for non-ART medications is associated with lower adherence as measured by TFV-DP in DBS. Future research should investigate whether reducing non-ART medication complexity improves ART adherence and exposure in PWH.