Shifting antiretroviral drug distribution from Outpatient Clinics to Hospital Pharmacies in Italy. Evolution of ART delivery methods and impact on treatment adherence.

Abstract

Objectives: This retrospective observational study assesses adherence to antiretroviral therapy before and after the transition to pharmacy-based treatment dispensation.

Methods: Two 14-month periods were identified: before (P1) and after (P2) the transition to pharmacy-based provision of antiretrovirals. P2 also coincided with the SARS-CoV-2 pandemic. Adherence was assessed using a mathematical index to estimate the delay in refilling medication (delay index Di).

Results: 1,266 people with HIV were included. Higher values of Di were found to be associated with P2 (ß 0.17, 95%CI 0.04-0.07), primarily driven by a significant delay in the initial months of the SARSCoV-2 pandemic in Italy, with Di +0.051 ± 0.13 from March to May 2020 vs. Di +0.048 ±0.12 in the rest of P2. Higher Di was also associated with multi-tablet regimens (ß 0.06, 95%CI 0.006-0.03), whereas switching regimens was associated with lower Di (ß -0.06, 95%CI -0.07-0.04). The odds of HIV RNA>50 copies/mL were higher with higher Di (OR 2.78; 95%CI 1.14-6.75), but lower in P2 compared to P1 (OR 0.38; 95%CI 0.27-0.53).

Conclusions: Despite an apparent adherence decline due to delays in treatment refills during the first months of the SARS-CoV-2 pandemic, the transition to pharmacy-based antiretrovirals supply was associated with lower frequency of uncontrolled HIV replication.