Background and Importance Simplification strategies aimed to improve antiretroviral therapy adherence, tolerability and compliance have emerged during recent decades. In this context, long-acting cabotegravir/rilpivirine injectable has been recently commercialised as a new promising treatment alternative, and pharmacist-led long-term monitoring could be beneficial to ensure treatment effectiveness and safety.

Aim and Objectives Assess the long-term real-life effectiveness and safety of cabotegravir/rilpivirine.

Material and Methods This was an observational, longitudinal and prospective study performed between March and September 2023. Patients were included if they started treatment with either a one-month oral lead-in (OLI) with cabotegravir/rilpivirine followed by long-acting therapy or directly with the long-acting injection regimen (at month 0, 1, 3 and 5) and received at least 4 injectable doses and excluded if participated in FLAIR and ATLAS studies. Sociodemographic (age, sex at birth), anthropometric (body mass index [BMI]) and viral (HIV-RNA viral load at baseline and 5-month follow-up) data were collected. Treatment was considered effective when patients achieved or maintained virological suppression

Drug adverse effects were collected and followed-up through active pharmacist validation, and clinical and nursing-staff monitoring.

Results 30 patients were included (90% male sex at birth, mean age 43.7 years). 1 patient had a BMI>30. At baseline, all patients had undetectable viral load (HIV-RNA<50 copies/mL) and 6(20%) started with OLI.

At 5-months follow-up, 28(93.3%) patients had an undetectable viral load. 2 patients abandoned treatment after 1 month, due to an unknown archived rilpivirine mutation (one patient had a VL of 113,146 copies/mL and the other remained undetectable).

90% of patients reported at least 1 adverse effect, being the most frequent: injection-site reactions (83.3% of patients reported gluteal pain, 13.3% induration), followed-by low-grade fever (10%), fatigue (6.7%) and diarrhoea (6.7%).

Conclusion and Relevance Cabotegravir/rilpivirine effectiveness and safety were favourable in this cohort of baseline virologically suppressed patients. No treatment interruptions due to adverse effects were observed but resistance mutations need to be considered.

Although small sample size, low proportion of female patients and a short-term follow-up due to recent commercialisation, this study could be of help due to lack of studies reporting data on cabotegravir/rilpivirine effectiveness in real-life population and long-term pharmacist treatment monitoring

Conflict of Interest No conflict of interest.