OBJECTIVE: Switching from oral anti-retroviral therapy (ART) to intramuscular administration of Cabotegravir-Rilpivirine (CAB+RPV) has been observed to decrease the number of pills that patients need to take, enhance patient satisfaction, and promote better adherence to treatment. Clinical trials have reported not only the virological and immunological effectiveness of these intramuscular medications but have also assessed their safety and patient satisfaction. This transition eliminates the challenges related to patient adherence and compliance with daily oral regimens.

PATIENTS AND METHODS: Our observational study included 14 people living with HIV (PLWH) who were under medical care at the “Gaetano Martino” University Hospital in Messina, Italy. These individuals were virologically suppressed and had been adherent to ART for at least 6 months. Importantly, they did not have documented or suspected resistance mutations to Cabotegravir + Rilpivirine (CAB+RPV). Data were collected at different time points: at the beginning of the study, one month after the lead-in phase with oral CAB+RPV, and one month after the first and second injections of CAB+RPV. Additionally, we routinely measured CD4+, CD8+, CD4+/CD8+ ratio, HIV-RNA plasma viral load, and clinical chemistry parameters. Statistical analysis was performed with Jamovi 2.0 for MacOS. Patient treatment satisfaction was assessed through a questionnaire, where we formulated and administered a series of questions to our patients to gauge their satisfaction with the intramuscular administration of these long-acting medications. Specifically, we asked them a simple question to determine whether they were satisfied or dissatisfied with the new method of administering CAB+RPV.

RESULTS: In our study, we enrolled 14 individuals living with HIV (PLWH), predominantly males (92.9%), with a median age of 36 years (IQR: 30.25-39.75). Of these participants, 85.7% had transitioned from an integrase strand transfer inhibitor (INSTI)-based regimen, 7.1% from a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen, and 7.1% from a protease inhibitor (PI)-based regimen. Notably, HIV-RNA remained undetectable throughout the assessment period. Following the first intramuscular (IM) injection, 78.5% reported moderate to severe pain, decreasing to 57.1% after the second injection. While not statistically significant, we observed a positive trend in CD4+ percentage (p=0.641) and CD4/CD8 ratio (p=0.368), with a non-significant decrease in CD4+ T-cell count (p=0.882). The transition to IM CAB+RPV did not significantly impact low-density lipoprotein cholesterol (LDLc) levels (p=0.417). When questioned about satisfaction with the new treatment regimen, 71.4% of PLWH expressed contentment with the injectable regimen, while 21.4% chose not to respond.

CONCLUSIONS: People living with HIV (PLWH) who were on long-acting ART (LA-ART) with CAB+RPV expressed satisfaction with their new treatment regimen, and viral load remained undetectable in all cases. Pain, as reported in clinical trials, emerged as the primary side effect. Our real-life experience affirmed the virological and immunological effectiveness, safety, and patient satisfaction associated with long-acting ART using CAB+RPV.