Effectiveness and safety of darunavir/cobicistat/emtricitabine/tenofovir alafenamide therapy in an observational Italian cohort: The DIAMANTE study

Aim: DIAMANTE is a retrospective and prospective, non-interventional, cohort study to describe the effectiveness of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in real clinical practice in Italy. Patients & methods: The study enrolled 246 patients: group 1 included patients treated with a darunavir-based regimen (n = 81); group 2 included patients who received antiretroviral treatment not including darunavir before D/C/F/TAF (n = 43); and group 3 included naive patients (n = 122). Effectiveness was evaluated as the virological response at week 48. Results: The D/C/F/TAF virological response rate was 72.1-78.8% and was obtained despite longer follow-up intervals due to the coronavirus 2019 pandemic. The safety of D/C/F/TAF was good as was the overall patient satisfaction and quality of life. Conclusion: This study confirmed the effectiveness and tolerability of D/C/F/TAF in a real-life setting both in naive and pretreated patients, with and without darunavir. Clinical Trial Registration: NCT03577470 (ClinicalTrials.gov.