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.Plain language summary: How effective and safe is a darunavir-based treatment for patients affected by HIV?: Darunavir-based antiretroviral therapies have been shown to be effective in providing a long-lasting reduction of HIV-RNA level in the blood up over detection limit and to have a good safety profile in patients infected with HIV. This study shows the effectiveness and safety of the combination of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) given to patients living with HIV. The study, which took place in Italy, included 246 patients infected with HIV. The groups were: patients that had previously received a darunavir-based treatment; patients that had received a different antiretroviral treatment (not including darunavir) and; patients that had never been treated.The results of the study confirm that D/C/F/TAF is safe and caused a strong virological response.Tweetable abstract: Italian real-world study confirms efficacy and safety of darunavir-based therapy for HIV patients. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide regimen induces a strong virological response, ensuring long-lasting results. Promising for HIV treatment. #HIVresearch #AntiretroviralTherapy.