Patient-Reported Outcomes in an Observational Cohort of HIV-1-Infected Adults on Darunavir/Cobicistat-Based Regimens: Beyond Viral Suppression

• DOI: 10.1007/s40271-020-00413-y
• Publication Date: 2020-04-08T02:02:31Z
• Authors: Andrea Antinori; Maria V. Cossu; Barbara Menzaghi; Gaetana Sterrantino; Nicola Squillace; Valentina Di Cristo; Annamaria Cattelan; Emanuele Focà; Antonella Castagna; Giancarlo Orofino; Daniela Valenti; Gabriella D’Ettore; Lucia Aprea; Sergio Ferrara; Maria E. Locatelli; Giordano Madeddu; Emanuele Pontali; Paolo Scerbo; Barbara Rossetti; Alessia Uglietti; Roberta Termini; Francesco Rucci; Andrea Gori; Daniela Mancusi
• Keywords: Adult; Male; Anti-HIV Agents; HIV Infections; single-tablet regimen; treatment-naive; open-label; antiretroviral adherence; HIV; darunavir; validation; durability; cobicistat; trial; HIV Protease Inhibitors; Middle Aged; 3. Good health; Cohort Studies; 03 medical and health sciences; 0302 clinical medicine; Italy; Patient Satisfaction; Surveys and Questionnaires; Humans; Cobicistat; Drug Therapy, Combination; Female; Original Research Article; Patient Reported Outcome Measures; Prospective Studies; Darunavir

This prospective, multicenter, non-interventional cohort study enrolling human immunodeficiency virus (HIV)-1-infected, virally suppressed adult outpatients in Italy aimed to describe results obtained from patient-reported outcome questionnaires regarding treatment satisfaction and symptom perceptions in HIV-1-positive patients who switched to cobicistat-boosted darunavir antiretroviral regimens, coming from ritonavir-boosted protease inhibitors.Patients entered this study between June 2016 and February 2017, once their treating physician had considered them eligible for cobicistat-boosted darunavir-based treatment as per clinical practice. Patients' satisfaction regarding regimen and current symptom burdens were assessed using two previously validated, patient-reported outcome questionnaires: HIV Treatment Satisfaction Questionnaire (HIV-TSQ) and HIV Symptoms Distress Module (HIV-SDM). These questionnaires were administered at prespecified time-points: enrollment (Visit 1), 4-8 weeks later (Visit 2), and 48 ± 6 weeks after study enrollment (Visit 4). Data of patient-reported outcome total scores for both questionnaires are presented as median with 25th-75th percentiles. Questionnaires scores were analyzed overall and stratified by gender when applicable. A p value of less than 0.05 was considered statistically significant. A sensitivity analysis was conducted to evaluate the role of lost to follow-up, using the "last observation carried forward" method.A total of 348 patients were enrolled in this study; 296 patients (208 male and 88 female) provided both evaluable HIV-TSQ and HIV-SDM at enrollment and at 4-8 weeks, while 250 patients (174 male and 76 female) provided questionnaire data at enrollment and at 48 ± 6 weeks. The total scores of HIV-TSQ showed improvements in patient satisfaction in the overall population both at Visit 2 and Visit 4 (p < 0.001, sign test) and also when stratified by gender throughout the study period. In addition, the overall burden of symptoms, as shown by the HIV-SDM scores, decreased.Switching to a cobicistat-boosted darunavir-based therapy led to overall increased patient satisfaction and reduced symptom burden when compared with previous regimens. The use of patient-reported outcomes in clinical daily practice could provide a useful tool towards achieving guideline goals to achieve "fourth 90", having 90% of virally suppressed patients with a good health-related quality of life.