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

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 and Daniela Mancusi ()
Additional contact information
Andrea Antinori: National Institute for Infectious Diseases “Lazzaro Spallanzani”-IRCCS
Maria V. Cossu: ASST Fatebenefratelli Sacco
Barbara Menzaghi: Infectious Diseases, Azienda Socio-Sanitaria Territoriale della Valle Olona-Busto Arsizio
Gaetana Sterrantino: University of Florence
Nicola Squillace: “San Gerardo” Hospital, ASST Monza
Valentina Di Cristo: University of Milan
Annamaria Cattelan: Azienda Ospedaliero-Universitaria di Padova
Emanuele Focà: University of Brescia and Spedali Civili General Hospital
Antonella Castagna: IRCSS San Raffaele Scientific Institute
Giancarlo Orofino: Amedeo di Savoia Hospital
Daniela Valenti: FROM Research Foundation, Papa Giovanni XXIII Hospital
Gabriella D’Ettore: Sapienza University
Lucia Aprea: VIII Divisione di Malattie Infettive, A.O.R.N. Cotugno
Sergio Ferrara: University of Foggia
Maria E. Locatelli: UOC Malattie Infettive, ARNAS “Garibaldi”
Giordano Madeddu: University of Sassari
Emanuele Pontali: Infectious Diseases, E.O. Ospedali Galliera
Paolo Scerbo: “Pugliese-Ciaccio” Hospital
Barbara Rossetti: Siena University Hospital
Alessia Uglietti: Janssen-Cilag SpA
Roberta Termini: Janssen-Cilag SpA
Francesco Rucci: University of Milan
Andrea Gori: University of Milan
Daniela Mancusi: Janssen-Cilag SpA

The Patient: Patient-Centered Outcomes Research, 2020, vol. 13, issue 3, No 10, 375-387

Abstract: Abstract Objective 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. Methods 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. Results 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

Date: 2020
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DOI: 10.1007/s40271-020-00413-y

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