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

A. Antinori, M.V. Cossu, B. Menzaghi, G. Sterrantino, N. Squillace, V. Di Cristo, A. Cattelan, E. Focà, A. Castagna, G. Orofino, D. Valenti, G. D’Ettore, L. Aprea, S. Ferrara, M.E. Locatelli, G. Madeddu, E. Pontali, P. Scerbo, B. Rossetti, A. UgliettiR. Termini, F. Rucci, A. Gori, D. Mancusi

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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 < 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. Conclusions: 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.

Original languageEnglish
Pages (from-to)375-387
Number of pages13
Issue number3
Publication statusPublished - 2020


  • abacavir plus lamivudine
  • cobicistat plus darunavir
  • emtricitabine plus tenofovir disoproxil
  • adult
  • antiretroviral therapy
  • anxiety disorder
  • Article
  • assessment of humans
  • bloating
  • body image
  • body weight loss
  • cohort analysis
  • diarrhea
  • fatigue
  • female
  • follow up
  • headache
  • hepatitis C
  • HIV Symptoms Distress Module
  • HIV Treatment Satisfaction Questionnaire
  • human
  • Human immunodeficiency virus 1 infection
  • hypertension
  • Italy
  • major clinical study
  • male
  • middle aged
  • mixed infection
  • multicenter study
  • nausea
  • observational study
  • osteopenia
  • pain
  • patient satisfaction
  • patient-reported outcome
  • priority journal
  • prospective study
  • sensitivity analysis
  • skin disease


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