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 < 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 language | English |
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Pages (from-to) | 375-387 |
Number of pages | 13 |
Journal | Patient |
Volume | 13 |
Issue number | 3 |
DOIs | |
Publication status | Published - 2020 |
Keywords
- 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