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

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.

Patient Satisfaction with Once-Daily Single-Tablet Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide (DRV/c/FTC/TAF): A Real-World Study of Patient Self-Reported Outcomes in HIV-1–Diagnosed Adults

“…Overall, the HIV symptoms reported in this study were similar to those reported through PROs in previous studies. 21–28 For example, fatigue, anxiety, and body image were also among the most common symptoms reported in patients who switched from a ritonavir-boosted PI to a cobicistat-boosted PI in an Italian cohort study. 21 …”

“…Overall, the HIV symptoms reported in this study were similar to those reported through PROs in previous studies. [21][22][23][24][25][26][27][28] For example, fatigue, anxiety, and body image were also among the most common symptoms reported in patients who switched from a ritonavir-boosted PI to a cobicistatboosted PI in an Italian cohort study. 21 PROs, such as HIVTSQs and HIV-SDM, are becoming more prevalent in use as demand is increasing from regulatory authorities to provide real-world data that includes patient perspectives with new drug filings.…”

Patient-Reported Treatment Satisfaction and Quality of Life Among People Living with HIV Following the Introduction of Dolutegravir-Based ART Regimens in Ukraine

“…This could have been due to DTG-based regimens having a single daily pill and fewer food restrictions. Drug simplification and use of fixed dose polypills over multiple pills have been associated with increases in treatment satisfaction in ART switching studies [18] and with increased adherence [37]. An observational study following DTG scale-up in Brazil found higher rates of ART adherence with daily dosing, DTG-based regimen (DTG + TDF/3TC), in routine practice [38].…”

“…PROs provide information about patient's perceptions of their general health status, and therefore are important proxies for distal clinical health outcomes useful in measuring clinical effectiveness and safety [14][15][16]. They can be used to measure improvements in HIV care and health outcomes at individual, institutional, and population levels [15,17,18] and have been demonstrated to predict HIV treatment persistence [19] and adherence [20][21][22]. Commonly used PRO measures and instruments in HIV care include but are not limited to treatment satisfaction, health-related quality of life (QoL), self-rated mental and physical health, and treatment side-effects [16].…”

Darunavir/Cobicistat Is Associated with Negative Outcomes in HIV-Negative Patients with Severe COVID-19 Pneumonia

“…The rationale for the use of DRV/c over lopinavir/ritonavir was argued by more favorable metabolic profile and less DDI, as shown in the HIV setting. 13,14 However, an in vitro study showed that DRV had no antiviral activity against SARS-CoV-2, as the binding site of DRV little interact with SARS-CoV-2 main protease active site. 15 In addition, a recently published RCT reported that administration of DRV/c for 5 days did not fasten a viral clearance over a standard of care alone in a small sample of 30 patients.…”