Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Jun;13(3):375-387.
doi: 10.1007/s40271-020-00413-y.

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

Andrea Antinori  1 , Maria V Cossu  2 , Barbara Menzaghi  3 , Gaetana Sterrantino  4 , Nicola Squillace  5 , Valentina Di Cristo  6 , Annamaria Cattelan  7 , Emanuele Focà  8 , Antonella Castagna  9   10 , Giancarlo Orofino  11 , Daniela Valenti  12 , Gabriella D'Ettore  13 , Lucia Aprea  14 , Sergio Ferrara  15 , Maria E Locatelli  16 , Giordano Madeddu  17 , Emanuele Pontali  18 , Paolo Scerbo  19 , Barbara Rossetti  20 , Alessia Uglietti  21 , Roberta Termini  21 , Francesco Rucci  22 , Andrea Gori  23   24 , Daniela Mancusi  25
Affiliations

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

Andrea Antinori et al. Patient. 2020 Jun.

Erratum in

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.

PubMed Disclaimer

Conflict of interest statement

Andrea Antinori received a grant from Gilead Sciences, ViiV Healthcare, and Janssen-Cilag; he received consulting fees or honorarium from ViiV Healthcare, Janssen-Cilag, and Merck. Emanuele Foca has received consultancy fees and honoraria by several pharmaceutical companies in the field of HIV infections. Annamaria Cattelan received a grant from Janssen-Cilag and consulting fees or honorarium from ViiV Healthcare, MSD, Gilead Sciences, and Janssen-Cilag. Giordano Madeddu received consulting fees or honorarium from ViiV Healthcare, Gilead Sciences, MSD, and Janssen-Cilag; he received a speaker’s fee from ViiV Healthcare, Angelini, and Pfizer. Emanuele Pontali received consulting fees or honorarium for advisory board participation for Janssen-Cilag; he received payments for training activities for Janssen-Cilag. Barbara Rossetti received consulting fees or honorarium for educational activities with REPs and a support for meeting participation. Andrea Gori received a grant from Janssen-Cilag, ViiV Healthcare, MSD, BMS, Abbvie, Gilead Sciences, Novartis, Pfizer, Astellas, AstraZeneca, and Angelini; he received consulting fees or honorarium from Janssen-Cilag, ViiV Healthcare, MSD, BMS, Abbvie, Gilead Sciences, Novartis, Pfizer, Astellas, AstraZeneca, and Angelini. Maria V. Cossu, Barbara Menzaghi, Gaetana Sterrantino, Nicola Squillace, Valentina Di Cristo, Antonella Catagna, Giancarlo Orofino, Daniela Valenti, Gabriella D’Ettore, Lucia Aprea, Sergio Ferrara, Maria E. Locatelli, Paolo Scerbo, and Francesco Rucci have no conflicts of interest that are directly relevant to the content of this article. Alessia Uglietti, Roberta Termini, and Daniela Mancusi are Janssen employees.

Figures

Fig. 1
Fig. 1
Median HIV Treatment Satisfaction Questionnaire-Change (HIV-TSQc) scores reported during the study. V2 Visit 2 (after 4–8 weeks from enrollment), V4 Visit 4 (after 48 ± 6 weeks from enrollment)
Fig. 2
Fig. 2
HIV Treatment Satisfaction Questionnaire-Change (HIV-TSQ) selected item scores reported during the study
Fig. 3
Fig. 3
HIV Symptoms Distress Module (HIV-SDM) questionnaire results reported during the study for the presence of symptoms in the overall population. Data were statistically analyzed using the McNemar test
Fig. 4
Fig. 4
HIV Symptoms Distress Module (HIV-SDM) results stratified by gender for the presence of the most relevant symptoms. Data denoted with “*” were statistically analyzed using the McNemar test. Data denoted by “**” were statistically analyzed using the sign test, performed when the discordant pairs were ≤ 20
Fig. 5
Fig. 5
HIV Symptoms Distress Module (HIV-SDM) median total scores stratified by protease inhibitors (PIs). Data were statistically analyzed using the signed-rank test for comparison within groups, between Visit 2 (V2) and Visit 1 (V1), or between Visit 4 (V4) and Visit 1 (V1)
None
See this image and copyright information in PMC

References

    1. Antiretroviral Therapy Cohort Collaboration Survival of HIV-positive patients starting antiretroviral therapy between 1996 and 2013: a collaborative analysis of cohort studies. Lancet HIV. 2017;4:e349–e356. doi: 10.1016/S2352-3018(17)30066-8. - DOI - PMC - PubMed
    1. O’Connor J, Smith C, Lampe FC, et al. Durability of viral suppression with first-line antiretroviral therapy in patients with HIV in the UK: an observational cohort study. Lancet HIV. 2017;4:e295–e302. doi: 10.1016/S2352-3018(17)30053-X. - DOI - PMC - PubMed
    1. Sheth AN, Ofotokun I, Buchacz K, et al. Antiretroviral regimen durability and success in treatment-naive and treatment-experienced patients by year of treatment initiation, United States, 1996–2011. J Acquir Immune Defic Syndr. 2016;71:47–56. doi: 10.1097/QAI.0000000000000813. - DOI - PMC - PubMed
    1. Lazarus JV, Safreed-Harmon K, Barton SE, et al. Beyond viral suppression of HIV: the new quality of life frontier. BMC Med. 2016;14:94. doi: 10.1186/s12916-016-0640-4. - DOI - PMC - PubMed
    1. Webster P. UNAIDS survey aligns with so-called fourth 90 for HIV/AIDS. Lancet. 2019;393:2188. doi: 10.1016/S0140-6736(19)31231-0. - DOI - PubMed

Publication types