Abstract
Purpose
Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide can be used as a single-tablet regimen (STR, DRV/c/FTC/TAF) or multiple-tablet regimen (MTR, DRV/c+FTC/TAF) to treat patients with human immunodeficiency virus (HIV). This study described treatment patterns and predictors of adherence among patients with HIV initiated on DRV/c/FTC/TAF or DRV/c+FTC/TAF.
Patients and Methods
A retrospective longitudinal study was conducted using linked claims and electronic medical records from Decision Resources Group’s Real World Data Repository (7/17/2017–6/1/2019). Treatment-naïve and treatment-experienced virologically suppressed adults with HIV-1 prescribed DRV/c/FTC/TAF or DRV/c+FTC/TAF (index date) were included. Six-month persistence (no treatment gaps >60 and >90 days) and adherence (proportion of days covered [PDC]) to the index regimen were evaluated among patients with ≥6 months of observation post-index. Predictors of low adherence (PDC<80%) were evaluated using a logistic regression model.
Results
Among 2633 eligible patients (49.5 years old, 29% female, 37% African American/Black), 12% were treatment-naïve pre-index and 88% switched from a previous antiretroviral therapy; 84% initiated DRV/c/FTC/TAF and 16% initiated DRV/c+FTC/TAF. Among 822 DRV/c/FTC/TAF patients with ≥6 months of observation post-index, 80% and 86% had no >60- and >90-day gaps in DRV/c/FTC/TAF coverage, respectively, while among 204 DRV/c+FTC/TAF patients with ≥6 months of observation post-index, 69% and 75% had no >60- and >90-day gaps in DRV/c+FTC/TAF coverage, respectively. Mean (median) PDC for the index regimen was 81% (93%) for patients treated with DRV/c/FTC/TAF and 73% (83%) for patients treated with DRV/c+FTC/TAF. Predictors of low adherence included younger age (odds ratio [OR]=2.36, p=0.017), higher Quan-Charlson comorbidity index (OR=1.32, p=0.012), use of MTR regimen at index (OR=1.69, p=0.022), and prior low adherence (OR=2.56, p<0.001).
Conclusion
Among patients initiating a DRV/c-based regimen, those initiating STR had higher 6-month adherence/persistence than those initiating MTR, highlighting the potential benefits of the STR formulation, particularly among younger patients with multiple comorbidities and prior low adherence.
Abbreviations
ART, antiretroviral therapy; c, cobicistat; CCI, Charlson comorbidity index; CFR, Code of Federal Regulations; CI, confidence interval; DHHS, US Department of Health and Human Services; DRG, Decision Resources Group; DRV, darunavir; EMR, electronic medical record; ER, emergency room; FTC, emtricitabine; HIPAA, Health Insurance Portability and Accountability Act; HIV, human immunodeficiency virus; HRU, healthcare resource utilization; ICD-9 CM, International Classification of Diseases, 9th Revision, Clinical Modification; ICD-10 CM, International Classification of Diseases, 10th Revision, Clinical Modification; INSTI, integrase strand transfer inhibitor; IRB, Institutional Review Board; MTR, multi-tablet regimen; NNRTI, non-nucleoside reverse transcriptase inhibitors; OR, odds ratio; PDC, proportion of days covered; PI, protease inhibitor; SD, standard deviation; STR, single-tablet regimen; TAF, tenofovir alafenamide; US, United States.
Data Sharing Statement
The data that support the findings of this study are available from DRG but restrictions apply to the availability of these data, which were used pursuant to a data use agreement. The data are available through requests made directly to DRG, subject to DRG’s requirements for data access.
Ethics Approval and Informed Consent
Data are de-identified and comply with the patient requirements of the HIPAA. As this was an analysis of claims data, IRB approval was not required. Per Title 45 of the CFR, Part 46.101(b)(4),Citation31 the administrative claims data analysis of this study is exempt from the IRB review for two reasons: (1) it is a retrospective analysis of existing data (hence no patient intervention or interaction), (2) no patient-identifiable information is included in the claims dataset.
Consent for Publication
All authors confirm that the contents of this manuscript can be published.
Acknowledgments
Medical writing assistance was provided by Samuel Rochette, MSc, and Loraine Georgy, PhD, employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC, which funded the development and conduct of this study and manuscript.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
Dr Wing Chow is an employee of Janssen Scientific Affairs, LLC, during the conduct of the study; and owns stocks/shares at Johnson & Johnson, outside the submitted work. Ms Prina Donga is an employee of Janssen Scientific Affairs, LLC. Ms Aurélie Côté-Sergent is an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC, which funded the development and conduct of this study and manuscript. Dr Carmine Rossi is an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC, which funded the development and conduct of this study and manuscript. Mr Patrick Lefebvre is an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC, which funded the development and conduct of this study and manuscript, and funded additional HIV researches in the past 36 months. Ms Marie-Hélène Lafeuille is an employee of Analysis Group, Inc., a consulting company, that has provided paid consulting services to Janssen Scientific Affairs, LLC to conduct this study; and has provided paid consulting services to Pharmacyclics and GlaxoSmithKline, outside the submitted work. Dr Hélène Hardy is an employee of Johnson and Johnson. Mr Bruno Emond is an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Affairs, LLC, which funded the development and conduct of this study and manuscript. The authors report no other conflicts of interest in this work.