Clinical Outcomes of Single Tablet vs. Multi-Tablet Antiretroviral Regimens in HIV-Infected Individuals

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1 Clinical Outcomes of Single Tablet vs. Multi-Tablet Antiretroviral Regimens in HIV-Infected Individuals Abstract #18 IRB Approved Jeannie Ong, Pharm.D., AAHIVP PGY2 HIV Pharmacotherapy Resident University of Oklahoma Oklahoma City, OK Infectious Diseases Institute (IDI) Federally funded by the Ryan White HIV/AIDS Program Multidisciplinary team Pharmacists provide Medication therapy management Medication adherence assessment Monthly pill box fill service Initial counseling with newly diagnosed HIV patients or patients returning into medical care Provides care to over 1,800 patients annually 4 Disclosure Jeannie Ong Potential conflicts of interest: none Sponsorship: none Proprietary information or results of ongoing research may be subject to different interpretations Speaker s presentation is educational in nature and indicates agreement to abide by the non-commercialism guidelines provided OU Pharmacist Care Center University of Oklahoma College of Pharmacy operated clinic located on the OUHSC campus HIV/AIDS Drug Assistance Program (ADAP) Retail and mail-order service for all Oklahoma residents receiving ADAP services 2 5 Learning Objectives 1. Recognize the importance of medication adherence and its clinical impact on HIV-infected patients 2. Identify various factors why patients might be ineligible for single tablet regimens for the treatment of HIV Pharmacist Pre-Test Assessment 3 6 1

2 Introduction ART Key Points HIV & AIDS >1.2 million Americans 1 in 8 are unaware Goals of HIV antiretroviral therapy (ART) Achieve viral suppression Restore and preserve immunologic function Reduce morbidity and prolong duration/quality of survival Reduce viral mutations Prevent HIV transmission Medication adherence Same time everyday All or nothing Do not split regimen take together Pill boxes Alarm clocks Key chains Calendars Mobile apps Motivational interviewing Education CDC. HIV/AIDS. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents Single Tablet Regimens (STRs) Barriers to Medication Adherence Pill burden Side effects Cost Perceived importance Stigma Denial Mental illness Substance abuse Psychosocial factors Homelessness Lack of social support Multi-factoral Positively Aware Multi-Tablet Regimens (MTRs) Presence of viral mutations leading to medication resistance Formulary issues (hospital or department of corrections) Patient specific characteristics (i.e. renal function) Drug intolerance Drug-drug interactions Medication Adherence HIV medication adherence goal 95% 99 patients utilizing computerized caps Based on one type of therapy that was MTR Based on now obsolete therapy 9 Paterson DL, et. al. Ann Intern Med. 2000;133:

3 First FDA-Approved STR 2006 Atripla Current Practice Atripla Currently alternative therapy CNS effects: strange vivid dreams, dizziness, drowsiness Current data: Lacking on the comparative effectiveness of newer formulated STRs compared with MTRs 13 Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. 16 Since the Approval of Atripla Study Questions STRs have been associated with: Reduced pill burden Improved medication adherence Higher patient satisfaction Virologic suppression Fewer hospitalization Reducing healthcare costs 1. What adherence threshold is associated with viral suppression? 2. Do STRs still improve medication adherence and viral suppression compared to MTRs? Paterson DL, et. al. Ann Intern Med. 2000;133: Cohen CJ, et al. BMJ Open 2013;3:e Bangsberg DR, et al. AIDS Nov 27;24(18): FDA-Approved STRs Other Current Studies 2006 Atripla 2012 Stribild 2015 Genvoya Dr. Marcus Tad Autry: Adherence rates among regimens in treatment-naïve patients only 2011 Complera 2014 Triumeq 2016 Odefsey Dr. Krista Williams: Adherence rates of integrase inhibitor-based regimens compared to other ARV classes

4 Study Aims Objective: examine the clinical outcomes of fixed-dose, single tablet regimens compared to multi-tablet regimens in HIV-infected individuals Clinical hypothesis: whether HIV-infected individuals taking STR antiretroviral therapy experience better clinical outcomes compared to individuals taking MTR Medication Possession Ratio (MPR) Utilizes pharmacy claims data Perfect adherence will be reported as 100% Possible for MPR to exceed 100% Methods Single-center, retrospective, observational study OU Infectious Disease Institute clinic between 2011 and 2016 Disease parameters - baseline CD4 cell count, plasma HIV RNA, date of HIV diagnosis, co-morbidities Demographic - age, race, sex, HIV risk category, HIV treatment naïve or experienced, ART Methods Inclusion Criteria HIV-infected 6 months ART 4 viral loads (AUC) Exclusion Criteria Outside pharmacy Incarceration < 6 months ART < 4 viral loads Statistical Analysis Descriptive statistics for patient demographics Medication possession ratio will be calculated to analyze refill claims data to assess patient adherence to antiretroviral therapy Viral load AUC estimates viral control over time Multivariate regression analysis examines the relationship between MPR and viral load AUC Marginal effects analysis examines the probability of achieving viral suppression with MPR levels Endpoints Primary MPR Virologic suppression Secondary Effects on MPR Gender Race/ethnicity Age Exposure risk factor(s)

5 Results & Conclusion Pharmacist Post-Test Assessment Phase I: Enrollment Phase II: Data Collection Phase III: Data Analysis Hypothesis It is our prediction that patients receiving STR will demonstrate improved clinical outcomes such as superior medication adherence and will achieve higher rates of virologic suppression Clinical Outcomes of Single Tablet vs. Multi-Tablet Antiretroviral Regimens in HIV-Infected Individuals 26 Abstract #18 IRB Approved Jeannie Ong, Pharm.D., AAHIVP PGY2 HIV Pharmacotherapy Resident University of Oklahoma Oklahoma City, OK Pharmacist Post-Test Assessment 27 5