Persistence with anti -retroviral therapy improved between 2001 … · 2016-05-25 · Persistence...
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Persistence with anti-retroviral therapy improved between 2001 and 2010 in the US Bora Youn, MS, MPH; Yoojin Lee, MS, MPH; Theresa Shireman, PhD, RPh; Omar Galárraga, PhD; Aadia Rana, MD; Ira Wilson, MD 11th International Conference on HIV Treatment and Prevention Adherence May 9-11, 2016
Transcript of Persistence with anti -retroviral therapy improved between 2001 … · 2016-05-25 · Persistence...
Persistence with anti-retroviral therapy improved between 2001 and 2010 in the US
Bora Youn, MS, MPH; Yoojin Lee, MS, MPH; Theresa Shireman, PhD, RPh; Omar Galárraga, PhD; Aadia Rana, MD; Ira Wilson, MD
11th International Conference on HIV Treatment and Prevention AdherenceMay 9-11, 2016
Study Background
Continuous use of anti-retroviral therapy (ART) is a critical component of the Care Continuum
Improved ART adherence in some individual HIV clinics and academic-based cohorts
Limited nationally representative data on time trends or sociodemographic predictors
Generalizable estimates can help identify areas for targeted interventions
Objectives
(1) To examine the changes in ART persistence in representative U.S. population with Medicaid between 2001 and 2010(2) To determine the factors associated with ART persistence in a real-world setting
Persistence vs. Implementation
PERSISTENCE: duration of use without exceeding the permissible gap
IMPLEMENTATION: % of doses taken as prescribed during the corresponding period of persistence
StartMedication
PermissibleGap
Ends Medication
Non-persistent periods
Data
Medicaid Analytic Extract (MAX) file, 2001-2010 Medicaid is the single largest source of care for HIV patients 14 states with the highest HIV prevalence (75% of US cases)
Individuals with HIV based on ICD-9 diagnosis codes and ART fill records
n=397,836
Individuals with complete ART regimen episoden=227,531
Individuals fully observable in the Medicaid FFS system n=44,456
Study Inclusion Criteria
Individuals who initiated ART (no ART fill records six month prior to initiation & continuously eligible)
n=91,741
Outcome Measurement
Treatment duration: first ART fill date to the last fill date before the 90 days permissible gap (treatment discontinuation)
Censoring for survival analysis– End of the study– Death– Lost Medicaid FFS coverage
Study Variables
Main Independent Variable
Treatment initiation year (2001-2003, 2004-2006, 2007-2010)
Covariates
Age group Gender Race/Ethnicity State Initial ART regimen type
(integrase inhibitor based, NRTI based, NNRTI based, PI based, multiple classes)
Initial NRTI backbone (TDF/ABC, AZT, ddl/d4T, others)
Single tablet regimen use
Statistical Analysis
Chi-square tests used to examine the differences among the patients who initiated ART during the three time periods
Kaplan-Meier plots used to compare crude time to discontinuation
Cox-proportional hazards models used to evaluate the factors associated with non-persistence, adjusting for covariates
0
4000
8000
12000
16000
20000
2001-2003 2004-2006 2007-2010
Treatment Initiation Year
Cohort Characteristics
0.0
10.0
20.0
30.0
40.0
50.0
<25 25-34 35-44 45-54 55+
Age group
2001-2003 2004-2006 2007-2010
0.0
20.0
40.0
60.0
Male Female
Gender
2001-2003 2004-2006 2007-2010
0.0
20.0
40.0
60.0
Black White Hispanic Asian/PI/NA Multi/unknown
Race/Ethnicity
2001-2003 2004-2006 2007-2010
n=18,336
n=13,286 n=12,834
%
% %
All p<.0001
Cohort Characteristics
0.0
10.0
20.0
30.0
40.0
50.0
60.0
IntegraseInhibitor
Based
NNRTI based PI based NRTI based multipleclasses
Initial ART regimen type
2001-2003 2004-2006 2007-2010
0.0
20.0
40.0
60.0
80.0
100.0
TDF/ABC AZT ddl/d4T others
Initial NRTI backbone
2001-2003 2004-2006 2007-2010
0.0
20.0
40.0
60.0
80.0
100.0
Yes
Single Tablet Regimen Use
2001-2003 2004-2006 2007-2010
0.0
10.0
20.0
30.0
40.0
50.0
CA FL GA IL LA MA MD NC NJ NY OH PA TX VA
State
2001-2003 2004-2006 2007-2010
%
%
%
%
All p<.0001
Time to treatment discontinuation (unadjusted Kaplan-Meier Curve)
Log-rank test p<.0001
Initiation year 2001 - 2003
Initiation year 2004 - 2006
Initiation year 2007 - 2010
Time from ART initiation (months)
Prop
ortio
n pe
rsist
ent o
n tr
eatm
ent
Time to treatment discontinuation by State and Race/Ethnicity
0
5
10
15
20
25
30
35
40
45
CA NJ NC PA MAMD VA IL OH NY FL GA LA TX
25% time Median time
0
5
10
15
20
25
30
35
40
25% time Median time
mon
ths
Cox Proportional Hazards Model
HR<1: Less likely to discontinue ART The following factors were associated with lower hazards of
treatment discontinuation: older age, male, non-black, newer ART regimen, initiation in recent years, living in NJ, and single tablet regimen use.
aHR 95% CI p-value
Calendar year (ref=2001-2003)
2004-2006 0.93 (0.90, 0.97) 0.0001
2007-2010 0.81 (0.77, 0.85) <.0001
Cox Proportional Hazards Model
0.0
0.2
0.4
0.6
0.8
1.0
1.2
1.4
1.6
1.8
NJ MD PA VA CA NC IL OH MA FL GA LA TX
Adjusted Hazard Ratio of Treatment Discontinuation by States (ref=NY)
Cox Proportional Hazards Model
aHR 95% CI p-value
Gender (ref=female) Male 0.89 (0.86, 0.91) <.0001
Race/Ethnicity (ref=Black)
Asian/PI/NA 0.85 (0.73, 0.98) 0.03
Hispanic 0.86 (0.83, 0.90) <.0001
Multiracial/Unknown 0.82 (0.77, 0.87) <.0001
White 0.83 (0.80, 0.87) <.0001
Regimen Type(ref=PI based)
Integrase Inhibitor Based 0.77 (0.58, 1.02) 0.07
NNRTI based 0.90 (0.87, 0.93) <.0001
NRTI based 1.03 (0.99, 1.08) 0.18
Multiple Classes 1.36 (1.26, 1.45) <.0001
NRTI backbone (ref=TDF/ABC)
AZT 1.33 (1.27, 1.38) <.0001
ddl/d4T 1.35 (1.29, 1.42) <.0001
others 1.14 (1.01, 1.29) 0.03Single tablet regimenuse (ref=no) Yes 0.72 (0.67, 0.78) <.0001
Conclusions
Marked improvement in ART persistence between 2001 and 2010
Site adherence counseling as a potential explanatory factor
Significant problems with non-persistence remain, with clear disparities for Blacks and women
State differences are concerning, may relate to Medicaid generosity, and merit further study
Limitations
No follow-up with the patients after Medicaid disenrollment
No viral loads or CD4 counts Not generalizable to the uninsured, commercially
insured, and Medicare population Not all states were included
Implications
National, population-based data that can be generalized to HIV patients in the U.S with Medicaid
Can help identify areas for targeted interventions Differences between the results of persistence and
implementation analysis (next presentation)
Acknowledgements
Team Members: Yoojin Lee, Theresa Shireman, Omar Galárraga, Aadia Rana, and Ira Wilson
NIMH 1R01MH102202 Providence/Boston Center for AIDS Research
(Providence/Boston CFAR NIH/NIAID grant P30AI042853)
Thank you
