Significant Uptake of Truvada for
Pre-exposure Prophylaxis (PrEP) Utilization in
the US in Late 2014 – 1Q2015
IAPAC Treatment, Prevention, and Adherence Conference (June 28-30)
Bush, Staci; Ng, Leslie; Magnuson, David; Piontkowsky, David;
Mera Giler, Robertino
Gilead Sciences
‡
Background: Timeline of PrEP Community activation
Feb 2015 - CROI Data
Sept. 2014 - CDC High-Impact HIV
Prevention Funding $210 mil
Summer 2014 - Advocate Response
#Truvada“Whores”
May 2014 – USPHS/CDC Guidelines
July 2012 FDA Approves Truvada for PrEP
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Bush, S. et al; IAPAC Prevention 2015; #74
Method
 The objective of this study is to explore the increase of PrEP utilization
between January 1, 2012 and March 31, 2015.
 An estimated 39% of TVD Prescriptions were analyzed from a national
prescription database. An algorithm was used to identify TVD for PrEP
use in this sample.
 De-identified patient data included:
– Prescription refills
– Medical claims
– Patient demographics
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Bush, S. et al; IAPAC Prevention 2015; #74
Gilead’s Algorithm for PrEP Indication
Unique PrEP users were identified by excluding
ICD-9 codes of TVD use for HIV treatment, HBV, and PostExposure Prophylaxis (PEP).
HIV
Exclude a prior
diagnosis of HIV
disease
Exclude all
concomitant use of any
other antiretroviral
treatment.
HBV
Exclude a prior
diagnosis of chronic
hepatitis B infection
PEP
Exclude specific
codes contaminated
needle stick and /or
prophylaxis.
Exclude anti Chronic
Hepatitis B specific
treatment
Exclude a prior
diagnosis of an
opportunistic infection
Bush, S. et al; IAPAC Prevention 2015; #74
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New PrEP Starts per Quarter
2000
1761
Number of Subjects Starting PrEP
1800
Q1
Q2
1600
Q3
1395
1400
Total Unique Individuals = 8,512
1200
Q4
1242
Q1
Q2
1000
Q3
Q4
753
800
Q1
530
600
400
389
293
321
317
365
336
378
Q2
432
Q3
Q4
200
Q1
0
Q1
2012
Q2
Q3
Q4
Q1
2013
Q2
Q3
Q4
Q1
2014
Q2
Q3
Q4
IMS National Prescription Database accounts for approx. 39%
of all TVD prescriptions
Q1
2015
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Bush, S. et al; IAPAC Prevention 2015; #74
New PrEP Starts per Quarter
332% increase
2000
1761
Number of Subjects Starting PrEP
1800
Q1
Q2
1600
Q3
1395
1400
Total Unique Individuals = 8,512
1200
Q4
1242
Q1
Q2
1000
Q3
Q4
753
800
Q1
530
600
400
389
293
321
317
365
336
378
Q2
432
Q3
Q4
200
Q1
0
Q1
2012
Q2
Q3
Q4
Q1
2013
Q2
Q3
Q4
Q1
2014
Q2
Q3
Q4
IMS National Prescription Database accounts for approx. 39%
of all TVD prescriptions
Q1
2015
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Bush, S. et al; IAPAC Prevention 2015; #74
New PrEP Starts by Gender
2000
1761
1800
Number of Subjects Starting PrEP
1,573
1600
1395
1400
1242
Total Unique Individuals = 8,512
1200
1,234
1,089
1000
Males
753
800
530
600
389
321
400
293
317
200
133
142
160
175
191
Q1
Q2
Q3
198
365
336
378
611
411
286
193
181
208
157
172
155
170
146
119
142
153
161
188
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
164
0
2012
432
Females
2013
2014
2015
IMS National Prescription Database accounts for approx. 39%
of all TVD prescriptions
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Bush, S. et al; IAPAC Prevention 2015; #74
Percent of PrEP Initiation by Age
<24
25-34
35-44
> 45
Percent
40
20
0
<24
25-34
35-44
> 45
2012
15.6
31.4
24.4
28.6
2013
14.9
31.9
26.9
26.3
2014
10.5
34.6
26.9
28
2015
9.3
32
28.4
30.3
The proportion of new PrEP starts under 24 y/o are lower than other age
groups at all time points.
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Bush, S. et al; IAPAC Prevention 2015; #74
Geographic Distribution of PrEP Users (2012-15)
Midwest
17%
WA
MT
ND
M
N
OR
ID
Northeast
21%
VT
WI
SD
IA
NE
NV
MO
NJ
OH
IN
IL
KS
KY
VA
WV
AZ
RI
CT
NYC, LI
PA
UT
CO
NH
MA
NY
MI
WY
CA
ME
VA
DE
MD
NM
West
31%
NC
TN
OK
AR
SC
MS
AK
TX
AL
GA
LA
FL
South
30%
No regional differences among individuals receiving PrEP determined by age
N = 45 subjects did not have region information
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Bush, S. et al; IAPAC Prevention 2015; #74
PrEP Growth Trend
Unique individuals in IMS
8000
7000
6000
5000
3,920
2015 Projection at same
rate
Individuals Starting PrEP
4000
3000
2000
1,320
1,511
Total Unique Individuals = 8,512
1000
1,761
0
2012
2013
2014
2015
First Quarter
IMS National Prescription Database accounts for approx. 39%
of all TVD prescriptions
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Bush, S. et al; IAPAC Prevention 2015; #74
PrEP Growth Trend
Unique individuals in IMS
8000
7000
6000
5,283
5000
3,920
2015 Projection at same
rate
Individuals Starting PrEP
4000
3000
2000
1,320
1,511
Projected Unique Individuals
Through 2015 = 13,895
1000
1,761
0
2012
2013
2014
2015
First Quarter
IMS National Prescription Database accounts for approx. 39%
of all TVD prescriptions
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Bush, S. et al; IAPAC Prevention 2015; #74
PrEP Growth Trend
Unique individuals in IMS
8000
7,044
7000
6000
5,283
5000
3,920
2015 Projection at same
rate
Individuals Starting PrEP
4000
3000
2000
1,320
1,511
Projected Unique Individuals
Through 2015 = 13,895
1000
1,761
0
2012
2013
2014
2015
First Quarter
IMS National Prescription Database accounts for approx. 39%
of all TVD prescriptions
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Bush, S. et al; IAPAC Prevention 2015; #74
Limitations:

The inability to track all prescriptions
 The lack of specific ICD codes for PrEP
 Possible projection errors
 Exclusion of patients with HBV from the data set who may be
receiving TVD for both PrEP and off-label HBV treatment
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Bush, S. et al; IAPAC Prevention 2015; #74
Conclusion
Using a National Prescription Database that accounts for 39% of all
Truvada prescriptions:
 The latest uptake data on Truvada for PrEP show that comparing
1Q 2014 to 1Q 2015, the incident usage in the US increased 332%,
from 529 to 1,761 individuals, in that time period.
 In the same data base, there were 8,512 unique PrEP Individuals
from January 2012 to March 2015.
 The gender of PrEP users in the US nationally appears to be
shifting. The number of males initiating PrEP increased, while the
number of females has remained static.
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Bush, S. et al; IAPAC Prevention 2015; #74
Thank you.
Staci.bush@gilead.com
O: 650-522-6267
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BACKGROUND
Bush, S. et al; IAPAC Prevention 2015; #74
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Gilead’s Algorithm for PrEP Indication
Since there is no diagnosis code for PrEP, this involved examining all
diagnosis codes where Truvada was prescribed, and excluding diagnosis
codes for other possible Truvada uses.
HIV
Exclude all concomitant use of any other
antiretroviral treatment.
Exclude a prior diagnosis of HIV disease
(ICD9 = 042); asymptomatic HIV infection
(V08); HIV-2 infection (079.53) or
nonspecific serologic evidence of HIV
(795.71)
Exclude a prior diagnosis of
opportunistic infection:
HBV
Exclude anti
Chronic Hepatitis B
specific treatment
Exclude a prior
diagnosis of chronic
hepatitis B infection
(70.22, 70.23,
70.32, 70.33).
PEP
Exclude specific
codes of E920.5
(contaminated
needle stick) and
/or V078 V079
(prophylaxis).
(Candidiasis of bronchi, trachea,
esophagus 112.84, or lungs 112.4,
Toxoplasmosis 130.X,
Coccidioidomycosis 114, Cryptococcosis
117.5, Cryptosporidiosis 007.4, CMV
retinitis 078.5, Kaposi's sarcoma 176.0,
Mycobacterium avium complex 031.2
031.0, Pneumocystis carinii pneumonia
136.3)
•
.
Bush, S. et al; IAPAC Prevention 2015; #74
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National Sales Perspective
A total of 77% of TVD pharmacy shipments are tracked to
retail or mail order pharmacies
CHAIN STORES
FOOD STORES
INDEPENDENT
MAIL SERVICE
LONG-TERM CARE*
CLINICS*
FEDERAL FACILITIES*
HMO*
HOME HEALTH CARE*
23%
NON-FEDERAL HOSPITAL*
MISC - OTHER*
MISC - PRISONS*
18%
59%
MISC - UNIVERSITIES*
RETAIL PHARMACIES
77% of shipments to pharmacies contributed claims data:
59% to retail pharmacies;
18% to mail order pharmacies
23% unable to be tracked: hospitals, clinics, prisons, universities, long
term care, or ADAP programs
UNSEEN – HOSPITALS,
CLINICS, PRISONS,
UNIVERSITIES, LONG TERM
CARE, OR ADAP PROGRAMS
MAIL ORDER PHARMACIES
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Bush, S. et al; IAPAC Prevention 2015; #74