significant uptake of truvada for pre-exposure prophylaxis
TRANSCRIPT
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
‡
2
Background: Timeline of PrEP Community activation
July 2012 FDA Approves Truvada for PrEP
Summer 2014 - Advocate Response
#Truvada“Whores”
Sept. 2014 - CDC High-Impact HIV Prevention Funding $210 mil
Feb 2015 - CROI Data
May 2014 – USPHS/CDC Guidelines
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
Exclude a prior diagnosis of HIV disease
Exclude all concomitant use of any other antiretroviral treatment.
Exclude a prior diagnosis of an opportunistic infection
Bush, S. et al; IAPAC Prevention 2015; #74 4
HIV
Exclude a prior
diagnosis of chronic
hepatitis B infection
Exclude anti Chronic
Hepatitis B specific
treatment
HBV
Exclude specific codes contaminated needle stick and /or prophylaxis.
PEP
Unique PrEP users were identified by excluding
ICD-9 codes of TVD use for HIV treatment, HBV, and Post-
Exposure Prophylaxis (PEP).
New PrEP Starts per Quarter
293 317 389
321 365 336
378 432
530
753
1242
1395
1761
0
200
400
600
800
1000
1200
1400
1600
1800
2000
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1
Nu
mb
er
of
Su
bje
cts
Sta
rtin
g P
rEP
2012 2013 2014 2015
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
5
Bush, S. et al; IAPAC Prevention 2015; #74
IMS National Prescription Database accounts for approx. 39%
of all TVD prescriptions
Total Unique Individuals = 8,512
New PrEP Starts per Quarter
293 317 389
321 365 336
378 432
530
753
1242
1395
1761
0
200
400
600
800
1000
1200
1400
1600
1800
2000
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1
Nu
mb
er
of
Su
bje
cts
Sta
rtin
g P
rEP
2012 2013 2014 2015
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
6
332% increase
Total Unique Individuals = 8,512
Bush, S. et al; IAPAC Prevention 2015; #74
IMS National Prescription Database accounts for approx. 39%
of all TVD prescriptions
New PrEP Starts by Gender
160 175 191 157 172 155 170 146 119 142 153 161 188
133 142 198
164 193 181 208
286 411
611
1,089
1,234
1,573
0
200
400
600
800
1000
1200
1400
1600
1800
2000
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1
Nu
mb
er
of
Su
bje
cts
Sta
rtin
g P
rEP
2012 2013 2014 2015
Males
Females
Total Unique Individuals = 8,512
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Bush, S. et al; IAPAC Prevention 2015; #74
293 317
389 321
365 336
378 432
530
753
1242
1395
1761
IMS National Prescription Database accounts for approx. 39%
of all TVD prescriptions
2012 2013 2014 2015
<24 15.6 14.9 10.5 9.3
25-34 31.4 31.9 34.6 32
35-44 24.4 26.9 26.9 28.4
> 45 28.6 26.3 28 30.3
0
20
40
Perc
en
t
<24 25-34 35-44 > 45
Percent of PrEP Initiation by Age
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The proportion of new PrEP starts under 24 y/o are lower than other age groups at all time points.
Bush, S. et al; IAPAC Prevention 2015; #74
South 30%
WA
OR
CA NV
ID
UT
AZ
MT
NM
CO
WY
NE
KS
ND
SD MI
WI
MN
IA
MO
IN IL OH
KY
ME
NH VT
RI
NY
CT
NJ
MA
PA NYC, LI
AK TX
OK AR
LA
AL GA
SC
NC
VA MD DE
MS
WV
TN
VA
FL
Midwest 17%
Northeast 21%
West 31%
No regional differences among individuals receiving PrEP determined by age
N = 45 subjects did not have region information
Geographic Distribution of PrEP Users (2012-15)
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Bush, S. et al; IAPAC Prevention 2015; #74
PrEP Growth Trend
0
1000
2000
3000
4000
5000
6000
7000
8000
2012 2013 2014 2015
Un
iqu
e in
div
idu
als
in
IM
S
2015 Projection at samerate
Individuals Starting PrEP
First Quarter
10
1,320 1,511
3,920
1,761
Bush, S. et al; IAPAC Prevention 2015; #74
Total Unique Individuals = 8,512
IMS National Prescription Database accounts for approx. 39%
of all TVD prescriptions
PrEP Growth Trend
0
1000
2000
3000
4000
5000
6000
7000
8000
2012 2013 2014 2015
Un
iqu
e in
div
idu
als
in
IM
S
2015 Projection at samerate
Individuals Starting PrEP
First Quarter
11
1,320
5,283
1,511
3,920
1,761
Projected Unique Individuals Through 2015 = 13,895
Bush, S. et al; IAPAC Prevention 2015; #74
IMS National Prescription Database accounts for approx. 39%
of all TVD prescriptions
PrEP Growth Trend
0
1000
2000
3000
4000
5000
6000
7000
8000
2012 2013 2014 2015
Un
iqu
e in
div
idu
als
in
IM
S
2015 Projection at samerate
Individuals Starting PrEP
First Quarter
12
1,320
5,283
7,044
1,511
3,920
1,761
Projected Unique Individuals Through 2015 = 13,895
Bush, S. et al; IAPAC Prevention 2015; #74
IMS National Prescription Database accounts for approx. 39%
of all TVD prescriptions
Limitations:
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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
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
BACKGROUND
Bush, S. et al; IAPAC Prevention 2015; #74 16
Gilead’s Algorithm for PrEP Indication
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:
(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 17
HIV
Exclude anti Chronic Hepatitis B specific treatment
Exclude a prior diagnosis of chronic hepatitis B infection (70.22, 70.23, 70.32, 70.33).
HBV
Exclude specific codes of E920.5 (contaminated needle stick) and /or V078 V079 (prophylaxis).
PEP
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.
CHAIN STORES
FOOD STORES
INDEPENDENT
MAIL SERVICE
LONG-TERM CARE*
CLINICS*
FEDERAL FACILITIES*
HMO*
HOME HEALTH CARE*
NON-FEDERAL HOSPITAL*
MISC - OTHER*
MISC - PRISONS*
MISC - UNIVERSITIES*
A total of 77% of TVD pharmacy shipments are tracked to retail or mail order pharmacies
Bush, S. et al; IAPAC Prevention 2015; #74
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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
National Sales Perspective
59% 18%
23%
RETAIL PHARMACIES
UNSEEN – HOSPITALS, CLINICS, PRISONS, UNIVERSITIES, LONG TERM CARE, OR ADAP PROGRAMS
MAIL ORDER PHARMACIES