1. David Magnuson, Trevor Hawkins, Robertino Mera
Adolescent Use of Truvada (FTC/TDF) for HIV Pre-Exposure Prophylaxis (PrEP) in the United States: ( )
David Magnuson, Trevor Hawkins, Robertino Mera
Gilead Sciences Inc., Foster City, CA USA

2. Disclosures
All authors are employees and shareholders of Gilead Sciences, Inc.
This study was funded by Gilead Sciences, Inc.

3. Introduction
FTC/TDF has been approved for HIV Pre-exposure Prophylaxis (PrEP) in adults at high risk of sexually acquired HIV infection in the United States (US), European Union (EU) and at least 19 other countries
In 2016, there were 37,782 new HIV diagnoses in the US
8,451 (21%) new HIV infections were in individuals aged 13 – 24 years
6,848 (81%) were in young gay/bisexual men1
There is limited data on the use of FTC/TDF for HIV PrEP in adolescents in the US
ATN 113, a study of HIV PrEP in 79 MSM aged 15 – 17 years in the US, demonstrated good overall safety and acceptability but a high HIV incidence and poor retention in care
CHAMPS PlusPills, a study of HIV PrEP adolescents aged 15 – 19 years (99 females, 49 males) in South Africa demonstrated PrEP was well tolerated but that PrEP usage and adherence diminished over time
Challenges for PrEP update in adolescents in the US include stigma, the need for parental consent in some states, lack of insurance coverage, the potential disclosure of confidential information on the parents’ insurance bill and difficulties in adherence with a high rate of discontinuation compared to older adults
Use in adolescents weighing at least 35 Kg was approved in the EU on 05 February 2018 and in the US on 15 May 2018
References: 1 – Division of HIV/AIDS Prevention, CDC, April 2018

4. Objectives
To describe the real world use of FTC/TDF for HIV PrEP in adolescents (12 – 24 years) in the US over 6 years, from January 2012 to December 2017
To evaluate the differences in demographics, treating physicians for adolescents who prescribed FTC/TDF for HIV PrEP, and payment source

5. Study Design
Data Source:
National, electronic pharmacy claims data collected from at least 80% of all US retail pharmacies
All data was de-identified, and included prescription refill data, medical claims and procedures, and individual demographics limited to age and sex, and provider specialty
A validated algorithm identified FTC/TDF for HIV PrEP use by excluding FTC/TDF use for HIV treatment, post-exposure prophylaxis (PEP), and off-label chronic hepatitis B treatment1
Sensitivity 99.6% and Specificity 87.0%
References: 1 – R Mera-Giler, et al. National HIV Prevention Conference, Dec 2015, Atlanta, GA

6. All Individuals Starting FTC/TDF for PrEP in US, 2012 – 2017
6-YearTotal: ,223
25 and older: 149,893 (84.6%)
12 – 24 : ,330 (15.4%)
Proportion
12 – 24 years
17.0%
17.8%
15.1%
14.6%
13.8%
16.9%

7. Adolescents Starting FTC/TDF for PrEP in US, 2012 – 2017
6-YearTotal: 27,330
18 – 24: ,740 (90.5%)
12 – 17: ,590 (9.5%)
Proportion
12 – 17 years
19.8%
21.6%
14.8%
12.3%
3.9%
3.9%

8. Comparison of Adolescent Males and Females Starting FTC/TDF for PrEP
Proportion of Males and Females
Numbers of Males and Females
Age / Sex 12 13 14 15 16 17 18 19 20 21 22 23 24 M 32 56 93
209
598
1,298
1,776
2,367
3,231
4,296
5,069 F 64
186
352
502
516
542
664
723
771
827
923
1,045
1,152
Total 86
202
384
558
609
751
1,262
2,021
2,547
3,194
4,154
5,341
6,221

9. Common Prescribers of FTC/TDF for PrEP by Age Category
21%
13%
38% 2% 4%
22%
12%
39% 6%
14%
11%
18% 7%
38% 2%
24%
13%
16%
For ages 12-17, pediatricians are the leading prescribers for FTC/TDF for PrEP; and females have a higher proportion by EM (22% vs. 15%) and males have a higher proportion by FP (11% vs. 25%) (p<0.0001)
For both ages and ≥25, FP and IM are the leading prescribers for FTC/TDF for PrEP; and females have a higher proportion by EM and males have a higher proportion by FP and IM (p<0.0001)

10. Payment Methods for FTC/TDF for PrEP by Age Category
For ages 12-17, Medicaid accounted for 59% of payments for FTC/TDF for PrEP
For both ages and ≥25, commercial insurance became the primary payment method for FTC/TDF for PrEP

11. Limitations
Claims data only indicates when a prescription was filled and not that the person took the medication
Claims data does not contain dosing information (e.g., daily dosing or on- demand dosing)
Claims data does not contain information on race/ethnicity, risk factors for HIV, or transgender status
Claims data does not include data from closed health care systems (e.g. Kaiser), Veteran’s Administration, colleges/universities, and active duty military health care

12. Conclusions
This retrospective analysis of FTC/TDF for PrEP usage in the US revealed that adolescents < 24 years accounted for 15.4% of FTC/TDF for PrEP usage, and adolescents < 18 years accounted for only 1.5% of FTC/TDF for PrEP usage
For adolescents < 18 years, females accounted for 83.5% of usage. For older adolescents 18 – 24 years, FTC/TDF for PrEP is predominately used by males (84.2%)
Pediatricians are the most common prescribers for adolescents < 18 years of age
Recent approval in the US and the EU to expand the indication for FTC/TDF for HIV PrEP to include adolescents > 35 kg may improve access to PrEP for adolescents
There remains an important unmet need to improve awareness and engagement in HIV prevention for adolescents and young adults at risk for HIV

13. Acknowledgments
Thanks to all the young people and their health care providers who contributed data for this analysis