1. Mera et al. AIDS2016 TUAX0105LB Gilead Sciences, Inc., Foster City, CA, USA FTC/TDF (Truvada) for HIV Pre-Exposure Prophylaxis (PrEP) Utilization in the United States: 2012−2015 Robertino Mera, Scott McCallister, Brian Palmer, Gal Mayer, David Magnuson, M. Keith Rawlings

2. Disclosures  All authors are employees and shareholders of Gilead Sciences 2

3. Background  In 2012 FTC/TDF (Truvada) was licensed in the United States for pre- exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 for adults at high risk of infection  Centers for Disease Control (CDC) estimates that an individual living in the US has a 1 in 99 chance of HIV infection during their lifetime* – Lifetime risk by race/ethnicity and gender:  Black men, 1 in 20; Black women, 1 in 48  Hispanic men, 1 in 48; Hispanic women, 1 in 227  White men, 1 in 132; White women, 1 in 880 – Lifetime risk for men who have sex with men (MSMs)  Black MSM, 1 in 2  Hispanic MSM, 1 in 4  White MSM, 1 in 11 *CDC, 23 Feb 2016. 3

4. Lifetime Risk of HIV Diagnosis in the US Source: CDC 23 Feb 2016. 4 Northeast South Midwest West

5. Seroconversion Rates in Clinical Studies of FTC/TDF for PrEP  HIV-1 seroconversion rates for participants on FTC/TDF for PrEP are variable in clinical studies (0.5 to 4.7 per 100 person-years exposure) *FTC/TDF only. TGW, transgender women Seroconversion rate/ 100 person-years IPERGAYPROUDIPREXPartner’s PrEP* TDF2FemPrEPMTN003/ VOICE* MSM MSM, TGW Discord Hetero Couples Hetero Men & Women Women France Canada UK S. America Africa USA AfricaBotswanaAfrica Molina NEJM 2015;373:2237-46; McCormack Lancet 2016;387:53-60; Grant NEJM 2010;363:2587-99; Baeten NEJM 2012;367:399-410; Thigpen NEJM 2012;367:423-34; Peterson PLoS Clin Trials 2007;2:e27; Marrazzo NEJM 2015;372:509-18.

6. In 32 Demonstration Projects, Seroconversion Rates were Consistent with Clinical Studies 32 individual studies of FTC/TDF for PrEP  8,478 participants – 7,002 men; 1,388 women; 76 transgender women  7,061 cumulative person-years of FTC/TDF exposure Results  67 HIV-1 seroconversions  0.95/100 p-y seroconversion rate (95% CI: 0.74, 1.21) McCallister, ASM Microbe 2016, Abs 371LB 6 0.1–1.5/ 100 p-y 9 projects Seroconversion Rates From 32 Projects >1.5/ 100 p-y 6 projects 0/100 p-y 17 projects

7. 32 FTC/TDF PrEP Demonstration Projects Seroconversion Rates By Sex/Gender *Includes genderqueer, androgynous designations. McCallister, ASM Microbe 2016, Abs 371LB. 7 Men n=7002 Women n=1388 Transgender Women* n=76 Total exposure, p-y621478848 Number of HIV-1 seroconversions 6421 Rate/100 p-y (95% CI) 1.03 (0.80-1.32) 0.25 (0.03-0.92) 2.07 (0.05-11.52)

8. Methods  National, electronic, patient-level prescription data was collected from 80% of US retail pharmacies that dispensed FTC/TDF between January 2012 and December 2015  All patient-level prescription data were de-identified and linked to confirmatory data from a de-identified medical insurance claims database  A validated algorithm was then used to filter out non-PrEP prescriptions 8

9. Algorithm to Quantify FTC/TDF Use for PrEP  All medical diagnosis codes where FTC/TDF was prescribed were evaluated; other possible uses of FTC/TDF were excluded Bush S, ASM Microbe 2016, Abstract 2651 9

10. Unique Individuals Starting FTC/TDF for PrEP in US, 2012 to 2015 (by quarter) 10 2015 2014 20132012 201320142015 79,684 unique individuals started FTC/TDF for PrEP: 1,671 in Q4 2012 → 14,000 in Q4 2015 738% increase

11. Men and Women Starting FTC/TDF for PrEP in US, 2012 to 2015 11 4-YearTotal: 79,684 6,210 Women: 18,812 Men: 60,872 9,023 21,906 42,545

12. 60,872 Men 18,812 Women Age of Individuals Starting FTC/TDF for PrEP in US 2012-2015  Mean age of 79,684 unique individuals: 36.2 years 12 <25 years ≥25 years

13. Region and State Use of FTC/TDF for PrEP 2012-2015 SouthNortheastMidwestWest TX6.8%NY15.9%IL5.4%CA16.7% FL5.7%MA5.1%MN2.5%WA3.5% GA3.7%PA4.7%OH2.1%AZ1.8% DC3.3%NJ2.5%MO1.2%CO1.5% NC1.7%CT0.8%MI1.2%OR1.2% MD1.5%RI0.5%IN1.0%NV0.6% VA1.2%NH0.2%WI0.6%UT0.5% TN1.0%ME0.2%KS0.5%NM0.4% LA0.9%VT0.1%IA0.3%HI0.2% AL0.5%NE0.2%ID0.2% SC0.4%ND0.1%MT0.1% KY0.4%SD0.0%WY0.1% OK0.4%AK0.0% MS0.3% DE0.3% AR0.2% WV0.1% CA, NY, TX, FL, & IL account for 50.5% of unique individuals starting FTC/TDF for PrEP 13

14. US States with Highest Rates of FTC/TDF for PrEP 2012-2015 *US Census Bureau population estimate, 1 July 2015. 14

15. Top 20 US Cities with FTC/TDF for PrEP Use in 2015 (January to December) 15 Total Number of Individuals Prescribed FTC/TDF for PrEP in 2015 West San Francisco, CA1094 Los Angeles, CA660 Seattle, WA574 San Diego, CA279 Beverly Hills, CA218 Denver, CO202 Phoenix, AZ186 Portland, OR186 Midwest Chicago, IL1001 Minneapolis, MN378 Northeast New York, NY2936 Boston, MA548 Philadelphia, PA500 Bronx, NY169 South Washington, DC840 Atlanta, GA524 Houston, TX388 Dallas, TX400 Austin, TX286 Orlando, FL168 2015 accounts for 39-55% of starts in each city

16. Summary  The number of unique individuals starting FTC/TDF for PrEP has increased annually since the approval in the US – 79,684 through end of 2015, a 738% increase from 2012 to 2015  Highest rates of FTC/TDF for PrEP use are in men (76.4%) and in those age 25 and up (85.0%)  Massachusetts, New York, Illinois have highest rates of FTC/TDF for PrEP use (per population), while some states with highest lifetime risk of HIV diagnosis still have lower numbers on FTC/TDF for PrEP  Despite this US trend of increasing use of FTC/TDF for PrEP, barriers should be addressed in those at high risk of HIV acquisition: – Women, individuals <25 years, states with historically high infection rates 16

17. Acknowledgments  National Prescription Database – IMS Health, CT, USA – Symphony Health Solutions, AZ, USA  Statistical analyses – Gilead Sciences Department of Drug Safety and Public Health 17

18. Mera et al. AIDS2016 TUAX0105LB Backup

19. Lifetime Risk of HIV Diagnosis in the US Source: CDC. Lifetime risk of HIV diagnosis February 23, 2016. 19 Northeast South Midwest West