Honors PrEP : Beyond the Basics

1. Honors PrEP: Beyond the Basics Margaret Higham, MD Tufts University, Medical Director of Health Service

2. Disclosure • The presenter is a paid consultant providing medical advice for binx health • The presenter was paid to consult on a one-time project with Gilead Sciences within the past 12 months.

3. ACHA HIV PrEP Guideline • Released January 2019 • Taskforce with wide representation: • Margaret Higham MD, Tufts University • Joanne Brown DNP, APRN, University off Kentucky • Joanne Clinch MD, Wake Forest University • Ted ColemanPhD, CHES, California State University San Bernardino • Blake Flaugher, MPH,CHES, University of California Davis • Scott Henderson MD, University of Missouri • Ariel Watriss NP-C, Tufts University https://acha.org/documents/resources/guidelines/ACHA_HIV_PrEP_Guidelines_Jan2019.pdf

4. GoalsReview common challenges/concerns providing PrEP • Importance • Identifying candidates • Hepatitis Testing • Expense • Insurance and Confidentiality • Development of resistance • Increased STIs • Managing q 3 month monitoring • Future advances

5. Importance

6. Appropriate for college health • 39,000 new cases HIV in US in 2017 (1) • 21% were in adolescents and young adults (13-24 y/o) • 80% were 20-24 y/o • USPSTF has given PrEP its strongest rating: A (2) • “There is high certainty that the net benefit is substantial.” • Lifetime Risk of HIV in young MSM in 2016: (3) • African American 1:2 • Hispanic 1:4 • Caucasian 1:11 • CDC. HIV Among Youth. https://www.cdc.gov/hiv/group/age/youth/index.html • https://www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/prevention-of-human-immunodeficiency-virus-hiv-infection-pre-exposure-prophylaxis • CDC 2016 Conference on Retroviruses and Opportunistic Infections. http://www.cdc.gov/nchhstp/newsroom/croi-2016.html 6

7. Identifying appropriate candidates

8. Who is a candidate for PrEP? • CDC: “HIV negative and at “Substantial Risk for HIV” • What does this mean? • Type of sex • # of contacts • STIs • Transactional Sex • Sexual Networks • Increased risk taking/substance use • Requesting PrEP

9. Estimated per-act risk for acquiring HIV from an infected source, by exposure acta

10. STIs and HIV Bacterial STIs greatly increase risk for HIV • Local disruption of the genital epithelium w acute infection • Impact of infection on the microbiome with prolonged effect • Indicator of a social network with high STI/HIV rates Importance of Triple Site Testing: Urine/Genital, Throat, Anal • CDC. HIV Among Youth. https://www.cdc.gov/hiv/group/age/youth/index.html • https://www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/prevention-of-human-immunodeficiency-virus-hiv-infection-pre-exposure-prophylaxis • CDC 2016 Conference on Retroviruses and Opportunistic Infections. http://www.cdc.gov/nchhstp/newsroom/croi-2016.html 10

11. Who is a Candidate? Examples • 19 y/o black cis male student who has a positive throat GC test • Latinx gay cis male who has a primary partner in another state • 18 y/o gay white cis male from Tennessee who has never had sex, comes to HS the 2nd week of school, asking for PrEP • 20 y/o white cis female junior who has 1-2 male contacts per month. She meets them on social media apps and they go out to bars. • A 23 y/o trans woman on estrogen, who tells you she has had one partner in past 6 months

12. Hepatitis Testing

13. Hepatitis Testing • Hepatitis B most important • Hep B S AG • Why? • Ensure Immunization • Hepatitis C • Baseline testing • As per any MSM testing • Hepatitis A • Universal Immunization CONFIDENTIAL – DO NOT COPY OR DISTRIBUTE 13

14. Insurance &Confidentiality

15. Insurance & Confidentiality • Insurance: • Most cover PrEP w/o prior authorization • STI Testing covered under ACA • Confidentiality • PATCH Bill in MA • EOB for confidential services can be re-directed CONFIDENTIAL – DO NOT COPY OR DISTRIBUTE 15

16. Financial Concerns

17. Financial Concerns • Medication Costs a key concern • Patient assistance resources available • Co-pay relief card • $7,200 per year—co-pay and deductibles • Can also help w prior authorizations CONFIDENTIAL – DO NOT COPY OR DISTRIBUTE 17

18. Development of resistant strains

19. Development of resistant strains? • Has occurred but rare—5 case reports • Biggest issue is starting PrEP in window period • Know performance characteristics of your HIV test • Student comes in asking for PrEP. Almost always uses condoms, but 1 week ago had condomless anal receptive sex. • Monday am, male student comes in for PrEP. Had a sexual contact he didn’t feel good about on Saturday night. 19

20. Does PrEP Increase STIs?

21. Does PrEP Increase STIs? • Most studies say yes -- somewhat • Australian Study done in 2016-2018: • ~3,000 persons on PrEP, MSM and TGW, mean f/u 1 year • 25% of participants accounted for 76% STIs • STI data from before and after initiation PrEP available on ~1,400 participants • STI incidence increased 69.5 per 100 person/yrs to 98.4 per person/yrs29% • What should we make of this? • Traeger M et al Association of HIV Preexposure Prophylaxis With Incidence of Sexually Transmitted Infections Among Individuals at High Risk of HIV Infection. JAMA. 2019;321(14):1380-1390. doi:10.1001/jama.2019.2947

22. Logistics

23. Helping Students Succeed • Meet the student where they aare—have empathy • Q 3 month office visits and testing • Send reminders 2 weeks before refill • Flexible w appointments • Strategies for summer • 4 month prescription (or more?) • HIV test during summer, send results to you • Phone call • Planned Parenthood

24. Future Advances

25. Future Advances—Medication • New medications, some with improved pharmacokinetics • Higher intracellular drug levels, more quickly • Vaginal rings, Injections • On Demand/Intermittent Treatment “2-1-1” • 2 pills 2-24 hours before sex • 1 pill daily for 2 days

26. Future Advanes—Monitoring • Home-based monitoring and support w digital tools, telehealth, apps • PrEP@Home, Emory University • 55 participants • On-line behavioral monitoring • At home testing—self collected urine, rectal swab, throat swab, blood microtube and dried blood spot for HIV, syphilis and Cr • > 85% indicated they would use this system in future • Majority rated each collection component as acceptable or highly acceptable • 1/3 reported they would be more likely to persist in care Aaron J Siegler, Kenneth H Mayer, Albert Y Liu, Rupa R Patel, Lauren M Ahlschlager, Colleen S Kraft, Rossi Fish, Sarah E Wiatrek, Patrick S Sullivan, Developing and Assessing the Feasibility of a Home-based Preexposure Prophylaxis Monitoring and Support Program, Clinical Infectious Diseases, Volume 68, Issue 3, 1 February 2019, Pages 501–504, https://doi.org/10.1093/cid/ciy529

27. Ratings of the PrEP@Home system among 55 participants 27

28. Summary • Overview of challenges and advances in the field of HIV PrEP • Remember ACHA PrEP Guidelines • margaret.higham@tufts.edu