Mark T. Sawkin , PharmD , AAHIVP University of Missouri-Kansas City School of Pharmacy

1. Pharmacist-Managed HIV Pre-Exposure Prophylaxis (PrEP) Clinic: Preliminary Outcomes From an Urban Community Health Clinic Mark T. Sawkin, PharmD, AAHIVP University of Missouri-Kansas City School of Pharmacy Clinical Assistant Professor Sam A. Zakkour, PharmD University of California-San Francisco PGY2 Resident

2. Presenter DisclosuresMark T. Sawkin, PharmD, AAHIVP The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 months: • Pharmacist Advisory Boards • Gilead Sciences, Inc. • Viiv Healthcare

3. Learning Objectives • Identify a unique opportunity for pharmacists to become involved in HIV prevention. • Describe the role of a clinical pharmacist in the development and management of an HIV PrEP clinic. • List various clinical services pharmacists can provide within an HIV PrEP clinic.

4. Introduction • More than 1.2 million people in the United States are living with HIV infection • Estimated incidence of 50,000 new HIV infections per year

5. Global Health Observatory Data, World Health Organization

6. Introduction • In 2012 the FDA approved the use of once daily tenofovir disoproxil fumerate/emtricitabine (Truvada) for HIV Pre-Exposure Prophylaxis (PrEP). • Its ability to prevent HIV is dependent on medication adherence, an issue clinical pharmacists are adept at addressing.

7. Methods • A clinical protocol was developed based on guidance from the Center for Disease Control and the US Public Health Service 2014 Clinical Practice Guidelines addressing PrEP eligibility, safety, monitoring requirements, and when to discontinue therapy.

8. Methods: Screening Recommended Indications for PrEP Use by MSM • Adult man • Without acute or established HIV infection • Any male sex partners in the past 6 months • Not in a monogamous partnership with a recently tested, HIV negative man AND at least one of the following • Any anal sex without condoms (receptive or insertive) in the past 6 months • Any sexually transmitted infection diagnosed or reported in the past 6 months • Is in an ongoing sexual relationship with an HIV positive male partner US Public Health Service Pre-Exposure Prophylaxis for the Prevention of HIV Infection in the United States—2014 Clinical Practice Guideline

9. Methods: MSM Screening US Public Health Service Pre-Exposure Prophylaxis for the Prevention of HIV Infection in the United States—2014 Clinical Practice Guideline

10. Methods: Screening Recommended Indications for PrEP Use by Heterosexually Active Men & Women • Adult person • Without acute or established HIV infection • Any male sex partners in the past 6 months • Not in a monogamous partnership with a recently tested, HIV negative man AND at least one of the following • Is a man who has sex with both women and men (behaviorally bisexual) • Infrequently uses condoms during sex with 1 or more partners of unknown HIV status who are known to be at substantial risk of HIV infection (IVDU or bisexual male partner) • Is in an ongoing sexual relationship with an HIV positive male partner US Public Health Service Pre-Exposure Prophylaxis for the Prevention of HIV Infection in the United States—2014 Clinical Practice Guideline

11. Methods: Screening Recommended Indications for PrEP Use by Injection Drug Users • Adult person • Without acute or established HIV infection • Any injection of drugs not prescribed by a clinician in the past 6 months AND at least one of the following • Any sharing of injection of drug preparation equipment in the past 6 months • Been in a methadone, buprenorphine or suboxone treatment program in the past 6 months • Risk of sexual acquisition US Public Health Service Pre-Exposure Prophylaxis for the Prevention of HIV Infection in the United States—2014 Clinical Practice Guideline

12. Methods: Laboratory Tests and Other Diagnostic Procedures • Confirmed HIV negative test • Assess for acute HIV infection • HIV antibody test for those with recent exposure (broken condom, relapse to IVDU with shared injection equipment, etc.) • Renal function • Calculated creatinine clearance<60ml/min should not be prescribed PrEP therapy • Hepatitis serology US Public Health Service Pre-Exposure Prophylaxis for the Prevention of HIV Infection in the United States—2014 Clinical Practice Guideline

13. Methods: Pharmacist’s Role • Educate patients about the medication and the regimen to maximize their safe use • Provide support for medication adherence • Supply effective contraception to women who do not wish to become pregnant • Provide HIV risk reduction support and prevention services • Monitor patients to detect HIV infection, medication toxicities, and level of risk behavior • Minimize barriers to care (financial, transportation, etc.) • Maintain routine follow up with patients

14. Methods: Providing PrEP Indicated Medication: Truvada www.pbs.org

15. Methods: Medication Education Truvadapreprems.com

16. Methods: Payment Options for PrEP • Private Insurance: varied based on plan • Medicaid (800-541-2831) • Covers rx cost, medical appointments, and lab tests • Gilead Medication Assistance Program (855-330-5479) • Patient must be uninsured or insurance does not cover any prescription cost • Patient must have an annual income less that 500% FPL - ~$60,000 • Gilead Co-Pay Coupon Card (www.gileadcopay.com) • Covers up to $300/month in prescription co-payments • Patient must have insurance and NOT be enrolled in Medicare or Medicaid • Patient Access Network (866-316-7263) • One time grant to cover $4,000 of prescription costs for one year • Patient must have private insurance, Medicare, or Medicaid • Patient must have annual income less than 500% FPL

17. Methods: PrEP Related Billing Codes • Templates and standing orders were created in our electronic medical record to reflect our protocol at each stage of PrEP therapy.

18. Methods: Follow Up • Pharmacists follow-up with patients two to four weeks after PrEP initiation, and every three months thereafter to address adherence, side effects, provide risk reduction counseling, repeat safety labs, and to reassess the need for continued therapy.

19. Methods: Laboratory Monitoring Schedule Before and After Initiating Truvada for PrEP US Public Health Service Pre-Exposure Prophylaxis for the Prevention of HIV Infection in the United States—2014 Clinical Practice Guideline

20. Methods: Summary US Public Health Service Pre-Exposure Prophylaxis for the Prevention of HIV Infection in the United States—2014 Clinical Practice Guideline

21. HIV PrEP Clinic56 Enrolled Patients

22. Future Research Does taking Truvada for HIV Pre-Exposure Prophylaxis contribute to risky sexual practices or risk compensation? • We hope to learn if taking Truvada for HIV Pre-Exposure Prophylaxis increases, decreases, or minimally influences risky sexual behavior or risk compensation using data collected from optional surveys provided to patients.

23. Getting the word out • Local community efforts to increase knowledge and awareness of HIV PrEP • Health department partnerships • Kansas City PrEP Task Force • Meets monthly at KCHD • Membership: various clinics and providers in KC area • Current survey initiative to assess prescribing practices and establish a directory of PrEP Providers

24. In the news… • New York Times piece on October 5, 2015 • San Francisco model • Treatment as prevention – treating when someone tests positive • PrEP • 1992: 2,332 new HIV infections • 2014: 302 new HIV infections

25. Conclusions • A protocol-based pharmacist led HIV PrEP clinic is a feasible expansion of clinical pharmacists services in an urban ambulatory care clinic. • Structure of the clinic should incorporate pre-existing clinic routines to minimize disruptions in workflow and confusion regarding support staff and provider responsibilites. • CDC and US Public Health Service practice guidelines can serve as the foundation for developing monitoring schedules needed to ensure safety of PrEP therapy.

26. Discussion • The most common concern patients expressed with regards to PrEP (aside from safety and efficacy) was cost of the medication. • Medication coverage/cost has not been a barrier for any patient in the PrEP program • Pharmacists can play a major to increase access to HIV Pre-Exposure Prophylaxis management for those most vulnerable to acquire HIV in an urban community health clinic • Institutional support, provider and patient interest, and strong community partners such as the local area PrEP Task Force are necessary components for developing a PrEP clinic within an urban community clinic