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 Disclosures Mark 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
Patients interested in PrEP were referred for screening with general medicine physicians and pharmacists trained on PrEP and HIV risk assessment.
These screening items may also be good risk reduction items while doing the intake/screening.
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
All patients who sexual or drug injection history indicates consideration of prep and who are interested in taking prep must undergo laboratory testing to identify those for whom this intervention would be harmful or for whom it would present specific health risks that would require close monitoring.
HIV testing: confirmed negative test as Truvada is not sufficient for HIV therapy on its own
Acute HIV infection: same reasoning
Renal function: tenofovir containing regimens has shown to decrease renal function and occasional cases of acute renal failure including Fanconi’s syndrome have occurred.
Hepatitis B: when patients with active HBV infection stop taking Truvada, liver function must be closely monitored because reactivated HBV infection can result in hepatic damage.
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
- If eligible for therapy, safety labs were ordered and a follow-up visit was scheduled with a clinical pharmacist to discuss lab results and the PrEP
Risk Evaluation and Mitigation Strategy
- Medication reconciliations were conducted to address potential drug interactions with medication prescribed by outside providers, and adherence counseling was provided to help ensure optimal medication use

14. Methods: Providing PrEP
Indicated Medication: Truvada
Generic Name
Trade Name
Dose
Frequency
Side Effects
Tenofovir disoproxil fumerate (TDF)
Viread
300mg
Once a day
Nausea, flatulence
Emtricitabine (FTC)
Emtriva
200mg
Rash, headache
TDF + FTC
Truvada
300mg/200mg -
FDA approved drug is Truvada
Via collaborative practice, prescribe 1 month with 2 refills to actively continue care with patients
Explain table
Truvada for PrEP is a REMS (Risk Evaluation and Mitigation Strategies) drug thus further patient education is needed
Time truvada reaches maximum intracellular concentrations in the blood is about 20 days of daily oraldosing, 7 days in rectal tissue, and 20 days in cervicovaginal tissues

15. Methods: Medication Education
Truvadapreprems.com provides many useful documents for both the patient and provider. We use these to create information folders that we use to target take home points for patients and
Truvadapreprems.com

16. Methods: Payment Options for PrEP
Private Insurance: varied based on plan
Medicaid ( )
Covers rx cost, medical appointments, and lab tests
Gilead Medication Assistance Program ( )
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 (
Covers up to $300/month in prescription co-payments
Patient must have insurance and NOT be enrolled in Medicare or Medicaid
Patient Access Network ( )
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
Medication assistance program applications were initiated with the clinical pharmacist for uninsured patients. Completed application and most recent HIV results were submitted to manufacturer.
For insured patients, pharmacy benefits providers were contacted to verify formulary and the monthly out-of-pocket cost for patients. When needed, co-pay coupons and external payer sources were utilized to help patients access medication.

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.
- Pharmacists conduct follow-up visits to assess adherence and side effects, provide risk reduction counseling, repeat safety labs, and 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 Clinic 56 Enrolled Patients
56 actively enrolled patients
33 insured patients: 59%
23 uninsured: 41%

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