1. PrEP for HIV Prevention
HENNEPIN COUNTY Public HEALTH CLINC
RED DOOR SERVICES

2. Overview What is Prep? Indications for usage Who is a candidate?
Monitoring & follow-up
Paying for PrEP
Resources

3. What is PrEP?
Truvada: Combination of 2 anti-retrovirals (emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)
Works by inhibiting HIV-1 from replicating as it enters the body, prevents the virus from establishing a permanent infection
Dosed as a single pill (300/200mg) once daily.
Approved in July 2012 by the FDA for PrEP
Currently this is the only drug approved for PrEP
Source: Truvada Training Guide for Healthcare Providers
CDC, PrEP Guideline

4. PrEP Studies iPrEx - 2010: Partners PrEP - 2012:
MSM/ Trans* Women (n=2499)
34 new HIV infections within the Truvada study group
3 of the 34 had detectable levels of medication
Over 90% risk reduction (adjusted for proper adherence)
Partners PrEP :
Sero-discordant couples (n=4747)
Three-pronged study (Truvada – Tenofovir – Placebo)
30 new HIV infections; 13 within the Truvada study group
31% had detectable levels of medication
90% risk reduction (adjusted for proper adherence)

5. Indications of Usage
“TRUVADA is indicated in combination with safer sex practices for pre- exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.”

6. PrEP Candidates (CDC) Confirmed HIV negative individuals who -
Not in a monogamous relationship w/ recently tested HIV – partner
Infrequent condom use w/ partners of unknown status
Men who have both male and female sex partners
Any anal sex w/o condoms in the past 6 mos
Any STI diagnosed or reported in the past 6 mos
In ongoing relationship with HIV + partner
Sharing injection equipment in the past 6 mos
Attended methadone/suboxone/buprenorphine treatment in the past 6 mos

7. PrEP Candidates (Gilead)
Confirmed HIV negative individuals who:
Inconsistent/no condom use
Diagnosis of STI
HIV+ sexual partners
Sex within high prevalence areas or social networks
Sex work
Substance use
Incarceration

8. PrEP Candidates (Red Door)
Confirmed HIV negative individuals who:
African American MSM
Trans* women
White MSM with:
Reported meth use in the last 12 mos
Diagnosed w/ rectal STI in the last 12 mos
Diagnosed w/ primary Syphilis in the last 12 mos
HIV+ Partner who is:
Newly diagnosed
Not on ART
Detectible viral load

9. PrEP services at Red Door
Our original goal was 60 patients in 1 year, started 4/2013.
To date we have over 450 active patients.
PrEP Coordinator: Javier Bucher
Primary contact
He sees patient’s throughout the 2nd and 3rd visit, then they are handed off 100% to NP.
Screening and intake
46 question assessment tool about sexual behavior and risk
HIV and syphilis testing if not done within the last 30 days.
Adherence support
Risk reduction counseling
Payment assistance

10. Nurse practitioner role
Prescriber Checklist and agreement form (may be necessary for a prior authorization)
Full STI screen and PrEP lab work every 3 months.
HIV testing
Syphilis, CT/GC and Hepatitis B & C lab work (if indicated for C)
Hep B vaccine
Kidney function tests; Creatinine Clearance (CrCl) (monitored at initial visit, first follow up, then every 6 months if normal)
Creatinine clearance, cannot be less than 60 mL/min
Only taken 1 or 2 men off due to low function, taking work out supplements with creatinine in them. Stop medication and supplements for 1 month, re-draw
Discuss side effects (nausea, vivid dreams, diarrhea)
Medication adherence (also done with Javier)

11. Checklist for Prescribers
Checklist of key components for prescribers to consider before prescribing PrEP
Checklist items include
Confirming a negative HIV-1 test
Screening for signs or symptoms of acute HIV infection
Counselling on safety risks
Importance of adherence 11

12. Paying for PrEP Truvada = $1,300 - $1,800 per bottle (30 ct)
Covered by most insurance
Gilead Advancing Access Program
Co-pay assistance ($300/month or $3600/year)
Full coverage for uninsured that qualify
PAN (Patient Assistance Network) foundation – currently maxed out
PAF (Patient Advocate Foundation)

13. Barriers to PrEP Medical mistrust
Lack of PrEP savvy/ sex positive providers
Financial responsibilities
Socioeconomic challenges
Stigma

14. Resources/references
Truvada PrEP REMS (Risk Evaluation and Mitigation Strategy)
Truvada for PrEP
CDC PrEP Clinical Guidelines
New England Journal of Medicine
iPrEx & Partners PrEP study

15. Discussion and Questions