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

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

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. 2014.

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 - 2012: 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)

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.”

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

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

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

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

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)

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

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)

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

Resources/references Truvada PrEP REMS (Risk Evaluation and Mitigation Strategy) http://www.truvadapreprems.com/ Truvada for PrEP https://start.truvada.com/hcp/ CDC PrEP Clinical Guidelines http://www.cdc.gov/hiv/guidelines/preventing.html New England Journal of Medicine iPrEx & Partners PrEP study http://whatisprep.org/ http://men.prepfacts.org/

Discussion and Questions