PrEP Case Consultation Susanne Doblecki-Lewis, MD Associate Professor of Clinical Medicine Division of Infectious Diseases University of Miami Miller School of Medicine November 30, 2016

Biomedical HIV Prevention… that Works PrEP PEP ART Prior to exposure Time of transmission After infection

Where are We Now - Prevention 2.0 Using PrEP to Prevent Transmission McCormack S, et al. Lancet. 2016 Jan 2; 387(10013); 53-60; Molina JM, et al. N Engl J Med. 2015 Dec 3; (373)2237-2246; Baeten J, et al. CROI 2015 Feb 23-26; abstract 24.

PrEP Use Has Escalated Quickly Data from: Rawlings K et al. (McCallister S presenting) FTC/TDF (Truvada) for HIV pre-exposure prophylaxis (PrEP) utilization in the United States: 2013-2015. 21st International AIDS Conference, Durban, abstract TUAX0105LB, 2016.

A Variety of Providers are Involved in PrEP Care Physician providers: Family Medicine, Internal Medicine, Pediatrics, Ob/Gyn, Infectious Diseases Nurse Practitioners & Physician Assistants in many settings RNs (100% efficacy in SF project with 700 men) Pharmacists (Seattle project)

PrEP is Prescribed in a Variety of Settings Municipal STD Clinics Sexual Health and Wellness Clinics Community Health Centers Federally Qualified Health Centers HIV-Treatment Centers

Some Questions for Today How to choose nPEP or PrEP? How to transition from nPEP to PrEP? How to pay for PrEP?

Biomedical HIV Prevention PEP PrEP ART Prior to exposure Time of transmission After infection 72 hours

PEP Implementation PEP is time sensitive Need to begin medication ASAP, <72 hours Important to get baseline testing for HIV, also HBV and HCV, STIs Preferably HIV Ag/Ab test if available http://www.cdc.gov/hiv/pdf/programresources/cdc-hiv-npep-guidelines.pdf

HIV Testing and Detection of HIV http://www.rnceus.com/fl2hiv/test2.html (accessed Nov 2016)

PEP – What to Give Give 3 drugs for 28 days Recheck HIV test Tenofovir/Emtricitabine/Raltegravir Tenofovir/Emtricitabine/Dolutegravir Tenofovir/Emtricitabine/Darunavir/Ritonavir Recheck HIV test 4-6 weeks 3 months 6 months http://www.cdc.gov/hiv/pdf/programresources/cdc-hiv-npep-guidelines.pdf

How to Give nPEP If possible, give a “Starter Pack” of 3-5 days of meds, or the entire 28 day course This requires supply of medication on hand in the clinic or pharmacy Adherence may be better when whole 28 day course is given Two drug nPEP is not recommended in current guidelines http://www.cdc.gov/hiv/pdf/programresources/cdc-hiv-npep-guidelines.pdf

How to Pay for nPEP Commercial insurance covers nPEP May have high copay Need to communicate urgency by phone Medicaid will cover nPEP Patient Assistance Programs, likely multiple Good resource for process for PAPs for nPEP: https://www.health.ny.gov/diseases/aids/providers/standards/docs/payment_options_npep.pdf

Case A 33 year old man presents 24 hours after an episode of condomless receptive anal intercourse with a man who he subsequently learned was HIV positive. He states that he has had 10 partners in the last 6 months and uses condoms inconsistently. He has a history of rectal gonorrhea and secondary syphilis within the last year.

Questions Is he a good candidate for nPEP? What about PrEP?

Source: http://www.cdc.gov/hiv/policies/law/risk.html

This is a good candidate for PrEP due to repeated exposure (not just one episode) However, had a high risk exposure within last 72 hours, so nPEP is indicated

Start nPEP Baseline rapid HIV test is negative Start 3-drug nPEP HIV Ag/Ab test is negative Re-test at 4 weeks

4 Week Post-Exposure HIV Ag/Ab repeat test is negative Can transition directly to PrEP without gap http://www.cdc.gov/hiv/pdf/programresources/cdc-hiv-npep-guidelines.pdf

How to Give PrEP? Creatinine (CrCl > 60 mg/dl) Hepatitis B serology (vaccinate if neg) Pregnancy test for women Baseline HIV test Evaluate for symptoms of acute HIV infection

What to Prescribe? Tenofovir/Emtricitabine (Truvada®) is the only FDA approved drug for PrEP One tablet daily is the only approved dosing strategy Pre/Post Coital dosing is NOT recommended Prescribe up to a 90 day supply http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf

Side Effects & What to Expect Side-effects are generally minimal Occasional GI upset that usually resolves in 1-2 weeks Renal dysfunction is rare and reverses with discontinuation. Bone mineral density decrease may occur but clinical significance is unclear 7 days needed to achieve protective levels in rectal mucosa 21 days for women

How to Follow a Patient on PrEP? Quarterly check-ins for HIV testing, side effects, counseling, prescription Creatinine at 3 months & every 6 months if OK STD testing every 6 months http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf

www.projectinform.org/pre-chart (in English and Spanish)

Thanks for Attending Guidelines are available to answer many questions: http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf http://www.hivguidelines.org/ PrEPline 855-448-7737 at the National Clinician Consultation Center http://nccc.ucsf.edu/clinician- consultation/prep-pre-exposure-prophylaxis/