1. 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

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

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

4. 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: st International AIDS Conference, Durban, abstract TUAX0105LB, 2016.

5. 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)

6. 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

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

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

9. 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

10. HIV Testing and Detection of HIV
(accessed Nov 2016)

11. 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

12. 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

13. 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:

14. 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.

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

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

17. 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

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

19. 4 Week Post-Exposure HIV Ag/Ab repeat test is negative
Can transition directly to PrEP without gap

20. 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

21. 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

22. 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

23. 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

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

25. Thanks for Attending
Guidelines are available to answer many questions:
PrEPline at the National Clinician Consultation Center
consultation/prep-pre-exposure-prophylaxis/