Download PrEP Case Consultation - Institute of AIDS and Emerging Infectious

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
Prior to exposure
PEP
Time of
transmission
ART
After infection
Where are We Now - Prevention 2.0
Using PrEP to Prevent Transmission
100
80
60
40
20
0
PROUD
IPERGAY
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.
PARTNERS DEMO
PrEP Use Has Escalated Quickly
80000
79684
60000
40000
20000
14000
0
1300
2013
3250
2014
2015
2016
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
PrEP
Prior to exposure
PEP
Time of
transmission
72 hours
ART
After infection
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
– 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/standard
s/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/preppre-exposure-prophylaxis/