Presentations text content in PrEP : HIV Pre-exposure Prophylaxis
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PrEP: HIV Pre-exposure Prophylaxis
Katherine Marx, MS, MPH, FNP-BC
June 2014
Slide2Disclosure
I, Katherine Marx, have no relevant financial, professional, or personal relationships to disclose.
Slide3Objectives
Know current US recommendations for PrEPIdentify candidates for PrEP
Learn about resources for providing
PrEP
Slide4Combination HIV Prevention
Biomedical InterventionsBehavioral InterventionsStructural Interventions
Slide5Biomedical Interventions
PrEPPost-exposure prophylaxisTreatment as preventionDiagnosis and treatment of sexually transmitted infections
Prevention of mother-to-child
t
ransmission of HIV
Contraception to prevent unplanned pregnancy among women with HIV
Voluntary male
c
ircumcision
Blood safety
Injection safety
Microbicides
Slide6PrEP: Pre-exposure Prophylaxis
How does it work?Uninfected person takes antiretrovirals
May prevent replication of virus & infection
Daily adherence to TDF/FTC
Slide7NRTI
’
s and NNRTI
’
s work here
http://
www.aidsinfo.nih.gov
/education-materials/fact-sheets/19/73/the-
hiv
-life-cycle
Slide8June 2013
CDC Interim Guidance:
PrEP
for IDU
PrEP
Timeline
November 2010
iPrEx
January 2011
CDC Interim Guidance:
PrEP
for MSM
August 2012
TDF2
Partners
PrEP
August 2012
CDC Interim Guidance:
PrEP
for
heterosexuals
July 2012
FEM-
PrEP
June 2013
Bangkok TDF Study
July 2012
FDA Approval
TDF/FTC
PrEP
January 2014
NYS AIDS Institute
Guidance for
PrEP
May 2014US Public Health ServiceClinical Practice Guideline for PrEP
March 2013
VOICE
Slide9PrEP Studies: HIV transmission risk lowest when participants took
PrEP consistently
STUDY
OVERALL
Reduction in risk of HIV infection
Detectable level of medication in the blood
Reduction in risk of HIV infection
iPrEx
44%
>90%
TDF2
62%
---
Partners
PrEP
75%
90%
BTS
49%
74%
Adapted from summary of research at http://www.cdc.gov/hiv/prevention/research/prep/
Slide10Slide11Slide12PrEP Utilization
Rawlings K, Mera R,
Pechonkina
A, et al. Status of
Truvada
for HIV pre-exposure prophylaxis (
PrEP
) in the United States: an early drug utilization analysis. 53rd ICAAC. September 10-13, 2013. Denver. Abstract H-663a.
Female
Male
Slide13PrEP: Candidates
Substantial risk of acquiring HIV infectionMen who have sex with men (MSM)HIV-positive sexual partner
Recent bacterial STI
High number of sex partners
History of inconsistent/no condom use
Commercial sex work
http://
www.cdc.gov
/
hiv
/
/guidelines/PrEPguidelines2014.pdf
Slide14PrEP: Candidates
Substantial risk of acquiring HIV infectionTransgender individualsEngaging in high-risk sexual behaviors
www.hivguidelines.org
Slide15Risk Behavior Assessment for MSM
In the past 6 months:
Have you had sex with men, women, or both?
(if men or both sexes)
How many men have you had sex with?
How many times did you have receptive anal sex (you were the bottom) with a man who was not wearing a condom?
How many of your male sex partners were HIV-positive?
(if any positive)
With these HIV-positive male partners, how many times did you have
insertive
anal sex (you were the top) without you wearing the condom?
Have you used methamphetamines (such as crystal or speed)?
http://
www.cdc.gov
/
hiv
/
/guidelines/PrEPguidelines2014.pdf
Slide16PrEP: Candidates
Substantial risk of acquiring HIV infectionHeterosexual women and menHIV-positive sexual partner
Recent bacterial STI
High number of sex partners
History of inconsistent/no condom use
Commercial sex work
High-prevalence area or network
http://
www.cdc.gov
/
hiv
/
/guidelines/PrEPguidelines2014.pdf
Slide17PrEP: Candidates
Substantial risk of acquiring HIV infectionInjection drug users (IDU)HIV-positive injecting partner
Sharing injection equipment
Recent drug treatment (but currently injecting)
http://
www.cdc.gov
/
hiv
/
/guidelines/PrEPguidelines2014.pdf
Slide18PrEP vs. nPEP
Case #1:24 year old white MSM who presents 4 hours after unprotected receptive anal sex, for the first time, with his HIV-infected partner.
Slide19nPEP
Non-occupational Post-exposure ProphylaxisHigh risk exposureAs soon as possible28 day course
Tenofovir
/
emtricitabine
+
raltegravir
www.hivguidelines.org
Slide20PrEP vs. nPEP
Case #2:24 year old MSM on nPEP
, day 27/28. Struggles with consistent condom use and regularly has unprotected receptive anal intercourse with his HIV-infected partner.
Slide21PrEP: Clinical Eligibility
Documented negative HIV test No signs/symptoms of acute HIV infection
Normal renal function
No contraindicated medications
Documented hepatitis B infection & vaccination status
http://
www.cdc.gov
/
hiv
/
/guidelines/PrEPguidelines2014.pdf
Slide22PrEP: HIV Testing
Are signs/symptoms of acute HIV present now or in prior 4 weeks?
Option 1: retest antibody in one month
Option 2: HIV antibody/antigen assay
Option 3: HIV-1 viral load
http://
www.cdc.gov
/
hiv
/
/guidelines/PrEPguidelines2014.pdf
Slide23Acute HIV Infection
SymptomsFeverFatigueMyalgia
Skin rash
Headache
Pharyngitis
Cervical Lymphadenopathy
Arthralgia
Night sweats
Diarrhea
Daar
ES,
Pilcher
CD, Hecht
FM.
Curr
Opin HIV AIDS. 2008;3(1):10-15.
Slide24PrEP: Considerations
AgeReproductive planOsteopenia/osteoporosis
www.hivguidelines.org
Slide25PrEP: Risk Reduction
Case #3:32 year old black female seeks pregnancy.
She is not infected with HIV.
Her partner is HIV-infected and not currently on antiretroviral treatment.
Slide26Providing PrEP
Before starting
PrEP
:
Clinical eligibility
Educate
Side effects
Limitations
Daily adherence
Symptoms of
seroconversion
Monitoring schedule
Safety
Criteria for discontinuation
Partner information
Social history: housing, substance use, mental health, domestic violence
Every visit:
Assess adherence
Risk reduction counseling
Provide condoms
www.hivguidelines.org
Slide27Providing PrEP
After confirmation of clinical eligibility:Prescribe no more than 90-day supply of
PrEP
Truvada
1 tablet PO daily
(
tenofovir
300mg +
emtricitabine
200mg)
Insurance prior approval
Truvada
for
PrEP
Medication Assistance Program
Every visit:
Assess adherence
Risk reduction counseling
Provide condoms
http://
www.cdc.gov
/
hiv
/pdf/guidelines/PrEPguidelines2014.pdf
Slide28Providing PrEP
3-month visit:HIV testAssess for acute infection
Check for side effects
Pregnancy testing
Prescribe 90-day supply of medication
Every visit:
Assess adherence
Risk reduction counseling
Provide condoms
http://
www.cdc.gov
/
hiv
/
/guidelines/PrEPguidelines2014.pdf
Slide29Providing PrEP
6-month
HIV test
STI test
Pregnancy test
Renal function
90 day prescription
9-month
HIV test
Pregnancy test
90 day prescription
12-month
HIV test
STI tests
Pregnancy test
Renal function
90 day prescription
Assess the need to continue
PrEP
Every visit:
Assess adherence
Risk reduction counseling
Provide condoms
http://
www.cdc.gov
/hiv/pdf/guidelines/PrEPguidelines2014.pdf
Slide30Support Adherence
Develop trust, avoid judgmentPlanMonitor
Educate
Identify barriers
Assess for side effects
http://
www.cdc.gov
/
hiv
/
/guidelines/PrEPguidelines2014.pdf
Slide31Discontinuing PrEP
Positive HIV resultAcute HIV signs or symptomsNon-adherence
Renal disease
Changed life situation: lower HIV risk
http://
www.cdc.gov
/
hiv
/
/guidelines/PrEPguidelines2014.pdf
Slide32PrEP: Research
PrEP in the real worldIntermittent dosingNew medications
New formulations
Slide33PrEP Summary
EffectiveFDA approvedWell-tolerated
However,
Short-term data only
Daily adherence required
Side effects
Drug resistance in acute infection
Could lead to fewer condoms being used
Cost
Logistics
Slide34PrEP Resources
CDC: http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf
NYSDOH AI:
http://www.hivguidelines.org/
PrEP
Watch/ AVAC:
http://www.prepwatch.org/
Slide35Additional Resources
NY/NJ AETC PrEP Webinarshttp://nynjaetc.virtualforum.com/pif.asp?Prog_ID=14060902&securitycode=KXbFYh
http://nynjaetc.virtualforum.com/pif.asp?Prog_ID=14052303&securitycode=01r27E
http://nynjaetc.virtualforum.com/pif.asp?Prog_ID=14050908&securitycode=o9k2C2
Slide36Katherine Marx, MS, MPH, FNP-BC
PrEP : HIV Pre-exposure Prophylaxis
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