Transcript PrEP HIV Pre-exposure Prophylaxis

PrEP: HIV Pre-exposure Prophylaxis
Katherine Marx, MS, MPH, FNP-BC
June 2014
Disclosure
I, Katherine Marx, have no relevant financial,
professional, or personal relationships to
disclose.
Objectives
• Know current US recommendations for PrEP
• Identify candidates for PrEP
• Learn about resources for providing PrEP
Combination HIV Prevention
• Biomedical Interventions
• Behavioral Interventions
• Structural Interventions
Biomedical Interventions
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PrEP
Post-exposure prophylaxis
Treatment as prevention
Diagnosis and treatment of sexually transmitted infections
Prevention of mother-to-child transmission of HIV
Contraception to prevent unplanned pregnancy among
women with HIV
Voluntary male circumcision
Blood safety
Injection safety
Microbicides
PrEP: Pre-exposure Prophylaxis
• How does it work?
– Uninfected person takes antiretrovirals
– May prevent replication of virus & infection
• Daily adherence to TDF/FTC
NRTI’s and NNRTI’s work here
http://www.aidsinfo.nih.gov/education-materials/fact-sheets/19/73/the-hiv-life-cycle
PrEP Timeline
November 2010
iPrEx
August 2012
TDF2
Partners PrEP
July 2012
FEM-PrEP
January 2011
CDC Interim Guidance:
PrEP for MSM
June 2013
Bangkok TDF Study
March 2013
VOICE
July 2012
FDA Approval
TDF/FTC PrEP
August 2012
CDC Interim Guidance:
PrEP for
heterosexuals
June 2013
CDC Interim Guidance:
PrEP for IDU
January 2014
NYS AIDS Institute
Guidance for PrEP
May 2014
US Public Health Service
Clinical Practice
Guideline for PrEP
PrEP 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/
PrEP Utilization
1600
1400
1200
1000
800
Female
600
Male
400
200
0
2011
2012
2013
estimate
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.
PrEP: Candidates
Substantial risk of acquiring HIV infection
• Men 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/pdf/guidelines/PrEPguidelines2014.pdf
PrEP: Candidates
Substantial risk of acquiring HIV infection
• Transgender individuals
– Engaging in high-risk sexual behaviors
www.hivguidelines.org
Risk 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/pdf/guidelines/PrEPguidelines2014.pdf
PrEP: Candidates
Substantial risk of acquiring HIV infection
• Heterosexual women and men
– HIV-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/pdf/guidelines/PrEPguidelines2014.pdf
PrEP: Candidates
Substantial risk of acquiring HIV infection
• Injection drug users (IDU)
– HIV-positive injecting partner
– Sharing injection equipment
– Recent drug treatment (but currently injecting)
http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
PrEP 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.
nPEP
Non-occupational Post-exposure Prophylaxis
• High risk exposure
• As soon as possible
• 28 day course
• Tenofovir/emtricitabine + raltegravir
www.hivguidelines.org
PrEP 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.
PrEP: Clinical Eligibility
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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/pdf/guidelines/PrEPguidelines2014.pdf
PrEP: 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/pdf/guidelines/PrEPguidelines2014.pdf
Acute HIV Infection
Symptoms
• Fever
• Fatigue
• Myalgia
• 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.
PrEP: Considerations
• Age
• Reproductive plan
• Osteopenia/osteoporosis
www.hivguidelines.org
PrEP: 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.
Providing PrEP
Every visit:
Assess adherence
Risk reduction counseling
Provide condoms
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
www.hivguidelines.org
Providing PrEP
Every visit:
Assess adherence
Risk reduction counseling
Provide condoms
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
http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
Providing PrEP
Every visit:
Assess adherence
Risk reduction counseling
Provide condoms
3-month visit:
• HIV test
• Assess for acute infection
• Check for side effects
• Pregnancy testing
• Prescribe 90-day supply of medication
http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
Providing PrEP
6-month
• HIV test
• STI test
• Pregnancy test
• Renal function
• 90 day prescription
Every visit:
Assess adherence
Risk reduction counseling
Provide condoms
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
http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
Support Adherence
Develop trust, avoid judgment
• Plan
• Monitor
• Educate
• Identify barriers
• Assess for side effects
http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
Discontinuing PrEP
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Positive HIV result
Acute HIV signs or symptoms
Non-adherence
Renal disease
Changed life situation: lower HIV risk
http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
PrEP: Research
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PrEP in the real world
Intermittent dosing
New medications
New formulations
PrEP Summary
• Effective
• FDA approved
• Well-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
PrEP Resources
• CDC:
http://www.cdc.gov/hiv/pdf/prepguidelines20
14.pdf
• NYSDOH AI: http://www.hivguidelines.org/
• PrEP Watch/ AVAC:
http://www.prepwatch.org/
Additional Resources
NY/NJ AETC PrEP Webinars
• http://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
Katherine Marx, MS, MPH, FNP-BC