Katherine Marx, MS, MPH, FNP-BC Northwest/Caribbean AETC

1. PrEP: HIV Pre-exposure Prophylaxis
Katherine Marx, MS, MPH, FNP-BC
June 2014

2. Disclosure
I, Katherine Marx, have no relevant financial,
professional, or personal relationships to
disclose.

3. Objectives
• Know current US recommendations for PrEP
• Identify candidates for PrEP
• Learn about resources for providing PrEP

4. Combination HIV Prevention
• Biomedical Interventions
• Behavioral Interventions
• Structural Interventions

5. Biomedical Interventions
• 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

6. PrEP: Pre-exposure Prophylaxis
• How does it work?
– Uninfected person takes antiretrovirals
– May prevent replication of virus & infection
• Daily adherence to TDF/FTC

7. NRTI’s and NNRTI’s work here
http://www.aidsinfo.nih.gov/education-materials/fact-sheets/19/73/the-hiv-life-cycle

8. June 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 2014
US Public Health Service
Clinical Practice
Guideline for PrEP
March 2013
VOICE

9. 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/

12. PrEP 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.
0
200
400
600
800
1000
1200
1400
1600
2011 2012 2013
estimate
Female
Male

13. 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

14. PrEP: Candidates
Substantial risk of acquiring HIV infection
• Transgender individuals
– Engaging in high-risk sexual behaviors
www.hivguidelines.org

15. 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

16. 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

17. 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

18. 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.

19. nPEP
Non-occupational Post-exposure Prophylaxis
• High risk exposure
• As soon as possible
• 28 day course
• Tenofovir/emtricitabine + raltegravir
www.hivguidelines.org

20. 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.

21. PrEP: 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/pdf/guidelines/PrEPguidelines2014.pdf

22. 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

23. 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.

24. PrEP: Considerations
• Age
• Reproductive plan
• Osteopenia/osteoporosis
www.hivguidelines.org

25. 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.

26. Providing 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

27. Providing 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

28. Providing PrEP
3-month visit:
• HIV test
• Assess 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/pdf/guidelines/PrEPguidelines2014.pdf

29. Providing 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

30. Support Adherence
Develop trust, avoid judgment
• Plan
• Monitor
• Educate
• Identify barriers
• Assess for side effects
http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf

31. Discontinuing PrEP
• 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

32. PrEP: Research
• PrEP in the real world
• Intermittent dosing
• New medications
• New formulations

33. 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

34. 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/

35. 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

36. Katherine Marx, MS, MPH, FNP-BC