prep: pre-exposure prophylaxis
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PrEP: HIV Pre-exposure ProphylaxisKatherine 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• 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
June 2013CDC Interim Guidance:PrEP for IDU
PrEP TimelineNovember 2010iPrEx
January 2011CDC Interim Guidance: PrEP for MSM
August 2012 TDF2 Partners PrEP
August 2012CDC Interim Guidance:PrEP for heterosexuals
July 2012FEM-PrEP
June 2013Bangkok TDF Study
July 2012FDA ApprovalTDF/FTC PrEP
January 2014NYS AIDS InstituteGuidance for PrEPMay 2014US Public Health ServiceClinical Practice Guideline for PrEP
March 2013VOICE
PrEP Studies: HIV transmission risk lowest when participants took PrEP consistentlySTUDY OVERALL
Reduction in risk of HIV infection
Detectable level of medication in the bloodReduction 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
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.
2011 2012 2013 estimate0
200
400
600
800
1000
1200
1400
1600
Female
Male
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
• 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 InfectionSymptoms• 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
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 adherenceRisk reduction counselingProvide condoms
www.hivguidelines.org
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 adherenceRisk reduction counselingProvide condoms
http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
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 adherenceRisk reduction counselingProvide condoms
http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
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 adherenceRisk reduction counselingProvide condoms
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
• 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
• 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/prepguidelines2014.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