prep: pre-exposure prophylaxis

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