Download PrEP - UCR Health

Michael Hughes, MD
Assistant Clinical Professor UCR
Eisenhower Medical Associates
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HIV Incidence (new infections): The estimated
incidence of HIV has remained stable overall in
recent years, at about 50,000 new HIV
infections per year. Within the overall
estimates, however, some groups are affected
more than others. MSM continue to bear the
greatest burden of HIV infection, and among
races/ethnicities, African Americans continue
to be disproportionately affected.
http://www.cdc.gov/hiv/statistics/basics/ataglance.html
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Behavioral strategies
Treatment as prevention
PrEP (Pre-exposure Prophylaxis)
PEP (Post-exposure Prophylaxis)
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PrEP is a combination of two antiretroviral
medications tenovir disoproxil fumarate (TDF)
and emtricitabine (FTC), taken in a single daily
pill for HIV prevention
This combination pill (brand name Truvada)
was approved by the FDA for use as HIV
treatment in 2004, and approved for PrEP in
July 2012
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No significant differences in serious adverse events, renal
function markers or deaths among patients taking study drug
compared to those taking placebo
Adverse events more common on TDF or TDF/FTC than placebo
in any study included :
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Short-duration nausea, vomiting; dizziness
Back pain; decreased weight
Mild elevation in liver enzymes; mild neutropenia
(more with TDF/FTC than TDF)
Small but statistically significant decreases in bone mineral density; no
difference in atraumatic fractures
Among women who became pregnant, study drug was not associated with
increased pregnancy complications
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/
Men Who Have
Sex with Men
Heterosexual
Women and Men
Injection Drug
Users
Detecting substantial
risk of acquiring HIV
infection:
*Sexual Partner with HIV
*Recent bacterial STI
*High number of sex partners
*History of inconsistent or no condom
use
*Commercial sex work
*Sexual Partner with HIV
*Recent bacterial STI
*High number of sex partners
*History of inconsistent or no condom
use
*Commercial sex work
*Lives in high-prevalence area or
network
*HIV-positive injecting partner
*Sharing injection equipment
*Recent drug treatment (but currently
injecting)
Clinically eligible:
*Documented negative HIV test before
prescribing PrEP
*No signs/symptoms of acute HIV
infection
*Normal renal function, no
contraindicated medicines
*Documented Hep B virus infection and
vaccination status
*Documented negative HIV test before
prescribing PrEP
*No signs/symptoms of acute HIV
infection
*Normal renal function, no
contraindicated medicines
*Documented Hep B virus infection and
vaccination status
*Documented negative HIV test before
prescribing PrEP
*No signs/symptoms of acute HIV
infection
*Normal renal function, no
contraindicated medicines
*Documented Hep B virus infection and
vaccination status
Prescription
Daily, Continuing, oral doses of
TDF/FTC (Truvada), < 90 day supply
Daily, Continuing, oral doses of
TDF/FTC (Truvada), < 90 day supply
Daily, Continuing, oral doses of
TDF/FTC (Truvada), < 90 day supply
Other Services:
*Follow-up visits every 3 months to
provide: HIV test, medication adherence
counseling, behavior risk reduction
support, side effect assessment
*At 3 months and then every 6 months
assess renal function
*Every 6 months test for bacterial STI
*Follow-up visits every 3 months to
provide: HIV test, medication adherence
counseling, behavior risk reduction
support, side effect assessment
*At 3 months and then every 6 months
assess renal function
*Every 6 months test for bacterial STI
*Follow-up visits every 3 months to
provide: HIV test, medication adherence
counseling, behavior risk reduction
support, side effect assessment
*At 3 months and then every 6 months
assess renal function
*Every 6 months test for bacterial STI
* Do oral/rectal STI Screening
*assess pregnancy intent
*pregnancy test every three months
*access to clean needles/syringes and
drug treatment services
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
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http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
In the past 6 months:
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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
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
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http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
Substantial risk of acquiring HIV infection
 Transgender individuals
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Engaging in high-risk sexual behaviors
www.hivguidelines.org
Substantial risk of acquiring HIV infection
 Injection drug users (IDU)
HIV-positive injecting partner
 Sharing injection equipment
 Recent drug treatment (but currently injecting)
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http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
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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
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Are signs/symptoms of acute HIV present
now or in prior 4 weeks?
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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
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.
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Age
Reproductive plan
Osteopenia/osteoporosis
www.hivguidelines.org
Every visit:
Assess adherence
Risk reduction counseling
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
Every visit:
Assess adherence
Risk reduction counseling
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
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http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
Every visit:
Assess adherence
Risk reduction counseling
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
Every visit:
Assess adherence
Risk reduction counseling
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
http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
Develop trust, avoid judgment
 Plan
 Monitor
 Educate
 Identify barriers
 Assess for side effects
http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
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CDC:
http://www.cdc.gov/hiv/pdf/prepguidelines
2014.pdf
NYSDOH AI: http://www.hivguidelines.org/
PrEP Watch/ AVAC:
http://www.prepwatch.org/
REMS clinician materials
http://www.truvadapreprems.com/truvada
prep-resources