Transcript Pre-Exposure Prophylaxis (PrEP)

PRE-EXPOSURE
PROPHYLAXIS FOR
PRIMARY CARE
ERIK WERT, D.O FACOI
MEDICAL DIRECTOR INGHAM
COMMUNITY HEALTH CENTERS
INGHAM COUNTY HEALTH
DEPARTMENT
Objectives
• 1) Know the current guidelines for
PrEP
• 2) To identify individuals who would
benefit from PrEP
• 3) Conversion of Post-Exposure
Prophylaxis to Pre-Exposure
• 3) ICHC partnership between CBO
and ICHD to facilitate the program
Institute of Medicine
Barriers to care:
“ironically, it requires greater intimacy to discuss
sex, than engage in it”
Institute of Medicine (1997)
Background
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Approximately 50,000 new cases of HIV yearly
Prevalence rates have increased since ART
Rates are decreasing in heterosexual/IDU
Higher rates in MSM  MSM of color
• Access question
• Higher rates in transgender patients
• General US population 0.6% of population,
transgender is 1.15%
Background
• Youth – 13y/o to 24 y/o make up
approximately 1/5 of new cases
• Most individuals did not know their
HIV status
• Decreasing in all racial groups except
African American, and African
American MSM highest
HIV Testing
Universal HIV Screen
Early Detection HIV +
Early Implementation of ART
HIV Negative
Risk Behavior/PrEP
Reduction of HIV
CDC, USPSTF and AAP all recommend screening
Opt out, not opt-in
Clinical Guidelines
• Established by CDC and USPHS
• Current indications
1) Recommended for sexual active MSM at
substantial risk for HIV (1A)
2) Recommended for heterosexual active
males and females at risk for HIV (1A)
3) Recommended option for IDU (1A)
4) Heterosexual active females with males
infected with HIV + (Sero-discordant)
couples (IIB)
Additional
• Exclude all possible acute infection or
chronic infection
• FDA recommends Truvada™ (TDF/FTC) at
fixed dose 300mg/200mg daily (IA)
• IUD/Heterosexuals – there is possibility of
TDF alone, but not in MSM
• Information in adolescents is insufficient
(IIIB)
• Currently studies on adolescent and
pregnant women is ongoing
Descovy ™ (TAF/FTC)
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Newer formulation of TDF  TAF
Less toxic to renal system
Allowed to CrCl of 30ml/min
DO NOT USE FOR PrEP.
They are working on new formulations
Common Patient Questions
• How Does it work?
• May prevent the replication of virus
• Can I take it as needed?
• No, it’s a daily medication
• Is your patient going to be compliant
• Current CDC recommendation is DAILY
• IPERGAY – on demand – worked
• Do I have to take it for my lifetime?
• No, you take it during periods where risk is
highest
TDF (Tenofovir)
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NRTI – Nucleotide reverse transcriptase
For PrEP – fixed doses 300mg
Well tolerated
Lactic Acidosis and hepatomegaly and steatosis
Monitor for Hep B infection
• Check status, vaccinate if needed
• Some decline in bone density (approximately 1%)
• Renal function – can cause an ARF
• Can only be used with GFR > 60ml/min
FTC (Emtricetabine) Emtriva ™
• NRTI – Nucleoside Reverse
Transcriptase inhibitor
• Fixed dose 200mg
• Always used in combination
• Renal adjustment
• Lactic Acidosis and hepatomegaly
• Active against Hepatitis B, but not use
to treatment – not recommended
PrEP Timeline
iPrEx (2010) & US MSM
August 2012
TDF2
Partners PrEP
July 2012
FEM-PrEP
January 2011
CDC Interim Guidance:
PrEP for MSM
May 2014
US Public Health Service
Clinical Practice
Guideline for PrEP
July 2012
FDA Approval
TDF/FTC PrEP
June 2013
Bangkok TDF Study
March 2013
VOICE
June 2013
CDC Interim Guidance:
PrEP for IDU
August 2012
CDC Interim Guidance:
PrEP for
heterosexuals
January 2014
NYS AIDS Institute
Guidance for PrEP
Studies
• iPrEx studied TDF/FTC, MSM and
FTM – finding those who took less
likely to be infected – when controlled
for serum levels significant reduction
was noted
• THIS LEAD TO THE CDC issuing its
interim guidelines in 2011
Studies
• US MSM – Randomized, double
blinded, placebo study using just TDF
and noted decreased bone
mineralization of approximately 1% at
the femoral neck
• THIS IS TEMPORARY resolves after
discontinuation
Studies
• FEM-PrEP – TDF/FTC in females was stopped
due to inability to determine effectiveness
Reason:
ADHERENCE WAS LOW
• TDF-2 (Botswana) – This randomized controlled,
oral PrEP in males and females – decreased
rates
Reason
ADHERENCE WAS HIGHER
Studies
• Bangkok TDF Study – IDU using only
TDF found lower rates
• PROUD STUDY – MSM in UK,
placebo arm halted when the
divergence happened
Assessment of Risk
• Risk Behaviors
• Do you have sex with men, women, both
• How many partners have you had
• Do you engage in receptive anal
intercourse
• Do you consistently use condoms
• Were any of your partners HIV +
• Have you used methamphetamine
Risk
• Transgender
• Have a 2x the rates of HIV infection
• Average US population is 0.6%, transgender
is 1.15%
• Income disparity
• May lead to risky behaviors
Risk
Screen by anatomy and
behavior, never sexual
orientation or gender
identity
After Risks
• Discuss behavioral interventions
• PrEP has side effects
• Consistent use of condoms still required to
reduce STI/STD
Complicated Cases
• If partner is HIV +
• Is the partner on therapy?
• Are they virally suppressed?
• In heterosexual couples if partner is
suppressed there is a 96% reduction
• No data in MSM
• Experience
• Many individuals want to go on for their
own control of the situation
Indications MSM
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Adult Male (PrEP indication only >18y/o)
R/O acute or established HIV infection
Any male partner in last 6 months
In a non-monogamous relations
And one of the following
• Any anal intercourse in last 6 months
• Any STI in last 6 Months
• In an ongoing relationship with HIV +
partner
PrEP Heterosexual males/female
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Adult: > 18 y/o
No acute or established HIV
Any sex with opposite partner
Non-monogamous relationship with recently
tested HIV –
At least one of the following
1. Male who is msmw
2. Partner who is HIV +
3. Infrequent use of condoms with individual who
has unknown HIV status and at high risk
IUD
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Have you ever injected drugs not prescribed
In past 6 months have you injected using needles, syringes used
by another person
In past 6 months have you been on medications for treatment
RECOMMENDATION INDICATIONS
1. Adult > 18 y/o
2. No active HIV infection
3. Any injection in last 6 months
3.
At least one of following
1. Shared of injection or prep material
2. Been in treatment in last 6 months
Risk of HIV as noted in the MSM or Heterosexual
PEP to PrEP
• Individuals who have high risk
exposure who are placed on PostExposure Prophylaxis
• CDC Guidelines
• Truvada + Raltegravir (isentress) 400mg BID
• NEW: Truvada + Dolutegravir (Tivicay) 50mg
qd
• Discussion conversion to PrEP
PEPPrEP
• This discussion should occur early
• If the individual is interested obtain the
baseline lab work
LAB TESTING
• CDC
• Hepatitis B/C
• Creatinine Clearance - CMP
• RPR
• Urine Gonorrhea and Chlamydia
• Urine Pregnancy Test
• ICHC/ICHD
• HSV ½
• Hepatitis A
• +/- Anal Pap Smear – No consensus
• Oral and Anal
• Can be self collected
• Check with Lab what tubes and media to use
Hepatitis Panel
• Hepatitis A IgG
• Acutely IgM
• Hepatitis B surface Ag
• Hepatitis B surface Ab
• Hepatitis B Core Total Antibody
• Acutely IgM
• Hepatitis C Antibodies
Hepatitis B serology Testing
Immunization
• The reason we prefer the panel is to
dictate vaccination
• Consider the Hepatitis A vaccine in all
MSM if not always ready immunized
• HPV vaccination per the guidelines
Providing PrEP
• Scripts are 3 months supplies only
• Have to come in for evaluation
• Medication adherence
• Re-enforcement of behavioral
• Re-assess the need for PrEP
Complaints
• Most common is nausea, headache,
abdominal pain, flatulence
• Start up syndrome – resolves in about 1-2
weeks in most patients
Interactions
• No issues with Oral Contraceptives
• No interaction with hormone replacement
for transgender patients
• No effects of methadone or buprenorphine
• Medication that can effect renal function
care a concern – Aminoglycosides,
NSAIDs, anti-herpetic drugs
• Remember CrCl > 60 – so if borderline
order BMP more frequently
Monitoring
• Prescribed in three month intervals
• Every three months (CDC)
• Pregnancy Tests
• HIV test – Rapid or blood draw
• Discussion of psycho social
ICHC/ICHD Variation
1. BMP, RPR, Hep C
2. Screening oral/anal/urine of GC/Chlamydia
Monitoring
• Every 6 Months (CDC)
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CMP
STI Testing
RPR
HIV
Pregnancy testing
Monitoring
• At every evaluation consider
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Does the patient still needed it
Has there been social changes
Where are they in the social changes
Consider the duration of the
relationships
Consideration
• Information if patient discontinues
• Check the HIV status
• Documents why the medication is
discontinued
• Recent medication changes
Special Consideration
• Pregnancy
• FDA and perinatal antiretroviral usage
• Limited safety data
• Patient with chronic hepatitis B
• Both TDF/FTC are active against
Hepatitis B
• Only TDF is indicated for Hepatitis B
• Would recommend ID to deal with this
issue
PrEP FAILURE
• To date only 1 case of failure
• Back story: MSM, consistent with Truvada ™
seroconverted to HIV +
• Had Stopped using barrier prophylaxis
• Multiple sexual receptive anal encounter 45 days
preceding
• VIRAL PATTERN: Resistant to TDF and FTC
• This mutation is very uncommon less then 1%
• Also resistant to INSTI
This resistance pattern shows more transmitted rather
then acquired
Intersection
Interactions
• ICHC is a division of the ICHD
• Connection to the STI/STD department
• Allows for smooth transitions
• CBO – Local non-profits – HIV organization
provides PEP/PrEP referrals
• Private offices  outreach to offices who would like
patients put on it an monitored
• Send letters to PCP
• Discuss findings
Cases
• 24 year old MSM presents with request for
PrEP 
• Questions?
Question
• When was his last sexual interaction
• Does he engage in oral or anal
• Does he engage in receptive or insertive
sex
• Does he know the status of his partner
• ANSWER: Anal receptive, partner unknown
Question
• IS HE A CANDIDATE for PrEP?
LABS
• Check
• What if the patient is having any
symptoms (prodromal) in last 4 weeks?
• What do you do?
Answer
1. You can defer and recheck a HIV
antibody test
2. Check an HIV antigen/Antibody test (4th
generation)
3. Check a HIV viral load
Question
• Answer: NO, He is more a candidate for
PEP  with possible conversion to PrEP
in the future
• So TDF/FTC + Raltegravir or Dolutegravir
Follow UP
• Patient returns after completing 28 Days of
PEP, what can you do?
References
• http://www.cdc.gov/hiv/prevention/researc
h/prep/
• http://www.cdc.gov/hiv/pdf/PrEPguidelines
2014.pdf
• http://www.inpractice.com/Textbooks/HIV/
Antiretroviral_Therapy/ch10_pt1_Overview
.aspx
• NYSDOH AI: http://www.hivguidelines.org/