11. PRE-EXPOSURE PROPHYLAXIS
(PREP)?
Pre
Before
Exposure
When a fluid containing micro organism
comes into contact with mucous membrane or
non-intact skin
Prophylaxis
An action taken to prevent infection or disease
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12. DEFINITION
What is PrEP?
Pre-exposure prophylaxis, or PrEP,
is a strategy that involves use of
antiretroviral medications (ARVs)
to reduce the risk of HIV infection
in people who are HIV negative.
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13. WHAT DOES PREP CONSIST OF ?
PREP includes use of one or two anti-retroviral
drugs by HIV-negative individuals starting
before an exposure and continuing afterwards
◦ A potential option to prevent infection from
ongoing exposures to HIV during periods of
risk.
A recently proven strategy still being studied.
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15. 1. A combination of two HIV medicines
(TENOFOVIR AND EMTRICITABINE),
TRUVADA is approved for daily use
as PrEP to help prevent an HIV-
negative person from getting HIV
from a partner who’s positive.
2 Studies have shown that PrEP is highly
effective for preventing HIV if it is
used consistently.
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17. Are for oral administration, and are
available in the following strengths:
Film-coated tablet containing
1. EMTRICITABINE = 200 mg
2. TENOFOVIR = 300MG
As active ingredients.
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TRUVADA tablets
19. DOSES
1. Take Truvada with or without food at the
same time each day.
2. If you take Truvada for PrEP, take it every
day and not just when you think that you
were exposed to HIV.
3. Always combine use of PrEP with
condoms and other safer sex practices.
4. WHAT SHOULD I DO IF I FORGET A DOSE?
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20. Truvada can cause serious, life-threatening side
effects. These include a build up of lactic acid
in the blood (lactic acidosis)
and liver problems.
CONTACT DOCTOR IF ANY OF FOLLOWING SYMPTOMS
1. Weakness or tiredness, Unusual (not normal) muscle pain
2. Shortness of breath or fast breathing/Irregular heart beat
3. Stomach pain with nausea and vomiting/dizziness
4. Hands or feet that feel cold or turn blue
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WARNING
22. PrEP Candidates
1. MEN WHO HAVE SEX WITH MEN (MSM)
WHO:
a. Have an HIV-positive sexual partner
b. Have a recent bacterial STI
c. Have a high number of sex partners
d. Have a history of inconsistent/no
condom use
e. Engage in commercial sex work
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23. ARE YOU A GUY WHO HAS SEX
WITH GUYS??
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25. 3. Injection drug users (IDU) who:
a. Have an HIV-positive injecting partner
b. Share injection equipment
c. Have been through recent drug treatment (but
currently injecting)
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26. 4. Heterosexual women and
men who:
1. Have an HIV-positive sexual partner
2. Have a recent bacterial STI
3. Have a high number of sex partners
4. Have a history of inconsistent/no
condom use
5. Engage in commercial sex work
6. Live in a high-prevalence area or
network
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38. HOW DOES PREP WORK?
Infection does not occur instantly after an exposure
to HIV
◦The virus needs to spread throughout the body
◦This may take up to 3 days after the exposure
THE “WINDOW OF OPPORTUNITY” FOR PREP
◦ The brief period of time - after an exposure - where HIV
has not yet spread throughout the body
◦ DURING THIS TIME, PREP MAY BE ABLE TO STOP HIV SPREAD
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39. Rule out Acute HIV Infection
before PrEP
SYMPTOMS OF ACUTE HIV
1. Fever , Fatigue
2. Myalgia , Skin rash
3. Headache , Pharyngitis
4. Cervical Lymphadenopathy , Arthralgia
5. Night sweats , Diarrhea
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40. BARRIERS TO USE OF PREP
1. Eligibility
2. Adherence
3. Increased risky sexual practices
4. Side effects
5. Reimbursement
6. Patient accountability
7. Provider knowledge, comfort, and willingness to
prescribe
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41. CONCERNS WITH USE
OF PREP?
1. Side-effects and toxicity
2. Drug resistance
3. Adherence
4. Risk compensation
5. Access
6. Cost
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42. 2014 PrEP Prescribing
Guidelines
1. Determine eligibility: negative HIV test, high risk
of infection and creatinine clearance > 60ml/min
2. Assess for HBsAg and pregnancy (female
patients)
3. Prescribe : Tenofovir-emtricitabine (Truvada) one
pill once daily (90 day supply)
4. Monitor: creatinine clearance, HIV status, and
pregnancy every 3 months and STI screen every 6
months; counsel on adherence and risk reduction
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43. Before starting PrEP:
1. CLINICAL ELIGIBILITY
2. EDUCATE
◦ Side effects
◦ Limitations
◦ Daily adherence
◦ Symptoms of seroconversion
◦ Monitoring schedule
◦ Safety
◦ Criteria for discontinuation
3. PARTNER INFORMATION
4.SOCIAL HISTORY: housing, substance use, mental health,
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44. 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
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45. CONTD…..
3-month visit (1st )
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
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46. CONTD….
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
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48. 1. Positive HIV result
2. Acute HIV signs or symptoms
3. Non-adherence
4. Renal disease
5. Changed life situation: lower
HIV risk
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49. On-Demand PrEP
IPERGAY:
◦ Randomized trial, 400 high-risk MSM
◦ peri-coital PrEP: (3 DOSE SCHEDULE )
Truvada 4 tablets 24 hours before sex, a
second dose 24 hours later, and a last one 24
hours later
◦86% reduction in HIV acquisition with on-
demand PrEP
◦ Intervention Préventive de l
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50. Future of PrEP
Cabotegravir: HIV integrase inhibitor
◦Can be administered orally or as
long-acting subcutaneous or
intramuscular injection
◦Single injection of long-acting
version could be effective for up to
3 months
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Candidates for PrEP are people at ongoing, substantial risk of acquiring HIV infection. The next few slides will show several groups to consider as candidates for PrEP.
PrEP is appropriate to discuss with an HIV-negative female attempting conception with an HIV-infected male. It is recommended that the HIV-infected male partner should also be on treatment as prevention with undetectable viral load, in order to lower risk of HIV transmission.
nPEP is an alternative to PrEP if the risk is one-time or over.
These are the most common symptoms of acute HIV, with fever being the most common (75%), and diarrhea the least common on the list (27%).
NYS AIDS Institute guidelines have useful checklists for pre-prescription assessment and education.
The most common side effects of TDF are nausea and flatulence. The most common side effects of emtricitabine are rash and headache. Side effects are more common in the first month of treatment and often subside after a few weeks, which is known as the “start-up syndrome.”
If a patient considering PrEP has an HIV infected partner, ask about whether they are on antiretrovirals and if there is resistance information available.
a patient’s social history can identify potential barriers to adherence to PrEP and indications for referral for services.
CDC guidance recommends prescribing no more than a 90-day supply at the first prescription.
TDF 300mg daily is an acceptable alternative only for IDU and heterosexually active adults.
The CDC does not recommend:
Alternate medications in place of or in addition to TDF/FTC or TDF
Intermittent or episodic dosing
Expedited partner treatment for PrEP
CDC guidelines recommend visits every 3 months after the first prescription for PrEP. Consider the NYS AIDS Institute guidelines recommendation for closer follow up, especially for adherence-related concerns: check in with patients at 2-weeks to assess for medication toleration and side effects. Visit at 30-days to check for side effects, assess renal function in those at increased risk of kidney disease and for risk reduction, adherence and condom provision. The AIDS Institute guideline recommends continuation of visits every 30 days if adherence is an issue. (www.hivguidelines.org)
Continue seeing patients every 3 months.
Renal function is monitored with estimated creatinine clearance.
Consider the NYS AIDS Institute recommendation of a urinalysis for proteinuria and rechecking hepatitis status at the 12 month mark.
If a patient seroconverts on PrEP, check CD4 and VL, send genotype and link to HIV care. Counsel on HIV transmission prevention and offer partner notification services.
Upon discontinuation, document: HIV status, reason for discontinuation, and recent adherence and reported sexual risk behavior.