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Post-Exposure Prophylaxis (PEP) For Healthcare Workers
CONSENT FORM
I have reported a significant exposure to blood and/or body fluids that may include the virus that causes AIDS (Human
Immunodeficiency Virus). I understand that post-exposure prophylaxis will be recommended based on the most current
CDC guidelines (Sept. 30, 2005 MMWR: Updated U.S. Public Health Service Guidelines for the Management of
Occupational Exposures to HBV, HCV and HIV and Recommendations for Post exposure Prophylaxis), New York State
Dept Of Health AIDS Institute (Oct 2012), and updated US public health service guidelines SHEA (Sept 2013).
Occupational Exposure Risk
The average risk of acquiring HIV infection from a percutaneous (needlestick, sharp) exposure is 0.3% (1in 300).
However, the risk is increased if the exposure involved a larger volume of blood (i.e. hollow-bore needle, a deep injury, a
needle previously placed in the patient’s artery or vein) and a source patient with end-stage AIDS. The risk of acquiring
HIV infection after a mucous membrane exposure is 0.09% (1 in a 9,000) and for skin exposures less than 0.09%. The
risk for skin contact is higher if the skin contact is prolonged, involves an area that is extensive or in which skin integrity
is visibly compromised and/or involves a higher HIV titer.
Benefits of Treatment
The use of antiretrovirals as postexposure prophylaxis (PEP) has been recommended by the CDC since 1996 and has been
updated periodically. As of September 2013, the U.S. Public Health Service Guidelines (SHEA) has recommended the
use of three drug (PEP) for all HIV positive exposures. This recommendation came about by a group of “Expert Panel
Consultants” who reviewed the 2005 guidelines, as well as the most updated HIV medications and their safety and
tolerability. The ultimate goal is prevention of an HIV seroconversion following an occupational exposure.
TGH Employee Health staff and/or an Infectious Disease physician has reviewed my exposure and has recommended PEP
medication. I understand it is advised that I start the PEP medications as soon as possible after my exposure, ideally
within 2-3 hours. I understand the interval in which PEP is no longer beneficial for humans is undefined, although animal
studies suggest that PEP is not as effective if started later than 72 hours post-exposure. Depending on my occupational
risk, consideration will be given to initiating PEP medications up to two weeks after an exposure.
PEP (Post-Exposure Prophylaxis) Medication
The recommended PEP treatment regimen for all HIV positive exposures is:


Truvada 300mg: One table daily for 28 days
AND
Isentress 400mg: One tablet two times a day for 28 days
Information on PEP Medications
Truvada : (Tenofivir DF (TDF) 300 mg and Emtricitabine (FTC) 200 mg)
Truvada is a combination of two medications called nucleotide analogues or nukes. Both medications inside
Truvada interfere with an enzyme called reverse transcriptase, which is used by HIV infected cells to make
new viruses. Since Truvada inhibits, or reduces the activity of this enzyme, this drug causes HIV infected
cells to slow down or stop producing new viruses.
Although usually well tolerated, the most common side effects reported with short term therapy of Truvada
include diarrhea, mild nausea; headache, and fatigue. Rare but more serious side effects include liver toxicity
and lactic acidosis.
Isentress (Raltegravir 400 mg)
Isentress is an HIV medication in a class called integrase inhibitors.Integrase is one of three viral enzymes necessary
for HIV replication.Integrase does what the name implies,it integrates or blends HIV genetic material into DNA of
human CD4 cells.This blending of DNA makes it possible for the infected cell to make new copies of HIV.By
interfering with integrase,these inhibitors prevent HIV genetic material from integrating into CD4 cell, thus stopping
HIV replication.
Although usually well tolerated, the most common side effects reported with short term therapy of Isentress include
insomnia , headache and nausea Less common side effects may include elevation of liver enzymes, kidney stones
and decrease in white blood cell count and platelets.
Contraindications to PEP medications
1.
2.
3.
Breast-feeding or Pregnancy (unless approved by Infectious Disease and/or OB/GYN physicians)
Severe renal or hepatic insufficiency
Severe anemia or immunosuppression
You must answer the following questions before PEP medications can be prescribed:
 yes
 no
Are you pregnant or breast-feeding?
 yes
 no
Do you have or have you ever had a medical condition that affects your liver?
 yes
 no
Do you have any medical condition or take any medication that may alter or
suppress your immune system (i.e. leukemia, cancer, chemotherapy, radiation, )
 yes
 no
Do you have severe anemia?
If the healthcare worker answered yes to any of the above questions, consult with the Infectious Disease physician
prior to prescribing PEP medications.
 yes
 no
Yes
 no
 yes
 no
Do you agree to avoid pregnancy while taking the post-exposure medications and
until post exposure follow up is completed?? ( men and women)
 yes
 no
Do you agree to use a reliable form of birth control ?
Are you currently under the treatment of a physician? If yes, please describe:
_____________________________________________________________
_____________________________________________________________
Are you currently taking ANY medication? If yes, please list:
1.___________________________________________________________
2.___________________________________________________________
3.___________________________________________________________
4.___________________________________________________________
Type: ________________________________________________________
Treatment and Follow-up:
If I decide to take the post-exposure prophylaxis medications, I agree to comply with the following:
1.
On my initial Employee Health visit I will have my weight measured and my blood pressure, pulse and
temperature taken. I will have blood drawn for the following tests: CBC, CMP and HIV antibody test. I may have
hepatitis B and/or hepatitis C and serum pregnancy testing, if indicated.
2.
If I am seen after hours, I may have my blood drawn for CBC and CMP. I may have a stat serum pregnancy test
if indicated. If evaluated afterhours, my HIV antibody and Hepatitis B and C test will be drawn in Employee
Health Services at my follow-up visit (within 72hr).
3.
Follow-up visits will be scheduled two weeks, four weeks, six weeks, twelve weeks, six months and 12 months
after my exposure. Blood tests will be repeated at each visit to monitor my liver and blood count.
4.
Employee Health will give me a prescription for a 14 day supply of medication at my initial visit. I will receive a
prescription for a second 14-day supply at my two-week follow-up visit. I will take the medication as prescribed
for 28 days.
5.
If I am seen after hours, the Inpatient pharmacy or alternate (ER Pharmacy) will give me a four-day supply of my
post-exposure medication. I must report to Employee Health within 72 hours of my exposure to complete my
post-exposure evaluation and treatment.
6.
If I experience any adverse reactions or decide to discontinue treatment, I will notify Employee Health Services
immediately.
Revisions/Substitutions
The PEP Regimen will be revised periodically in accordance with federal and state guidelines recommendations.
The PEP Regimen may be substituted with other antiretrovirals, protease inhibitors or additional medications
upon the discretion of the infectious Disease physician .
Treatment Options:
I understand that treatment with the post-exposure prophylaxis medications is voluntary. If I choose to refuse or
discontinue PEP medication, neither my employment nor my treatment will be affected. Declining to take PEP
medications will not affect my workers compensation benefits.
 Decline Post-Exposure Prophylaxis (PEP) medication
I understand that post-exposure prophylaxis medication has been recommended for my occupational exposure to HIV. I
have been given the opportunity to ask questions and have read the information on the recommended PEP medication. I
decline to start the PEP medication at this time.

Agree to Take Post-Exposure Prophylaxis (PEP) medication
I have read the information on post-exposure prophylaxis treatment for occupational exposure to HIV. I have been given the
opportunity to ask questions concerning PEP treatment and agree to take the prescribed PEP treatment for my exposure. I
agree to comply with all follow-up requirements in Employee Health related to my PEP medication.
Signature:
Name (Print):
Date:_____________________________________
Department: _________________________________
Witness Signature: ____________________________________________________________________________________
Date of Exposure:
Time of Exposure: ________________________________
Date and Time of First Dose of Medication: _________________________________________________________________
Employee Health Services
EHS 9/2013