Section: UTMB On-line Documentation Subject: Healthcare Epidemiology Policies and Procedures Topic: Bloodborne Pathogens (BBP) Occupational Post-Exposure Prophylaxis

1.2 - Policy 05.12.09 - Revised 1997 - Author

1.2 Bloodborne Pathogens (BBP)-Occupational Post-

Exposure Prophylaxis

Purpose	The purpose of this document is to establish UTMB policy for the initiation of prophylaxis after occupational exposure to the human immunodeficiency virus (HIV) and hepatitis B virus (HBV) and early treatment of infection with the hepatitis C virus (at time of seroconversion) to prevent chronic infection. This policy has been developed from the most current medical literature, clinical experience at UTMB and the September 30, 2005 recommendations from the Centers for Disease Control and Prevention (CDC). This prophylaxis protocol and regimen will be continuously updated with the most recent medical information.
Audience	All employees of UTMB hospitals and clinics, contract workers, volunteers, and students.
Definitions	• An occupational exposure requiring the initiation of prophylaxis is defined as: - Percutaneous injury (e.g. needlestick, laceration with a sharp object) - Contact of mucous membranes or ocular membranes - Contact of non-intact skin (e.g. skin that is chapped, abraded) with Blood or other potentially infectious fluid (semen; vaginal secretions; and cerebrospinal, synovial, pleural, peritoneal, pericardial and amniotic fluids; bloody body fluids and unfixed tissue). • An occupational exposure requiring monitoring is defined as: - Percutaneous injury (e.g. needlestick, laceration with a sharp object) - Contact of mucous membranes or ocular membranes - Contact of non-intact skin (e.g. skin that is chapped, abraded) - Contact with intact skin that is prolonged or involves an extensive area with Blood or other potentially infectious fluid (semen; vaginal secretions; and cerebrospinal, synovial, pleural, peritoneal, pericardial and amniotic fluids; bloody body fluids and unfixed tissue).

Occupational Exposure Monitoring	All UTMB employees and students with a documented occupational exposure shall have the exposure evaluated and documented by a healthcare provider following the standard protocol. The healthcare provider shall: • Recommend prophylaxis for percutaneous exposures, contact of mucous membranes or non-intact skin. with Blood or other potentially infectious fluid (semen; vaginal secretions; and cerebrospinal, synovial, pleural, peritoneal, pericardial and amniotic fluids; bloody body fluids and unfixed tissue). • Obtain source-patient blood for analysis. • Refer other exposures to the Employee Health Center/Student Health Services at UTMB for enrollment in the occupational monitoring program.
Prophylaxis	Prophylaxis shall be recommended to all UTMB employees or students: • HIV: - For percutaneous exposures, contact of mucous membranes or non-intact skin. with Blood or other potentially infectious fluid (semen; vaginal secretions; and cerebrospinal, synovial, pleural, peritoneal, pericardial and amniotic fluids; bloody body fluids and unfixed tissue). - Ideally within two hours after exposures, but may be initiated up to 96 hours after exposure. - With appropriate drug therapy. - Until the source-patient blood has been obtained and analyzed. If the source-patient HIV status is determined to be negative, prophylaxis will be discontinued. - HBV-Prophylaxis for HBV prevention will be evaluated on an individual basis. - HCV-Employees/students testing positive for Hepatitis C Qualitative RNA (PCR) at 6 weeks, 3 months or 6 months, will be referred immediately to a hepatologist for early treatment to prevent chronic hepatitis C infection.

EMPLOYEE/STUDENT CHECKLIST

r Wash exposed area immediately.

r Notify Supervisor immediately (supervisor to assist with obtaining source consent & lab work).

r Have supervisor document in source’s medical record “source of occupational exposure” and

that labs were drawn for HIV, HCV, and HBS (Hepatitis B surface antigen) with source’s consent.

r Seek post-exposure care:

for employees on campus report to for students on campus report to

Employee Health (7:30 AM-4:30 PM) Student Wellness (8AM-5PM)

(409) 747-9172 (409) 747-9320

r Report to Emergency Department, after hours, weekends, or holidays (Follow-up in Employee Health/Student Wellness the next business day).

Employee/student should report to Employee Health/Student Wellness or Emergency Department as soon as possible, but at least within 2 hours of exposure.

r Off-site Exposures - Follow clinic specific policy.

Obtain packet from supervisor or visit website (see below) for required forms, procedures,

and information.

r Complete “Bloodborne Pathogen (BBP) Exposure Notification Form” [In packet & available

at Employee Health].

- Off-site – Complete form and fax to Employee Health/Student Wellness.

- On-campus – Report to Employee Health/Student Wellness (form will be completed

there).

- If seen in the Emergency Department, form should be completed there and faxed

- to Employee Health/Student Wellness.

Employee Health Student Wellness

Fax (409) 747-9182 Fax (409) 747-9330

***You must report the exposure and have HIV lab testing done within ten (10) days

to receive maximum benefits if a Worker’s Comp claim were to be filed in the future.

r Follow up with Employee Health/Student Wellness.

r For questions, visit: www.utmb.edu/policy/hcepidem/search/01-02.pdf

SUPERVISOR/FACULTY CHECKLIST

r Refer employee/student for post exposure care immediately.

for employees on campus report to for students on campus report to

Employee Health Student Wellness

(409) 747-9172 (409) 747-9320

Employee/student should report to Emergency Department, after hours, weekends, or holidays (Follow-up in Employee Health/Student Wellness the next business day).

Employee/student should report to Employee Health/Student Wellness or Emergency Department as soon as possible, but at least within 2 hours of exposure.

r Assist employee/student with obtaining source consent and source lab work.

r Document in source’s medical record “source of occupational exposure” and that labs were

drawn for HIV, HCV, and HBS with source’s consent.

r Remind employee/student to report exposure by completing “BBP Exposure Notification Form”.

- Off-site – Complete form and fax to Employee Health/Student Wellness.

Employee Health Student Wellness

Fax (409) 747-9182 Fax (409) 747-9330

- On-campus – Report to Employee Health/Student Wellness (form will be completed there).

- If seen in the Emergency Department, form should be completed there and faxed to

Employee Health/Student Wellness.

Employee Health Student Wellness

Fax (409) 747-9182 Fax (409) 747-9330

r For questions call Employee Health Center at (409)747-9172 or Student Wellness at

(409)747-9320; after hours call the Access Center at 1-800-917-8906.

For questions, visit www.utmb.edu/policy/hcepidem/search/01-02.pdf

PROVIDER CHECKLIST

r Provide necessary medical care to treat the injury/exposure.

r Refer to the BBP Flow Chart and Procedures [Enclosed] as a guide for post-exposure.

care

r Use Laboratory testing forms [enclosed] as a reference.

r Use UTMB Occupational Exposure prescription to prescribe only enough medication

until follow-up appointment or source results available.

r Complete the BBP Exposure Notification Form [enclosed] and fax to Employee

Health/Student Wellness.

- Employee Health – FAX # (409) 747-9182

- Student Wellness – FAX # (409) 747-9330

r Provide patient education information [enclosed].

r Complete Informed Consent for Prophylaxis form [enclosed].

r Billing may be submitted to:

UTMB, Employee Health

Attn: Kathryn Jinkins

301 University Boulevard, Route 1161

Galveston, TX 77555-1161

Reimbursement will be for reasonable & customary charges for authorized or medically necessary tests as noted in enclosed information. Any additional charges will not be reimbursed.

POST-EXPOSURE PROCEDURE

I. MANAGE THE EXPOSURE

A. Wash the area immediately with soap and water.

B. For exposure to eyes, mouth, and/or nose flush area with water.

II. NOTIFY SUPERVISOR/FACULTY IMMEDIATELY

A. Supervisors will assist in obtaining source consent and lab work.

B. Supervisors & faculty shall release the employee or student from their duties

immediately to seek post-exposure care.

III. PROCEDURE FOR SOURCE TESTING

A. Obtain source consent & lab specimen.

B. Use Physician Order Entry (POE) for HIV consent for alert and oriented patients.

C. General consent for comatose/general anesthesia patients will suffice but needs

to be documented on Lab Requisition (form MM 68693).

D. Refusals should be documented on Lab Requisition (form MM 68693). Notify

UTMB Legal 24 hours a day. The Legal Department will make the decision

on how source blood will be obtained. (Contact Legal by calling the hospital

operator).

E. Complete Lab Requisition (form MM 68693).

§ Employees who are off campus can contact employee health and they will fax a completed lab slip to put in the bag with the specimens.

F. Assure consent status is documented on form.

G. Obtain one (1) serum separator tube.

H. Label tube

I. Document exposure in source’s medical record & that labs were drawn for

“source of occupational exposure”.

J. Send blood to Laboratory Medicine, Sample Management, Rm. 5.136,

McCullough Building.

K. Laboratory results for personnel will be sent to Employee Health/Student

Wellness for follow-up. Source laboratory results will be placed in the

source’s medical record when consent is granted, or when general consent

is invoked. If source refuses testing, results will be sent to Employee

Health/Student Wellness.

IV. EMPLOYEE/STUDENT POST EXPOSURE CARE

A. Monday through Friday 7:30 AM to 4:30 PM go immediately to the Employee

Health Center. Students are seen in Student Wellness 8AM to 5PM.

B. Holidays, weekends, or after hours – Go to the Emergency Department immediately.

1. Triage to ensure initiation of prophylaxis within 2 hours of exposure (percutaneous injury or contamination of mucous membranes or nonintact

skin with blood, body fluids visibly contaminated with blood, unfixed tissue,

semen, vaginal secretions, and cerebrospinal, synovial, pleural, peritoneal, pericardial, and amniotic fluids).

2. Obtain consent for HIV through Physician Order Entry (POE).

3. Submit Employee/Student specimens using form MM 68693 – two

serum separator tubes labeled appropriately.

a. Order labs for exposed individual [HIV-1/HIV-2 antibody, HCV antibody

and HBA]. HBS should be ordered for employees/students who have

never received vaccine or who have a history of HBV immunization

prior to coming to UTMB.

b. Additional lab if Employee/Student is starting prophylaxis – CBC

(use additional lavender top tube for CBC), ALT, AST, total bilirubin,

GGT, Creatinine and BUN. Females must have a urine or serum

pregnancy test.

c. Assure consent for testing is documented.

d. Send specimens to Sample Management, Room 5.136 McCullough.

4. Post-exposure Treatment

a. Offer tetanus/diphtheria booster following percutaneous injury if

none within last 10 years.

b. Offer HBV vaccine if source is known to be positive for hepatitis B

or is high risk for hepatitis B and employee/student has not

been vaccinated against hepatitis B.

c. Offer Hepatitis B Immune Globulin 0.06 ml/kg IM if source is known

to be positive for hepatitis B or is high risk and employee/student

has not been vaccinated against hepatitis B.

d. Employees/students testing positive for Hepatitis C Qualitative

RNA (PCR) at 6 weeks, 3 months or 6 months, will be referred

Immediately to a hepatologist.

e. Recommend HIV prophylaxis following percutaneous injury or

contamination of mucous membranes or nonintact skin with blood,

body fluids visibly contaminated with blood, unfixed tissue, semen,

vaginal secretions, and cerebrospinal, synovial, pleural, peritoneal,

pericardial, and amniotic fluids (goal is to begin within 2 hours

of exposure).

f. See Appendix A for warnings on drug interactions.

g. Prophylaxis medications – write “UTMB Occupational

Exposure” on prescription

1) Fos-amprenavir (Lexiva 700mg tab), 2 tablets

by mouth with food every 12 hours for 4 weeks.

2) Emtricitabine (Emtriva 200mg cap), one capsule by mouth every

24 hours for 4 weeks.

3) Tenofovir (Viread 300 mg tab), one tablet by mouth every

24 hours for 4 weeks.

4) Provide with 72-96 hour supply of medication.

5) Assure Consent for Post-Exposure Prophylaxis is completed.

h. Employee/Student is Pregnant – For pregnant women, prophylaxis

should be reserved for those with HIGH RISK exposures, and

tenofovir (Viread) should not be used. In this case, an alternate

regimen should be used:

1) Combivir (300 mg [AZT] and 150 mg lamivudine [Epivir], in

fixed dose combination cap), one capsule by mouth with food every

12 hours and for 4 weeks.

2) Kaletra (lopinavir/ritonavir 200/50mg tabs), 2 tablets by mouth with or

without food every 12 hours for 4 weeks.

3) Provide with 72 – 96 hour supply of medication.

4) Assure Consent for Post-Exposure Prophylaxis is completed.

5) Pregnant employees/students will be followed up by Employee

Health/Student Wellness and will be referred to the Maternal/Child Clinic

(409)772-2798.

V. OFF-CAMPUS EXPOSURE OF UTMB EMPLOYEES/STUDENTS

A. Maternal-Child Health Clinics – refer to clinic specific policies for initial

management.

B. Primary Care Outpatient Clinic – refer to clinic specific policies for

initial management.

C. TDCJ – refer to TDCJ specific policies for initial management.

D. Procedure Questions

Employee Health (7:30 AM-4:30 PM) Student Wellness (8AM-5PM)

(409) 747-9172 (409) 747-9320

V. Any employee claiming a work-related exposure to HIV infection must provide

the employer with the BBP Notification Form and document that within 10

days after the date of the exposure, the employee had a test result indicating

absence of HIV, HBV, or HCV infection. (Texas Vernon’s Civil Statute,

Health & Safety Code Section 85.116 (c) for the purpose of qualifying

for workers’ compensation or any other similar benefits or compensation.)

After hours, weekends, and holidays – call the Access Center (1-800-917-8906).

Employees/students with off campus exposure shall notify Employee Health/Student

Wellness as soon as possible even when treatment initiated elsewhere.

References

1. CDC. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HBV, HCV, and HIV and recommendations for Postexposure Prophylaxis. MMWR 2001; 50 (No. RR-11):1-53.

2. CDC. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HIV and recommendations for Postexposure Prophylaxis. MMWR 2005; 54 (No. RR-9):1-13.

3. Jaeckel E, Cornberg M, Wedemeyer H, et al. Treatment of acute hepatitis C with interferon alfa-2b. N Engl J Med 2001; 345:1452-7.

4. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. January 29, 2008; 1-128. Available at

http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf

NOTIFICATION FORM

Person completing form_________________Signature___________________Date/Time________

Name_________________________________________ r Employee r Student

Dept/School _____________________________________________________________________

Supervisor/Faculty ________________________________________________________________

Home # _________________Work # __________________Pager #_________________________

Employee# or Student SSN _____________Date of Exposure ____/_____/____Time ____am_ pm __

Location where exposure occurred (Building, Floor, Rm) __________________________________

Personal Protective Equipment Used: rGloves rGoggles/Mask/Faceshield rGown rOther

Was a safety device being used? rYes rNo If so, did it work? rYes rNo

Type & Brand of safety device ______________________________________________________

Body part exposed (circle one) hand, eye, mouth, other (please identify)______________________

Describe how exposure occurred. ____________________________________________________

_______________________________________________________________________________

Type of body fluid exposed to: rblood rbody fluid contaminated by blood rsemen

rvaginal secretions rCSF rsynovial rperitoneal

rpericardial ramniotic runfixed human tissue

Type of exposure: rneedlestick…..Depth of injury ___________________

(check all that apply) rcut…….Depth of injury ___________________

Fluid injected rYes rNo – Estimated volume: _________

rMucous membrane

rNon-intact skin (e.g., chapped, abraded, or otherwise non-intact)

Did this exposure occur during the employee’s/student’s normal work activities? rYes rNo

Is patient source known? rYes rNo Was source consent obtained? rYes rNo

Source lab testing done? rYes rNo Source on antiretroviral therapy? rYes rNo

List Drugs ___________________________________

Was source blood sent to lab? rYes rNo

Source name _______________________ UH#_______________ Location__________________

Exposed employee/student lab testing done? rYes r No

(For Females)- Pregnancy test result________________

Was prophylaxis initiated? rYes rNo Date/Time of 1st dose ____/_____/____Time ____am_ pm __

Have you had training on Universal Precautions within the last 12 months? rYes rNo

FAX THIS FORM TO:

(409) 747-9182-Employees (409) 747-9330-Students

For questions call:

Mon-Fri 7:30am-4:30 pm Mon-Fri 8:00am-5:00pm

(409) 747-9172-Employees (409) 747-9320-Students

Access Center 1-800-917-8906

BLOODBORNE PATHOGENS EXPOSURE MANAGEMENT FORM *

University of Texas Medical Branch – Employee Health/Student Wellness

Name ____________________________________________________________________________

^{(Last) (First) (MI)}

rEmployee rStudent Employee Dept._________________ Position______________________

Phone: _______________________ __________________________ _______________________ ^{(Home) (Pager) (Work)}

Date of Exposure _______________________ Time of Exposure ___________________ am/pm

Initial Care of Injury/Exposure Site_______________________________________________________________________________

__________________________________________________________________________________

Date of Evaluation (Initial) ___________________ Time of Evaluation (Initial) ____________ am/pm

r Completed BBP Notification Form attached.

SOURCE INFORMATION AT TIME OF INCIDENT rKnown Source rUnknown Source

Name ___________________________________UH#_____________________________________

Account # _________________________Location ________________________________________

SOURCE LAB RESULTS

	Date Drawn	Results
HIV
HBS (Hep B surface antigen)
HCV

HEPATITIS AND TETANUS

Hepatitis B Vaccine		[ 0 ] [ 1 ] [ 2 ] [ 3 ]
Last Dose: _______________
Antibody Response:			r Positive r Negative r Unknown
Hepatitis B Vaccine Given:			r Yes	r No	Date Given:	_______________
Immunoprophylaxis:	HBIG		r Yes	r No	Date Given:	_______________
Tetanus/Diptheria Booster (dT/Tdap): Date of Last Dose: ____________________
Booster Given:			r Yes	r No	Date Given:	_______________

* See Appendix B for flow diagram on exposure management.

HIV EXPOSURE

INITIAL VISIT

BP______________ P_____________ R__________ T__________ WT___________ HT__________

Medication(s) ______________________________ Drug Allergy(s) ____________________________

______________________________

______________________________

Clinical Findings:

EMPLOYEE/STUDENT BASELINE LAB

Consent for HIV Testing	rYes rNo
Date _______________

EMPLOYEE/STUDENT RESULTS

	Date Drawn	Results
HIV1/HIV2
HBA* (Hep B surface antibody)
HCV antibody
HBS (Hep B surface antigen)

*For employees/students who have never received vaccine or who have a history of HBV immunization prior to coming to UTMB, a HBS (Hepatitis B surface antigen) test should be done.

Prophylaxis Baseline Labs: RESULTS
CBC
Total bilirubin, ALT, AST, GGT
Pregnancy Test (urine or serum)
Creatinine, BUN
Blood glucose
Employee/Student (Circle one)

Results

Reported ___/___/___ Via ____________ By________________

CHECK FOLLOW-UP NEEDED: FOLLOW-UP DIRECTIONS:

r 2 Weeks	(If on prophylaxis)
r 4 Weeks	(If on prophylaxis)
r 6 Weeks	(HIV+source. HCV+source)
r 3 Months	(HIV+source. HCV+source. Unknown source)
r 6 Months	(HIV+source. HCV+source. Unknown source).
r 12 Months	(HIV+source)

HIV+source = HIV drawn

HCV+source = HCV Qual-RNA (PCR) drawn

HIV/HCV (-) = HIV drawn

Unknown source = HIV and HCV drawn

2 WEEK FOLLOW-UP ___/___/___ RESULTS 4 WEEK FOLLOW-UP __/__/__ RESULTS

If placed on prophylaxis: If placed on prophylaxis:

CBC			CBC
Total bilirubin, ALT, AST, GGT			Total bilirubin, ALT, AST, GGT
Pregnancy Test (urine or serum)			Creatinine, BUN
Creatinine, BUN			Blood glucose
Blood glucose
Results			Results
Reported __/__/__ Via ____ By ____________			Reported __/__/__ Via ____ By ______________

6 WEEK FOLLOW- UP ___/___/___ RESULTS

HIV, CBC
Total bilirubin, ALT, AST, GGT Creatinine, BUN, blood glucose
HCV Qual RNA (PCR) (only if source blood Hep C+)
Results
Reported __/__/__ Via ____ By ________________

3 MONTH FOLLOW-UP __/__/__ RESULTS 6 MONTH FOLLOW-UP __/__/__ RESULTS

HIV			HIV
HCV Qual RNA (PCR) (only if source blood Hep C+)			HCV Qual RNA (PCR) (only if source blood Hep C+)

Results Results

Reported __/__/__ Via ________ By_______________ Reported ___/___/___ Via _______ By __________

12 MONTH FOLLOW UP __/___/___RESULTS

HIV

Results

Reported ___/___/___ Via ________ By_______________

ASSESSMENT/RECOMMENDATIONS:

Warnings discussed to avoid pregnancy and/or breast feeding during treatment (females)

rYes rNo

Employee Assistance Program/Counseling r Referral Made r Declined

Post-Exposure Treatment: r Recommended r Not Recommended

Informed Consent: r Obtained r Refused

Post-Exposure Prophylaxis: r Declined r Provided

Date/Time of 1st dose ____/____/____-_________AM/PM

Printed Materials Provided: r Yes r No

Comments:

Nurse ___________________________________________Date _____________________________

Healthcare Provider ________________________________Date _____________________________

Provider Information: Name _____________________________________________

Clinic _____________________________________________

Address_____________________________________________

_____________________________________________

Phone _____________________________________________

After follow-up is completed, for employees for students

provider is to forward to: Employee Health Student Wellness

Primary Care Pavilion Rebecca Sealy Hospital 400 Harborside Drive 301 University Boulevard

Route 1161 Route 0169

FAX (409) 747-9182 FAX (409) 747-9330

For questions call: Employees (409) 747-9172 Students (409) 747-9320 Access Center (800) 917-8906

Patient Information

Risk of HIV Infection

The average risk of HIV infection due to all types of reported percutaneous exposures to HIV-infected blood is 0.3%. A percutaneous exposure is defined as a needlestick or laceration/puncture with a sharp object.

The risk appears to be greater than 0.3% for exposure to HIV (+) patients involving deep injury, visible blood on the device causing the injury, a device previously placed in the source patient’s vein or artery, or the source patient dying of AIDS within 60 days post-exposure.

Risk of Hepatitis B or Hepatitis C Infection

The average risk of Hepatitis B virus (HBV) infection in susceptible persons after percutaneous exposure to HBV-infected blood is 6 – 30%. The risk of Hepatitis C virus (HCV) infection after percutaneous exposure to HCV-infected blood is 7.4% (95% CI 3.9%-12.5%).

Prophylaxis for Exposure to HIV (Revised March 2008)

Prophylaxis is being offered to employees and students who have a percutaneous injury, contamination of mucous membranes or nonintact skin, to HIV during the performance of their duties. Prophylaxis in these circumstances is voluntary. The FDA has not approved antiretroviral therapy for post-exposure use; therefore, use of these medications post-exposure for healthcare workers is considered investigational. The CDC says “Because most occupational exposures to HIV do not result in infection transmission, potential toxicity must be carefully considered when prescribing post-exposure prophylaxis (PEP)”.

Medication Schedule

Regimen 1

Prophylaxis will be treatment for four weeks with:

fos-amprenavir (Lexiva 700 mg tab), two tablets by mouth with food every 12 hours emtricitabine (Emtriva 200 mg cap), one capsule by mouth with or without food every 24 hours and

tenofovir (Viread 300 mg tab), one tablet by mouth with or without food every 24 hours.

Side effects associated with fos-amprenavir (Lexiva) that may go away with treatment include diarrhea, headache, nausea, vomiting, stomach pain, and rash. If they continue or are bothersome, check with your doctor. There may be allergic reactions in patients with sulfa hypersensitivity. There may be hyperglycemia (increased blood sugar), new onset or exacerbation of diabetes mellitus.

Side effects associated with emtricitabine (Emtriva) include nausea, diarrhea, abdominal pain, headache, rash and skin discoloration. Treatment-limiting toxicities are very uncommon with this medication.

Side effects associated with tenofovir (Viread) include nausea, vomiting, dizziness, gas, loss of appetite, joint or muscle pain, or rash. Rarely, this medication may cause jaundice with dark urine, yellowing of the skin or eyes, and in some cases abdominal or stomach pain.

Regimen 2 (see below) is to be used instead of Regimen 1 during pregnancy or if pregnancy is possible, for those with sulfa hypersensitivity, or if there is intolerance to components of Regimen 1.

Regimen 2

Treatment will also be for four weeks with:

Combivir (300 mg [AZT] and 150 mg lamivudine [Epivir] in fixed dose combination cap) one capsule by mouth with food every 12 hours for 4 weeks and

Kaletra (lopinavir/ritonavir (200/50mg tabs), 2 tablets by mouth with or without food every 12 hours for 4 weeks.

Side effects associated with AZT include headache, nausea, muscles aches and pains, fatigue, and trouble sleeping. These side effects are expected to stop when AZT is discontinued. Severe anemia (low red blood cells), neutropenia (low white blood cells), and liver cell damage are serious side effects that may develop in individuals taking AZT.

Side effects associated with lamivudine (Epivir) are uncommon and include nausea, diarrhea, abdominal pain, muscle pain, headache, dizziness, and difficulty sleeping. Any history of pre-existing renal impairment should be noted, and the dose should be reduced if renal insufficiency (creatinine clearance < 50% of normal) is present.

Side effects associated with lopinavir/ritonavir (Kaletra) include nausea, vomiting, diarrhea, weakness, hyperlipidemia, elevated serum transaminases, hyperglycemia, and fat maldistribution.

The risk of long-term toxicities, for example, birth defects, reproductive capacity, development of tumors, or other long-term effects of these medications are unknown.

Pregnancy

The risks of adverse effects to a developing fetus from antiretroviral therapy taken by a pregnant woman are unknown, but the risks are likely to be greater in the first trimester. Therefore, females taking antiretroviral therapy post-exposure should be aware that there may be risks associated with antiretroviral therapy during pregnancy, and prophylaxis should be reserved for those with HIGH RISK exposures. If a female is found to be HIV ELISA positive or to have a low value on viral load test, they should be referred to the HIV Maternal Fetal Child Health Clinic (409) 772-2798.

Routine Occupational Exposure Follow-up

Follow-up is determined by the results of the initial lab work drawn on the source of the occupational exposure. It proceeds as follows:

HIV(+) source known Obtain HIV antibody @ exposure

6 weeks

3 months

6 months

12 months

HCV(+) source known Obtain HCV antibody @ exposure

Obtain HCV Qual RNA (PCR) at 6 weeks

3 months

6 months

Unknown source Obtain HIV& HCV antibody @ exposure

3 months

6 months

If the source results are HIV (-) and HCV (-), you will be offered a one-time 6-month follow-up at which time only an HIV will be drawn.

Special Precautions after an HIV(+) or High Risk Exposure

S Do not share a toothbrush. Gums can bleed easily, getting blood on the toothbrush.

S Do not share razors as blood may go undetected on the blade.

S Avoid pregnancy until HIV infection is ruled out (i.e. generally 6 months following exposure, but up to one year).

S Use safe sex practices-male/female latex condoms for barrier protection or abstain from sex during the follow-up period until HIV infection has been ruled out.

S Do not donate blood, plasma, organs, tissue or semen during the follow-up period.

S Seek medical evaluation for any acute illness that occurs during the follow-up period.

INFORMED CONSENT FOR PROPHYLAXIS AFTER

BLOODBORNE PATHOGENS EXPOSURE

As a patient, you have the right to be informed about your risk after a bloodborne pathogens (BBP) exposure and the recommended prophylaxis. This disclosure is not meant to alarm you; however, there are certain side effects which are associated with prophylaxis. I have read and understand the patient information entitled “Occupational Exposures to Bloodborne Pathogens-Patient Information,” which explains risks of infection, prophylaxis, medication schedule, pregnancy precautions, follow-up and special precautions.

r I hereby voluntarily consent to prophylaxis for exposure to blood and body fluids infected or possibly infected with human immunodeficiency virus-1(HIV-1). The medications include:

r I hereby decline prophylaxis following my exposure to bloodborne pathogens. The healthcare provider has informed me of the possible risks associated with refusing this medication. The nature and purpose of the proposed prophylaxis & the risks and hazards if the treatment is withheld, have been explained to me by a healthcare provider. I have had an opportunity to discuss these matters with a healthcare provider and to ask questions about my exposure, alternatives, and the proposed treatment.

EMPLOYEE Date Time

HEALTHCARE PROVIDER Date Time

WITNESS Date Time

***** Please forward to Employee Health/Student Wellness *****







Appendix A. Prescription and over-the-counter drugs that should not be administered with protease inhibitors (PIs) because of drug interactions.

Drug	Comment
Antimycobacterials: rifampin	Decreases plasma concentrations and area under plasma concentration curve of the majority of PIs by approximately 90%, which might result in loss of therapeutic effect and development of resistance
Benzodiazepines: midazolam, triazolam	Contraindicated because of potential for serious or life-threatening events (e.g., prolonged or increased sedation or respiratory depression)
Ergot derivatives: dihydroergotamine, ergotamine, ergonovine, methylegonovine	Contraindicated because of potential for serious or life-threatening events (e.g., acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues)
Gastrointestinal motility agent: cisapride	Contraindicated because of potential for serious or life-threatening events (e.g., cardiac arrhythmias)
HMG-CoA reductase inhibitors (“statins”): lovastatin, simvastatin	Potential for serious reactions (e.g., myopathy, including rhabdomyolysis); atorvastatin may be used cautiously, beginning with lowest possible starting dose, and monitoring for adverse events
Neuroleptic: pimozide	Contraindicated because of potential for serious or life-threatening events (e.g., cardiac arrhythmias)
Inhaled steroids: fluticasone	Coadministration of fluticasone and ritonavir-boosted protease inhibitors are not recommended unless the potential benefit to the patient outweighs the risk for systemic corticosteroid side effect
Herbal products: St. John’s wort (hypericum perforatum), garlic	Coadministration might reduce plasma concentrations of protease inhibitors, which might result in loss of therapeutic effect and development of resistance Garlic might lower saquinavir level

This table does not list all products that should not be administered with PIs (atazanavir, lopinavir/ritonavir, fosamprenavir, indinavir, nelfinavir, saquinavir).

Product labels should be consulted for additional information regarding drug interactions.

Sources: US Department of Health and Human Services. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Washington, DC: US Department of Health and Human Services; 2005. Available at http://www.aidsinfo.nih.gov/guidelines/adult/AA_040705.pdf; University of California at San Francisco Center for HIV Information. Database of antiretroviral drug interactions. Available at http://hivinsite.ucsf.edu/InSite?page=ar-00-02.

Appendix B. OCCUPATIONAL EXPOSURES TO BLOODBORNE PATHOGENS (BBP)*

Supervisor/Employee/Student Actions









Treatment Provider (Employee Health/Student Wellness/ED) or Off-site Provider