Instructions and Consent Form for Post-Exposure Prophylaxis for HIV

I sustained an Occupational Bloodborne Pathogen exposure to body fluids potentially infected with HIV, the virus that causes AIDS, in my workplace. The risk of infection with HIV from my exposure is unknown, but studies have estimated the average risk to be 0.3%. A case-control study showed that taking medications used to treat HIV after exposure reduced the risk of contracting HIV through that exposure. After discussion with clinicians at the UM-Occupational Health Service (OHS)/Emergency Department, I have decided to take a course of medication in an effort to decrease the risk of occupational related HIV transmission. Although there are significant gaps in our knowledge about the best way to prevent occupational HIV infection, this medication regimen is consistent with the most recent recommendations of the Centers for Disease Control and Prevention. The regimen I will be taking is as follows:

_____ Truvada (Emitrictabine/Tenofovir) one tablet daily and

_____ Raltegravir 400 mg twice daily for four weeks.

When the source patient has drug resistant HIV infection and in certain other circumstances, clinicians at UM-OHS will consult with an infectious diseases physician at UMHS to determine the best regimen. If alternative treatment is recommended I will be referred to an Infectious Disease specialist. I give my permission for the specialist to access my medical records.

Side effects of Truvada include: sore throat, depression, headache, dizziness, nausea, diarrhea, stomach pain and weight gain, decrease in urination, extreme weakness, tiredness, confusion, lightheadedness, numbing, tingling or burning pain in hands, arms, legs or feet. Side effects associated with Raltegravir include: skin rash, nausea, vomiting, loss of appetite or stomach pain, eye or eyelid redness pain or swelling, dark colored urine or pale stools I will immediately seek medical attention if I experience any allergic reaction, swelling or tingling in my mouth or throat, chest tightness, trouble breathing, unusual tiredness or weakness, fever or chills, yellowing of skin or whites of eyes or blistering skin rash.

Although any side effects I develop are expected to resolve once I stop taking the medication, I understand that the long-term effects of these medications, either singly or in combination, are unknown.

If I am pregnant or become pregnant during the course of treatment, I will not take these medications without the knowledge and recommendation of my primary care or obstetric provider and an Infectious Disease Specialist. If I am breastfeeding, I will not continue to do so while taking this medication without the knowledge and recommendation of my child’s primary care provider. The risks of these medications on the fetus or breastfeeding child are not fully understood at this time. I understand that if I am not pregnant I should be using contraception during the course of treatment and for four weeks following treatment. The date of the first day of my last menstrual period is: _____________________

I will be provided this medication free of charge through my employer. In agreeing to take this through my employer, I agree to be seen in the UM-Occupational Health Service weekly while on the medication to have blood drawn to monitor for any toxic effects. I also am aware that according to the OSHA Bloodborne Pathogens Standard, I am offered baseline HIV antibody testing and follow up testing at 6 weeks, 3 months, and 6 months post exposure. HIV testing done through UM-Occupational Health Service is coded and every effort is made to maintain confidentiality but testing is not anonymous. If I agree to take this medication, I will also let the clinicians in OHS (or ED if OHS is unavailable) know about any side effects or concerns I may have regarding the medications. If I wish to stop taking the medications during the four week course, I will inform OHS at the first available opportunity.

I have read this consent form and have had the opportunity to ask questions. I have received medical information sheets for these medications and I wish to take the medications as described above.

Employee Name/ID# __________________________________________

Witness/Title _________________________________________________