Instructions and Consent Form for Post-Exposure Prophylaxis for HIV
I have been exposed to 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 recent case-control study showed that taking zidovudine, a medication used to treat HIV, after exposure reduced the risk of contracting HIV through that exposure.
After discussion with the Employee Health Service (EHS)/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:
_____ Combivir (ZDV 300 mg/Lamivudine 150 mg ) two times a day
_____ Kaletra (400 mg Lopinavir/100 mg Rotinavir) two times a day. Dosage
form for Kaletra is (200 mg Lopinavir/50 mg Rotinavir per tablet) for a
four week course. I have been given enough medication or a prescription
to last until my next EHS appointment or until the first day that I can
be seen in EHS.
The known side effects of Zidovudine and Lamivudine include headache, muscle pain, tiredness, loss of appetite, trouble sleeping and nausea. Uncommonly, fever, vomiting, dizziness, diarrhea, low red and/or white blood cell count, low platelet count, liver inflammation and muscle inflammation have been reported with these drugs and, additionally, pancreas inflammation has been reported uncommonly with Lamivudine.
Side effects associated with Kaletra include diarrhea, fatigue, headache, nausea and increased cholesterol and triglycerides. All protease inhibitors have been associated with hyperglycemia in patients with or without diabetes. Numerous drug interactions with Kaletra have been reported; the drug should not be administered with rifampin, St. John's Wort, simvastatin or lovastatin. Contraindications for use include drugs highly dependent on CYP3A or CYP2D6 for clearance: astemizole, terfenadine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, pimozide midazolem, triazolam.
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. 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 is 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 Employee Health Service at one, two, four and six weeks after the exposure incident and to have blood drawn to monitor for any toxic effects. I also am aware that according to the Bloodborne Pathogens Standard, I am offered baseline HIV antibody testing and follow up testing at 3 and 6 months. HIV testing done through Employee 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 EHS (or ED if EHS 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 EHS at the first available opportunity.
I have read this consent form and have had the opportunity to ask questions. I wish to take the medications as described above.
Employee Name/ID# __________________________________________
Witness/Title _________________________________________________
