SIV/SHIV Exposure Medical Response Guidance for the University of Wisconsin-Madison

Transcription

1 SIV/SHIV SIV/SHIV Exposure Medical Response Guidance for the University of Wisconsin-Madison 1.0 Instructions: Information in this guidance is meant to inform both laboratory staff and health professionals about the risks and treatment in the event of an infectious agent exposure. In using this guidance, please consider that multiple routes of exposure may occur in a lab and that organism strains will sometimes be genetically modified to incorporate traits such as antimicrobial resistance. Research protocols and other available guidance such as Health Canada material safety data sheets will be provided as supporting information when available. It should be assumed that when exposures do occur, that the healthcare provider will be provided with information about the specific organism and strain involved, route of exposure, inoculum concentration, and victim vaccination and serological status, when available. This document was developed by UW Occupational Medicine in consultation with the UW Division of Infectious Disease. The information provided below is intended to provide guidance for treating physicians. Treatment and evaluation plans should be individualized to the patient based on the patient s symptoms, exposure risk, and underlying health status. If there are any questions about this document, please contact University Health Services, Occupational Medicine at Signs and Symptoms of Infection- Describe signs and symptoms associated with the agent. There are only three known cases of SIV seroconversion in the literature. In all three cases, patients remained entirely asymptomatic. CD4 counts demonstrated no laboratory evidence of decreased immunity. 3.0 Infectivity- Describe infective dose, relevant exposure routes (considering laboratory use), incubation period and potential severity of infection. The exact infective dose is unknown. The following is a list of potentially infectious material. Blood and blood products (serum/plasma) CSF Unfixed tissue and tissue cultures (viral stocks) Although there is no clear data, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, saliva, semen/cervical secretions, breast milk, and amniotic fluid should also be considered infective Feces, nasal secretions, sputum, sweat, tears, and vomitus are not considered infectious. Routes of infection include the following Puncture wounds Exposure to non-intact skin (abrasions, cuts, dermatitis) Mucous membrane exposures (eyes, nose, mouth) It is unknown whether infection can occur via the respiratory tract. 12/2/13 Page 1 of 6

2 The incubation period for infection in humans after an identified exposure is unknown but estimated to be similar to HIV, with antibody conversion generally occurring within six months. Based on a blinded serosurvey in 1992, the CDC estimates 0.6% of laboratory workers handling SIV have antibodies to SIV. Of the three know cases of SIV seroconversion reported in the literature, two of the cases were associated with blood contaminated hollow bore needle stick injuries from an SIV positive monkey. The third case was in a laboratory worker with dermatitis who did not use gloves while handling SIV positive blood and tissue culture samples. The risk of SIV transmission is extrapolated from HIV transmission estimates. The average risk of transmission after a hollow bore needle puncture is 0.3%. Three factors increase this risk: a visibly blood needle, a needle that was previously in a blood vessel, and a deep puncture wound. The average risk of transmission after a mucous membrane exposure is 0.09%. 4.0 Description of First Aid - Provide an overview of first aid treatment of exposures considering that multiple routes of exposure could occur (needlestick, aerosol, eye, skin and ingestion). Cleanse the exposed area for a minimum of 15 minutes as soon as possible following exposure. 1. Eyes or mucous membranes: use sterile saline or water to irrigate for 15 minutes, preferably in an eye wash station. For all eye exposures, BOTH eyes should be irrigated. 2. Skin: wash with the disinfectant product approved for your laboratory for at least 15 minutes **ALL POTENTIAL EXPOSURES MUST BE REPORTED TO UW OCCUPATIONAL HEALTH ( ) **THE SIV STATUS OF THE ANIMAL SHOULD GENERALLY BE KNOWN. PLEASE NOTIFY THE VETERINARIAN and ask regarding the following: The viral load of the inoculum, whether it came from a recently infected animal and whether that animal was symptomatic or asymptomatic. 5.0 Urgency of Medical Care- Describe how soon medical attention should be sought, i.e. is an ER visit necessary, a visit to University Health Services, or simply schedule a visit with a personal physician. All exposures should be evaluated as soon as possible, preferably within 2 hours, to determine if post exposure prophylaxis (PEP) is warranted. If PEP is indicated, it needs to be administered promptly. UW UHS Occupational health should be contacted at or If they are closed (after hours, weekends and holidays), please proceed to the UWHC Emergency Department. 12/2/13 Page 2 of 6

3 6.0 Description of Medical Response- Provide an overview for clinical treatment of exposures to the agent considering that multiple routes of exposure could occur (needlestick, aerosol, eye, skin and ingestion) and that strains of agents will vary and sometimes include antimicrobial resistance. Initial Evaluation 1) Healthcare provider should re-wash the exposed area for 15 minutes as described above in First Aid section. 2) Healthcare provider should document date, time, and location of injury and the type of animal tissue or fluid involved in exposure. If available/relevant (see Indications for SIV Prophylaxis below), the viral load of the inoculum, whether the animal was symptomatic or asymptomatic, and whether the animal was recently infected should be recorded. The strain if SIV involved as well as any recombinants should be documented. 3) Evaluation of general health including potential pregnancy, medications and the date of the last tetanus booster. 4) If the exposure involved an animal, the healthcare provider will also evaluate for possible antibiotic prophylaxis and herpes B prophylaxis. 5) If an exposure has occurred, then blood work for SIV surveillance should be sent to the CDC. This includes HIV and SIV antibody tests as well as viral load testing. Please see the attached instructions Procedure for the collections and shipment of whole blood specimens to the CDC, IATA guidance document for shipping infectious substances, and IATA packing instructions for biologic specimens. These outline how the specimen should be collected, labeled and shipped. They also review who should be contacted and what information regarding the exposure should be provided. Indications for SIV Prophylaxis SIV postexposure prophylaxis for 4 weeks with a three drug regimen is recommended for exposure to any type of potentially infectious SIV material. Two drug regimens are no longer recommended for retrovirus postexposure prophylaxis. The current preferred three drug regimen is: Tenofovir-Emtricitabine (TDF/FTC 300/200 mg ; once daily ) plus Raltegravir (400 mg twice daily). Side effects: mild GI upset (nausea and vomiting 27%; diarrhea 21%; gas, pain or bloating 16%), headache (15%), fatigue (14%); Precautions / Interactions: hepatitis B, osteoporosis, renal disease This regimen avoids medications which should not be used during the first trimester of pregnancy, in women who are trying to conceive or are not using effective and consistent contraception, and avoids medications which can interact with omeprazole or similar acid lowering agents. 12/2/13 Page 3 of 6

4 The preferred three drug regimen for pregnant or breastfeeding (i.e. continues to breast feed though not recommended ) women is: Lopinavir/Ritonavir (LPV/r twice daily) and Zidovudine/Lamivudine (ZDV/3TC once daily) Side effects: GI upset, fatigue and headache Precautions / Interactions: hepatitis B, hemoglobin <9.5, neutrophil count < 1000; St John s wort should be avoided; co-administration with simvastatin or lovastatin increases the risk of myotoxicity; pravastatin does not interact and can be substituted. Other preferred regimens may be considered for specific medical histories or risk factors (renal disease, pregnancy or breastfeeding). SIV viruses with the M184V/I mutation or the K65R mutation also require an alternate regimen. These situations would require direct input from the UW Infectious Disease physician on-call. (Current approaches used by CDC include the following: Emtricitabine resistant viruses containing the M 184V/I mutation: tenofovir, raltegravir and darunavir boosted with ritonavir; Tenofovir resistant viruses containing the K65Rmutation, usually resistant to emtricitabine also: raltegravir, zidovudine, and darunavir boosted with ritonavir.) If it is decided to start PEP the following lab work should be obtained: CBC with differential Creatinine AST and ALT Urine pregnancy test in all women of childbearing age If PEP is prescribed, baseline lab work should be performed as outlined above. This should be repeated, with the exception of the urine pregnancy test, at 2 weeks and 4 weeks to assess for toxicity. At this 2 week mark, the worker should be seen by the clinician to ensure all wounds are healing properly and evaluate for medication side effects. Often, these can be handled symptomatically by prescribing anti-emetics and anti-motility agents. At the end of four weeks, the worker and clinician should follow-up. Any wounds should be inspected. Antivirals should be discontinued and the plan for follow up blood work (viral and antibody testing) reviewed. Follow-up All workers with an SIV exposure should be monitored for seroconversion and infection. Whole blood for SIV testing at the CDC should be drawn at the time of exposure, 3 weeks, 6 weeks, 3 months, 6 months and one year after. Procedure for the Collection and Shipment of Whole Blood Specimens to the CDC 1. Collect ml of EDTA-treated blood on Monday through Thursday using standard clinical venipuncture techniques. For samples collected outside this period please contact Bill Switzer at the CDC ( ; bis3@cdc.gov) to make other shipping arrangements. 2. All specimens and paperwork should be coded without any personal identifiers. 12/2/13 Page 4 of 6

5 3. Place the sample in a shipping container following the instructions found at the CDC or IATA websites ( and ship at room temperature to the CDC Serum Bank using an overnight, next morning delivery service. 4. Unless other arrangements are made, all shipments are to be sent to: CDC Serum Bank (STAT) Centers for Disease Control and Prevention 1600 Clifton Road NE Atlanta, GA Attention: Project Provide advance notice of the shipment by FAXing a copy of the shipment manifest to both Bill Switzer ( ) and the CDC Serum Bank ( ) the day the samples are collected. Alternatively, notification to Bill Switzer will suffice. bswitzer@cdc.gov 6. Please provide details of the specific exposure in an to Bill Switzer, including when, where, how the exposure occurred, the strain of SIV or SHIV involved, animal species, occupation, and antiretroviral treatment. (to be done by UHS) 7.0 Description of Medical Surveillance- Describe the advisability of medical surveillance strategies (in particular baseline and annual serology) for those working with the agent. If doing so would likely improve the identification, diagnosis or treatment of exposures, please indicate so. Surveillance, such as annual serology, for SIV is not indicated in the absence of exposure. 8.0 Considerations for Infection Control-Describe any special precautions required to prevent the further spread of infection. Include precautions for the healthcare, workplace, and home setting. The worker should be counseled to reduce risk for secondary transmission by avoiding unprotected sex, breast feeding, and blood or tissue donation during the incubation period. 9.0 Reporting-Describe any public health or federal regulatory reporting requirements. Include the timing and mechanism for reporting. Public Health: None Other: None 12/2/13 Page 5 of 6

6 10.0 References: Wilson, D and L Chosewood. Biosafety in Microbiological and biomedical laboratories, 5 th edition. Revised December, Available at Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents; Update of March 27, 2012; Dept of Health and Human Services Document Revisions Revision History Revision Number Date Description of Revision Initial Approval 4/13/12 ASW original 1 4/2013 ASW edits 2 12/2/13 Changed to new format 12/2/13 Page 6 of 6