CDC. MMWR 2001;50(RR-11) cdc/mmwr/PDF/rr/rr5011.pdf

1. Updated U.S. Public Health Service Guidelines for theManagement of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis • CDC. MMWR 2001;50(RR-11) • http://www.cdc.gov/mmwr/PDF/rr/rr5011.pdf

2. Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV) • Bloodborne viruses • Can produce chronic infection • Transmissible in healthcare settings • Data from multiple sources (e.g., surveillance, observational studies, serosurveys) used to assess risk of occupational transmission

3. Preventing Transmissionof Bloodborne Virusesin Healthcare Settings • Promote hepatitis B vaccination • Treat all patients as potentially infectious • Use barriers to prevent blood/body fluid contact • Prevent percutaneous injuries

4. Factors Influencing Occupational Risk of Bloodborne Virus Infection • Prevalence of infection among patients • Risk of infection transmission after a blood exposure • Nature and frequency of blood exposures

5. Prevalence of Bloodborne Virus Infection in Patients • Generally higher in hospitalized patients than general population • Varies with geographic area • Varies with patient group

6. Source HBV HBeAg + HBeAg - HCV HIV Risk 22.0-30.0% 1.0-6.0% 1.8% 0.3% Risk of Bloodborne Virus Transmission after Occupational Percutaneous Exposure

7. Frequency of Percutaneous Injury in Healthcare Personnel • Based on CDC estimates, 384,325 (95% CI 311,091-463,922) percutaneous injuries are sustained by healthcare personnel in US hospitals annually* • The number of injuries sustained outside of hospital settings is unknown • Frequency of percutaneous injury varies by occupational group and healthcare setting * Panlilio, AL, et. al. Estimate of the Annual Number of Percutaneous Injuries in U.S. Healthcare Workers. 4th Decennial Conference, March 5-9, 2000

8. National Surveillance System For Healthcare Workers http://www.cdc.gov/ncidod/hip/SURVEILL/nash.HTM

9. Exposure Types for Blood/Body Fluid Exposures* Reported to NaSHJune 1995-December 2000(n=12,678) Non-intact skin 352 (3%) Bite 131 (1%) Percutaneous 10,378 (82%) Mucous membrane 1817 (14%) * Excluding intact skin exposures and clean needlesticks. Exposures involving more than one site (4% of all exposures) are counted as one exposure according to the highest risk route for bloodborne virus transmission.

10. Device Types for Percutaneous Injuries Reported to NaSHJune 1995-December 2000 (n=10,378) Solid sharp (32%) Suture needle (17%) Scalpel (7%) Other (8%) Other/ unknown (6%) Glass (2%) Hollow-bore needle (60%) IV stylet Phlebotomy needle * Other hollow-bore needle Winged steel needle Hypodermic needle 10% 12% 3% 29% 6% * Vacuum tube collection/holder/needle

11. Reasons for Updating the PHS Guideline • New antiretroviral drugs • Emerging HIV drug resistance • Overuse of PEP for low or no risk exposures • HBV, HCV, and HIV issues best presented in a single document

12. Elements of an Effective Postexposure Management Program • Clear policies/procedures • Training of healthcare personnel (HCP) • Rapid access to • clinical care • postexposure prophylaxis (PEP) • testing of source patients/HCP • Injury prevention assessment

13. Elements of Postexposure Management • Wound management • Exposure reporting • Assessment of infection risk • type and severity of exposure • bloodborne infection status of source person • Appropriate treatment, follow-up, and counseling

14. Postexposure Management:Wound Care • Clean wounds with soap and water • Flush mucous membranes with water • No evidence of benefit for: • application of antiseptics or disinfectants • squeezing (“milking”) puncture sites • Avoid use of bleach and other agents caustic to skin

15. Postexposure Management:The Exposure Report • Date and time of exposure • Procedure details…what, where, how, with what device • Exposure details...route, body substance involved, volume/duration of contact • Information about source person and exposed person • Exposure management details

16. Type of exposure percutaneous mucous membrane non-intact skin bites resulting in blood exposure Body substance blood bloody fluid potentially infectious fluid or tissue Source person presence of HBsAg presence of HCV antibody presence of HIV antibody if source unknown, assess epidemiologic and clinical evidence Postexposure Management: Assessment of Infection Risk

17. Postexposure Management: Unknown or Untestable Source • Consider information about exposure • where and under what circumstances • prevalence of HBV, HCV, or HIV in the population group • Testing of needles and other sharp instruments not recommended • unknown reliability and interpretation of findings • hazard of handling sharp instrument

18. Postexposure Management:Evaluating the Source • Informed consent should be obtained in accordance with state and local laws • Confidentiality of the source person

19. Postexposure Management:Evaluating the Source (cont.) • If the HBV, HCV, and/or HIV status of the source is unknown, perform testing • Perform testing as soon as possible • Consult laboratory regarding most appropriate test to expedite obtaining results

20. Postexposure Management: Evaluating the Source for HBV • Presence of hepatitis B surface antigen (HBsAg) indicates source is infected with HBV

21. Postexposure Management: Evaluating the Source for HCV • Repeatedly reactive results by EIA for anti-HCV should be confirmed by supplemental test (RIBA or HCV PCR) • Direct virus assays not recommended

22. Postexposure Management:Evaluating the Source for HIV • EIA • Consider rapid test if EIA testing cannot be completed within 24-48 hours • Confirmation of reactive result not necessary for PEP management • Direct virus assays (e.g., PCR, p24 antigen) not recommended

23. Occupational HBV Exposures

24. Estimated Incidence of HBV infections among HCP and General Population, United States, 1985-1999 Healthcare Personnel GeneralU.S. Population

25. Hepatitis B Vaccination Coverage of HCP in 113 US Hospitals, 1994-1995* Received 3 Doses, % 81 73 72 71 63 59 44 44 66.5 No. Eligible 149 196 1,056 61 645 132 222 69 2,530 • Occupation • Phlebotomist/technician • Radiologist/therapist • Nurse • Physician/resident • Nurse aide • Maintenance/security • Clerical • Food service • Total *Arch Intern Med 1997;157:2601

26. Concentration of HBV in Body Fluids HighModerate Low/Not Detectable BloodSemen Urine SerumVaginal FluidFeces Wound exudatesSaliva Sweat Tears Breast Milk

27. Elements of Postexposure Management: HBV • Baseline evaluation and testing of exposed person with unknown HBV immune status • Consideration of treatment • when to give • what to give • Follow-up testing and counseling

28. Postexposure Management: Baseline HBV Testing of Exposed* Person • Test for anti-HBs if person has been vaccinated, but vaccine response is unknown • Baseline testing not necessary if exposed person has not been vaccinated or vaccine response is known * Source HBsAg positive or status unknown

29. Recommended Postexposure Management: PEP for Exposure to HBV Vaccination and antibody status of exposed person Unvaccinated Previously vaccinated Known responder Known nonresponder Antibody response unknown • Treatment when source is HBsAg positive • HBIG x 1 and initiate hepatitis B • vaccine series • No treatment • HBIG x 1and initiate re-vaccination or • HBIG x 2 • Test exposed person for anti-HBs • 1. If adequate, no treatment • If inadequate, HBIG x 1 • and vaccine booster

30. Recommended Postexposure Management: PEP for Exposure to HBV Vaccination and antibody status of exposed person Unvaccinated Previously vaccinated Known responder Known nonresponder Antibody response unknown Treatment when source is not tested or status unknown Initiate hepatitis B vaccine series No treatment If known high-risk source treat as if source were HBsAg positive Test exposed person for anti-HBs 1. If adequate, no treatment 2. If inadequate, vaccine booster and recheck titer in 1-2 mos

31. Side Effects of Hepatitis B Vaccine • Pain at injection site • Mild to moderate fever • Anaphylaxis in an estimated 1 in 600,000 doses given • No serious adverse events detected through surveillance • No risk of adverse effects to fetus

32. Regimen Multiple doses of HBIG alone when 1st dose initiated within 1 week Hepatitis B vaccine series alone Combination of HBIG and vaccine series Prevention of HBV Infection 70-75% 70-75% 85-95% Efficacy of HBV PEP* * Estimated for adults, based on perinatal data

33. Hepatitis B Vaccine:Long-Term Efficacy • Anti-HBs titers decline to <10 mIU/mL in 30-50% of adults within 8-10 years after vaccination • Exposure to HBV results in anamnestic anti-HBs response that prevents clinically significant HBV infection • Immune memory remains intact for at least 20 years after immunization • Chronic HBV infection rarely documented among vaccine responders • Booster doses currently not recommended

34. Postexposure Management: Follow-up HBV Testing of Exposed Person • Perform follow-up anti-HBs testing in healthcare personnel who receive hepatitis B vaccine • test for anti-HBs 1-2 months after last dose • anti-HBs response to vaccine cannot be ascertained if HBIG received in the previous 3-4 months

35. Postexposure Management:HBV Postexposure Counseling • Refrain from donating blood, plasma, organs, tissue, or semen. • No need for: • modification of sexual practices or refraining from becoming pregnant • special precautions to prevent secondary transmission. • modification to patient care responsibilities for exposed person • If acute HBV infection, evaluate according to published recommendations

36. Occupational HCV Exposures

37. Occupational Transmission of HCV • Inefficiently transmitted by occupational exposures • Average incidence 1.8% (range 0-7%) following percutaneous exposure from HCV-positive source • Case reports of transmission from blood splash to mucous membrane • Prevalence 1-2% among healthcare personnel • Lower than among adults in the general population • 10 times lower than for HBV infection

38. Elements of Postexposure Management: HCV • Baseline evaluation and testing • Follow-up testing and counseling

39. Postexposure Management:Baseline HCV Testing of Exposed Person • If HCV-positive source, test exposed person for anti-HCV and ALT • If source not infected, baseline testing not necessary

40. Postexposure Prophylaxis for HCV • Not recommended after exposure • immunoglobulin not effective • no data on use of antivirals (e.g., interferon), and may be effective only with established infection • antivirals not FDA approved for this setting

41. Postexposure Management:Follow-up of HCV-Exposed HCP • Test for anti-HCV and ALT 4-6 months after exposure • Test for HCV-RNA at 4-6 weeks for earlier diagnosis of HCV infection. • Confirm anti-HCV EIA-positive results with supplemental test (e.g., RIBA) • No guidelines for therapy during acute infection • when HCV infection identified early, refer worker to a specialist for proper management

42. Postexposure Management:HCV Postexposure Counseling • Refrain from donating blood, plasma, organs, tissue, or semen. • No need for: • modification of sexual practices or refraining from becoming pregnant • special precautions to prevent secondary transmission. • modification to patient care responsibilities for exposed person, even if HCV infected

43. Occupational HIV Exposures

44. U.S. Healthcare Personnel with Documented and Possible Occupationally Acquired AIDS/HIV Infection, by Occupation, June 2001* Documented Possible Occupation Transmission (No.) Transmission ( No.) Dental worker, including dentist ---- 6 Embalmer/morgue technician 1 2 Emergency medical technician/paramedic ---- 12 Health aide/attendant 1 15 Housekeeper/maintenance worker 2 13 Laboratory technician, clinical 16 17 Laboratory technician, nonclinical 3 ---- Nurse 24 34 Physician, nonsurgical 6 12 Physician , surgical ---- 6 Respiratory therapist 1 2 Technician, dialysis 1 3 Technician, surgical 2 2 Technician/therapist, other than above ---- 9 Other healthcare occupations ---- 4 Total 57 137 * http://www.cdc.gov/hiv/pubs/facts.htm#Transmission

45. Percutaneous 48 Unknown 2 Both 2 Mucocutaneous 5 Exposures Resulting in Occupational HIV Transmission* June 2001 * http://www.cdc.gov/hiv/pubs/facts.htm#Transmission

46. Sharp Objects Associated with 51 Percutaneous Injuries Resulting in HIVSeroconversion in 50 Healthcare Personnel*June 2001 * http://www.cdc.gov/hiv/pubs/facts.htm#Transmission

47. Average Risk of HIV Infection to Healthcare Personnel by Exposure Route • Percutaneous 0.3% • Mucous membrane 0.09% • Non-intact skin <0.1%

48. Risk Factors for HIV Transmission After Percutaneous Exposure to HIV-Infected Blood: CDC Case-Control Study* Risk Factor Adjusted OR ratio (95% CI) Deep injury 15 (6.0-41) Visible blood on device 6.2 (2.2-21) Procedure involving needle 4.3 (1.7-12) placed in artery or vein Terminal illness in source patient 5.6 (2.0-16) Postexposure use of zidovudine 0.19 (0.06-0.52) *Cardo et al., New Engl J Med 1997;337:1485-90.

49. Criteria to Establish HIV PEP as a Standard of Care • Biological plausibility • Indirect scientific evidence of efficacy • animal models • human studies • Safety • Feasibility

50. Animal Studies of PEP Efficacy • Data have been difficult to interpret and extrapolate to humans, but provide encouraging evidence of PEP efficacy • Different virus strains, route of inoculation, dose of inocula, and drug regimens used • Delaying time to PEP, shortening the duration, or decreasing the dose reduced effectiveness of PEP