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participating institutions:
Johns Hopkins University AIDS Service, New York State DOH AIDS Institute, The CORE Center, Cook County Hospital



POST-EXPOSURE PROPHYLAXIS

last updated: June 29, 2001


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Occupational Transmission of HBV

Risk for Occupational Transmission of HBV

HBV infection is a well recognized occupational risk for HCP (25). The risk of HBV infection is primarily related to the degree of contact with blood in the work place and also to the hepatitis B e antigen (HBeAg) status of the source person. In studies of HCP who sustained injuries from needles contaminated with blood containing HBV, the risk of developing clinical hepatitis if the blood was both hepatitis B surface antigen (HBsAg)-and HBeAg-positive was 22%-31%; the risk of developing serologic evidence of HBV infection was 37%-62%. By comparison, the risk of developing clinical hepatitis from a needle contaminated with HBsAg-positive, HBeAg-negative blood was 1%-6%, and the risk of developing serologic evidence of HBV infection, 23%-37% (26).

Although percutaneous injuries are among the most efficient modes of HBV transmission, these exposures probably account for only a minority of HBV infections among HCP. In several investigations of nosocomial hepatitis B outbreaks, most infected HCP could not recall an overt percutaneous injury (27,28), although in some studies, up to one third of infected HCP recalled caring for a patient who was HBsAg-positive (29,30). In addition, HBV has been demonstrated to survive in dried blood at room temperature on environmental surfaces for at least 1 week (31). Thus, HBV infections that occur in HCP with no history of nonoccupational exposure or occupational percutaneous injury might have resulted from direct or indirect blood or body fluid exposures that inoculated HBV into cutaneous scratches, abrasions, burns, other lesions, or on mucosal surfaces (32‚ 34). The potential for HBV transmission through contact with environmental surfaces has been demonstrated in investigations of HBV outbreaks among patients and staff of hemodialysis units (35‚37).

Blood contains the highest HBV titers of all body fluids and is the most important vehicle of transmission in the health-care setting. HBsAg is also found in several other body fluids, including breast milk, bile, cerebrospinal fluid, feces, nasopharyngeal washings, saliva, semen, sweat, and synovial fluid (38). However, the concentration of HBsAg in body fluids can be 100-1000-fold higher than the concentration of infectious HBV particles. Therefore, most body fluids are not efficient vehicles of transmission because they contain low quantities of infectious HBV, despite the presence of HBsAg.

In serologic studies conducted in the United States during the 1970s, HCP had a prevalence of HBV infection approximately 10 times higher than the general population (39‚42). Because of the high risk of HBV infection among HCP, routine preexposure vaccination of HCP against hepatitis B and the use of standard precautions to prevent exposure to blood and other potentially infectious body fluids have been recommended since the early 1980s (43). Regulations issued by the Occupational Safety and Health Administration (OSHA) (2) have increased compliance with these recommendations. Since the implementation of these recommendations, a sharp decline has occurred in the incidence of HBV infection among HCP.

PEP for HBV

Efficacy of PEP for HBV. The effectiveness of hepatitis B immune globulin (HBIG) and/or hepatitis B vaccine in various postexposure settings has been evaluated by prospec-tive studies. For perinatal exposure to an HBsAg-, HBeAg-positive mother, a regimen combining HBIG and initiation of the hepatitis B vaccine series at birth is 85%-95% effective in preventing HBV infection (44,45). Regimens involving either multiple doses of HBIG alone or the hepatitis B vaccine series alone are 70%-75% effective in prevent-ing HBV infection (46). In the occupational setting, multiple doses of HBIG initiated within 1 week following percutaneous exposure to HBsAg-positive blood provides an estimated 75% protection from HBV infection (47‚49). Although the postexposure efficacy of the combination of HBIG and the hepatitis B vaccine series has not been evaluated in the occupational setting, the increased efficacy of this regimen observed in the perinatal setting, compared with HBIG alone, is presumed to apply to the occupational setting as well. In addition, because persons requiring PEP in the occupational setting are generally at continued risk for HBV exposure, they should receive the hepatitis B vaccine series.

Safety of PEP for HBV. Hepatitis B vaccines have been found to be safe when admin-istered to infants, children, or adults (12,50). Through the year 2000, approximately 100 million persons have received hepatitis B vaccine in the United States. The most com-mon side effects from hepatitis B vaccination are pain at the injection site and mild to moderate fever (50‚55). Studies indicate that these side effects are reported no more frequently among persons vaccinated than among those receiving placebo (51,52). Approximately 45 reports have been received by the Vaccine Adverse Event Report-ing System (VAERS) of alopecia (hair loss) in children and adults after administration of plasma-derived and recombinant hepatitis B vaccine; four persons sustained hair loss following vaccination on more than one occasion (56). Hair loss was temporary for approximately two thirds of persons who experienced hair loss. An epidemiologic study conducted in the Vaccine Safety Datalink found no statistical association between alopecia and receipt of hepatitis B vaccine in children (CDC, unpublished data, 1998). A low rate of anaphylaxis has been observed in vaccine recipients based on reports to VAERS; the estimated incidence is 1 in 600,000 vaccine doses distributed. Although none of the persons who developed anaphylaxis died, anaphylactic reactions can be life-threaten-ing; therefore, further vaccination with hepatitis B vaccine is contraindicated in persons with a history of anaphylaxis after a previous dose of vaccine.

Hepatitis B immunization programs conducted on a large scale in Taiwan, Alaska, and New Zealand have observed no association between vaccination and the occurrence of serious adverse events. Furthermore, in the United States, surveillance of adverse events following hepatitis B vaccination has demonstrated no association between hepatitis B vaccine and the occurrence of serious adverse events, including Guillain-Barré syndrome, transverse myelitis, multiple sclerosis, optic neuritis, and seizures (57‚59) (CDC, unpublished data, 1991). However, several case reports and case series have claimed an association between hepatitis B vaccination and such syndromes and diseases as mul-tiple sclerosis, optic neuritis, rheumatoid arthritis, and other autoimmune diseases (57,60‚ 66). Most of these reported adverse events have occurred in adults, and no report has compared the frequency of the purported vaccine-associated syndrome/disease with the frequency in an unvaccinated population. In addition, recent case-control studies have demonstrated no association between hepatitis B vaccination and development or short-term risk of relapse of multiple sclerosis (67,68), and reviews by international panels of experts have concluded that available data do not demonstrate a causal association between hepatitis B vaccination and demyelinating diseases, including multiple sclerosis (69).

HBIG is prepared from human plasma known to contain a high titer of antibody to HBsAg (anti-HBs). The plasma from which HBIG is prepared is screened for HBsAg and antibodies to HIV and HCV. The process used to prepare HBIG inactivates and eliminates HIV from the final product. Since 1996, the final product has been free of HCV RNA as determined by the polymerase chain reaction (PCR), and, since 1999, all products avail-able in the United States have been manufactured by methods that inactivate HCV and other viruses. No evidence exists that HBV, HCV, or HIV have ever been transmitted by HBIG commercially available in the United States (70,71).

Serious adverse effects from HBIG when administered as recommended have been rare. Local pain and tenderness at the injection site, urticaria and angioedema might occur; anaphylactic reactions, although rare, have been reported following the injection of human immune globulin (IG) preparations (72). Persons with a history of anaphylactic reaction to IG should not receive HBIG.

PEP for HBV During Pregnancy. No apparent risk exists for adverse effects to developing fetuses when hepatitis B vaccine is administered to pregnant women (CDC, unpublished data, 1990). The vaccine contains noninfectious HBsAg particles and should pose no risk to the fetus. HBV infection during pregnancy might result in severe disease for the mother and chronic infection for the newborn. Therefore, neither pregnancy nor lactation should be considered a contraindication to vaccination of women. HBIG is not contraindicated for pregnant or lactating women.







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