See the 2010 TREATMENT GUIDELINES for the most recent treatment information.
Hepatitis B is caused by infection with HBV. The incubation period from the time of exposure to onset of symptoms is 6 weeks to 6 months. HBV is found in highest concentrations in blood and in lower concentrations in other body fluids (e.g., semen, vaginal secretions, and wound exudates). HBV infection can be self-limited or chronic. In adults, only approximately half of newly acquired HBV infections are symptomatic, and approximately 1% of reported cases result in acute liver failure and death. Risk for chronic infection is inversely related to age at infection: approximately 90% of infected infants and 30% of infected children aged <5 years become chronically infected, compared with 2%–6% of adults. Among persons with chronic HBV infection, the risk for premature death from cirrhosis or hepatocellular carcinoma (HCC) is 15%–25%.
HBV is efficiently transmitted by percutaneous or mucous membrane exposure to infectious blood or body fluids that contain blood. The primary risk factors that have been associated with infection among adolescents and adults are unprotected sex with an infected partner, unprotected sex with more than one partner, MSM, history of other STDs, and illegal injecting-drug use.
CDC’s national strategy to eliminate transmission of HBV infection includes 1) prevention of perinatal infection through routine screening of all pregnant women for HBsAg and immunoprophylaxis of infants born to HBsAg-positive mothers and infants born to mothers with unknown HBsAg status, 2) routine infant vaccination, 3) vaccination of previously unvaccinated children and adolescents through age 18 years, and 4) vaccination of previously unvaccinated adults at increased risk for infection (2,4). High vaccination coverage rates, with subsequent declines in acute hepatitis B incidence, have been achieved among infants and adolescents (2,203,204). In contrast, vaccination coverage among the majority of high-risk adult groups (e.g., persons with more than one sex partner in the previous 6 months, MSM, and IDUs) have remained low, and the majority of new infections occur in these high-risk groups (4,205–207). STD clinics and other settings that provide services targeted to high-risk adults are ideal sites in which to provide hepatitis B vaccination to adults at risk for HBV infection. All unvaccinated adults seeking services in these settings should be assumed to be at risk for hepatitis B and should receive hepatitis B vaccination.
Diagnosis of acute or chronic HBV infection requires serologic testing (Table 4). HBsAg is present in both acute and chronic infection. The presence of IgM antibody to hepatitis B core antigen (IgM anti-HBc) is diagnostic of acute or recently acquired HBV infection. Antibody to HBsAg (anti-HBs) is produced after a resolved infection and is the only HBV antibody marker present after immunization. The presence of HBsAg and total anti-HBc, with a negative test for IgM anti-HBc, indicates chronic HBV infection. The presence of anti-HBc alone might indicate a false-positive result or acute, resolved, or chronic infection.
|HBsAg†||Total anti-HBc§||IgM¶ anti-HBc||Anti-HBs**|
|+††||-||-||-||Early acute infection; transient (up to 18 days) after vaccination|
|-||+||+||-||Acute resolving infection|
|-||+||-||+||Recovered from previous infection and immune|
|-||+||-||-||False-positive (i.e., susceptible); previous
infection; low-level chronic infection,§§
passive transfer to infant born to HBsAg- positive mother
|-||-||-||+||Immune if concentration is ≥10 mIU/mL¶¶; passive transfer after HBIG*** administration|
* The symbol for negative test results is “–,” and the symbol for positive test results is “+.”
† Hepatitis B surface antigen.
§ Antibody to hepatitis B core antigen.
¶ Immunoglobulin M.
** Antibody to HBsAg.
†† To ensure that an HBsAg-positive test result is not a false-positive, samples with repeatedly reactive HBsAg results should be tested with a licensed (and, if appropriate, neutralizing confirmatory) test.
§§ Persons positive for only anti-HBc are unlikely to be infectious except under unusual circumstances involving direct percutaneous exposure to large quantities of blood (e.g., blood transfusion and organ transplantation).
¶¶ Milli-international units per milliliter.
*** Hepatitis B immune globulin.
No specific therapy is available for persons with acute hepatitis B; treatment is supportive. Persons with chronic HBV infection should be referred for evaluation to a physician experienced in the management of CLD. Therapeutic agents approved by FDA for treatment of chronic hepatitis B can achieve sustained suppression of HBV replication and remission of liver disease in some persons. In addition, patients with chronic hepatitis B might benefit from screening to detect HCC at an early stage.
Two products have been approved for hepatitis B prevention: hepatitis B immune globulin (HBIG) and hepatitis B vaccine. HBIG provides temporary (i.e., 3–6 months) protection from HBV infection and is typically used as PEP either as an adjunct to hepatitis B vaccination in previously unvaccinated persons or alone in persons who have not responded to vaccination. HBIG is prepared from plasma known to contain high concentrations of anti-HBs. The recommended dose of HBIG is 0.06 mL/kg.
Hepatitis B vaccine contains HBsAg produced in yeast by recombinant DNA technology and provides protection from HBV infection when used for both preexposure immunization and PEP. The two available monovalent hepatitis B vaccines for use in adolescents and adults are Recombivax HB® (Merck and Co., Inc., Whitehouse Station, New Jersey) and Engerix-B® (GlaxoSmithKline Biologicals, Pittsburgh, Penn-sylvania). A combination vaccine (hepatitis A and hepatitis B) for use in adults, Twinrix® (GlaxoSmithKline Biologicals, Pittsburgh, Pennsylvania), also is available. The recommended HBV dose varies by product and age of recipient (Table 3).
When selecting a hepatitis B vaccination schedule, the health-care provider should consider the need to achieve completion of the vaccine series. Approved adolescent and adult schedules for both monovalent hepatitis B vaccine (i.e., Engerix-B® and Recombivax HB®) include the following: 0, 1, and 6 months; 0, 1, and 4 months; and 0, 2, and 4 months. A 4-dose schedule of Engerix-B® at 0, 1, 2, and 12 months is licensed for all age groups. A 2-dose schedule of Recombivax HB® adult formulation (10 µg) is licensed for adolescents aged 11–15 years. When scheduled to receive the second dose, adolescents aged >15 years should be switched to a 3-dose series, with doses 2 and 3 consisting of the pediatric formulation (5 µg) administered on an appropriate schedule. Twinrix® may be administered to persons aged ≥18 years at risk for both HAV and HBV infections at 0, 1, and 6 months.
Hepatitis B vaccine should be administered IM in the deltoid muscle and may be administered simultaneously with other vaccines. For adolescents and adults, the needle length should be 1–2 inches, depending on the recipient’s weight (1 inch for females weighing <70 kg), 1.5 inches for males weighing <120 kg; and 2 inches for males weighing >120 kg and females >100 kg). A 22- to 25-gauge needle is recommended. If the vaccine series is interrupted after the first or second dose of vaccine, the missed dose should be administered as soon as possible. The series does not need to be restarted after a missed dose.
In adolescents and healthy adults aged <40 years, approximately 30%–55% acquire a protective antibody response (anti-HBs ≥10 mIU/mL) after the first vaccine dose, 75% after the second, and >90% after the third. Vaccine-induced immune memory has been demonstrated to persist for at least 15–20 years. Periodic testing to determine antibody levels in immunocompetent persons is not necessary, and booster doses of vaccine are not recommended.
Hepatitis B vaccination is generally well-tolerated by the majority of recipients. Pain at the injection site and low-grade fever are reported by a minority of recipients. Evidence for a causal association between receipt of hepatitis B vaccination and anaphylaxis exists, which is estimated to occur in 1 of 1.1 million doses of vaccine administered among children and adolescents; no deaths have been reported after anaphylaxis. Vaccine is contraindicated in persons with a history of anaphylaxis after a previous dose of hepatitis B vaccine and in persons with a known anaphylactic reaction to any vaccine component. No evidence for a causal association has been demonstrated for other adverse events reported after administration of hepatitis B vaccine.
Hepatitis B vaccination is recommended for all unvaccinated adolescents, all unvaccinated adults at risk for HBV infection, and all adults seeking protection from HBV infection. For adults, acknowledgement of a specific risk factor is not a requirement for vaccination.
Hepatitis B vaccine should be routinely offered to all unvaccinated persons attending STD clinics and to all unvaccinated persons seeking treatment for STDs in other settings. Other settings where all unvaccinated adults should be assumed to be at risk for hepatitis B and should receive hepatitis B vaccination include correctional facilities, facilities providing drug abuse treatment and prevention services, health-care settings serving MSM, and HIV testing and treatment facilities. All persons who receive clinical services in these settings should be offered hepatitis B vaccine, unless they have a reliable vaccination history (i.e., a written, dated record of each dose of a complete series). In all settings, vaccination should be initiated even though completion of the vaccine series might not be ensured.
Prevaccination serologic testing for susceptibility may be considered to reduce the cost of vaccinating adult populations that have an expected high prevalence of HBV infection (i.e., >20%–30%) (e.g., IDUs and MSM [especially in older age groups]). In addition, prevaccination testing for susceptibility is recommended for unvaccinated household, sexual, and needle-sharing contacts of HBsAg-positive persons.
Anti-HBc is the test of choice for prevaccination testing; persons who are anti-HBc–positive should be tested for HBsAg. If persons are determined to be HBsAg negative, no further action is required. If persons are determined to be HBsAg positive, the person should be referred for medical follow-up, including counseling and evaluation for antiviral treatment (see Management of HBsAg-Positive Persons). In addition, all household members, sex partners, and needle-sharing partners of HBsAg-positive persons should be vaccinated.
Serologic testing should not be a barrier to vaccination of susceptible persons, especially in populations that are difficult to access. In the majority of situations, the first vaccine dose should be administered immediately after collection of the blood sample for serologic testing. Vaccination of persons who are immune to HBV infection because of current or previous infection or vaccination does not increase the risk for adverse events.
Serologic testing for immunity is not necessary after routine vaccination of adolescents or adults. Testing after vaccination is recommended for persons whose subsequent clinical management depends on knowledge of their immune status (e.g., health-care workers or public safety workers at high risk for continued percutaneous or mucosal exposure to blood or body fluids). In addition, testing is recommended for 1) HIV-infected persons and other immunocompromised persons to determine the need for revaccination and the type of follow-up testing; and 2) sex and needle-sharing partners of HBsAg-positive persons to determine the need for revaccination and for other methods to protect themselves from HBV infection.
If indicated, testing should be performed 1–2 months after administration of the last dose of the vaccine series by using a method that allows determination of a protective level of anti-HBs (≥10 mIU/mL). Persons determined to have anti-HBs levels of <10 mIU/mL after the primary vaccine series should be revaccinated with a 3-dose series, followed by anti-HBs testing 1–2 months after the third dose. Persons who do not respond to revaccination should be tested for HBsAg. If HBsAg positive, the person should receive appropriate management (see Management of HBsAg-Positive Persons); if HBsAg negative, the person should be considered susceptible to HBV infection and counseled concerning precautions to prevent HBV infection and the need for HBIG PEP for any known exposure (see PEP).
Both passive-active PEP with HBIG and hepatitis B vaccination and active PEP with hepatitis B vaccination alone have been demonstrated to be highly effective in preventing transmission after exposure to HBV (2). HBIG alone also has been demonstrated to be effective in preventing HBV transmission, but with the availability of hepatitis B vaccine, HBIG typically is used as an adjunct to vaccination.
Exposure to HBsAg-Positive Source. Unvaccinated persons or persons known not to have responded to a complete hepatitis B vaccine series should receive both HBIG and hepatitis vaccine as soon as possible (preferably ≤24 hours) after a discrete, identifiable exposure to blood or body fluids that contain blood from an HBsAg-positive source (Table 5). Hepatitis B vaccine should be administered simultaneously with HBIG in a separate injection site, and the vaccine series should be completed by using the age-appropriate vaccine dose and schedule (Table 3). Exposed persons who are in the process of being vaccinated but who have not completed the vaccine series should receive the appropriate dose of HBIG (i.e., 0.06 mL/kg) and should complete the vaccine series. Exposed persons who are known to have responded to vaccination are considered protected and need no further vaccine doses. Persons who have written documentation of a complete hepatitis B vaccine series and who did not receive post-vaccination testing should receive a single vaccine booster dose. Alternatively, these persons can be managed according to guidelines for management of persons with occupational exposure to blood or body fluids that contain blood (207).
|Cause of Exposure||Suggested action|
|Discrete exposure to an HBsAg*-positive source||Percutaneous (e.g., bite or needlestick) or mucosal exposure to HBsAg-positive blood or body fluids that contain blood||Administer hepatitis B vaccine and hepatitis B immune globulin (HBIG)†|
|Sexual or needle-sharing contact of an HBsAg-positive person||Administer hepatitis B vaccine and HBIG†|
|Victim of sexual assault/abuse by a perpetrator who is HBsAg-positive||Administer hepatitis B vaccine and HBIG†|
|Discrete exposure to a source with unknown HBsAg status||Victim of sexual assault/abuse by a perpetrator with unknown HBsAg status||Administer hepatitis B vaccine†|
|Percutaneous (e.g., bite or needlestick) or mucosal exposure to blood or body fluids that contain blood from a source with unknown HBsAg status||Administer hepatitis B vaccine†|
* Hepatitis B surface antigen.
† Immunoprophylaxis should be administered as soon as possible, preferably within ≤24 hours. Studies are limited on the maximum interval after exposure during which postexposure prophylaxis is effective, but the interval is unlikely to exceed 7 days for percutaneous exposures and 14 days for sexual exposures. The hepatitis B vaccine series should be completed.
Exposure to Source with Unknown HBsAg Status. Unvaccinated persons who have a discrete, identifiable exposure to blood or body fluids containing blood from a source with unknown HBsAg status should receive the hepatitis B vaccine series, with the first dose initiated as soon as possible after exposure (preferably within 24 hours) and the series completed by using the age-appropriate dose and schedule. Exposed persons who are not fully vaccinated should complete the vaccine series. Exposed persons with written documentation of a complete hepatitis B vaccine series require no further treatment.
Pregnancy. All pregnant women receiving STD services should be tested for HBsAg, regardless of whether they have been previously tested or vaccinated. All HBsAg-positive pregnant women should be reported to state and local perinatal hepatitis B prevention programs. HBsAg-negative pregnant women seeking STD treatment who have not been previously vaccinated should receive hepatitis B vaccination. Additional information regarding management of HBsAg-positive pregnant women and their infants is available at http://www.cdc.gov/mmwr/PDF/rr/rr5416.pdf.
HIV Infection. HIV infection can impair the response to hepatitis B vaccination. HIV-infected persons should be tested for anti-HBs 1–2 months after the third vaccine dose (see Postvaccination Testing for Serologic Response). Modified dosing regimens, including a doubling of the standard antigen dose and administration of additional doses, might increase the response rate.
This section provides recommendations for management of all HBsAg-positive persons. Additional recommendations for management of HBsAg-positive persons who are coinfected with HIV are available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5315a1.htm.
All persons with HBsAg-positive laboratory results should be reported to the state or local health department.
- To verify the presence of chronic HBV infection, HBsAg-positive persons should be retested. The absence of IgM anti-HBc or the persistence of HBsAg for 6 months indicates chronic HBV infection.
- Persons with chronic HBV infection should be referred for evaluation to a physician experienced in the management of CLD. Some patients with chronic hepatitis B will benefit from early intervention with antiviral treatment or screening to detect HCC at an early stage.
- Household, sexual, and needle-sharing contacts of chronically infected persons should be identified. Unvaccinated sex partners and household and needle-sharing contacts should be tested for susceptibility to HBV infection (see Prevaccination Antibody Screening) and should receive the first dose of hepatitis B vaccine immediately after collection of the blood sample for serologic testing. Susceptible persons should complete the vaccine series by using an age-appropriate vaccine dose and schedule. Persons who are fully vaccinated should complete the vaccine series.
- Sex partners of HBsAg-positive persons should be counseled to use methods (e.g., condoms) to protect themselves from sexual exposure to infectious body fluids (e.g., semen and vaginal secretions), unless they have been demonstrated to be immune after vaccination (anti-HBs >10 mIU/mL) or previously infected (anti-HBc positive).
- To prevent or reduce the risk for transmission to others, HBsAg-positive
persons should be advised concerning the risk for transmission to household,
and needle-sharing contacts and the need for such contacts to receive hepatitis
B vaccination. HBsAg-positive persons also should be advised to
- use methods (e.g., condoms) to protect nonimmune sex partners from acquiring HBV infection from sexual activity until the partner can be vaccinated and immunity documented;
- cover cuts and skin lesions to prevent the spread of infectious secretions or blood;
- refrain from donating blood, plasma, body organs, other tissue, or semen; and
- refrain from sharing household articles (e.g., toothbrushes, razors, or personal injection equipment) that could become contaminated with blood.
- To protect the liver from further harm, HBsAg-positive persons should
be advised to
- avoid or limit alcohol consumption because of the effects of alcohol on the liver;
- refrain from starting any new medicines, including OTC and herbal medicines, without checking with their health-care provider; and
- obtain vaccination against hepatitis A if liver disease is determined to be present.
When seeking medical or dental care, HBsAg-positive persons should be advised to inform those responsible for their care of their HBsAg status so that they can be appropriately evaluated and managed. Information regarding HBsAg-positive women who are pregnant is available in this report (see Special Populations, Pregnant Women). Other counseling messages also should be considered.
- HBV is not spread by hugging, coughing, food or water, sharing eating utensils or drinking glasses, or casual contact.
- Persons should not be excluded from work, school, play, child care, or other settings because they are infected with HBV.
- Involvement with a support group might help patients cope with chronic HBV infection.