Bloodborne pathogens such as hepatitis B (HBV) and C virus (HCV) represent
an important hazard for healthcare workers (HCWs) . In the general
population, HCV prevalence varies geographically from about 0.5% in northern
countries to 2% in Mediterranean countries, with some 5 million chronic
carriers estimated in Europe; while HBV prevalence ranges from 0.3% to
3%. The World Health Organization (WHO) estimates that each year in Europe
304 000 HCWs are exposed to at least one percutaneous injury with a sharp
object contaminated with HBV, 149 000 are exposed to HCV and 22 000 to
The probability of acquiring a bloodborne infection following an occupational
exposure has been estimated to be on average <0.3% for HIV, 0.5% for
HCV and 18%-30% for HBV, depending on the type of exposure (percutaneous
injuries with hollow-bore, blood-filled needles carry the highest risk
of infection), the body fluid involved, and the infectivity of the patient
To implement and standardise a rational management of occupational exposures
to HIV, HBV and HCV among HCWs in Europe, representatives of nine European
countries participated in a project funded by the European Commission,
and developed a comprehensive set of recommendations.
We present here recommendations for the general management of occupational
risk of bloodborne infections, HBV vaccination and management of HBV and
HCV exposures. A description of the project and recommendations for HIV
post-exposure management, including antiretroviral prophylaxis, has been
previously published , and so issues related to occupational risk and
prevention of HIV infection following an occupational exposure will not
be discussed further.
Exposure prevention is the primary strategy to reduce the risk of occupational
bloodborne pathogen infections. All preventive efforts should be made
to reduce the risk of occupational exposures.
Healthcare organisations should have a system readily available to their
personnel that includes educational programmes, written protocols for
prompt reporting, evaluation, counselling, treatment, and follow-up of
occupational exposures that might place HCWs at risk of acquiring a bloodborne
Educational programmes and training
All HCWs should be informed, educated and trained about:
- The possible risks and prevention of bloodborne infections after an occupational
- The measures to prevent bloodborne pathogen exposures
. Implementation of standard precautions
. Provision of personal protective equipment and safety devices
. Implementation of safer procedures.
. HBV vaccination
- The principles of post-exposure management and the importance of seeking
urgent advice following any occupational exposure immediately after it occurs,
as certain indicated interventions must be initiated promptly to maximise their
Reporting an occupational exposure
Local health policies should specifically identify a designated healthcare
provider to whom HCWs can be urgently referred in case of exposure,
and who will be responsible for post-exposure management, provision
of prophylaxis and clinical and serological follow-up. Access to clinicians
who can provide post-exposure care should be available during all working
hours, including nights and weekends.
HCWs should be made aware in advance of the medicolegal and clinical
relevance of reporting an occupational exposure, how to report it and
to whom it should be reported, and have ready access to expert consultants
to receive appropriate counselling, treatment and follow-up.
- HCWs should be vaccinated against HBV, with a standard vaccination
- Before entering nursing and medical schools and before employment in
healthcare settings, vaccination or demonstration of immunisation against
HBV is strongly recommended .
- Pre-vaccination screening is not routinely indicated .
- Antibody titre against HBsAg (anti-HBs) should be assessed 1-2 months
after completion of a 3-dose vaccination series .
- New vaccines or alternative schedules that could determine a higher
response rate or a stronger response should be used if available [7-8].
- Combined hepatitis A and hepatitis B vaccine is recommended in case
of susceptible HCWs with HCV infection or other liver diseases , and
could be considered for all HCWs regardless of their clinical status
Primary 3-dose vaccination: three standard doses (according to manufacturers)
of recombinant HBV vaccine administered intramuscularly in the deltoid
region, preferably with a 25 mm needle , at 0, 1, and 6 months.
Responders: subjects with post-vaccinal anti-HBs levels, determined at
1-2 months from the last dose of vaccine, equal to or greater than 10
Non-responders: subjects with post-vaccinal anti-HBs levels, determined
at 1-2 months from the last dose of vaccine, lower than 10 mIU/mL, who
tested negative for HBsAg, and anti-HBc [see section 2c].
Post –vaccination management
HBV vaccination responders
- Responders are protected against HBV infection .
- Routine booster doses of HBV vaccine are not recommended for known responders,
even if anti-HBs levels become low or undetectable .
- Periodic antibody concentration testing after completion of the vaccine series
and assessment of the response is not recommended .
HBV vaccination non-responders
- 5%-10% of the adult population will not respond to standard HBV vaccination.
- Risk factors for vaccine non-response include: male sex, older age,
cigarette smoking, obesity, immunodeficiency, renal failure, intragluteal
vaccine administration, chronic diseases, certain HLA haplotypes and
coeliac disease [15-16].
- If non-responders test HBsAg/anti-HBc negative:
Administer a fourth dose and then retest the HCWs for response 1-2 months
If no response has been elicited, complete a full course of conventional
vaccine at the standard doses (i.e. administer a fifth and sixth dose),
and retest the HCW for response 1-2 months after the last dose of vaccine
Possible alternative strategies, that need further evaluation, to overcome
nonresponse to standard HBV vaccination are: Vaccines containing S subunit,
pre-S1 and pre-S2 particles [19-20]; Three intradermal 5 ?g doses of
standard vaccine, given every two weeks ;Combined hepatitis A and
hepatitis B vaccines ; High-dose standard vaccine series [18, 23-24]
Management of isolated anti-HBc
- Test isolated anti-HBc positive HCWs for IgM anti-HBc and HBV-DNA ,
possibly with sensitive PCR assays, to determine whether these subjects
are low-level HBsAg carriers, or in the window phase, or have occult
HBV infection [26-27].
- If negative for anti-HBc IgM and HBV-DNA, initiate vaccination, and
test the HCW 30 days after the first dose of vaccine: an anti-HBs titre
exceeding or equal to 50 mIU/mL indicates an anamnestic response (isolated
anti-HBc indicated infection with HBV) [28-29]. True positive subjects
with isolated anti-HBc (those with anamnestic response) have resistance
to HBV re-infection and do not need to complete vaccination or to receive
HBV post-exposure prophylaxis .
- If anti-HBs response is <50 mIU/mL30 days after the first dose
of vaccine, complete the vaccination schedule and test the HCW: an
anti-HBs titre exceeding or equal to 10 mIU/mL 30 days after the third
vaccine indicates a primary response (isolated anti-HBc was a false
- In case of an exposure to an HBsAg positive source, manage subjects
with ‘unresolved’ isolated anti-HBc as susceptible.
Management of HBsAg-positive and HCV-Ab-positive HCWs
- HCWs who prove to be HBsAg-positive and/or HCV-Ab positive should be
counselled regarding the need for medical evaluation and regarding
prevention of HBV and/or HCV transmission to others.
- Evaluation of the risk they pose to patients by an expert review panel
according to national and international recommendations to prevent worker-to-patient
transmission is strongly recommended .
Management of occupational exposures
Immediate treatment of the exposure site
- Percutaneous exposure: encourage bleeding and wash with soap and water
- Cutaneous contaminations: wash with soap and water.
- Mucous membranes contamination: flush with water.
- Eyes should be irrigated with clean water, saline, or sterile irrigants.
- Although no evidence exists that using antiseptics/disinfectants reduces
the risk of bloodborne pathogen transmission, their use is not contraindicated,
as both viruses are enveloped and are supposed to be relatively sensitive
to many chemical agents.
- The application of caustic agents (i.e. bleach) or the injection of
antiseptics or disinfectants onto the wounds is not recommended .
- In case of an occupational exposure to an at risk bloodborne infection,
baseline HBV, HCV, HIV immune status of the exposed HCW should be available.
- For medicolegal reasons, store a plasma and serum sample of the exposed
HCW at baseline.
- Evaluate the exposure’s potential to transmit HBV, HCV, and HIV,
based on the type of exposure and body material involved .
- Evaluate the source patient’s serostatus for antibodies against
HIV (HIV-Ab), HCV (HCV-Ab) and for HBsAg. If unknown, inform the source
patient of the incident and obtain an informed consent. Results should
be readily available. Source testing for HBsAg can be avoided when the
HCW is known to be protected by vaccine or natural immunity. Direct virus
assays (e.g. HBV-DNA or HCV-RNA/HCV Ag) are not recommended.
- Store a plasma and a serum sample from the source for further investigations.
- Consider as infected sources who refuse testing or cannot be tested.
Management of exposures to HBV
The management of a possible occupational exposure to HBV differs according
to the susceptibility and serostatus of the exposed HCW [TABLES 1,2].
When necessary, post-exposure prophylaxis with HBV vaccine, hepatitis
B immunoglobulin (HBIG) or both must be started as soon as possible,
preferably within 24 hours from the exposure and no later than one
week [32-33]. This management is no different in pregnant HCWs .
HBsAg-positive HCWs should receive clinical evaluation and their serostatus,
as well as risk for hepatitis D, should be assessed.
If, notwithstanding optimal post-exposure management, acute B hepatitis
develops, the person should be referred for medical management to a specialist
knowledgeable in this area.
- Serological follow-up is not recommended when post-exposure management
is in accord with the above mentioned recommendations.
Management of exposures to HCV
Currently, there is no available prophylaxis for HCV.
Data from the literature suggest that therapy (interferon or PegIFN +/-Ribavirin)
may prevent chronicisation when administered to patients with acute HCV
infection . However, while it is documented that viral clearance
can spontaneously occur after acute infection , it is unclear whether
treatment of the acute or early (first six months) phase is more effective
than early treatment of chronic C hepatitis [37-38]. Further studies
to clarify these issues are ongoing. As medical advice and personal choices
could change in the near future, an optimal follow up management of occupational
HCV exposure should allow prompt identification of infection, and be
cost effective, bearing in mind that estimated incidence of HCV infection
following an occupational exposure is on average 0.5%.
1. HCV-Ab positive, untested or unidentifiable source
- Test the HCW for HCV-Ab (EIA) at baseline and 6 months from exposure;
extend to 12 months for exposures to HIV-HCV co-infected sources Confirm
positive results with a recombinant immunoblot assay or qualitative
- Perform ALT activity at baseline, and then monthly for 4 months after
- Perform qualitative HCV-RNA when an increased transaminase level is
- Some experts would also test for HCV-Ab at 3 months, as most seroconverters
are already positive at this time, and in order to reduce loss to follow-up
and the anxiety of the exposed HCW.
2. HCV-Ab negative source
- In case of HIV infection, immunosuppression or other conditions (i.e.
dialysis) associated with possible false negative results in the source,
follow recommendations for exposure to an HCV positive source.
Accidental blood and body fluid exposures entail the risk of occupational
infection by bloodborne pathogens in HCWs, mainly HBV, HCV, and HIV
Notwithstanding effective pre- and post-exposure prophylaxis for HBV
and the availability of post-exposure prophylaxis against HIV, the best
approach to avert cases of occupational bloodborne infection remains
to prevent these exposures.
However, the adoption of a rational pre- and post-exposure management
could help to minimise consequences and costs. In this regard, the recommendations
here presented are complementary to the European recommendations for
post-exposure prophylaxis of HIV infection in healthcare workers ,
both being developed within a project funded by the European Commission
with the aim to standardise the management of occupational exposures
to HIV/bloodborne infections in Europe. These recommendations must be
considered dynamic documents. Indeed, scientific evidence appearing in
the literature after the consensus meetings was also included in these
documents, and recommendations may change in the future with further
research and scientific information, as some issues remained unresolved
Among issues related to HBV vaccination, there was no unanimous consensus
regarding the post-vaccinal anti-HBs level to be considered as protective.
A minority of the expert panel suggested a more conservative approach,
in which those HCWs who have post-vaccinal anti-HBs levels between 10
and 100 mIU/mL are considered as low-responders. These subjects may,
due to waning antibodies, develop asymptomatic hepatitis B infection
and seroconversion after exposure, although only very rare cases of chronic
infection/disease have been reported . For these subjects, the same
recommendations used for non-responders could be applied, including HBsAg
determination. Indeed, among these subjects, concurrence of hepatitis
B surface antibodies and surface antigen is also possible .
No data directly assess the efficacy of HBIG in post-exposure prophylaxis
in HCWs. The use of hepatitis B vaccine alone after exposure to HBsAg-positive
blood seems to achieve comparable results to HB vaccine combined with
HBIG ; however, the vast majority of the expert panel agrees on HBIG
administration. Nonetheless, in the discussion, several reservations
were expressed regarding the administration of HBIG. For exposures to
a source of unknown serostatus, while the majority of the expert panel
would treat as if HBsAg positive, some experts would consider the option
of HBIG administration according to the probability of infection of source
patient (e.g, drug user, coming from high endemicity country, etc.).
In unvaccinated HCWs testing anti-HBs negative, it was suggested that
testing for anti-HBc would avoid HBIG administration if the subject had
natural immunity. Moreover, as a protective response should be elicited
in these subjects after the first three doses of vaccine during the accelerated
vaccination schedule, the administration of the second dose of HBIG could
be avoided; this same reservation was expressed for vaccinated HCWs with
an unknown antibody response, in view of the high probability that the
subject would respond to a booster dose, and for non-responders to primary
vaccination, in view of the high probability that the subject would respond
to a second, accelerated vaccination schedule.
Cost-effectiveness issues could also be considered; for example, in young
subjects, low-dose intramuscular or intradermal vaccination provides
long-term effective protection and can be used as a cost-saving vaccination
Finally, for the management of non-responders, nucleic acid vaccines
or DNA vaccines are candidate vaccines to prevent and treat viral hepatitis,
and hepatitis B DNA vaccine seems to induce protective antibody responses
in human non-responders to conventional vaccination . The preliminary
results of an ongoing trial are promising in this regard.
Regarding the management of HCV exposures, until new anti-HCV drugs such
as HCV serine protease inhibitors, which may eventually be used for post-exposure
prophylaxis, neutralising antibodies to hepatitis C virus , or an
anti-HCV vaccine are available , the discussion focuses on the opportunity
of treating acute infection, an issue thoroughly discussed during the
consensus meeting. The resulting dichotomy is mirrored in the follow-up
schedule. Further well-conducted, randomised clinical trials are needed
to conclusively support the treatment option. Whether treatment during
the acute phase could avoid the establishment of HCV reservoirs and therefore
ultimately contribute to decrease the risk of cirrhosis and hepatocellular
carcinoma, however, remains to be determined. New data will be necessary
to give definitive indications on these and other issues.
In the meantime, it is important to maintain surveillance of occupationally
exposed HCWs, and to promote a widespread implementation of preventive
strategies such as standard precautions, education on exposure risk,
better sharps disposal systems, personal protective equipment, and safety-engineered
sharp devices to ensure a safer working environment in the healthcare
This is a consensus document from the European project, ‘Standardization
of the management of occupational exposure to HIV/bloodborne infections
and evaluation of post-exposure prophylaxis in Europe’ funded by
European Commission’s Directorate-General for Health and Consumer
Protection, Unit F4 (Project number 2000/SID/107, grant no. SI2.322294);
the Ministero della Salute-ISS, and Ricerca Corrente IRCCS.
The European Occupational Post-Exposure Prophylaxis Study Group wishes
to thank Yohanka Alfonso Contreras for secretarial support, and Lorena
Fiorentini for administrative support.