Meeting conclusions on Prevention of viral hepatitis in Germany and the Nordic Countries: lessons learnt and the way forward (Oct/2003)

The Viral Hepatitis Prevention Board convened a meeting of international experts from the public and private sectors in the Nordic countries and Germany, October 13-14, 2003 in Berlin, Germany. The objectives of the meeting were to review and evaluate viral hepatitis prevention and control measures in Denmark, Finland, Iceland, Norway, Sweden, and Germany. These evaluations were based on information provided by the participants, and included:

• the latest epidemiological data for viral hepatitis in the Nordic countries and Germany;
• surveillance systems for infectious diseases including monitoring of adverse events following hepatitis B vaccination;
• successes as well as challenges of the Nordic and German experiences, and how to move forward in preventing and controlling viral hepatitis.

THE NORDIC COUNTRIES

Hepatitis A in the Nordic countries

All of the Nordic countries, with the exception of Iceland, reported hepatitis A outbreaks among injecting drug users in recent years. One of the reasons for these outbreaks is the dramatic increase in non-immune drug users that has been reported over the years in many of the Nordic countries. Other outbreak sources can be traced to persons who were infected with HAV within families, day-care centres, and other living situations. Very few cases of HAV infection in Sweden have been acquired in Africa, suggesting that Swedish travellers are well vaccinated before departure. For the last ten years, molecular genotyping has been used to identify individual outbreaks of hepatitis A and to determine the infection source.

Hepatitis B in the Nordic countries

Hepatitis B is a notifiable disease in all of the Nordic countries, all of which report acute and chronic hepatitis, with the exception of Finland, which makes no differentiation between acute and chronic cases. The main measures for hepatitis B

prevention in the Nordic countries are: (1) pre-exposure and post-exposure immunisations; (2) testing in pregnancy; and (3) harm-reduction measures among injecting drug users. All Nordic countries apply risk-group hepatitis B vaccination. However,

policies vary by country with regard to specific risk groups targeted for immunisation, reimbursement, and harmreduction measures among injecting drug users.

Hepatitis B epidemiology

In 2002, the incidence of acute hepatitis B per 100,000 inhabitants was relatively high in Norway, Finland, and Sweden, and extremely high in the northwest Russian border regions. These high incidence rates are mainly caused by outbreaks among injecting drug users and their sexual partners.

Immunisation

In all of the Nordic countries, injecting drug users are the main group recommended for vaccination. Male homosexuals are a target group only in Denmark, Norway and Sweden. Employees in high-risk occupations, such as some health-care workers, prison staff and the police, are also regarded as a target group for vaccination in all Nordic countries. Medical students, however, are not covered, as they are not considered officially employed. Most medical conditions warranting hepatitis B vaccination are covered by most of the countries. However, some risk groups, such as dialysis patients, are recommended for vaccination only in Norway and Sweden. Norway also has one of the most extensive immunisation programmes for immigrants from high-endemic areas,  including their newborns.

Reimbursement

There are wide variations in reimbursement policies not only by country but also locally by region. Some vaccines are free and covered by the State, others are free but covered by regional authorities, and some are free or paid by employers.

Harm-reduction measures among injecting drug users

There is a restrictive drug policy in all of the Nordic countries that bans the possession, use and trafficking of drugs. Measures to reduce demand and supply of drugs are therefore still the basis of prevention strategy in all the Nordic countries. The question of harm reduction measures is more controversial. While extensive free needle and needle exchange programmes or both are in use in Norway, Denmark and Finland, this is not generally the case in Sweden or Iceland. Clean needles and syringes are, however, available at pharmacies in all the countries. In Sweden, syringes can only be obtained by prescription from a doctor. Likewise, Sweden is more restrictive in offering drug-assisted treatment (like methadone and buprenorfin) than the other countries.

HBsAg-positive children in Swedish day-care centres

Sweden’s 1991 recommendations concerning HBsAg-positive children in day care are vague and ambiguous, and have resulted in a lack of consensus among its twenty-one counties on how the recommendations are to be interpreted and implemented. Sweden’s present recommendations are not in keeping with prevention measures that have been adopted in most European Union Member States, and with the WHO recommendation to include hepatitis B vaccine in national universal immunisation schedules. Implementing universal hepatitis B immunisation would help to resolve many issues that are linked to high costs and amount of time in contact tracing during hepatitis B outbreaks in day-care centres, and to ethical issues surrounding carriers and their contacts, while protecting all children regardless of ethnic background from HBV infection.

Nosocomial transmission of hepatitis B in Sweden

Nosocomial transmission of HBV is rare in Sweden. Data from the Swedish National Institute for Infection Control show a dramatic decrease since 1985 of HBV infections in staff from medical, dental, laboratory, and other related settings. However,  assessment of a small cluster of cases in a hospital setting in Sweden revealed that a number of prevention measures had not been implemented. Furthermore, 50% of the hospital staff that report injuries from needle sticks and sharps are unvaccinated against HBV infection, a situation that points to the need for mandatory hepatitis B vaccination for persons at occupational risk of HBV infection.

GERMANY

Germany’s health-care system

Recent demographic trends in Germany show an ageing population requiring long-term health care. This, combined with increasingly low birth rates and high levels of unemployment, has led to calls for reform. Currently there is also a huge imbalance between expenditures for prevention and for treatment of infectious diseases. There is a pressing need to carry out economic evaluations of preventive interventions that can be used at political levels to redress this imbalance. The various elements of the health-care system often lack interaction, although there are attempts to close some of the gaps.

The Infektionsschutzgesetz

Germany’s law on prevention and control of communicable diseases, the Infektionsschutzgesetz (IfSG), which went into effect in January 2001, has resulted in a significantly improved case-based surveillance system that takes into account fifteen notifiable diseases, more than fifty pathogens, and standardised, EU-compatible case definitions that must be used by local health departments.

Surveillance and monitoring

Since the Infektionsschutzgesetz took effect, Germany has been able to generate reliable nationwide vaccination  coverage data, with public health offices providing information on where compliance is lacking on a regional basis, and where catch-up campaigns need to be implemented for children and adolescents who may have missed a vaccination opportunity.

Streamlined reporting channels via electronic transmission and databases are available at all levels for local interventions, detecting national trends, and programme assessment, as well as other data derived from: (1) monitoring systems via checking of  vaccination certificates showing that vaccine coverage is rising quickly among children at school-age entry (six years); (2) seroprevalence surveys providing information on hepatitis B prevalence among the general population; (3) morbidity and mortality data (while these data are available, the quality of information provided on death certificates needs to be improved); (4) hospitalisation data allowing enhanced monitoring of acute and chronic cases of viral hepatitis;and (5) new investigative teams at  the Robert Koch-Institut to evaluate disease outbreaks.

Despite these advances, there is still under-reporting by physicians and diagnostic laboratories. Other limitations relate to: (a) the current monitoring system, which only assesses coverage data at school-age entry and not at the target age of two years; (b) lack of a vaccine registry due to data protection law in Germany; (c) supplemental data (e.g., whether an individual belongs to a risk group) due to data protection law; (d) relatively low vaccine coverage among adolescents and adults in risk groups; and (e) compliance data.

Vaccine recommendations

Vaccine recommendations continue to be made by the Ständige Impfkommission (STIKO), whose specific tasks are defined in the new law. German vaccination recommendations cover the following groups: (1) infants and adolescents – universal; (2) adults and risk groups (in line with international standards).

Adverse events following immunisation

Criteria have been established for definitions of adverse events following immunisation, known in German law as ‘complication after vaccination,’ or suspected adverse health effects exceeding normal reaction to vaccination. A vaccination certificate is a legal requirement to receive compensation, and the event must be reported within 24 hours.

Education, training, and resources

Weaknesses exist within Germany’s school system, which lacks an infrastructure that can provide medical information to its students. Efforts should be made to integrate education, life style, and vaccination in order to achieve high coverage. Efforts could be made to create a medical school-based team, administering vaccines, providing medical information, and checking and documenting the vaccination status of students.

Social health insurance

Social health insurance provides medical services through physicians and hospitals free of charge with some copayments for the patients, and covers 90% of the entire German population. The rest hold contracts with private health insurance companies.

Hepatitis A in Germany

Hepatitis A is a notifiable disease, as specified by the Infektionsschutzgesetz. Clinical diagnoses are reported by physicians; acute infections must be reported by laboratories. A case definition for hepatitis A in Germany (updated on 1 January 2004) has been established, which allows for a standardisation and differentiation of the reported cases. EU case definitions are taken into account. Information on whether an individual belongs to a risk group is not available in the surveillance data, and contact tracing remains the responsibility of local health departments.

Hepatitis A epidemiology

The notified incidence of cases of hepatitis A virus infection in Germany shows a marked decline since 1980, particularly in the east. In 2002, there was a higher incidence in the western States and the City-states of Berlin, Bremen, and Hamburg.

There is a clear seasonal pattern, with more cases of HAV infection occurring after the end of the summer holidays. The incidence of cases of HAV infection by gender and age group for the year 2002 is highest among the younger age group of five to nine years. The prevalence of anti-HAV antibodies is highest among those in older age groups, a consequence of a cohort effect.

Hepatitis A outbreaks

With decreasing seroprevalence in the younger age cohorts, the risk for outbreaks is increasing. As outbreak investigations require human resources, Germany will need to continue to train more field epidemiologists as experts in outbreak management. International collaboration can be fundamental for the discovery and the study of outbreaks, and should be further enhanced.

Hepatitis A immunisation

Hepatitis A vaccination is not generally recommended in Germany’s paediatric immunisation schedule, and coverage is low.

Hepatitis B in Germany

Hepatitis B has been a notifiable disease in Germany since 1980 in West Germany, and since 1983 in the east. A case definition was established in 2001 by the IfSG, based upon a clinical picture together with laboratory findings for acute cases. Also reportable are positive laboratory findings where the symptoms are either absent or unknown.

Hepatitis B epidemiology

Hepatitis B incidence rates have been declining in Germany since 1993. Notification data for 2002 by gender and age group show that the highest incidence of hepatitis B is among females between twenty and twenty-four years, and males between twenty-five and twenty-nine years, with decreasing incidence among older age groups for both genders. The overall prevalence of anti-HBc antibodies increases with age, with higher prevalence in western States than in the east.

Hepatitis B outbreaks

Hepatitis B outbreaks are rare in Germany. Sporadically occurring clusters of cases seem to be attributed to breaches in hygiene in long-term care facilities and dialysis centres.

Hepatitis B mortality rates

Hospitalisation data for the period 1998 to 2001 show that the number of deaths due to hepatitis increased among patients with chronic infection and decreased slightly for acute cases of hepatitis B and unspecified hepatitis.

Hepatitis B risk groups

In Germany, four main risk groups are candidates for hepatitis B vaccination: medical staff; men who have sex with men; injecting drug users; and haemodialysis patients. Other groups considered at risk for HBV infection are heterosexuals with multiple sex partners, travellers to areas of high hepatitis B endemicity, immigrants and refugees from such areas, household contacts and sex partners of HBV carriers, prison inmates and staff, and clients and staff in institutions of the mentally disabled. Notification data for 2002 show that the highest proportion of reported exposures for HBV is among those engaging in heterosexual intercourse.

Hepatitis B immunisation

By the early 1990s, many at-risk individuals were still not being vaccinated against hepatitis B and in view of the increase in the number of HBV infections, Germany’s hepatitis B vaccination strategy was beginning to be re-examined. In 1995, the STIKO issued new recommendations for universal hepatitis B vaccination for infants, children, and adolescents, together with the previous recommendations for risk groups.

The low hepatitis B vaccination coverage in adolescents illustrates that adolescents as well as teachers do not have a clear understanding of the necessity of prevention.

Therefore, there is a need to enhance uptake levels by providing information on vaccination and by making outreach efforts. An accelerated hepatitis B vaccination schedule is recommended for travellers to high-endemic areas and for drug users.

Screening pregnant women for hepatitis B

Newborns infected with HBV have a 25% lifetime risk of primary hepatocellular carcinoma or cirrhosis. Since highrisk screening criteria can miss a substantial proportion of HBsAg-positive women, Germany revised its screening regulations in 1994 to extend HBsAg testing to all pregnant women. Compliance is approximately 80%, raising questions as to whether screening should take place earlier than 32 weeks into pregnancy, as is done for rubella.

Newborns of women who test positive for HBsAg receive both HBIg and active hepatitis B immunisation at birth. Contact tracing of infected family members or partners, which is carried out at local levels, remains weak.

Wild-type HBV and HBV escape mutants

Escape mutants of HBV continue to be found in Germany. However, although potentially pathogenic, they are unlikely to pose a public health problem in the near future.

Hepatitis C in Germany

Nosocomial transmission

Despite a decrease in the prevalence and incidence of HCV infection over the last ten years, new infections in haemodialysis settings still occur. In most cases, transmission occurs by patient-to-patient spread of the virus rather than via contaminated dialysis equipment.

The prevalence of HCV infection among HCWs is not significantly higher than in the general population and lower than in medical settings. However, there is still a substantial residual risk of occupational HCV infection. Needles make up approximately 65% of the total percutaneous injuries in Germany. No consensus on the management and guidance of HCWs infected with HCV has been reached so far on an international level. Germany has set some restrictions on exposure-prone procedures performed by infected HCWs.

The available data point to the need for a continuous monitoring of infection control measures as well as increased awareness among health-care workers of the potential risks of nosocomial HCV transmission.

Long-term course of HCV infection

Several studies indicated that the long-term course of HCV infection is relatively slow, except in cases where alcohol abuse or co-infection with HIV or HBV is present.