Gaps in the prevention of perinatal transmission of hepatitis B virus between recommendations and routine practices in a highly endemic region: a provincial population-based study in China

Departments of Laboratory Medicine and Infectious Diseases, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing, China. .
BMC Infectious Diseases (Impact Factor: 2.61). 09/2012; 12(1):221. DOI: 10.1186/1471-2334-12-221
Source: PubMed


Hepatitis B virus (HBV) infection is endemic in China; perinatal transmission is the main source of chronic HBV infection. Simultaneous administration of hepatitis B immune globulin (HBIG) and hepatitis B vaccine is highly effective to prevent perinatal transmission of HBV; however, the effectiveness also depends on full adherence to the recommended protocols in daily practice. In the present investigation, we aimed to identify gaps in immunoprophylaxis of perinatal transmission of HBV between recommendations and routine practices in Jiangsu Province, China.
Totally 626 children from 6 cities and 8 rural areas across Jiangsu Province, China, born from February 2003 to December 2004, were enrolled; 298 were born to mothers with positive hepatitis B surface antigen (HBsAg) and 328 were born to HBsAg-negative mothers. Immunoprophylactic measures against hepatitis B were retrospectively reviewed for about half of the children by checking medical records or vaccination cards and the vaccine status was validated for most of children.
Of 298 children born to HBV carrier mothers, 11 (3.7%) were HBsAg positive, while none of 328 children born to non-carrier mothers was HBsAg positive (P < 0.01). The rates of anti-HBs ≥ 10 mIU/ml in children of carrier and non-carrier mothers were 69.5% and 69.2% respectively (P = 0.95). The hepatitis B vaccine coverage in two groups was 100% and 99.4% respectively (P = 0.50), but 15.1% of HBV-exposed infants did not receive the timely birth dose. Prenatal HBsAg screening was performed only in 156 (52.3%) of the carrier mothers. Consequently, only 112 (37.6%) of HBV-exposed infants received HBIG after birth. Furthermore, of the 11 HBV-infected children, only one received both HBIG and hepatitis B vaccine timely, seven missed HBIG, two received delayed vaccination, and one missed HBIG and received delayed vaccination.
There are substantial gaps in the prevention of perinatal HBV infection between the recommendations and routine practices in China, which highlights the importance of full adherence to the recommendations to eliminate perinatal HBV infection in the endemic regions.

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    • "It is concerning to see that the birth dose vaccine was delayed in 10.4% of the newborns and only half of the infants in the present investigation received HBIG within 24 hours after birth. The untimely use of first dose vaccine and the low rate of HBIG administration indicated that there are considerable gaps in the immunoprophylaxis against hepatitis B between the national recommendations and routine practices in China [20]. Therefore, more measures should be taken in the future to achieve full adherence to the recommended prophylaxis in preventing mother-to-child transmission of HBV. "
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    ABSTRACT: Background Many clinicians and hepatitis B virus (HBV)-infected pregnant women prefer elective caesarean section (ECS) to prevent mother-to-child transmission of HBV, since some studies found higher transmission of HBV in infants born by vaginal delivery (VD) than by cesarean section. However, other studies showed that ECS does not reduce the risk of being infected with HBV in infants. In this study, we aimed to clarify whether ECS may reduce the risk of mother-to-child transmission of HBV. Methods Totally 546 children (1–7-year-old) born to 544 HBsAg-positive mothers from 15 cities and rural areas across Jiangsu Province, China, were enrolled. Of these children, 137 (2 pairs of twins) were born to HBeAg-positive mothers; 285 were delivered by ECS and 261 others by VD (one pair of twin in each group). HBV serologic markers were tested by enzyme or microparticle immunoassay. Results The maternal and gestational ages, maternal HBeAg-positive rates, and children’s ages, gender ratios, hepatitis B vaccine coverage and administrations of HBIG were comparable between ECS and VD groups (all p >0.05). The overall prevalence of HBsAg in the 546 children was 2.4%, with 2.5% (7/285) and 2.3% (6/261) in those born by ECS and VD respectively (p = 0.904). Further comparison of chronic HBV infection in the 137 children of HBeAg-positive mothers showed that the HBsAg-positive rates in ECS and VD groups were 10.3% (7/68) and 8.7% (6/69) respectively (p = 0.750), while the mothers had similar HBV DNA levels (2.38 × 106 vs. 2.35 × 106 IU/ml, p = 0.586). Additionally, the overall rate of anti-HBs ≥10 mIU/ml in the children was 71.6%, with 72.3% and 70.9% in those born by ECS and VD respectively (p = 0.717). Conclusions With the recommended immunoprophylaxis against hepatitis B, ECS does not reduce the risk of mother-to-child transmission of HBV. Therefore, ECS should not be used in HBsAg-positive pregnant women to prevent mother-to-child transmission of HBV.
    BMC Pregnancy and Childbirth 05/2013; 13(1):119. DOI:10.1186/1471-2393-13-119 · 2.19 Impact Factor
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    ABSTRACT: Many clinicians do not encourage breastfeeding in hepatitis B virus (HBV) carriers, since HBV DNA can be detected in breast milk and breast lesions may increase exposure of infants to HBV. The aim of this study was to determine whether breastfeeding may add risk for perinatal HBV transmission. Totally 546 children (1-7-year-old) of 544 HBV-infected mothers were investigated, with 397 breastfed and 149 formula-fed; 137 were born to HBeAg-positive mothers. All children had been vaccinated against hepatitis B but only 53.3% received hepatitis B immune globulin (HBIG). The overall prevalence of HBsAg+, HBsAg-/anti-HBc+, and anti-HBs (≥10 mIU/ml) in children was 2.4%, 3.1%, and 71.6% respectively. The HBsAg prevalence in breast- and formula-fed children was 1.5% and 4.7% respectively (P = 0.063); the difference was likely due to the higher mothers' HBeAg-positive rate in formula-fed group (formula-fed 49.0% vs. breastfed 15.9%, P<0.001). Further logistic regression analyses showed that breastfeeding was not associated with the HBV infection in the children, adjusting for the effect of maternal HBeAg status and other factors different between the two groups. Under the recommended prophylaxis, breastfeeding is not a risk factor for mother-to-child transmission of HBV. Therefore, clinicians should encourage HBV-infected mothers to breastfeed their infants.
    PLoS ONE 01/2013; 8(1):e55303. DOI:10.1371/journal.pone.0055303 · 3.23 Impact Factor
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    ABSTRACT: The China GAVI Hepatitis B Immunization Project was initiated in 2002 with the signing of a Memorandum of Understanding between GAVI and the Government of China. The Project was one of the three (China, India, and Indonesia) GAVI-initiated special projects done to support countries too large to receive full GAVI support for hepatitis B vaccine and safe injections. The Project in China was designed by the Chinese Government and partners to deliver free hepatitis B vaccine and safe injections to all newborns in the 12 Western Provinces and Poverty Counties in 10 Provinces of Central China (1301 Counties with approximately 5.6 million births per year), eliminating the gap in immunization coverage between wealthier and poorer regions of China. The project budget (USD 76 million) was equally shared by GAVI and the Chinese Government. Initially planned for 5 years, two no cost extensions extended the project to 2011. Although China produced hepatitis B vaccine, before the project the vaccine was sold to parents who were also charged a "user fee" for the syringe and vaccine administration. Basic Expanded Program on Immunization (EPI) vaccines such as BCG, DTP, Polio, and measles vaccines were provided free to parents, although they were charged a user fee. Vaccines were sold by China CDC Offices at provincial, prefecture, county level and township hospitals, and village doctors received a substantial portion of their income from the sale of hepatitis B and other vaccines. The result of charging for hepatitis B vaccine was that coverage was relatively high in Eastern and wealthier counties in Central China (∼80-90%), but was much lower (∼40%) in Western China and Poverty Counties where parents could not afford the vaccine. The Project was administered by the China MOH and China CDC EPI program, and two Project Co-managers, one from the Chinese Government and the other an international assignee, were chosen. The project had an oversight Operational Advisory Group composed of the Chinese Government, WHO, UNICEF, and GAVI. The initial targets of the project as delineated in the initial MOU for the Project areas (HepB3 coverage will reach 85% at the county level, >75% of newborns at the county level will receive the first dose of hepatitis B within 24h of birth, and all immunization injections will be with auto disable [AD] syringes) were substantially exceeded. The differential in vaccine coverage between wealthier and poorer parts of China was eliminated contributing to a great improvement in equity. With additional contributions of the Chinese Government the Project was accomplished substantially under budget allowing for additional catch up immunization of children under 15 years of age. More than 5 million health workers were trained in how to deliver hepatitis B vaccine, timely birth dose (TBD), and safe injections, and public awareness of hepatitis B and its prevention rose significantly. TBD coverage was expedited by concurrent efforts to have women deliver in township clinics and district hospitals instead of at home. The effective management of the Project, with a Project office sitting within the China EPI and an Operational Advisory Group for oversight, could serve as a model for other GAVI projects worldwide. Most importantly, the carrier rate in Chinese children less than 5 years of age has fallen to 1%, from a level of 10% before the inception of the Project. Liver cancer, one of the major cancer killers in China (250,000-300,000 annual estimated deaths), will dramatically decline as immunized cohorts of Chinese children age. While hepatitis C and non-alcoholic liver disease also exist in China and can lead to liver cancer and cirrhosis, the majority of liver disease in China is hepatitis B related and therefore preventable. The authors believe that China's success in preventing hepatitis B is one of the greatest public health achievements of the 21st century. Work remains to be done in several key areas. There are still pockets of home births in rural provinces where a TBD is difficult to deliver, and China is strengthening its policy of screening pregnant women for HBsAg and delivering HBIG plus vaccine to newborns of HBV carrier mothers. Approximately 10% of the adult population of China remain chronic carriers of hepatitis B virus and cannot be helped by the vaccine, so prevention of liver cancer and cirrhosis in those groups remains a future challenge for China.
    Vaccine 12/2013; 31S9:J15-J20. DOI:10.1016/j.vaccine.2013.03.045 · 3.62 Impact Factor
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