Indian Pediatr 2009;46: 1005-1008
Hepatitis B Prevalence during Pregnancy
S Chatterjee, K
Ravishankar1, R Chatterjee2, A Narang3
and A Kinikar4
Department of Pediatrics, Calcutta Medical College, Kolkata;
Nilofer Hospital, Hyderabad; 2Department of Pediatrics, NRS
Medical College, Kolkata;
3Department of Pediatrics, PGIMER, Chandigarh; and 4BJ Medical
College, Pune, India.
Correspondence to: Dr Sukanta Chatterjee, 889 A, Lake
Town, Kolkata 700 089, West Bengal, India.
Manuscript received: April 11, 2008;
Initial review: May 9, 2008;
Accepted: September 9, 2008.
online: 2009 April 1.
In order to determine the efficacy of a new hepatitis
B immune globulin (HBIG), a phase 3, vertical transmission (mother to
child) clinical interventional trial of hepatitis B virus (HBV) post
exposure prophylaxis (PEP) was conducted at selected sites (n=15)
throughout India. This required a large screening program for HBsAg
positivity at prenatal clinics located in tertiary care hospitals.
36,379 pregnant women consented to be tested for Hepatitis B surface
antigen (HBsAg) by Rapid Test and if positive-confirmed by ELISA. The
weighted mean prevalence was 0.82% (95% CI, 0.72, 0.91). In conclusion,
the prevalence of HBV carrier state during pregnancy in India in this
study was low compared to previous reports.
Key Words: Hepatitis B, India, Pregnancy, Prevalence.
The carrier rate of Hepatitis B in India
may vary in the different regions and is often quoted as being 4.7%(1,2).
This is a mean of means of various studies and includes high risk
populations(2). In a systematic review and meta-analysis of the prevalence
of HBV infection in India, Batham, et al.(3) found that the point
prevalence among non-tribal populations is 2.4% (corresponding to a
chronic carrier rate of 1.9%). A great majority of the transmission of
Hepatitis B in India and other developing countries occurs by vertical
transmission from an infected carrier mother to the neonate, intrapartum
or antenatally. The probability of developing the carrier state following
HBV infection is greatest in early life and decreases with increasing age.
Up to 90% of babies born to carrier mothers may become carriers and they
are at a very high risk of developing chronic liver disease at a younger
age(4). It has been estimated that up to 10% of the 350 million Hepatitis
B chronic carriers worldwide arise in India. The burden of disease
globally by vertical transmission is significant and this has led to the
development of prophylaxis protocols adopted by many countries to decrease
the pool of chronic carriers worldwide.
We conducted this study in 15 centers all over India to
assess the prevalence of hepatitis B in pregnant women, mainly from
non-tribal urban regions. This was a part of a larger study to demonstrate
the safety and efficacy of a new hepatitis B immune globulin (HepaGamTM
Cangene Corporation, Winnipeg, Manitoba, Canada) for post exposure
This study was conducted from November 2003 to July
2006. For the purpose of this short communication, the epidemiological
data from the screening tests performed in 36,379 pregnant women at 15
centers will be reported. Study centers were selected for the study on the
basis of expected screenings or enrolments into the study. All pregnant
women attending the antenatal clinics of these centers were screened for
HBsAg at 5-9 months of gestation after informed consent was obtained. We
used a rapid HBsAg test Kit (ACON Laboratories Inc, USA). A positive HBsAg
test was confirmed by enzyme-linked immunosorbent assay (ELISA) after the
pregnant woman signed the second part of an Informed Consent Form,
consenting to her and her child’s participation in the study. Bioelisa
HBsAg ELISA kit (Biokit, Barcelona, Spain) were used according to the
manufacturer’s recommendations for HBsAg detection and absorbance was
measured using an ELISA reader (MRX Microplate Reader, Dynatech, USA). The
study was approved by DCGI (Permission No from DCGI: 12-51/2003-DC) and
hospital ethics committees at each of the 15 institutions involved in this
study, and the study was conducted in accordance with the ethical
principles of the Declaration of Helsinki, and in accordance with the
International Conference on Harmonization (ICH) of Technical Requirements
for Registration of Pharmaceuticals for Human Use, E6 Good Clinical
Practices: Consolidated Guidelines, Food and Drug administration (FDA)
regulations and IEC-required procedures.
This large scale screening program in 15 tertiary care
hospitals throughout India identified 398 (Table I) HBsAg
positive women allowing some epidemiological data to be collected of the
prevalence of HBV carrier state during pregnancy across all represented
populations in India.
Prevalence of HBsAg at Prenatal Screening
Weighted Mean 0.82%
* MS Ramaiah Medical College; +Vanivilas hospital, Bangalore Medical College.
Statistical analysis: The number of patients in
each study center varies so the mean might deliberately over-represent or
under-represent certain segments of the population. To restore balance of
the number of patients enrolled in each center, the prevalence of HBsAg
positivity was estimated using a weighted pooled point estimate along with
a 95% confidence interval(5). Using this method, less weight will be
placed on the study center with smaller number of enrolled patients and
greater weight on the study center with larger number of enrolled
patients. All calculations were performed using SAS® version 8.2. RNTMC
screened 472 subjects and 0 tested HBsAg positive by screening test kit,
the prevalence rate at this center was corrected to read 0.001 in order to
include this data into the formula for weighted prevalence rates (Table
Out of 36,379 pregnant women screened, 406 were HBsAg
positive by rapid screen Further testing of these 406 positive tests
determined that 398 were positive by ELISA. Thus the false positivity rate
of the rapid screen is 2%.
The range of prevalence of HBsAg positivity in pregnant
women varied from 0.4% (VHBMC, Bangalore) to 4.6% (SJMCH, Bangalore) and
the overall mean prevalence of HBsAg positivity was 1.09% (95% CI
0.99-1.21) and the overall weighted mean of the prevalence of HBsAg
positivity was 0.82% (95% CI 0.72-0.91). It has been confirmed that the
high prevalence of HBsAg positivity at SJMCH in Bangalore was due to
pre-selection of the population at this hospital since it is a referral
center for "infectious cases" for the area. The mean prevalence of HBsAg
positivity and weighted mean of the prevalence of HBsAg positivity
excluding SJMCH prevalence rate was calculated to be 1.05% (95% CI
0.95-1.16) and 0.81% (95% CI 0.72-0.90), respectively.
The prevalence of HBsAg positivity in pregnancy which
was observed in this prospective, intervention study is less than 50% of
previously reported non-tribal prevalence rates in systematic review of
literature(2,3). The main limitation of the study is that the centers were
located in urban areas and these centers were tertiary care referral
centers. However, volunteer patients were not selected on the basis of
referrals or walk-ins from the surrounding areas and not referrals except
SJMCH, Bangalore. There is little change in weighted mean prevalence of
HBsAg positivity excluding SJMCH (0.81%) compared to the overall weighted
mean prevalence of HBsAg positivity including SJMCH (0.82%). This sample
of patients screened and enrolled into the study may not be representative
of the prevalence of hepatitis B infection in rural areas but is
representative of the prevalence in urban areas.
The HBsAg rapid screen (Rapid Test Kit ACON
Laboratories Inc, USA) was accurate in 98% of cases when used in a mass
screening program of this nature and may be a cost effective means of
screening pregnant women for HBsAg to identify at risk populations
eligible for immunoprophylaxis of their neonates.
The weighted mean prevalence of HBsAg positivity in our
multi-center prospective study was 0.82%, which is roughly less than one
half of the previously reported point prevalence of HBsAg carrier state in
non tribal populations in India(3). Consequently, the pharmaoeconomics of
imple-menting an immuno-neprophylaxis program consisting of testing all
pregnant mothers for HBsAg status and the administration of HBIG and
recombinant hepatitis B vaccine within 12 hours of delivery to at risk
neonates across the India may roughly be one half the previously estimated
Contributors: All authors contributed to the study
design, concept, literature search, data analysis and drafting of the
Funding: Cangene Corporation, Winnipeg, Manitoba,
Competing interests: Cangene Corporation provided
study grant to the participating 15 tertiary care hospitals in India.
All the investigators contributed greatly to the
successful completion of this large clinical trial and the principal
authors wish to recognize the team for this large scale screening effort
and collection of the epidemiological data reported above (Annexure).
1. India Pediatric Hepatitis B
Immunoprophylaxis Study Group: K Srivastava, King George Medical
College, Lucknow; D Gandhi, Government Medical College, Baroda; J
Mondkar, LTM Medical College and General Hospital, Sion, Mumbai; S
Bhat, St John’s Medical College and Hospital, Bangalore; A Bavdekar,
Kem Hospital, Pune; P D’Souza, Goa Medical College, Panaji, Goa; P
Maiya, MS Ramaiah Medical College and Hospital, Bangalore; D
Balpande, India Gandhi Medical College, Nagpur; Dr. Shivananda,
Bangalore Medical College and Vanivilas Hospital, Bangalore; Dr
Shanti Mandowara, RNT Medical College, Udaipur, India.
2. India Obstetric Hepatitis B
Immunoprophylaxis Study Group: M Sanghamita, Calcuta Medical
College, Kolkata; G Devi, Nilofer Hospital, Hyderabad; D
Bandyopandhyay, NRS Medical College, Kolkata; S Gopalan, PGIMER,
Chandigarh; P Naphade, BJ Medical College, Pune; V Das, King George
Medical College, Lucknow; L Chauhan, Government Medical College,
Baroda; V Badhwar, LTM Medical College, Sion, Mumbai; A Mhaskar, St
John’s Medical College and Hospital, Bangalore; R Otiv, KEM
Hospital, Pune; P Nevrekar, Goa Medical College, Panaji, Goa; U Devi,
MS Ramaiah Medical College and Hospital, Bangalore, India.
3. Cangene Corporation (Winnipeg, Manitoba,
Canada) Hepatitis B Immunoprophylaxis Study Group: M Genereux, C
Hall, C Sinclair, J Dixit, P Sadri and D Jain.
What This Study Adds?
• The Hepatitis B carrier state prevalence in
women attending antenatal clinics in tertiary hospitals in urban
areas in India is less than 1%.
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