**FTS-CDC-NCHSTP**

**Moderator: Dale Babcock**

**April 2, 2008**

**11:00 am CT**

Coordinator: Thank you for standing by. At this time all participants
are in a listen only mode. After the presentation today, we will conduct
a question and answer session. To ask a question at that time, you will
press star 1.

Today's conference is being recorded. If you have objections, you may
disconnect at this time. I'd like to turn the meeting over to your host
today, Mr. Andrew Kroger. You may begin sir.

Andrew Kroger: Thank you and good day everybody. Welcome to Essentials
of Perinatal Hepatitis B Prevention, a training series for coordinators
and case managers 2008.

Today is the first of this four-part series. I'm Dr. Andrew Kroger, a
medical officer in the education information and partnership branch of
the National Center for Immunization and Respiratory Diseases, and I
will be the moderator for today's session.

To participate in today's program you need a telephone connection and a
separate Internet connection. In this four-part series, part one focuses
on case identification, part two deals with case management, part three
addresses assessment and evaluation and part four focuses on the
delivery hospital as safety net.

The learning objectives for this session is describe the key components
of case identification in a perinatal hepatitis B prevention program.
Today is April 2, 2008. For today's program we have Dr. Susan Wang. She
is a medical officer and the acting chief of the prevention branch in
CDC's Division of Viral Hepatitis. Libby Landrum is from Missouri. She
is the viral hepatitis prevention manager at the Bureau of HIV, STD and
Hepatitis with Missouri's Department of Health and Senior Services. Lisa
Jacques-Carroll will join us during the question and answer session.
Lisa is a public health advisor with CDC's Immunization Services
Division.

Today they will discuss case identification and we will include multiple
question and answer sessions. Please make a note of the following
information. If you have technical trouble, please dial star 0 on your
telephone. If you'd like to ask a question, please press star 1 on the
phone.

Continuing education credit is available only through the CDC/ATSDR
training and continuing education online system at
www.cdc.gov/tceonline. You must have a verification code specific to
this program to apply for CE credit. The code will be revealed during
the course of the program.

CDC, our planners and presenters wish to disclose that they have no
financial interests or other relationships with the manufacturers of
commercial products, suppliers of commercial services or commercial
supporters.

Presentations will not include any discussion of the unlabeled use of a
product or a product under investigational use. So with that, we will
begin our discussion of case identification. Dr. Wang, the mic is yours.

Susan Wang: Thank you Andrew. Hello everyone and thank you for joining
the Essentials of Perinatal Hepatitis B Prevention. Today's session is
on case identification. At the end of the conference today you should be
able to describe key components of case identification in a perinatal
hepatitis B prevention program.

Specifically we will review methods for improving the identification of
hepatitis B virus infected pregnant women and infants born to those
women who are at risk for infection.

Since this session is the first of a four-part training series, before
we delve into the issues of case identification, I would like to review
with you some important basic information on hepatitis B virus or HBV
infection.

What is the natural history of HBV infection? When a person first
becomes infected with HBV, he or she will have acute HBV infection which
may be symptomatic or asymptomatic. When symptoms and signs are present,
they may include anorexia, malaise, nausea, vomiting, abdominal pain and
jaundice.

A person who becomes infected with HBV may resolve the infection and
become immune to HBV (as you can see on the second row, right side of
the diagram), or the person may become chronically infected with HBV.
Over time, a chronically infected person may remain chronically infected
or may develop cirrhosis or liver cancer as a result of the chronic HBV
infection.

What is the burden of the hepatitis B disease in the United States? One
of 200 persons or 1.25 million persons have chronic HBV infections in
the United States. There were about 60,000 new HBV infections in 2004, a
decline from the 200,000 to 300,000 infections annually before hepatitis
B vaccination programs. About 4000 to 5000 deaths occur annually from
hepatitis B related chronic liver disease.

> With regards to perinatal hepatitis B in the United States,
> approximately 24,000 infants were born to HBV infected mothers in
> 2005. Without intervention, that is without immunoprophylaxis with
> hepatitis B vaccine and hepatitis B immune globulin, or HBIG, about
> 9100 of those 24,000 infants would become chronically infected with
> HBV and about 2300 would be expected to eventually die of chronic
> liver disease as a result of HBV infection.

To understand the importance of perinatal hepatitis B prevention
programs, it is important to realize that the natural history of HBV
infection is very dependent on the age when infection is acquired.

Among HBV infected children, symptomatic acute hepatitis B is rare while
the likelihood of developing chronic infection is very high. Less then
1% of infected infants develop acute HBV infections but 90% of them
develop chronic infection.

As you can see from the table here, there is an inverse relationship
between age and likelihood of developing chronic infection. As one gets
older it becomes less likely for one to develop chronic infection and
more likely that one develops acute symptomatic infection.

Because most morbidity and mortality occurs in persons with chronic
infection and is usually not apparent until adulthood, infection among
children goes unrecognized and is often not appreciated. However, to
reduce HBV morbidity and mortality it is clearly crucial to prevent HBV
infection in infants and young children.

There are two major modes of HBV transmission in infancy and early
childhood. One is through transmission from an infected mother to her
neonate during delivery and the second mode is transmission from an
infected household contact to the child. Importantly both of these modes
of transmission can be prevented by vaccination of newborns.

Transmission of infection from mother to infant most commonly occurs as
a result of percutaneous and permucosal exposure to the mother's
infected blood during birth. *In utero* transmission of HBV is rare,
accounting for less then 2% of all perinatal infections. HBV has not
been documented to be transmitted by breastfeeding.

Post-exposure prophylaxis is highly effective in preventing HBV
transmission after exposure. When given within 24 hours of birth,
hepatitis B vaccine and HBIG is 85% to 95% effective in preventing
transmission. Administration of hepatitis B vaccine alone at birth is
70% to 95% effective in preventing transmission.

Hepatitis B vaccine thus serves two very distinct purposes with regards
to HBV prevention. When administered at birth to an infant born to an
HBV infected mother, hepatitis B vaccine serves as post exposure
prophylaxis. This is analogous to how we use rabies vaccine after a bite
exposure to prevent rabies infection.

When hepatitis B vaccine is administered at birth to an infant born to
an uninfected mother, hepatitis B vaccine serves as pre-exposure
protection. If a father, grandparent or other household member is
HBV-infected, the vaccine will provide protection from future exposures.

Hepatitis B surface antigen or HBsAg is a marker for current HBV
infection. It is recommended that all pregnant be tested for HBsAg
during each pregnancy. This recommendation has been in place for many
years and is endorsed by many groups including the CDC, the Advisory
committee on Immunization Practices, or ACIP, the American College of
Obstetricians and Gynecologists, the American Academy of Pediatrics, the
American Academy of Family Practitioners and the U.S. Preventive
Services Taskforce.

Prenatal HBsAg testing is best done early in pregnancy in order to
provide appropriate care to the mother and in order to plan to provide
correct care for the newborn.

Women who are not tested prenatally should be tested at delivery. In
addition, women who are at high risk should be retested at delivery.
Women at high risk include women with more then one sex partner during
the previous six months, women who have undergone evaluation or
treatment for sexually transmitted diseases, women with history of
injection drug use, and women with HBsAg positive sex partners.

This diagram depicts how perinatal case identification usually is
expected to occur. When a woman undergoes HBsAg testing prenatally or at
the delivery hospital, the laboratory and the health care provider are
expected to report the positive test results to the local health
department.

The health department determines the pregnancy status for reports of
HBsAg-positive women and can thus identify pregnant women and infants
born to surface antigen positive women who need to be case managed to
ensure that the correct prevention activities take place.

This slide shows the routine methods by which infants born to surface
antigen positive women are identified to health departments. Most
commonly, laboratories report surface antigen positive test results to
health departments which then must work on determining pregnancy status
of surface antigen positive women.

Prenatal care providers are also generally required to report cases.
Occasionally surface antigen positive women self-report to the health
department, particularly if they've had a previous pregnancy and were
previously case managed. Hospitals may report cases that are identified
at the time of delivery.

These first four bullets represent identification methods that are
particularly valuable when they identify pregnant surface antigen
positive women to the health department prospectively. That is, before
the infant is born.

Prospective identification allows the health department to work with the
pregnant woman and with health care providers to prevent transmission to
the infant, to refer the mother for care for her own HBV infection, and
to evaluate and immunize household and sexual contacts of the infected
woman.

Occasionally the methods in the first four bullets identify the woman
and infant after the infant is born or retrospectively. The last method
of identification on this slide, what we call universal reporting
mechanisms, by this definition always identifies the infant born to the
infected mother after delivery.

These methods of universal reporting include review of birth
certificates and of newborn screening cards where the maternal surface
antigen status is recorded.

In states where birth certificates or unborn screening cards routinely
include this piece of maternal information, it should be possible to
determine for all newborns, as all newborns should have birth
certificates and newborn screens, what the mother's surface antigen
status is. This universal reporting method would in a perfect world, be
the most complete maternal surface antigen information for your state's
birth cohorts.

To help identify the target population for prevention, CDC calculates
the number of expected births to surface antigen positive women annually
using the National Health and Nutrition Examination Survey HBsAg
prevalence data and using the vital statistics birth data for each
project area.

When we compare the calculated number of expected births with the actual
identified births, we see that about 50% of the expected 24,000 infants
born to surface antigen positive women are identified by health
departments for case management annually.

The top line on this graph depicts the calculated number of expected
births to surface antigen positive women per year and the bottom line
shows the number of identified births per year.

In 1993, 41% of expected births were identified and in 2004 this had
increased to 50%. In absolute numbers you can see that over the years
the number of expected births has increased from 19,043 in 1991 to
23,919 in 2004.

Increases in the numbers of expected births over time is partially due
to demographic changes including increases in immigration from high
endemic countries. There are a number of gaps in identification of
cases. Laboratory reporting is often the only source used and is not
complete.

The key problem, as many of you know, is that an overwhelming volume of
positive surface antigen test results are reported to health departments
and need to be evaluated for pregnancy status.

Generally when surface antigen test results are reviewed, health
departments initially sort out all the ones on women of childbearing age
and then work on contacting providers to determine pregnancy status.

We know that some pregnant surface antigen positive women are not tested
or are not reported by providers. For example, some women who are known
to be surface antigen positive are not re-tested although it is
recommended that they get tested with each pregnancy. In other cases,
women with no prenatal care do not get tested at delivery. Nationally,
approximately 5% of women who deliver have not had any prenatal care.

Another gap in identification is that many hospitals do not report
cases. It is important for all health departments to evaluate where
their gaps in identification may be occurring.

This slide reviews some key methods to use to improve identification. On
a regular basis, it is important to verify that all laboratories are
reporting all surface antigen positive results to the health department.
Sometimes laboratories change or consolidate and reports temporarily are
discontinued.

It is important to have protocols in place to ensure review by health
departments of all surface antigen positive reports. Health departments
need to routinely monitor to insure that all delivery hospitals are
testing and reporting results. Wherever possible, establishing universal
reporting mechanisms will provide a way to retrospectively assess the
completeness of a health department's prospective identification system.

And finally, but perhaps not the most productive activity on your list,
is to remind prenatal care providers to screen pregnant women and report
positive results.

To evaluate laboratory reporting, start by keeping a list of
laboratories that conduct surface antigen testing in your project area.
Use the list to ensure that laboratories are regularly reporting cases
to the health department. Collaborate with your partners in the
communicable disease program to conduct laboratory evaluations. They are
probably visiting laboratories to verify completeness of reporting for
other communicable diseases such as for influenza or salmonella. Join
them on a visit or ask them to include in their evaluation such measures
as the completeness of surface antigen reporting and the timeliness of
surface antigen reporting.

Certain laboratories are higher priority to evaluate than others.
Priority labs include those that serve high morbidity areas or
populations, those that report large volumes of surface antigen test
results, those that serve prenatal clinics and laboratories in delivery
hospitals since those should capture women who did not receive prenatal
care.

How often should they be evaluated? Ideally, at least once per year for
the priority laboratories and at least every two to three years for
other laboratories. CDC will share more information on evaluating
laboratories in session three of this net conference training series.

To successfully identify cases, HBV prevention activities need to be
implemented by an array of partners, the perinatal program for a project
area, the local county health departments, delivery hospitals, partners
involved in universal reporting and prenatal care providers.

Let's take a look at everyone's roles. A perinatal prevention protocol
should be developed by each perinatal hepatitis B coordinator and
immunization program. This protocol describes perinatal HBV prevention
activities and outlines the responsibilities of all parties -- the
laboratories, the delivery hospitals, prenatal care providers,
pediatricians and health departments.

A perinatal hepatitis B prevention protocol is required by the CDC
immunization grant and should be disseminated annually to partners as a
reminder.

Sample protocols developed by several project areas are currently
available on the CDC perinatal hepatitis B coordinator Web site listed
on this slide. Health departments should have protocols in place to
review all hepatitis B surface antigen positive reports, select those
that come from women of childbearing age, determine pregnancy status of
those women, and to review the reports in a timely manner.

In turn, delivery hospitals should have policies and practices in place
to test unknown status or high risk women for surface antigen at
delivery. This often requires that they have standing orders in place.
Hospital laboratories, obstetrics, and nurseries should have policies in
place to report hepatitis B surface antigen positive delivering women to
ensure that information is used to prevent transmission of infection
from mother to infant.

Health departments should monitor the activities of delivery hospitals.
More information on evaluation of delivery hospitals will be shared in
session four of this series.

With regards to universal reporting mechanisms, health departments
should try to include maternal surface antigen status on electronic
birth certificates and/or on newborn metabolic screening cards.
Perinatal programs should gain access to these data on a regular basis
to identify cases retrospectively and figure out why those cases weren't
identified prospectively.

For quality control, it is important to partner with vital statistics
staff and with newborn screening staff to help educate hospital
personnel on how to properly complete birth certificate and newborn
screening forms.

Prenatal care providers may need to be reminded to screen all pregnant
women for surface antigen and to report all positive women to the health
department. CDC provides additional technical guidance on improving case
identification in chapter one of CDC's Managing a Perinatal Hepatitis B
Prevention Program, Guide to Life as a Program Coordinator, which can be
found on the website listed on this slide. Thank you.

Andrew Kroger: Great, thank you very much. We would not like to invite
our participants to call in and ask questions. To do that, please dial
star 1. Be sure to restrict your questions to the contents discussed
today. And please tell us your first name and the state that you're
from. I am going now to turn the mic temporarily over to our operator.

Coordinator: Thank you. Once again, to ask a question, please press
star 1. One moment please.

Andrew Kroger: While we wait for our first caller, why don't I draw on
one of our frequently asked questions? It has to do with the fact that
some of our prenatal care and pediatric providers state that they can't
provide information on the mother or infant because of HIPPA. What
should they do in this case, Lisa?

Lisa Jacques Carroll: Thanks Andrew. Actually HIPPA does permit
providers and hospitals to disclose patient information to state and
local health departments for perinatal case management because public
health staff are collecting these data for the purposes of disease
prevention and disease control.

There's actually a CDC Q & A document on how HIPPA rules relate to
perinatal hepatitis B prevention that was included on the perinatal
hepatitis B resource CD that we gave out at our December 2005 perinatal
Hep B coordinator's meeting.

If your program does not already have this CD, you can order it through
the perinatal hepatitis B coordinator resource webpage which was listed
at the end of Susan Wang's presentation.

Andrew Kroger: Great, thank you. Do we have a question in the queue?

Coordinator: Yes we do have a question Shelly McKernon, King County
Public Health.

Andrew Kroger: Hi.

Shelly McKernon: Hi, this is Shelly McKernon with King County. I just
wanted to know if you have a recommendation for childbearing age because
there're different standards out there and we used to have a much wider
range -- where it we went from very young to very old and was a lot of
work because hep B reports increased.

So is there a specific age you recommend or leave it up to local
jurisdictions to determine that?

Andrew Kroger: Great question. Lisa, do you want to handle that one?

Lisa Jacques Carroll: Sure Andrew. Actually we at the CDC, at least in
the perinatal hepatitis B prevention program, we don't provide a
standard age range for childbearing age. We let programs decide what age
range they feel is most appropriate for their program and I know from
doing site visits that different programs use different age ranges.

Some of them use really wide ranges such as 10 to 55 years of age, and
others use the more traditional age range of 15 to 45. So really I think
it's up to the individual program to decide which age range it should
use. Thanks.

Andrew Kroger: Great. We'll take the next question in the queue. Hello?
Do we have another question in the queue?

Coordinator: Yes, the question is from (Tanya). One moment. She's from
Arizona. (Tanya), your line is open.

(Tanya): I have a question regarding the number of infants that are
estimated to be missed that are being born to moms who are positive. And
I'm just kind of wondering how would changing the requirement and making
hepatitis B surface antigen reporting mandatory -- a mandatory 24 hour
reportable in women who are pregnant and identified as being positive
for the surface antigens, if that would help to eliminate that.

Andrew Kroger: Susan?

Susan Wang: Hi. I guess the hepatitis B surface antigen is a notifiable
disease in the United -- in all 50 states of the United States so
surface antigen positivity is a required reporting. For pregnant surface
antigen test results for 24 states that is by law, those states have
enacted laws locally so that it's also required.

So a number of states have done that and have found that that has helped
with increasing some of the reporting but in the end, provider reporting
is probably not the highest source for many programs in terms of the
reporting of cases.

Many of the reports are really coming in through the mandatory
laboratory reporting though unfortunately -- so that is a good way to
try to address this problem. So far it hasn't proven to close that gap
entirely between what's expected and the numbers that are actually
identified.

Andrew Kroger: Great, thank you. Good question. We'll take another one
from the queue.

Coordinator: The next question is from (Renee), Wichita Falls.

Renee: Hello?

Andrew Kroger: Hi, how are you?

Renee: This is (Renee) and I'm from Texas. I just had a question on
where the statistics are from that less then 2% of the infants are
infected in utero and I've had a few of these where I had an IGM
positive and a positive surface antigen and of course they didn't
develop into a chronic by the time they delivered. But evidently they
were acutely ill while they were pregnant.

And I just was wondering if (CDC) would recommend to go ahead and give
HBIG when the baby is born as well as the vaccine in those cases, like
we would if the (mother's) surface antigen were positive?

Andrew Kroger: Dr. Wang?

Susan Wang: I think if I understand you correctly, you're describing
pregnant women who are acutely infected during pregnancy but perhaps at
time of delivery are surface antigen negative. Is that correct?

Renee: Right, so they wouldn't be infected at birth, you know, per
typical infection, right?

Susan Wang: Right. I think, you know, for the routine situation, our
recommendation is that, you know, all babies whether born to surface
antigen positive or negative moms\...

Renee: Right.

Susan Wang: \...receive the birth dose, so certainly for these babies,
that would be important. I think, you know, depending on the clinical
situation, there may be reasons for this baby also to get HBIG, but that
would be something that is not a standard routine recommendation by CDC
and would be something that the obstetrician and pediatrician would need
to discuss in the context of the mother's health situation.

Renee: Right, well we make those recommendations so -- here locally --
so that was why I was wanting to see what your take on that would be
because we do -- just to cover that, you know, less then 2%.

Suzanne Wong: I think it's definitely something reasonable to consider,
you know, in addition to the HBIG there have been discussions about
situations where one knows that the mother is truly infected and whether
there are things that now are available such as anti virals and whether
there are other things that need to be explored.

Some of those, we don't have enough data to feel comfortable making an
outright recommendation and I think it has to be in the context of that
particular clinical situation.

(Renee): Alright, thank you.

Andrew Kroger: Thank you. Complicated clinical case issues. We'll take
the next question.

Coordinator: Thank you. The next question is from (Debra), (Kirk) County
Health Department.

Andrew Kroger: Hi (Debra).

(Debra): Hello. I'm actually in Alabama. Are copies of the slides going
to be available after the presentation on the website?

Andrew Kroger: I can answer that one. Yes the slides will be available
on the website tomorrow morning.

(Debra): Okay great. Thank you.

Andrew Kroger: You're welcome. We'll take the next question.

Coordinator: And that is from (Shelly), King County.

(Shelly): Hi. I just had a question about identifying women that may not
be being reported. Do you know if any places have done work or have any
suggestions for how to approach out of hospital births or midwifery kind
of births, attended births, and if any groups have looked at those
deliveries -- out of hospital deliveries and see if they actually
increase their reporting that way? And any suggestions for working with
those out of hospital births.

Andrew Kroger: Great question, Lisa.

Lisa Jacques Carroll: Hi. I don't have the statistics in front of me but
I want to say that something close to 99% of the births in the United
States are in hospitals and so it is a very small percentage of births
that would be taking place in those birthing centers or in homes.

And I also remember from looking at our vital stats national data that a
large proportion of those out of hospital births are to white or
Caucasian women which are low risk for HBsAg. So I would guess that the
yield would not be that great from those settings but I don't actually
know for sure if anybody has looked at that in the states or in the
cities. So I can't really answer your question any further than that.

Andrew Kroger: Okay, thank you very much for the good question. Do we
have another question in the queue?

Coordinator: Yes, we have one more question from (Martha) from Morgan.

(Martha): Hi. I had a question about your projections of the 24,000
births and I'm sorry to say I don't remember what year that projection
was for, but I'm wondering if we have more recent state projections?

And my second question is, given that we've been doing this program for
several years and we're only identifying an estimated 50% of the
possible cases, I'm wondering about what kind of validation you've done
on those estimations for the 24,000 births you expect to see a year?

I know our populations change and the NHANES is coming from race
demographic data. I'm wondering how that -- how those prevalences are
applied to states when we don't necessarily have race ethnicity
breakdowns by immigration status or by some of the sub populations that
might have higher rates then others within a larger group like the Asian
community?

Andrew Kroger: Good question, Susan?

Susan Wang: I think -- it sounds like you actually have number of
questions in your one question and let me see if I can piece out some of
them. I think with regards to the year that these data come from, it's
from 2004. That's our most recently available national vital statistic
data for the birth cohort, so 2004.

With regards to validation of the data, I would say that in general with
regards to what get reported through NNDSS, the National Notifiable
Disease Surveillance System, through reporting in general, is often only
a fraction -- and I'm talking about for any disease, not simply for
perinatal hepatitis B, but for any disease -- is often something like
half of what one thinks is actually out there simply because the
reporting mechanisms are never complete.

And so this figure of around 50% is not completely surprising but it
still speaks to the issue that we need to try to find more of them. We
are interested in working with programs to really drill down at the
local level to understand better if these estimates can be refined and
we are working also with birth certificate data currently since we
realize that the risk is not simply the race/ethnicity of the mothers
but actually where the mother is born.

So if a mother is born in a highly endemic country, that makes her high
risk. If she's Asian Pacific Islander, but has several generations in
the U.S., then she's not necessarily at higher risk then a Caucasian
American.

And so we're looking at birth certificate data for maternal birth
country and we will be trying to apply country prevalence data to that
and see whether we get the same numbers of estimated birth to surface
antigen positive women for those states as when we use the mechanism
that we've used for many years using the NHANES data.

So we are working on continuing to validate that and we would also be
very eager to partner or help support any local efforts at trying to
refine whether the numbers that we are estimating reflect what truly
should be found.

(Martha): Thank you.

Andrew Kroger: Thank you. I think we'll take one last question.

Coordinator: Thank you and that comes from (Barbara McNeely), Rhode
Island Health Department.

(Barbara McNeely): Hello there. Rhode Island is a small state. We get
lab reports in bulk, maybe 20 or 30 at a time, and we were just
wondering if anybody has been able to come up with a system to be able
to flag or somehow identify those moms who are pregnant, because it is
very time consuming when you get them to make these calls to find out if
she is pregnant or not. And I'm just -- we're just wondering if anybody
has faced that and come up with a solution?

Andrew Kroger: Great question. Susan?

Susan Wang: Well one thing that a couple of programs have done is when
they receive the lab reports, they look at who the ordering physician is
and they maintain a list that they are constantly updating of all
prenatal care providers for their project area.

And so they are specifically flagging all surface antigen test results
that are ordered by people labeled in their list as prenatal care
providers. And that helps them to hone in on the highest likelihood
women first.

We have talked with a number of project areas about trying to include
the pregnancy status on the test results but, of course, in order to
have that as part of the test results, it also needs to be part of the
test requisition form which is filled out by the physician or the
clinician.

And as many of you know, in order to get that kind of change to a test
requisition form, a fair amount of work needs to be done with the
private laboratory provider to get them to agree to do that and then to
actually get the health care providers to fill out the information.

So, unfortunately there's not a very simple quick solution to this and
it is something that ongoing work with laboratories will be very
necessary to accomplish.

Andrew Kroger: Thank you very much. We will definitely have time for
more questions at the end of this program but we should move on now. And
I would now like to turn the mic over to Libby Landrum. Libby.

Libby Landrum: Thank you Andrew. Hello everyone. My name is Libby
Landrum and I'm the viral hepatitis prevention manager with the Missouri
Department of Health and Senior Services.

I'm here today to talk with you about identification of hepatitis B
infected pregnant women for the purposes of appropriate and timely
immunoprophylaxis of the infants born to them to prevent mother-to-child
transmission of hepatitis B.

I'd like to thank Lisa of the CDC Perinatal Hepatitis B Prevention
Program for asking me to speak today about perinatal hepatitis B case
identification. I also want to thank all of you who have tuned into this
webinar.

Okay, let's begin and talk about how Missouri's perinatal hepatitis B
prevention program identifies cases. In Missouri, viral hepatitis B is a
reportable condition. Missouri is a dual reporting state which means
that both laboratories and health care providers are required to report
cases of hepatitis B, HBsAg, HBeAg, HDV, anti-HBc, IgM, anti-HBc,
anti-HBe and HBV-DNA positive results are reportable.

As you might imagine, we receive duplicate reports but we've decided
that too many reports are better then too few. In a Missouri state
statute, hepatitis B is considered a category two reportable disease and
must be reported to either the local public health department or the
state public health department within three days of knowledge.

Laboratories generally submit their hepatitis reports to the state
health department via printed laboratory reports either by mail or by
fax. Some of the laboratories submit their reports via electronic
transfer.

Electronic data must be decoded and entered into the state disease
registry. The department communicable disease staff and the local public
health agency staff, with the appropriate clearance, enter the hepatitis
B laboratory results, both acute and chronic, into the registry. Staff
may use the registry's notification options to see new hepatitis B cases
in their jurisdictions daily.

Health care providers submit their findings on a hard copy communicable
disease case report otherwise known as a CD1. They may fax or mail the
completed CD1 to either the local public health department or to the
state public health department.

Many times a Xerox copy of the original laboratory report will be
attached to the CD1. Sometimes an isolated copy of the laboratory report
is received with only the submitter information attached even though
Missouri law requires a completed CD1.

On average, Missouri receives around 350 hepatitis B laboratory results
each month. Of those, nearly 14%, or about 50 are hepatitis B viral DNA
tests. These numbers do not reflect the number of duplicates we get and
it takes time and effort for our staff to wade through them.

We receive laboratory reports from the hospital laboratories as well.
Once the hepatitis B laboratory reports and the CD1s are received,
they're reviewed by the appropriate staff, the perinatal hepatitis B
program staff at the state public health department, or the communicable
disease staff at the local public health agencies.

The case is assigned the appropriate condition code and status according
to accepted hepatitis B case definitions based on the CDC nationally
notifiable hepatitis B disease case definitions. And then they're
entered into the state disease registry.

The disease registry tracks the total number of hepatitis B cases.
Internal quality monitoring keeps the entered data as accurate as
possible. The registry generates notifications of the hepatitis B cases
entered every day. Each local health agency may check their electronic
notifications at any time to see about new cases in their jurisdiction.

Within the St. Louis County Public Health Department and the Kansas City
Public Health Department, we have contracted case managers who are
responsible to provide perinatal hepatitis B case management in their
assigned area.

Each case manager carries a caseload of 40 to 50 infants each year.
These contracted case managers were established in the two areas of the
state with the largest population and the largest number of hepatitis
cases identified per capita. These case managers also provide
consultations to surrounding counties assigned to them.

The state department case manager and I provide consultations, technical
assistance, case management and education to the remaining 96 counties.
In 2008, we had just entered into a contract for case management
services in the St. Louis city public health department.

We added this contract in St. Louis city because it's an area where we
suspect that cases are going undetected. By contractual agreement, all
of the case managers roles are dedicated to hepatitis B case management
activities. This is because the magnitude of their caseload requires
much more time and attention than the counties with fewer cases.

The counties with fewer cases tend to benefit more from consultations
and technical assistance on a case by case basis. The contracted case
managers are required to check their notifications daily.

There are two ways that cases are identified for case management. One is
prospective identification where an HBSAG positive pregnant woman is
identified prior to birth.

This is the preferred method of identification because it gives the
caseworkers time to educate the mother and providers about the disease
and how to prevent transmission to the newborn and household and sexual
contacts. The second method of identification is retrospective when an
infant born to an HBsAg positive mother is identified sometime after the
birth.

Missouri has been involved in following infants born to hepatitis B
infected women since 1993. As you can see from the graph on this slide,
identification of infants born to hepatitis B infected women has
increased dramatically from 2000 to 2007 as indicated by the yellow
bars.

Prospective identification of these infants has increased markedly and
is reflected by the blue bar. Retrospective identification of the
infants is indicated by the maroon bars. Case management is definitely
working in Missouri.

Targeted case managers in the metropolitan areas by case managers who
live in those areas and work through the local public health agencies
have shown significant work in increasing the number of HBsAg positive
pregnant women and enrolling them into case management.

Since Missouri continues to fall below the CDC estimates, we have
targeted St. Louis city as our most recent major identification effort.
A half time perinatal hepatitis B case manager will work exclusively
with the health care providers and the birthing hospital in that city
and will provide case management and hepatitis education in the
community.

We believe there are more hepatitis B infected pregnant women in this
city then have previously been identified within a population who may
have barriers to prenatal care and testing.

Missouri believes identification of pregnancy status is vital to
prospective identification of infants born to hepatitis B infected
women. In 2004, we added a hepatitis B pregnancy condition to the state
disease registry so that the pregnancy questions would have to be
answered during the investigation of the case.

A box in the hepatitis B data entry field is there to remind case
managers or investigators to check the pregnancy status on any hepatitis
B infected female between the ages of 11 and 55. This has helped in the
prospective identification of infants born to hepatitis B infected women
throughout the state.

Data entry staff have been required to enter hepatitis B pregnancy
condition into the state registry as a suspect case and then the case
managers assigns the pregnancy status of the hepatitis B infected female
to the case after contacting the physician.

The case manager will contact the health care provider first by
telephone to inquire about the pregnancy status. The health care
provider will usually verbally tell the case manager the pregnancy
status or is willing to respond to an official fax or email that has the
proper health department identification on it.

Some of the laboratory test reports will indicate pregnancy status. If
the pregnancy status is no, then the case is followed as any other
hepatitis B case. If the pregnancy status is yes, the case manager
enrolls the women into the perinatal hepatitis B prevention case
management program and follows it until the infant completes the
hepatitis B vaccination series and is tested to determine infection
status or immunity.

In spite of our best efforts, not all infants born to HBsAg positive
women are identified before birth. Subsequently, retrospective
identification of infants remains important to ensure that
immunoprophylactic interventions that can be given are given once we
become aware of the infant at risk.

To help us identify infants born to hepatitis infected women, we have a
memorandum of understanding with the Missouri Department of Vital
Records. They provide to us a monthly report of infants born with a
maternal risk factor for hepatitis B.

The source of this information is on a box on the Missouri birth
certificate where hospitals indicate infections that were present during
a woman's pregnancy. At this time, a maternal risk factor for hepatitis
B is either handwritten or typed into a box described as "other".

These infants are enrolled in the case management as appropriate. Once
in a while a coding error has been discovered. For example, a group B
step may be mistaken for hep B due to poor legibility of the
handwriting. False positives and false negatives may also be found.

When this happens, the case is corrected so that the staff does not
spend time investigating a case that's not really a case. Retrospective
case identification may occur when an infant is transferred from another
state or an infant who is born in another country comes to the U.S. and
completes the childhood vaccinations.

Sometimes we're notified as the result of a pediatric health care
provider or service provider who has established a relationship with us
knows that we follow these infants and refers them to us for case
management.

There are by chance reports that have occurred during an investigation
of a new HBsAg positive pregnant woman. The case manager may find the
woman has a younger infant and wasn't tested for the hepatitis B during
the previous pregnancy.

Retrospective infants have been discovered as the result of public
health services provided in a clinic or through service provision when
their staff notifies us of the infant because they're familiar with our
program.

And sometimes an unknown retrospective infant is discovered as part of a
multi-family household during the course of investigations of a known
pregnancy or infant.

I hope you can see the importance of establishing relationships with
partners. More time and care given to these relationships helps to
identify infants at risk for hepatitis B and allows the provision of
immunoprophylaxis to the infants and also to others at risk. Fostering
relationships with local public health agency staff who investigate and
follow cases and health care providers who provide care for the infants
and their families are especially important.

It is important to be knowledgeable about hepatitis disease and
interpretation of viral markers. Case managers must be available to
provide ready assistance to the partners. Every day I get calls and
someone asks me to help them interpret viral markers. We provide
guidance and support as those in the field work through their cases.

There are times when a case manager has difficulty in locating a family.
Our disease intervention specialist will help the case manager locate
the family and may go with the case manager for a home visit. Together,
they educate the family about hepatitis to achieve the best possible
outcome for the infants born at risk for hepatitis B.

There are many ways in Missouri that we build relationships with our
partners. We provide education to birthing hospital staff during site
visits and medical record reviews. During each site visit, we talk with
obstetrics, pediatrics, newborn nursery, infection control, and/or risk
management staff as we review the medical records together.

We provide hepatitis B, STD, perinatal HIV, congenital syphilis, and
hepatitis C education and we discuss the ACIP recommendations outlined
in the December 23, 2005 MMWR. We discuss also the benefits of
enrollment in the Vaccines for Children Program and encourage the
hospitals to enroll so that the birth dose of hepatitis B vaccine can be
readily available for administration to infants born to HBV infected
mothers.

During the year, we provide regional multidisciplinary education
workshops. We coined the phrase, "One is too many," because Missouri
feels passionately that one is too many when it comes to perinatal
hepatitis B infection in babies.

We provide training on hepatitis disease, viral marker interpretation,
hepatitis B immunoprophylaxis, universal birth dose policies, perinatal
HIV, and congenital syphilis prevention interventions. These face to
face interactions with health care providers have helped us in
identification of prospective infants at risk for hepatitis B.

To encourage health care providers to embrace the 2005 ACIP
recommendations regarding universal hepatitis B birth dose policy,
repeat HBsAg testing for pregnant women upon admission to labor and
delivery and administration of HBIG and hepatitis B vaccine dose one
within 12 hours of birth, we decided to mail letters annually to
physicians and nurse practitioners who specialize in pediatrics, family
practice, obstetrics and also to the local public health agency
communicable disease nurses to remind them of the importance of a
universal hepatitis B birth dose practice for all infants and
immunoprophylaxis for infants born to HBsAg-positive women.

A physician advisor told us that if you want the physicians to read your
letters, highlight the main points and the dot points that they can read
in a few minutes. They simply don't have the time to read a lengthy
letter. It is our hope that these letters will ensure that all pregnant
women are screened for HBsAg prenatally and that more physicians will
report these women to the health department.

Internal quality monitoring of the data has shown us that adding the
hepatitis B pregnancy condition to the state disease registry has been
beneficial. The pregnancy question is not always answered and the case
may be closed without a complete investigation. Beginning January 2,
2008, our departmental case manager will contact the health care
providers who submitted the report to us to find out if the woman is
pregnant or not for each HBsAg positive laboratory report for females
between the ages of 11 and 55.

We believe that this will increase the number of infants born to
hepatitis B infected women identified prospectively. Experience has
taught us that not all the case investigations follow the recommended
guidelines. Our staff believes that by investing the time and the effort
to determine the pregnancy status right away, our efforts will be
rewarded by finding pregnant HBsAg-positive women early enough to
provide timely immunoprophylaxis to their babies. Feel free to ask us
next year if we were right.

To illustrate the importance of developing positive relationships with
our partners to facilitate positive outcomes let's look at an example.
One cold night a homeless pregnant woman presented to a local birthing
hospital emergency room at 2:00 a.m. in the morning on a major holiday
weekend. She was ready to deliver at any moment.

It just so happens the hospital was one of which we had previously
conducted a site visit and medical record review where the infection
control, obstetric and newborn nursery staff sat with us as we reviewed
the medical records and we got to know one another.

We discussed the December 23, 2005 MMWR ACIP recommendations and
encouraged them to use this document to review the current policies and
practices regarding review of HBsAg prenatal results and repeat HBsAg
testing for women at continued risk and testing pregnant women admitted
of unknown hepatitis B status.

At the time of our visit, this hospital did not have standing orders for
HBsAg testing for pregnant women of unknown status admitted to labor and
delivery nor did they have a universal hepatitis B birth dose policy.
This hospital did, however, implement a universal birth dose policy and
a stat HBsAg testing policy for pregnant women of unknown status
admitted for labor and delivery.

Consequently the morning this homeless pregnant woman presented to the
emergency room HBsAg testing was ordered for her. The woman's laboratory
results indicated she was HBsAg positive. The infant was medically
stable and was given HBIG and the birth dose of monvalent hepatitis B
vaccine within 12 hours of birth.

The newborn nursery staff notified the hospital infection control nurse
and she notified the perinatal hepatitis B case manager that following
Monday morning. Established relationships between partners helped to
ensure that this infant received timely immunoprophylaxis.

The baby was followed in case management. Social service staff helped
this mother find safe housing and the case manager and the local public
health agency helped set up appointments and transportation for
completion of the infant's hepatitis B vaccine series and follow-up
serology testing. The baby's HBsAg was negative and his anti-HBs
indicated he was considered immune.

We all can work together to achieve outcomes. We cannot eliminate mother
to child transmission of hepatitis B unless we all work together toward
that end. We all have responsibility in cultivating relationships by
respecting one another's time and efforts regardless of the
circumstances. We are all responsible for providing education.

Outcomes will be successful if we keep the goals of hepatitis B
prevention a frequent topic of conversation because the most important
outcome is healthy hepatitis B-free babies. Thank you all for your time
and attention. I hope this information has been helpful and useful to
you as you engage in perinatal hepatitis management in your state. Thank
you very much.

Andrew Kroger: Great. Thank you very much Libby. We'd again like to
invite our participants to call in and ask questions. Remember to dial
star 1 and restrict your questions to the contents discussed today.
Please tell us your first name and the state that you're from. And I'm
going to turn the mic now temporarily over to our operator.

Coordinator: Thank you very much. Please stand by for any questions.

Andrew Kroger: While we are waiting for the first question, I would like
to provide some continuing education credit information. For CE credit,
go to www.cdc.gov/tceonline. The course number for this live event is
EC1356 through May 28, 2008. After May 28th, use the course number
WD1356. The verification code for either one is DW378F. And I will
repeat that, DW378F.

The archived version will remain available for up to three years after
this program or as long as the information remains current. CE will
expire on May 28, 2008 for the course EC1356 and on March 19, 2011 for
the course WD1356. So now I'm happy to take the first question if
there's one in the queue.

Coordinator: And yes, the first question comes from (Bruce) in
Philadelphia.

(Bruce): Hi, thanks Libby. This question is directed towards you
concerning the graph that you showed on your case identification rates
and how to increase identified births rate to a steady average of 130.
It looks like they started to increase after 2000.

But you mentioned that you were getting reports other then antigen --
and I'll use for example, the DNA and e antigens, and I was just curious
if you felt that was part of the reason. If you investigate those
individual tests without an antigen, do you do that and do you find that
there's an antigen sometimes involved?

Or, like here in Philly we've been getting DNAs without an antigen and
I've been finding that they're chronic cases because I can find them in
our perinatal Hep B database. So I was just curious to see what your
thoughts on that were?

Andrew Kroger: Libby?

Libby Landrum: Thank you for that question. First of all I'd like to say
I think the spike in identifying cases is directly related to the
establishment of case managers in those metropolitan areas.

And in regard to your question about the laboratory reports, I would say
in 2004, our laboratory reports at that time were primarily HBsAg and
it's been since then that we've started receiving the other types of
laboratory tests.

(Bruce): Do you investigate a (HBV) DNA without an antigen to find out
if that person actually does have an antigen as well?

Libby Landrum: Yes we do.

(Bruce): Oh, okay. I have another question. And I wasn't sure to bring
this up now or on the next, but since we're identifying cases, we had a
case here where this year she's currently pregnant again and deliver --
or actually has delivered, and in two previous pregnancies she's been
positive-- the child's been a vaccine failure with HBIG and Hep B three
dose, and she's an e-antigen positive mom.

With further investigation, I found that information out. So I was just
curious if there's anything out there for these moms to do differently
because there is something that as a panel, this is the neonatologist at
the area hospital, myself and the doctor that works here, Dr. (Watson),
we all spoke about and we did do something different.

But I was just curious if the panel has heard of anything different. I
don't know if there's anything that's not published yet or in the works,
as far as the treatment.

Susan Wang: Yes, this is Susan Wang. There has been some evaluation
overseas in Asia of trying to use antivirals during pregnancy. So far,
the data -- because in general, HBIG and hepatitis B vaccine is so
efficacious in many settings, it's 95% effective in preventing
transmission, that it's not common that you still have breakthroughs.

But you describe a clear cut situation where it sounds as though in two
previous pregnancies this woman had infants who received everything
according to the correct time schedule and yet were infected.

So in this particular situation, it certainly would merit consideration
of anti-virals. I have to say that selection of antivirals is still not
clear cut. This is sort of an emerging area and there are some pediatric
gastroenterologists in selective places around the country who could
provide some suggestions of what one might want to do.

In the long run, we would hope that this sort of situation would be part
of clinical trials so that one could make sense of the data and not
simply have anecdotal situations of what happened.

So if you contact us, we can help try to put you in touch with some
people. And the other piece of information I want to share is that the
National Institute of Health, NIH, is putting together a consensus HBV
treatment conference that is scheduled for October, 2008.

You can find information on that web -- on the NIH website about this
consensus conference and they will be reviewing clinical data for
chronic HBV treatment and hopefully will also address some thoughts
about pregnancy status although, again, pregnancy status does not come
up too often in clinical trials so the data are even more sparse.

But this is definitely an emerging area and something that should be,
you know, further investigated-- a consultation should be involved for
this particular situation.

(Bruce): Okay great.

Andrew Kroger: Thank you (Bruce).

(Bruce): Thank you.

Andrew Kroger: We'll take the next question.

Coordinator: Thank you. The next question is from (Lynn) in Georgia. You
may ask your question.

(Lynn): Hi. I wanted to ask, I hear repeatedly that there are different
programs that are successful with having the hospital, someone at the
hospital, whether it's infection control or somebody, report to their
case managers when a particular birth occurs that they've been tracking.

And I'm just wondering if anybody run into problems as we have with very
large birthing hospitals. For example, we have one in the metro area
that they nicknamed the baby factory because they have like five floors
of labor and delivery and they have lots and lots of births.

And they just don't have the time for that individual attention so
everybody is forced to just continually call them and ask them to pull
records after the fact. And of course, it serves moms from surrounding
counties so it's not just one county that they're dealing with.

So, I was just wondering if anybody has overcome that barrier or if
Michigan has run into that?

Libby Landrum: (Lynn), this is Libby from Missouri. And I'd just like to
say that we have a number of large birthing hospitals and it all depends
on the relationship that you build, that we have built with the
infection control officer there.

(Lynn): Okay.

Libby Landrum: And sometimes it's good and sometimes you just need to
keep fostering those relationships.

Lisa Jacques Carroll: I just wanted to add a little bit to that. I know
there are some programs that provid HBIG to their hospitals for the
babies born to positive moms and I know that that can be an incentive to
get the hospital to report the births to infected moms to you as sort of
an accounting mechanism for the use of the HBIG.

So, I'm not sure if that's something that's feasible. I know HBIG is a
very expensive product but that is another idea that comes to mind. And
this is Lisa.

(Lynn): Okay. Thanks.

Andrew Kroger: Thank you. I think we'll take one more question.

Coordinator: Thank you. And that would be from Maura in Massachusetts.

Maura: Hi. Thanks for the conference. I really appreciate it. I just
wanted to add to the different testing that we're finding in the
pregnancy and the anti-virals. We tend to see -- it starting to show a
pattern that women with Hep B e-antigen positive are having the children
that are actually turning out to be hepatitis B positive, for the few
that we do run in to if it's been tested, and not all women have been.
And I'm just curious if there's any pattern that you've seen in that?

Susan Wang: Hi.

Andrew Kroger: Good question.

Susan Wang: Yes, we do definitely have data that the e-antigen status --
the hepatitis B e-antigen status of the mother -- of the infected mother
-- plays an important role with regards to the risk for transmission.
For e-antigen negative women, the babies have a low likelihood,
somewhere around 5% to 20% likelihood of transmission occurring.

For e-antigen positive, up to 90% of babies born to e-antigen positive
mothers can become infected. The other marker besides hepatitis B
e-antigen that is useful to understand risk for transmission is the DNA
load.

Those -- both the e-antigen and the DNA load together provide
information of the transmissability and how much virus is circulating in
the mother. So those two pieces of information are important and in
fact, in our enhanced perinatal hepatitis B case management project, we
are encouraging routine collection of those additional markers.

And you may find it useful to collect it in your routine case management
data because these additional markers, if the woman is identified as
chronically infected should for her own health care be part of routine
testing for the woman, not specifically CDC recommended for perinatal
HBV transmission, but for the woman's own care.

And so these pieces of information will help in the future to decide in
a more specific manner the use of anti-virals when those become part of
the prevention activities. But they are not currently part of the
prevention activities or not currently routinely part of the prevention
activities simply because we are really very short on data.

Maura: Okay.

Andrew Kroger: Thanks Susan. Okay, thank you for your questions. At this
time, we are out of time so I will now move on to the closing
information, and to do that I will give some further housekeeping
information.

For continuing education credit, please go to www.cdc.gov/tceonline. The
course number for this live event is EC1356 through May 28, 2008. After
May 28th, use the course number WD1356 and the verification code for
either one is DW378F. And I will repeat that, DW378F.

Once you become familiar with the online system, you will find it easy
to use and a great way to keep track of CE credits earned from CDC
training programs. If you're having any difficulty or are new to the
system, please you can get assistance by phoning 1-800-41TRAIN. Another
number that you can call is 404-639-1292. And both of these numbers you
can call during business hours from 8:00 a.m. to 4:30 p.m. Eastern time.

If you do have any questions after this event, you can always get help
by way of your state perinatal coordinator or feel free to contact Lisa
Jacques Carroll here at CDC. Remember that our next session will take
place next Wednesday, April 9th at the same time, which is 12:00 noon
Eastern. And the topic for that session will be case management. So
please mark your calendars.

Okay I'd really like to thank everyone for joining us today. I want to
add one additional thing that I don't think was mentioned but it came up
during the question and answer, the slides for the course will be
available tomorrow morning. And I believe that those slides should be
available on the site on which you registered, so you can go to that
site and obtain the slides.

So with that, thanks everyone for joining us today and a special thanks
to our subject matter experts, Dr. Susan Wang and Libby Landrum and Lisa
Jacques Carroll. Thank you very much from Atlanta and have a great day.
Good bye.

END