May 5, 2014

Harold W. Jaffe, M.D., M.A.

Associate Director for Science
Centers for Disease Control and Prevention
1600 Clifton Road
Atlanta, GA 30333

Dear Dr. Jaffe:

On behalf of the Hepatitis B Foundation, we would like to ask the Centers for Disease Control
and Prevention (CDC) to reconsider the statistics which are currently used in CDC publications,
websites, conference presentations, and other venues on the prevalence of chronic hepatitis B
(CHB). We also request a conference call or in person meeting with you to discuss our
reasoning, as outlined below.

The Centers for Disease Control and Prevention (CDC) currently estimates that there are
805,000-1,405,000 persons living with chronic hepatitis B (CHB) in the U.S.,
1
an estimate that is
widely used in CDC publications, websites, conference presentations, and other venues. We
believe that this estimate should be revised. Each epidemiological study that has been published
with prevalence estimates has strengths and weaknesses. As the CDC has acknowledged,
2
the
National Health and Nutrition Examination Survey (NHANES) data which has been used as a
large part of the basis for the CDC estimate of CHB prevalence in the U.S. excludes some
populations, including prisoners, the homeless, and institutionalized persons, who might be at
increased risk for infection with the hepatitis viruses. Since NHANES is a survey of only the
civilian population, it also does not include active duty military personnel, a population that may
also be at increased risk for infection. We are concerned that the population included in the 2008
NHANES data used by the CDC for its estimate of CHB prevalence may not accurately reflect
the current population in the United States. As acknowledged by the CDC, estimates for certain
smaller racial/ethnic groups in whom multiple studies have shown higher rates of infection,
including Asians and Pacific Islanders (APIs), Alaska Natives, and Native Americans, cannot be
determined by NHANES because they are not adequately represented.
2, 3


In addition, although we know that NHANES interviewers are given clear instructions about
providing survey participants with assurances of total confidentiality, some immigrants may still
be wary of participating in government health-related research for fear, if undocumented, that
they will be reported to U.S. Immigration and Customs Enforcement or, if documented, that they
might be deported if health issues are discovered as part of the survey. We are encouraged that
the CDC is making efforts to improve sampling of these populations in their next round of
studies, including with the oversampling of the Asian population which began in 2011 and the
translation of survey materials into multiple Asian languages, but in the interim we think that the
CDC should post what we believe may be a more accurate prevalence range based on published
studies.



HEPATITIS B FOUNDATION CAUSE FOR A CURE
3805 Old Easton Road www.hepb.org
Doylestown, PA 18902
Phone: (215) 489-4900

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A 2010 report by the American Association for the Study of Liver Diseases estimates that there
are at least 2 million persons in the U.S. with CHB, 65 percent of whom are unaware of their
infection.
4
A similar estimate of up to 2 million persons with CHB in the U.S. was reported in an
extensive review of epidemiology in the Americas.
5
A follow-up to that study calculated the
current CHB prevalence to be approximately 1.99 million, using 2005 Census data with
relatively conservative serosurvey infection rates of 8.9% among foreign-born APIs and 1.4%
among U.S.-born APIs.
6
This study also noted that adding undocumented APIs (estimated to be
1.5 million in 2005), who are not accounted for in the NHANES estimate, could potentially
increase the CHB burden by an additional 100,000.

In 2012, a comprehensive meta-analysis based on a systematic survey of reports of HBsAg
seroprevalence rates in 102 countries combined data to determine country-specific pooled CHB
prevalence rates, and then multiplied these by the number of foreign born living in the United
States in 2009 by country of birth from the U.S. Census Bureau to yield the number of foreign
born with CHB from each country. Based on this meta-analysis, the researchers estimated a total
of 1.32 million (95% confidence interval: 1.04-1.61 million) foreign-born persons in the U.S.
living with CHB,
7
compared to the CDC estimate of 375,000-975,000 foreign-born persons with
CHB.
1
These authors note that considering their estimate of 1.04-1.61 million foreign-born
persons with CHB in conjunction with the current CDC estimates of 229,000-534,000 non-
institutionalized U.S.-born persons and 74,000 institutionalized persons with CHB, the total
prevalence of CHB in the U.S. may be as high as 2.2 million.

The CDC estimate for institutionalized persons may also be an underestimate. It includes both
residents of correctional settings (an estimated 2.0% prevalence, 44,000 persons with CHB) and
of other group living quarters (an estimated 0.5% prevalence, 30,000 persons with CHB),
including college dormitories, military quarters, nursing homes, group homes, and long-term
care facilities, as well as the homeless. In some of these populations, prevalence may be
substantially larger.

For example, CHB prevalence estimates from U.S. incarcerated populations vary widely across
studies, ranging from 0.9% in Tennessee
8
to 8.7% in Maryland;
9
however, the CDC estimate for
this population (2.0%) is based on a 2003 MMWR report that considered only a small number of
studies showing prevalence rates of only 1.0% to 3.7%.
10
Although the CDC has suggested that
HBsAg testing should be available in homeless shelters where the prevalence of CHB is likely to
be substantially higher because of the increased representation of injection drug users (IDUs) and
former IDUs (an estimated 58%) in shelters, the estimate of CHB prevalence in the homeless that
is used in their overall calculation of U.S. prevalence is only 0.5%.
1
According to the Institute of
Medicine, there is a substantially higher CHB prevalence in the homeless.
3
Taking all of these
considerations into account, we believe that the Kowdley et al figure of 2.2 million persons in the
U.S. living with CHB may be the most accurate estimate to date.





HEPATITIS B FOUNDATION CAUSE FOR A CURE
3805 Old Easton Road www.hepb.org
Doylestown, PA 18902
Phone: (215) 489-4900

3 | P a g e

We believe that showing broader ranges of prevalence data, as supported by these studies, could
expand opportunities for advocacy and awareness, as well as provide a solid basis for requesting
increased funding for research and education. We believe that in support of this, the CDC should
reconsider the estimate of CHB prevalence in the U.S. which it currently uses, as well as the
current methodology for estimating CHB prevalence. We appreciate your consideration of our
thoughts and would be happy to discuss this further at your convenience.


Sincerely,

Robert G. Gish, M.D., Medical Director, Hepatitis B Foundation

Kris V. Kowdley, M.D., Director of Research & Director of the Liver Center of Excellence,
Digestive Disease Institute, Virginia Mason Medical Center, Seattle, Washington

Carol L. Brosgart, M.D., Clinical Professor of Medicine, Division of Global Health, University
of California, San Francisco

Ryan Clary, Executive Director, National Viral Hepatitis Roundtable

Joan M. Block, R.N., B.S.N., Executive Director and Co-Founder, Hepatitis B Foundation

Timothy M. Block, Ph.D., President, Hepatitis B Foundation; President, Baruch S. Blumberg
Institute, Doylestown, PA; Professor and Director, Drexel Institute of Biotechnology and
Virology, Drexel University College of Medicine, Philadelphia, PA

Loc T. Le, M.D., Chair, National Task Force on Hepatitis B: Focus on Asian and Pacific Islander
Americans, Pikesville, MD





HEPATITIS B FOUNDATION CAUSE FOR A CURE
3805 Old Easton Road www.hepb.org
Doylestown, PA 18902
Phone: (215) 489-4900

4 | P a g e



1
Weinbaum CM, Williams I, Mast EE, Wang SA, Finelli L, Wasley A, Neitzel SM, Ward JW;
Centers for Disease Control and Prevention (CDC). Recommendations for identification and
public health management of persons with chronic hepatitis B virus infection. MMWR Recomm
Rep. 2008 Sep 19;57(RR-8):1-20.
2
Centers for Disease Control and Prevention (CDC). National Center for Health Statistics
(NCHS). National Health and Nutrition Examination Survey Data. Viral hepatitis. Hyattsville,
MD: U.S. Department of Health and Human Services, Centers for Disease Control and
Prevention. Available at: http://www.cdc.gov/nchs/data/nhanes/databriefs/viralhep.pdf.
3
IOM (Institute of Medicine). Hepatitis and liver cancer: a national strategy for prevention and
control of hepatitis B and C. 2010. Washington, D.C., The National Academies Press.
4
Levi J, Pastorfield C, Segal LM, Cimons M. HBV & HCV: Americas Hidden Epidemics. Trust
for Americas Health. Washington, D.C. September 2010:1-42.
5
Gish RG, Gadano AC. Chronic hepatitis B: Current epidemiology in the Americas and
implications for management. J Viral Hepat 2006;13:787-98.
6
Cohen C, Evans AA, London WT, Block J, Conti M, Block T. Underestimation of chronic
hepatitis B virus infection in the United States of America. J Viral Hepat. 2008 Jan;15(1):12-13.
7
Kowdley KV, Wang CC, Welch S, Roberts H, Brosgart CL. Prevalence of chronic hepatitis B
among foreign-born persons living in the United States by country of origin. Hepatology
2012;56:422-433.
8
Decker MD, Vaughn WK, Brodie JS, Hutcheson RH, Jr, Schaffner W. Seroepidemiology of
hepatitis B in Tennessee prisoners. J Infect Dis. 1984;150:450-459.
9
Solomon L, Flynn C, Muck K, Vertefeuille J. Prevalence of HIV, syphilis, hepatitis B, and
hepatitis C among entrants to Maryland correctional facilities. J Urban Health. 2004;81:25-37.
10
Weinbaum C, Lyerla R, Margolis HS; Centers for Disease Control and Prevention. Prevention
and control of infections with hepatitis viruses in correctional settings. Recomm Rep. 2003 Jan
24;52(RR-1):1-36.