ALF Public Statement on Hep B Screening
March 10, 2014
Virginia Moyer, MD, MPH
U.S. Preventive Services Task Force
540 Gaither Road
Rockville, MD 20850
RE: USPSTF Draft Recommendation Statement - Screening for Hepatitis B Virus Infection in Nonpregnant Adolescents and Adults
Dear Dr. Moyer:
The American Liver Foundation would like to convey our appreciation and support of the U.S. Preventive Services Task Force (USPSTF) “B” grade, which recommends screening for hepatitis B virus (HBV) in persons at high risk for infection.
The mission of the American Liver Foundation is to facilitate, advocate and promote education, support and research for the prevention, treatment and cure of liver disease.
Our organization supports individuals affected by liver diseases -- including HBV -- by providing viral hepatitis education programs and support services. Our national helpline (1-800-GO-LIVER) offers essential resources for patients and their families from the time of diagnosis through treatment and beyond. We have served many individuals with HBV whose diagnosis was delayed for many years and only learned they were infected when they developed complications of chronic infection such as hepatocellular carcinoma and cirrhosis. A “B” grade from USPSTF will provide the opportunity for individuals at risk of chronic HBV, such as Asian Pacific Americans (APAs), to be screened, vaccinated and effectively treated in a timely manner. According to the Centers for Disease Control and Prevention (CDC), 1 in 12 APAs is chronically infected with HBV, and 2 in 3 are unaware of their infection.
The USPSTF draft recommendation positions HBV as a public health priority and will facilitate much needed screening and vaccination for at-risk individuals and linkage to care for those living with chronic hepatitis B (CHB).
We strongly support the recommendation of the USPSTF and that of the Centers for Disease Control and Prevention (CDC) for routine testing and follow-up of individuals at high-risk for infection.
For the purpose of clarification and sharing additional thoughts for the draft Recommendation Statement, we would like to offer the following comments for your consideration. Again, we thank the USPSTF for providing this opportunity to review the information.
Although a thorough description of individuals who are at risk of HBV follows in the draft, “Nonpregnant Adolescents and Adults” leaves a notion that it refers to the general nonpregnant population. We recommend adding the phrase “high risk” and titling it “Screening for Hepatitis B Virus Infection in High Risk Nonpregnant Adolescents and Adults.”
Section entitled, “Rationale: Importance”
The prevalence of HBV mentioned on the draft is underestimated. There are reports and studies that suggest much higher estimates -- as high as 2.2 million -- compared to the CDC estimates of 375,000-975,000 foreign-born persons with chronic hepatitis B (CHB). ,,,,
Section entitled, “Rationale: Benefits of Detection and Early Intervention”
We recommend including the phrase “in high-risk groups” toward the end in the statement, “The USPSTF found adequate evidence that HBV vaccination is effective at decreasing disease acquisition.”
Section entitled, “Clinical Considerations: Patient Population Under Consideration”
We recommend including “individuals in high-risk groups who were vaccinated but not tested for HBV prior to vaccination” in addition to “asymptomatic, non-pregnant adolescents and adults who have not been vaccinated and other individuals at high risk for HBV infection.”
Section entitled, “Clinical Considerations: Assessment of Risk”
In addition to individuals from countries of origin where HBV prevalence is 2% or greater, HIV-positive individuals, intravenous drug users, household contacts of persons with HBV infection, and men who have sex with men, we recommend including individuals at high-risk of having acquired CHB because of vertical/perinatal transmission at birth or horizontal transmission in early childhood.
We found the guideline for testing of foreign-born patients confusing. It fails to cover all countries and regions with 2% or greater HBV prevalence. “Table 1. Prevalence of Hepatitis B Virus Infection by Country of Origin” contradicts with the figure provided in the draft titled “Prevalence of Hepatitis B Infection, Adults 19–49 Years, 2005.” Korea and/or East Asia where HBV prevalence is known to be 2% or greater, for example, is not included in Table 1. We recommend using the classification system from the 2008 MMWR report by Weinbaum et al., Table 3 (below), which may be more helpful to primary care providers who make the screening assessment based on place of birth.
We recommend including individuals infected with hepatitis C (HCV) in the high-risk groups for HBV screening. Studies indicate that up to 35% of individuals with HCV are exposed to HBV, and 3.5%-5.6% may be co-infected (with or without HIV). , HBV-HCV co-infection often increases the progression of liver disease and liver cancer. , Additionally, the Centers for Disease Control and Prevention (CDC) recommends vaccination of HBV and hepatitis A virus (HAV) in persons with chronic liver disease. ,
The draft provides examples of settings that serve large numbersof individuals at increased risk. In addition to sexually transmitted infection clinics, HIV testing and treatment centers, and health care settings that provide services for injection drug users or men who have sex with men, we recommend including facilities that serve a large population of immigrants such as community health centers.
The draft states that “most infected individuals do not develop complications.” However, depending on gender, up to 25%-45% of individuals with CHB die from cirrhosis of the liver or liver cancer. We recommend rephrasing so that the importance of HBV screening, vaccination and treatment is not minimized.
Section entitled, “Discussion: Burden of Disease”
HBV exemplifies the presence of health disparities in the U.S. We recommend including and emphasizing both acute and chronic infection as well as prevalence data on high-risk groups to provide a comprehensive representation of HBV in the U.S.
The draft references the actual number of acute HBV cases reported to the CDC and acknowledges that the real estimate is 6.5 times higher due to underreporting. It may be helpful to present the estimated 19,000 cases of HBV in 2011 instead of the actual 2,890 cases in 2011.
Incidence rates for reported cases of acute HBV infection were highest for black, non-Hispanic persons (race/ethnicity), higher for men than for women, and were highest for those aged 30-39 years.
Prevalence of chronic HBV has been estimated as high as 2.2 million. It was estimated based on cases from 2004-2008 that 53,800 cases of CHB were found among individuals immigrating to the U.S., and 3,800 new cases acquired in the U.S in each year, totaling 57,600 cases per year. It also notes that 25% of these individuals will develop serious complications such as cirrhosis of the liver and liver cancer if HBV is not timely treated, and immigrants with CHB represent 95% of HBV-related deaths.
The American Liver Foundation is grateful to the USPSTF for recognizing the national impact of HBV, the significant burden of HBV-related liver disease and liver cancer, and promoting HBV as a major public health issue in the Unites States. While we are pleased to share our comments and recommendations, we praise the USPSTF for proposing to upgrade the recommendation to a “B” grade in HBV screening for the high-risk populations listed.
We are hopeful this positive change provided by a “B” grade would increase screening and vaccination for at-risk individuals and linkage to care for those with CHB to prevent the progression of liver disease and liver cancer.
We believe that the strategy to eliminate HBV is most effective when stakeholders and communities affected by HBV participate in and actively promote all levels of prevention. The American Liver Foundation looks forward to disseminating the USPSTF’s new recommendation for “Screening for Hepatitis B Virus Infection in Nonpregnant Adolescents and Adults” prior to the National Hepatitis Testing Day on May 19, 2014.
National Board Chair
American Liver Foundation