USPSTF Shifts Course, Favors Hepatitis B Screening

Laurie Barclay, MD

May 30, 2014

Persons at high risk for hepatitis B virus (HBV) infection should be screened, according to a new recommendation from the US Preventive Services Task Force (USPSTF).

Michael L. LeFevre, MD, MSPH, and colleagues, on behalf of the USPSTF, published the recommendations online May 27 in the Annals of Internal Medicine.

"The recommendations are given a grade of B, which indicates that there is high certainty that the net benefit is moderate or that there is moderate certainty that the net benefit is moderate to substantial," Ruma Rajbhandari, MD, MPH, and Raymond T. Chung, MD, from Massachusetts General Hospital in Boston, write in an accompanying editorial. "These recommendations are a dramatic and welcome upgrade from the 2004 USPSTF guidelines, which issued a grade D recommendation against screening asymptomatic persons for HBV infection."

US prevalence of chronic HBV infection is approximately 700,000 to 2.2 million. About 15% to 25% of persons with chronic HBV infection die from cirrhosis or hepatocellular carcinoma, Dr. LeFevre and colleagues write.

"The natural history of chronic HBV infection varies but can include the potential long-term sequelae of cirrhosis, hepatic decompensation, and hepatocellular carcinoma," Dr. LeFevre and colleagues write. "Those with chronic infection also serve as a reservoir for person-to-person transmission of HBV infection. Screening for HBV infection could identify chronically infected persons who may benefit from treatment or other interventions, such as surveillance for hepatocellular carcinoma."

Highlights of Underlying Evidence

Roger Chou, MD and colleagues from Pacific Northwest Evidence-based Practice Center, Oregon Health & Science University, Portland, Oregon, reviewed evidence published through January 2014 on the benefits and harms of antiviral therapy, the benefits of education or behavior change counseling, and the association between improvements in intermediate and clinical outcomes after antiviral treatment. The systematic review was also published online May 27 in the Annals of Internal Medicine.

The authors found no randomized controlled trials or observational studies directly comparing the effects of screening for HBV infection vs no screening on clinical outcomes. However, in high-risk populations, vaccination against HBV infection was associated with reduced risk.

According to 11 mostly fair-quality trials, antiviral therapy may be more effective than placebo for lowering the risk for adverse clinical outcomes associated with HBV infection, but these differences did not reach statistical significance.

For various intermediate outcomes, antiviral therapy was more effective than placebo, according to 22 primarily fair-quality trials. Antiviral treatment was associated with a higher risk for withdrawal from therapy because of adverse events compared with placebo, but the risk for serious adverse events was no different for antiviral treatment than for placebo.

First-line antiviral agents may be superior to lamivudine, based on limited evidence.

Dr. Chou and colleagues note several limitations to their review, including the inclusion of only English-language articles, limited clinical outcome data for antiviral treatments, and the performance of several studies in countries with an HBV infection prevalence and natural history different from those in the United States.

"[S]creening can identify persons with chronic HBV infection, and antiviral treatment is associated with improved intermediate outcomes," they write. "However, research is needed to better define the effects of screening and subsequent interventions on clinical outcomes and to identify optimal screening strategies. The declining incidence and prevalence of HBV infection as a result of universal vaccination will probably affect future assessments of screening."

Highlights of Recommendations

The USPSTF defined high-risk groups as those populations with a HBV prevalence of at least 2%. The new screening recommendations apply to asymptomatic, nonpregnant adolescents and adults, including those who were vaccinated before being screened for HBV infection.

Specific high-risk groups that should be screened include:

  • persons born in countries and regions where prevalence of HBV infection is at least 2%;

  • persons who were born in the United States but who were not vaccinated as infants, and whose parents were born in regions such as sub-Saharan Africa and southeast and central Asia, where prevalence of HBV infection is 8% or more;

  • persons testing positive for HIV;

  • users of injection drugs;

  • men who have sex with men;

  • household contacts of persons with HBV infection.

Providers should use a hepatitis B surface antigen (HBsAg) test approved by the US Food and Drug Administration to screen for HBV infection, followed by a licensed, neutralizing confirmatory test for initially reactive screening results.

To help distinguish between HBV infection and immunity, testing should include a screening panel containing testing for antibodies to HBsAg and hepatitis B core antigen.

The USPSTF defines chronic HBV infection as persistence of HBsAg-positivity on testing for 6 months.

Treatment for HBV is antiviral therapy, and pegylated interferon-α2a, entecavir, and tenofovir are approved first-line agents.

Factors to be considered regarding treatment duration include the time required to suppress HBV DNA and normalize alanine aminotransferase levels, HBsAg positivity, coinfection, cirrhosis, and the choice of antiviral agent.

Other USPSTF recommendations on screening pregnant women for HBV infection and screening for hepatitis C virus infection in adults are posted on the USPSTF Web site.

Implications for Reimbursement

"We laud the USPSTF for its 2014 recommendations that will enable widespread adoption of screening for HBV infection in high-risk populations," Dr. Rajbhandari and Dr. Chung write. "Under the Patient Protection and Affordable Care Act, most private insurers and all Medicaid programs must cover any preventive service with a grade A or B recommendation by the USPSTF. Given this powerful mandate, we believe that the USPSTF should make every effort to ensure that its recommendations do not lag behind the evidence, because the administration of potentially high-impact antiviral therapy hinges on timely identification of infected persons."

The Agency for Healthcare Research and Quality funded the underlying evidence review. Various authors have reported receiving support from the agency.

Ann Intern Med. Published online May 27, 2014. LeFevre full text, Chou full text, Editorial full text


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