Clinical Guideline on HBV Released by ACP, CDC

Diana Phillips

November 21, 2017

A new clinical guideline on hepatitis B virus (HBV) urges physicians to vaccinate all unvaccinated adults who are at risk for infection, including pregnant women, and routinely screen at-risk adults.

The American College of Physicians (ACP) and the Centers for Disease Control and Prevention (CDC) published the clinical guideline online on November 20 in Annals of Internal Medicine. The authors also direct clinicians to refer all HBV-infected individuals for appropriate care and counseling.

"Although these topics have been addressed previously in clinical guidelines from the CDC, the U.S. Preventive Services Task Force (USPSTF), the American Association for the Study of Liver Diseases (AASLD), and the Advisory Committee on Immunization Practices, their recommendations vary and implementation has been suboptimal," Winston E. Abara, MD, PhD, from the CDC's National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, and colleagues report. "Most persons who are at risk for, are susceptible to, or have HBV infection are not screened, vaccinated, or linked to care," they write. "Recent studies have suggested additional at-risk groups that should receive HBV screening, treatment, or vaccination that were not in previously published clinical guidelines."

"The majority of people who are at risk for hepatitis B are not being appropriately screened or if they do have the disease, they are not being referred and linked to care. This is a cost-effective measure and the uptake is way too low," Jack Ende, MD, president of the ACP, said in a video statement accompanying the report. "Chronic hepatitis B can lead to cirrhosis, liver failure, or primary liver cancer. About 25% of infected patients will die premature[ly] from one of these complications. The HBV vaccination is the most effective way to prevent this illness and therefore its complications," he said.

The authors reviewed the literature on evidence for HBV vaccination, screening, and linkage to care and integrated new evidence with consensus across guidelines, using a high-value care framework developed by the ACP.

With respect to vaccination, the evidence supports universal vaccination for adults seeking protection from HBV infection and those deemed to be at increased risk for infection as a result of the following:

  • Sexual exposure;

  • Percutaneous or mucosal exposure to blood;

  • Chronic liver disease;

  • End-stage renal disease;

  • HIV infection;

  • Infection risk behaviors during pregnancy; or

  • International travel to regions with high or intermediate levels of endemic HBV infection.

Some of these individuals — particularly those who are immunocompromised or who have end-stage renal disease — may warrant higher vaccine dosages than dosages achieved through the typical three- or four-dose HBV vaccine series to ensure optimal protection, the authors write. Further, they note, "[t]hese persons should receive postvaccination testing, and those with suboptimal response (antibody to HBsAg [hepatitis B surface antigen] level < 10 mIU/mL) should be revaccinated."

Adverse effects from HPV vaccine are rare and mild, the authors stress. "[T]he most common are soreness at the injection site (3% to 29%) and mild fever (1% to 6%)," they write, noting that postvaccination anaphylaxis is rare, occurring once per 1.1 million doses.

Screening for HBV, via seromarkers for hepatitis B surface antigen, antibody to hepatitis B core antigen, and antibody to hepatitis B surface antigen should be conducted in high-risk populations, including

  • Individuals born in countries with 2% or higher HBV prevalence;

  • Men who have sex with men;

  • Intravenous drug users;

  • HIV-positive individuals;

  • Individuals with household and sexual contacts to HBV-infected persons;

  • Individuals requiring immunosuppressive therapy;

  • Individuals with end-stage renal disease;

  • Blood and tissue donors;

  • Individuals infected with hepatitis C virus;

  • Persons with elevated alanine aminotransferase levels (≥19 IU/L for women and ≥30 IU/L for men);

  • Incarcerated individuals;

  • Pregnant women; and

  • Infants born to HBV-infected mothers.

Although current guidelines from the CDC, the USPSTF, and the AASLD recommend screening for persons born in regions with intermediate-to-high prevalence of HBV infection or with other known HBV-related risks, as well as prevaccination testing for healthcare personnel at increased risk for HBV infection and those who perform exposure-prone procedures, "screening in these groups is suboptimal," the authors write.

The advice also extends to linking HBV-infected individuals to care and counseling as necessary. "Although not all patients with chronic HBV infection require treatment, they all should be routinely evaluated for hepatocellular carcinoma and treatment eligibility through history and physical examination," the authors state, pointing to evidence indicating that such linkages can significantly reduce HBV-associated morbidity and mortality.

"However, most persons with chronic HBV infection are not linked to care because they are unaware of their infection or are not referred despite their diagnosis," the authors report. This means that many of the 20% and 40% of individuals with chronic HBV infection who require treatment are not getting it, nor are their liver aminotransferase and HBV DNA levels being monitored, which is recommended for all HBV-infected individuals, they add.

In addition, "[o]nly 10% to 15% of eligible persons receive antiviral therapy, demonstrating that many who could benefit from therapy do not receive it," the authors explain. "Linkage to care ensures that patients with chronic HBV infection receive treatment when they become eligible (elevated HBV DNA and liver aminotransferase levels), hepatocellular carcinoma surveillance, behavioral risk reduction counseling, and vaccination of susceptible sexual and household contacts," they state.

For these reasons, all patients identified as HBsAg-positive should be referred for post-test counseling and HBV-directed care.

Multiple patient-, clinician- and system-level barriers prevent optimal uptake of HBV vaccination recommendations, the authors note. Examples include lack of knowledge or information about HBV infection and the benefits of the vaccine in the general public, as well as limited health literacy in certain populations. At the clinician level, lack of awareness of clinical care guidelines or population-specific risks for HBV infection, inadequate screening, and vaccine storage challenges are cited as obstacles. System-level barriers include inadequate funding and challenges associated with specialty referrals, the authors write.

Various strategies for overcoming these barriers are offered, including targeted patient and clinician education, universal screening and vaccination protocols, and culturally sensitive outreach and support.

"The burden and costs associated with chronic HBV infection in the United States are high. Vaccination of susceptible adults is important to prevent infection and reduce ongoing transmission," the authors state.

However, the existing, risk-based vaccination strategy may be insufficient for increasing HBV vaccine coverage. "Because the administration schedule typically includes 3 vaccine doses over 6 months, the vaccine series needs to be started and completed before exposure to the risk factor to protect persons at greatest risk," the authors explain. "Furthermore, the multitude of factors constituting an indication for adult hepatitis B vaccination can create implementation challenges for vaccine providers." For this reason, "[a]n adult vaccination strategy that is not based on risk may be the next step toward achieving elimination."

One author  reports receiving research grants from Gilead Sciences for hepatitis C treatment and seeing patients who receive free hepatitis C medications supplied by Gilead Sciences in the course of his patient care duties. One author is the treasurer of the ACP. One author reports personal fees from Takeda Pharmaceuticals outside the submitted work and is a member of the ACP Clinical Guidelines Committee and the American College of Rheumatology Quality of Care Committee. The remaining authors have disclosed no relevant financial relationships.

Ann Intern Med. Published online November 20, 2017. Full text

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