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HBV Panel: New Screening/Treatment Recommendations - It Is Time for a Simplified Approach to Hepatitis B Elimination, Editorial too.
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"This series of recommendations more closely mirror those of the 2015 World Health Organization treatment guidelines and represents a bold and important expansion of treatment eligibility. Growing evidence confirms the presence of ongoing significant risk for hepatocellular carcinoma and other liver events among patients with chronic HBV in the indeterminate and immunotolerant phases, and the highly complex and nuanced guidance of the liver societies may be associated with undertreatment in both primary care and specialty settings.....ongoing limitations in global access and implementation of HBV immunization are estimated to contribute to 63 million new cases of chronic HBV and 17 million HBV-related deaths between 2015 and 2030."
January 01, 2023
Douglas Dieterich, 1 Camilla Graham, 2 Su Wang, 3 Paul Kwo, 4 Young-Suk Lim, 5 Chun-Jen Liu, 6 Kosh Agarwal, 7 and Mark Sulkowski 8
Hepatitis B virus (HBV) infection is the leading cause of hepatocellular carcinoma (HCC) and liver-related deaths worldwide, causing 780,000 HBV-related deaths each year.
Our expert panel recommends universal, one-time testing for HBV for all adults and for all pregnant women with each pregnancy (see Figure). All adults over age 18 should be screened at least once in their lifetime, which will also ensure that those who did not mount an antibody response with infant vaccination or who were never vaccinated are identified and vaccinated.
Several studies have demonstrated that fewer than half of primary care providers are screening at-risk patients.
Risk-based screening failed to identify sufficient numbers of patients with HCV or HIV infection, and thus the guidelines for these infections have shifted to a universal, one-time test for all adults.
Many people living with HBV are not receiving regular monitoring for their HBV treatment or liver cancer screening.
Based on recent clinical data and real-world experience, the expert panel recommends antiviral treatment of all patients > 30 years of age with HBV DNA levels > 2000 IU/mL, regardless of ALT level or HBeAg status, and of all patients < 30 years of age with HBV DNA levels > 2000 IU/mL along with ALT above the upper limit of normal on repeat testing (Figure). Similarly, the WHO guidelines utilize the > 30 years of age, when no cirrhosis is present, as a threshold for treatment. 15
Lim et al demonstrated that using HBV DNA level of >2000 IU/mL alone for non-cirrhotic patients and removing ALT and HBeAg treatment eligibility parameters would avoid 43,300 cases of HCC, save 37,000 lives in Korea, and be considered highly cost-effective.
Our expert panel recommends monitoring ALT and HBV DNA every 3-6 months until viral suppression is achieved, and then every 6 months; HBsAg testing should be conducted annually (see sFigure). Genotypic resistance is low with first line ETV, TDF, and TAF and, therefore, testing is not recommended unless patients fail to respond to treatment or resistance is suspected.
HBV DNA suppression, the strongest predictor of disease progression and long-term outcomes, is achieved by 24-48 weeks of treatment with TDF, TAF, or ETV in at least half of patients with HBV monoinfection.
Newly diagnosed patients without cirrhosis who do not meet criteria for treatment initiation (see Figure) should have HBV DNA monitored every 6 months for approximately 2 years to ensure patients are truly in a low replicative state (HBV DNA levels consistently remain <2000 IU/mL), and annually thereafter.
Only a small percentage of patients per year will achieve HBsAg loss; therefore, long-term, continuous treatment is required for most patients until novel drugs become available that can induce functional HBV cure.
Universal screening and the simplification of HBV care pathways for primary care providers and front-line workers are critical steps to finding the missing millions living with hepatitis B and to ensuring equitable access to life saving care for them. Adapting recommendations so they are realistic and implementable within diverse settings is important. We must also take into account resource limitations and the cost burden to patients in our complicated health care system and create guidelines that are not so rigid as to become a barrier to care. Creating dashboards, registries, and electronic medical record tools are also valuable to support HBV monitoring. Educating patients and soliciting their treatment preferences are also part of ensuring that care has a meaningful impact on their lives. Increasing overall community awareness about hepatitis B, its link to liver cancer, and the interventions we have for testing, vaccination, and cure are importance messages, especially in affected communities. We must apply our scientific advances and medical recommendations with a lens of equity and population health if we are to achieve hepatitis B elimination.
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