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Liver Complications in Untreated Treatment-Ineligible versus Treated Treatment-Eligible Patients with Hepatitis B
Daniel Q Huang1,2, Dong Hyun Lee3,4, Michael H Le4
1Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
Insights
Patients with chronic hepatitis B (CHB) not meeting treatment criteria face higher risks of cirrhosis and liver cancer. Current guidelines may not fully identify all patients who could benefit from antiviral therapy for better outcomes.
Area of Science:
- Hepatology
- Viral Hepatitis
- Clinical Practice Guidelines
Background:
- Chronic hepatitis B (CHB) poses risks of cirrhosis and hepatocellular carcinoma (HCC).
- Current guidelines may not adequately identify CHB patients who would benefit from antiviral therapy.
- A significant number of CHB patients not meeting treatment criteria develop adverse outcomes.
Approach:
- Retrospective cohort study of 2,987 treatment-naive CHB patients.
- Compared adverse liver outcomes in untreated, treatment-ineligible patients versus treated, treatment-eligible patients.
- Utilized American Association for the Study of Liver Diseases (AASLD) 2018 criteria and sensitivity analyses with lower thresholds.
Key Points:
- Untreated, treatment-ineligible CHB patients had a 12.5% 5-year cumulative incidence of adverse liver outcomes versus 7.2% in treated, eligible patients (p=0.074).
- Multivariable analysis showed untreated, ineligible patients had a 2.38-fold higher risk of adverse liver outcomes (aHR: 2.38, p=0.04) by AASLD 2018 criteria.
- Sensitivity analysis using lower thresholds did not yield statistically significant results (p=0.09).
Conclusions:
- CHB patients never meeting AASLD 2018 treatment criteria and remaining untreated face double the risk of cirrhosis/HCC compared to treated, eligible patients.
- This suggests potential under-treatment in CHB management.
- Further refinement of treatment guidelines may be warranted to optimize patient outcomes.
Background:
A substantial number of patients who do not meet treatment criteria for chronic hepatitis B (CHB) later develop adverse outcomes such as cirrhosis and hepatocellular carcinoma (HCC). Our aim was to determine whether current practice guidelines adequately identify CHB patients who will benefit from antiviral therapy.
Methods:
We performed a retrospective cohort study comparing the incidence of adverse liver outcomes (cirrhosis and/or HCC) in untreated treatment-ineligible (at baseline and throughout follow-up) versus treated treatment-eligible patients according to standard American Association for the Study of Liver Diseases (AASLD) 2018 guidance (alanine aminotransferase [ALT] >70/50 U/L for men/women plus hepatitis B virus [HBV] DNA >20,000/2,000 IU/mL for HBeAg+/-) and with a sensitivity analyses using a lower threshold (ALT >40 U/L and HBV DNA >2,000 IU/mL).
Results:
We reviewed records of 5,840 patients from 5 clinics in California and identified 2,987 treatment-naive non-HCC CHB patients. Of those, 271 patients remained untreated treatment-ineligible, 514 patients were treatment-eligible and initiated treatment, with 5-year cumulative adverse liver incidences of 12.5% versus 7.2%, p = 0.074. On multivariable analysis adjusting for age, sex, diabetes, albumin, platelet count, and HBV DNA, compared to treated treatment-eligible patients, untreated treatment-ineligible patients had a significantly higher risk of adverse liver outcomes (adjusted hazard ratio: 2.38, 95% confidence interval 1.03-5.48, p = 0.04) in main analysis by AASLD 2018 criteria but not in sensitivity analysis using the lower treatment threshold (p = 0.09).
Conclusion:
Patients never meeting standard AASLD 2018 criteria for antiviral therapy and never treated had twice the risk of developing cirrhosis and/or HCC when compared to eligible and treated patients.
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