Nearly 30% of Patients Evaluated for Chronic Hepatitis B Eligible for Antiviral Therapy

Up to 30% of patients with chronic hepatitis B are eligible for treatment such as tenofovir or entecavir under current guidelines, a recent study in Austria found.

The study, published in the United European Gastroenterology Journal, included 751 patients with chronic hepatitis B who were evaluated for treatment between January 2010 and December 2020 at Vienna General Hospital.

Among the patients included in the study, 9.2% had severe fibrosis or cirrhosis, 5.7% were coinfected with hepatitis D, 23% to 29% met treatment criteria, and 80% to 90% of eligible patients began treatment.

Eligibility criteria vary among the European Association for the Study of the Liver (EASL), American Association for the Study of Liver Diseases (AASLD) and the World Health Organization (WHO). However, similar proportions of patients were identified as eligible for treatment, including 26.9% per EASL criteria, 29.0% per AASLD and 23.4% per WHO.

“Notably, the investigated treatment criteria might change in the future, as recent notions have supported the idea of expanding treatment indications in selected cohorts, especially in older patients and those with subclinical evidence for active disease, owing to an observed higher risk for adverse hepatic outcomes, although historically CHB without abnormal biochemical evidence has been associated with a rather benign disease trajectory,” the authors wrote.

Based on EASL criteria, the study found that 3.2% of patients had HBeAg-positive chronic infection, 7.6% had HBeAg-positive chronic hepatitis, 58.9% had HBeAg-negative chronic infection, and 30.4% had HBeAg-negative chronic hepatitis.

HBV-DNA was over 2,000 IU/mL in 36.4% of patients, and alanine aminotransferase was over 40 U/L in 37.3% of patients. Severe fibrosis/cirrhosis was found in 9.2% of patients.

Among patients tested, 5.7% were coinfected with hepatitis D, including one in three with cirrhotic CHB. However, nearly 30% of study participants weren’t tested.

“Given the availability of novel treatment options against HDV25 and the high prevalence of HDV coinfection in the overall cohort, installing universal anti-HDV antibody testing in every CHB patient seems warranted,” the authors wrote.

Overall, 23.4% to 29.5% of patients were eligible for treatment under current recommendations, with a treatment uptake rate of 79.8% to 89.2% among them. Tenofovir was the most prevalent treatment used at 61.8% followed by entecavir at 34.9%.

At five years of therapy, HBV-DNA was suppressed in all patients under treatment and no viral breakthroughs were reported. However, only 2.8% of patients under treatment cleared HBsAg levels and 28% cleared HBeAg.

“Stopping chronic antiviral treatment in selected patients with low HBsAg levels to instigate seroconversion should thus be considered under close monitoring,” the authors wrote. “Nonetheless, to date, most patients on chronic antiviral treatment require indefinite treatment. However, many promising compounds targeting ‘functional cure’ are currently under development.

Arbutus Biopharma announced a phase 1 clinical trial of its AB-161 HBV therapy earlier this month. The treatment is designed to reduce HBsAg levels and inhibit viral replication.

The WHO recently released a study showing that efforts to eliminate HBV as a global health threat have made progress, but must be accelerated to meet the goal. The study estimated that 90% of hepatitis B infections remain undiagnosed.