Many people with
chronic hepatitis B (CHB) virus infection have infrequent medical monitoring,
according to US research published in the online edition of Clinical Infectious Diseases. Analysis
of the records of over 2000 people followed for an average of six years
showed that a quarter did not have an annual assessment of a key marker of
liver function, only a third had yearly measurement of hepatitis B virus (HBV) DNA,
and that 11% of people with cirrhosis had never had a liver ultrasound. Only
32% of people were prescribed HBV therapy and 44% of those with cirrhosis
were not under treatment.
“We found that CHB
patients had suboptimal clinical monitoring and, accordingly, insufficient data
to determine disease phase and antiviral treatment eligibility,” comment the
850,000 individuals are living with CHB in the United States.
The infection has four phases that depend primarily on alanine aminotransferase
(ALT) level and HBV DNA levels. It is therefore essential that individuals have
these markers frequently assessed to guide decisions about treatment and care.
However, little is
known about the frequency with which people with CHB
infection in the US have the appropriate laboratory tests.
the Chronic Hepatitis Cohort Study (CHeCS) therefore examined data collected
from 2338 people between 2006 and 2013 to determine the frequency with which
individuals were monitored for disease activity and progression.
at four sites across the US. Data collected included patient demographics, type
of healthcare provider, laboratory and imaging results, cirrhosis status and
use of HBV therapy.
People with HIV,
hepatitis C, or hepatitis D were excluded.
The median duration
of follow-up was 6.3 years and a total of 14,000 patient-years of follow-up
were available for analysis.
people were aged between 30 and 59 years, half were male, 67% were of Asian or
Pacific Island descent, three-quarters had private health insurance, 72% had
received specialist liver-related care and 68% had never received HBV
(78%) had at least one ALT assessment annually. People were more likely to
have this test if they were aged 60 or over (91%), male (85%), white (82%),
were prescribed treatment (92%) and received specialist liver-related care
Just over a third
of individuals (37%) had annual HBV DNA monitoring and 18% had never had an HBV
DNA assessment. Factors associated with HBV DNA testing were similar to those
associated with annual ALT monitoring.
Analysis of the
subset of people with elevated ALT results showed that 57% subsequently had
an HBV DNA test.
A quarter of individuals were classified as having liver cirrhosis. Just over half (54%) had
annual HBV DNA monitoring but 11% had never had this type of test. As regarding
liver imaging, 53% had ever had a liver ultrasound, but only 27% of these
individuals had this assessment annually. Just 14% of people with cirrhosis
had an annual liver ultrasound.
Overall, 32% of
people were prescribed HBV therapy. Analysis of these individuals showed that
41% had cirrhosis, and 62% elevated ALT and HBV DNA before treatment
initiation. Of the 547 people with cirrhosis, only 56% were prescribed HBV
“We found that
patients in our cohort were insufficiently monitored for disease status, and
among those with cirrhosis, for HCC [hepatocellular
carcinoma] and viremia,” conclude the investigators. “As antiviral therapy for
CHB now includes potent and highly efficacious oral agents that have few
contraindications and minimal side effects, as well as a high barrier to
resistance, clinicians should be vigilant for opportunities to decrease the
likelihood of poor clinical outcomes.”
The author of an
accompanying editorial said the study’s finding were “important”. However, the
author notes that approximately a third of people with chronic HBV are
undiagnosed and that the paper did not address how screening for the infection
was incorporated into care at the study sites. A further unanswered question is
the proportion of people eligible for treatment who received therapy.
stresses that the cascade of HBV care can only be improved with better
screening and initial assessment for disease stage.
“We providers have
a large task ahead to find, diagnose and link to care those with chronic
hepatitis B,” concludes the author. “Regular monitoring of clinical and
laboratory parameters to provide antiviral treatment when indicated, as well as
surveillance for those at risk of HCC can decrease the risk of those dying
prematurely for liver cancer and liver failure.”