Many people in the US with chronic hepatitis B not being properly monitored

Many people with chronic hepatitis B 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 with the chronic infection 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% were prescribed HBV therapy and 44% of those with cirrhosis were not under treatment.

“We found that CHB [chronic hepatitis B] patients had suboptimal clinical monitoring and, accordingly, insufficient data to determine disease phase and antiviral treatment eligibility,” comment the researchers.

An estimated 850,000 individuals are living with chronic hepatitis B 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 patients have these markers frequently assessed to guide decisions about treatment and care.

Glossary

hepatitis B virus (HBV)

The hepatitis B virus can be spread through sexual contact, sharing of contaminated needles and syringes, needlestick injuries and during childbirth. Hepatitis B infection may be either short-lived and rapidly cleared in less than six months by the immune system (acute infection) or lifelong (chronic). The infection can lead to serious illnesses such as cirrhosis and liver cancer. A vaccine is available to prevent the infection.

deoxyribonucleic acid (DNA)

The material in the nucleus of a cell where genetic information is stored.

cirrhosis

Severe fibrosis, or scarring of organs. The structure of the organs is altered, and their function diminished. The term cirrhosis is often used in relation to the liver. 

alanine aminotransferase (ALT)

An enzyme found primarily in the liver. Alanine aminotransferase may be measured as part of a liver function test. Abnormally high blood levels of ALT are a sign of liver inflammation or damage from infection or drugs.

antiviral

A drug that acts against a virus or viruses.

However, little is known about the frequency with which people with chronic hepatitis B infection in the US have the appropriate laboratory tests.

Investigators from 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.

Study participants were received 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.

Individuals 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.

Two-thirds of participants 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 treatment.

Most people (78%) had at least one ALT assessment annually. Participants 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 (85%).

Just over a third of individuals (37%) had annual HBV DNA monitoring and 18% had never had a 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 participants were classified as having liver cirrhosis. Just over a 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 individuals were prescribed HBV therapy. Analysis of these people 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 antivirals.

“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.

The author 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.”

References

Spradling PR et al. Infrequent clinical assessment of chronic hepatitis B patients in United States general healthcare settings. Clin Infect Dis, online edition, 2016.

McMahon BJ et al. Sliding down the cascade of care for chronic hepatitis B virus infection. Clin Infect Dis, online edition, 2016.

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