Analysis of nearly 23 million lab tests finds only 1 in 3 patients with latent TB were also tested for chronic hepatitis B, despite similar risk factors in patients

Findings urge caution in the use of anti-tuberculosis therapies, which increase the risk of liver injury in patients co-infected with chronic hepatitis B virus

SECAUCUS, NJ, July 25, 2022 /PRNewswire/ — Simultaneous testing for chronic hepatitis B (HBV) and tuberculosis (TB) occurs in a minority of patients who test positive for either condition, despite similar risk profiles and, for some , a risk of TB treatment-induced liver damage, according to new research Diagnostics Health Trends® Study published in the Journal of Public Health Management and Practice.

The study was conducted by researchers at Quest Diagnostics (NYSE: DGX), Stanford University Palo Alto School of Medicine and Veterans Health Care System in Palo Alto, California. Based on analysis of results from 17,635,261 anonymized laboratory tests for hepatitis and 5,205,393 tests for tuberculosis performed by Quest Diagnostics between 2016 and 2020, the study is the most comprehensive evaluation of testing and estimates of the prevalence of these two infectious diseases. Existing research to date is limited by small study sizes and decades-old data.

Researchers assessed anonymized data from HBV surface antigen (HBsAg) and total antibody (HBcAb) tests as well as QuantiFERON® and T-SPOT®.TB series of interferon gamma release assay (IGRA) blood tests to assess latent tuberculosis infection. IGRA tests are recommended for many patients and generally considered more efficient and accurate than skin tests, which require multiple doctor appointments.[i][ii][iii].

Latent TB infection was defined as having a positive QuantiFERON or T-SPOT test.® test without a positive result for Mycobacterium tuberculosis complex (MTB) or mycobacterial culture during the study period (as this would indicate an active tuberculosis infection). The QuantiFERON or T-SPOT® the tests do not distinguish between active and latent.

Among patients tested for both infections, almost one in five (19.6%) with chronic hepatitis B also have latent tuberculosis, more than double the positive TB of patients without chronic hepatitis B (7, 3%). Among patients tested for both, the rate of positivity for chronic hepatitis B among those positive for latent tuberculosis was three times higher than for patients in whom latent tuberculosis was not found (1.5% against 0.5%).

Among the most significant results of the study, only one in three patients (32.3%) who tested positive for latent tuberculosis were also tested for HBV infection. Commonly used TB treatments can cause liver damage if given to patients who are also co-infected with HBV. The study also revealed that only 10.7% of patients with chronic HBV were also tested for latent tuberculosis.

The study authors wrote that the prevalence of co-infection is “substantial” and underscores the need for testing for co-infection “to mitigate the risk of drug-induced liver injury associated with anti-tuberculosis drugs in patients with concurrent chronic HBV”.

According to the main author Robert WangMD, Associate Clinical Professor, Stanford University“This study is the first large-scale analysis to my knowledge of the co-infection of tuberculosis and HBV, two prevalent and under-screened and under-treated infectious diseases in United States. Rapid identification of the underlying hepatitis B co-infection can help guide modification of TB treatment regimens with a lower risk of drug-induced liver injury. This review identified a significant gap in TB management and suggests the need for quality improvement initiatives to ensure routine HBV screening of TB patients before treatment begins.

Other results showed concurrent testing increased with age, from 7.2% in patients under 18 to 29.5% in those over 70. When assessed by race/ethnicity, the highest rate of testing for latent TB was observed among black/African American patients, while the highest prevalence of latent TB co-infection with HBV was observed in Asian American patients at 2.7% (based on race/ethnicity estimates derived from 3-digit ZIP codes). Additionally, the study observed higher rates of co-infection in parts of the south Californiathe San Francisco Bay Areaand from the south Nevadacompared to the rest of United States.

“Our nationally representative study provides important new insights into the magnitude of latent tuberculosis and HBV co-infection,” said the co-author. Harvey W. Kaufman, MD, Senior Medical Director and Director of the Health Trends Research Program for Quest Diagnostics. “It also provides important insights into demographic and regional patterns that can help guide public health and clinical decision-making.”

The Centers for Disease Control and Prevention (CDC) estimates that there are 862,000 people living with chronic HBV infection in the United States.[iv] The CDC also estimates that there have been 7,860 cases of tuberculosis reported in United States in 2021, although no less than 13 million people, many of whom were born outside United Stateshave latent tuberculosis infection.[v] Latent tuberculosis and chronic HBV are often asymptomatic and, in some patients, may progress to acute disease, causing liver damage or failure. Delays in diagnosis and treatment of latent tuberculosis and chronic HBV are associated with significant morbidity and mortality and result in 7 and 14 years of life lost, respectively.

The CDC also notes that rates of new HBV infections are highest in adults between the ages of 40 and 49, reflecting low hepatitis B vaccination coverage among adults. HBV infection is associated with intravenous drug use linked to the opioid crisis, incarceration, homelessness, and other social determinants of health. Given the relatively high infection rates in most Asiapeople of asian descent United States are also more likely to be infected with chronic HBV even without other risk factors, according to the CDC.

Study highlights include nationwide and quality laboratory testing method results. Weaknesses include the lack of drugs and other clinical data to identify treatment models.

About Quest Diagnostics Health Trends

Quest Diagnostics Health Trends ™ is a series of scientific reports that provide information on health topics, based on the analysis of objective clinical laboratory data, to improve patient care, population health management and public health policies. The reports are based on the Quest Diagnostics database of 60 billion anonymized lab test results, considered the largest of its kind in healthcare. Health Trends provided new insights to help with allergy and asthma management, prescription medication monitoring, diabetes, Lyme disease, heart disease, influenza, and workplace wellness. Quest Diagnostics also produces the Drug Testing Index (DTI)™, a series of national workplace drug positivity trend reports based on workplace drug testing data from the company’s employers. https://newsroom.questdiagnostics.com/health-trends

About Quest Diagnostics

Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world’s largest database of clinical laboratory results, our diagnostic insights reveal new pathways to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest serves one in three American adults and half of the doctors and hospitals in the United States each year, and our nearly 50,000 employees understand that, in the right hands and in the right context, our diagnostic knowledge can inspire actions that transform lives.www.QuestDiagnostics.com

[i] T-SPOT.TB. Packing note. Oxford Immunotec Inc.; 2013.
[ii] Lewinsohn DM, Leonard MK, LoBue PA, et al. American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Official Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children. Clin Infect Dis. 2017;64(2):e1-e33. doi:10.1093/cid/ciw694
[iii] David M. Lewinsohn, Michael K. Leonard, Philip A. LoBue, David L. Cohn, Charles L. Daley, Ed Desmond, Joseph Kean, Deborah A. Lewinsohn, Ann M. Loeffler, Gerald H. Mazurek, Richard J. O’Brien, Madhukar PaiLuca Richeldi, Max Salfinger, Thomas M. Shinnick, Timothy R. Sterling, David M. Warshauer, Gail L. WoodsOfficial American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention Clinical Practice Guidelines: Diagnosis of Tuberculosis in Adults and Children, Clinical infectious diseasesVolume 64, Number 2, January 15, 2017Pages e1–e33, https://doi.org/10.1093/cid/ciw694
[iv] Filardo TD, Feng P, Pratt RH, Price SF, Self JL. Tuberculosis – United States, 2021. MMWR Morb Mortal Wkly Rep 2022;71:441–446. DO I: http://dx.doi.org/10.15585/mmwr.mm7112a1external icon.
[v] CDC FACT SHEET United States: A snapshot. September 2018. tuberculosis in United States (cdc.gov)

SOURCE Quest Diagnosis