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—according to new findings.
The low testing rate suggests limited awareness of HDV-associated risks in patients with CHB, and underscores the need for earlier testing and diagnosis, lead author Robert J. Wong, MD, of Stanford University School of Medicine, Stanford, California, and colleagues, reported.
“Data among US populations are lacking to describe the epidemiology and long-term outcomes of patients with CHB and concurrent HDV infection,” the investigators wrote in Gastro Hep Advances (2025 Oct. doi: 10.1016/j.gastha.2024.10.015).
Prior studies have found that only 6% to 19% of patients with CHB get tested for HDV, and among those tested, the prevalence is relatively low—between 2% and 4.6%. Although relatively uncommon, HDV carries a substantial clinical and economic burden, Dr. Wong and colleagues noted, highlighting the importance of clinical awareness and accurate epidemiologic data.
The present study analyzed data from the Veterans Affairs (VA) Corporate Data Warehouse between 2010 and 2023. Adults with CHB were identified based on laboratory-confirmed markers and ICD-9/10 codes. HDV testing (anti-HDV antibody and HDV RNA) was assessed, and predictors of testing were evaluated using multivariable logistic regression.
To examine liver-related outcomes, patients who tested positive for HDV were propensity score–matched 1:2 with CHB patients who tested negative. Matching accounted for age, sex, race/ethnicity, HBeAg status, antiviral treatment, HCV and HIV coinfection, diabetes, and alcohol use. Patients with cirrhosis or hepatocellular carcinoma (HCC) at base-line were excluded. Incidence of cirrhosis, hepatic decompensation, and HCC was estimated using competing risks Nelson-Aalen methods.
Among 27,548 veterans with CHB, only 16.1% underwent HDV testing. Of those tested, 3.25% were HDV positive. Testing rates were higher among patients who were HBeAg positive, on antiviral therapy, or identified as Asian or Pacific Islander.
Conversely, testing was significantly less common among patients with high-risk alcohol use, past or current drug use, cirrhosis at diagnosis, or HCV coinfection. In contrast, HIV coinfection was associated with increased odds of being tested.
Among those tested, HDV positivity was more likely in patients with HCV coinfection, cirrhosis, or a history of drug use. On multivariable analysis, these factors were independent predictors of HDV positivity.
In the matched cohort of 71 HDV-positive patients and 140 HDV-negative controls, the incidence of cirrhosis was more than 3-fold higher in HDV-positive patients (4.39 vs 1.30 per 100,000 person-years; P less than .01), and hepatic decompensation was over 5 times more common (2.18 vs 0.41 per 100,000 person-years; P = .01). There was also a non-significant trend toward increased HCC risk in the HDV group.
“These findings align with existing studies and confirm that among a predominantly non-Asian US cohort of CHB patients, presence of concurrent HDV is associated with more severe liver disease progression,” the investigators wrote. “These observations, taken together with the low rates of HDV testing overall and particularly among high-risk individuals, emphasizes the need for greater awareness and novel strategies on how to improve HDV testing and diagnosis, particularly given that novel HDV therapies are on the near horizon.”
The study was supported by Gilead. The investigators disclosed additional relationships with Exact Sciences, GSK, Novo Nordisk, and others.
Hepatitis D virus (HDV) is an RNA “sub-virus” that infects patients with co-existing hepatitis B virus (HBV) infections. HDV infection currently affects approximately 15-20 million people worldwide but is an orphan disease in the United States with fewer than 100,000 individuals infected today.
Those with HDV have a 70% lifetime risk of hepatocellular carcinoma (HCC), cirrhosis, liver failure, death, or liver transplant. But there are no current treatments in the US that are Food and Drug Administration (FDA)-approved for the treatment of HDV, and only one therapy in the European Union with full approval by the European Medicines Agency.
Despite HDV severity and limited treatment options, screening for HDV remains severely inadequate, often only testing those individuals at high risk sequentially. HDV screening, would benefit from a revamped approach that automatically reflexes testing when individuals are diagnosed with HBV if positive for hepatitis B surface antigen (HBsAg+), then proceeds to anti-HDV antibody total testing, and then double reflexed to HDV-RNA polymerase chain reaction (PCR) quantitation. This is especially true in the Veterans Administration (VA)’s hospitals and clinics, where Wong and colleagues found very low rates of HDV testing among a national cohort of US Veterans with chronic HBV.
This study highlights the importance of timely HDV testing using reflex tools to improve diagnosis and HDV treatment, reducing long-term risks of liver-related morbidity and mortality.
Robert G. Gish, MD, AGAF, is principal at Robert G Gish Consultants LLC, clinical professor of medicine at Loma Linda University, Loma Linda, Calif., and medical director of the Hepatitis B Foundation. His complete list of disclosures can be found at www.robertgish.com/about.
Hepatitis D virus (HDV) is an RNA “sub-virus” that infects patients with co-existing hepatitis B virus (HBV) infections. HDV infection currently affects approximately 15-20 million people worldwide but is an orphan disease in the United States with fewer than 100,000 individuals infected today.
Those with HDV have a 70% lifetime risk of hepatocellular carcinoma (HCC), cirrhosis, liver failure, death, or liver transplant. But there are no current treatments in the US that are Food and Drug Administration (FDA)-approved for the treatment of HDV, and only one therapy in the European Union with full approval by the European Medicines Agency.
Despite HDV severity and limited treatment options, screening for HDV remains severely inadequate, often only testing those individuals at high risk sequentially. HDV screening, would benefit from a revamped approach that automatically reflexes testing when individuals are diagnosed with HBV if positive for hepatitis B surface antigen (HBsAg+), then proceeds to anti-HDV antibody total testing, and then double reflexed to HDV-RNA polymerase chain reaction (PCR) quantitation. This is especially true in the Veterans Administration (VA)’s hospitals and clinics, where Wong and colleagues found very low rates of HDV testing among a national cohort of US Veterans with chronic HBV.
This study highlights the importance of timely HDV testing using reflex tools to improve diagnosis and HDV treatment, reducing long-term risks of liver-related morbidity and mortality.
Robert G. Gish, MD, AGAF, is principal at Robert G Gish Consultants LLC, clinical professor of medicine at Loma Linda University, Loma Linda, Calif., and medical director of the Hepatitis B Foundation. His complete list of disclosures can be found at www.robertgish.com/about.
Hepatitis D virus (HDV) is an RNA “sub-virus” that infects patients with co-existing hepatitis B virus (HBV) infections. HDV infection currently affects approximately 15-20 million people worldwide but is an orphan disease in the United States with fewer than 100,000 individuals infected today.
Those with HDV have a 70% lifetime risk of hepatocellular carcinoma (HCC), cirrhosis, liver failure, death, or liver transplant. But there are no current treatments in the US that are Food and Drug Administration (FDA)-approved for the treatment of HDV, and only one therapy in the European Union with full approval by the European Medicines Agency.
Despite HDV severity and limited treatment options, screening for HDV remains severely inadequate, often only testing those individuals at high risk sequentially. HDV screening, would benefit from a revamped approach that automatically reflexes testing when individuals are diagnosed with HBV if positive for hepatitis B surface antigen (HBsAg+), then proceeds to anti-HDV antibody total testing, and then double reflexed to HDV-RNA polymerase chain reaction (PCR) quantitation. This is especially true in the Veterans Administration (VA)’s hospitals and clinics, where Wong and colleagues found very low rates of HDV testing among a national cohort of US Veterans with chronic HBV.
This study highlights the importance of timely HDV testing using reflex tools to improve diagnosis and HDV treatment, reducing long-term risks of liver-related morbidity and mortality.
Robert G. Gish, MD, AGAF, is principal at Robert G Gish Consultants LLC, clinical professor of medicine at Loma Linda University, Loma Linda, Calif., and medical director of the Hepatitis B Foundation. His complete list of disclosures can be found at www.robertgish.com/about.
—according to new findings.
The low testing rate suggests limited awareness of HDV-associated risks in patients with CHB, and underscores the need for earlier testing and diagnosis, lead author Robert J. Wong, MD, of Stanford University School of Medicine, Stanford, California, and colleagues, reported.
“Data among US populations are lacking to describe the epidemiology and long-term outcomes of patients with CHB and concurrent HDV infection,” the investigators wrote in Gastro Hep Advances (2025 Oct. doi: 10.1016/j.gastha.2024.10.015).
Prior studies have found that only 6% to 19% of patients with CHB get tested for HDV, and among those tested, the prevalence is relatively low—between 2% and 4.6%. Although relatively uncommon, HDV carries a substantial clinical and economic burden, Dr. Wong and colleagues noted, highlighting the importance of clinical awareness and accurate epidemiologic data.
The present study analyzed data from the Veterans Affairs (VA) Corporate Data Warehouse between 2010 and 2023. Adults with CHB were identified based on laboratory-confirmed markers and ICD-9/10 codes. HDV testing (anti-HDV antibody and HDV RNA) was assessed, and predictors of testing were evaluated using multivariable logistic regression.
To examine liver-related outcomes, patients who tested positive for HDV were propensity score–matched 1:2 with CHB patients who tested negative. Matching accounted for age, sex, race/ethnicity, HBeAg status, antiviral treatment, HCV and HIV coinfection, diabetes, and alcohol use. Patients with cirrhosis or hepatocellular carcinoma (HCC) at base-line were excluded. Incidence of cirrhosis, hepatic decompensation, and HCC was estimated using competing risks Nelson-Aalen methods.
Among 27,548 veterans with CHB, only 16.1% underwent HDV testing. Of those tested, 3.25% were HDV positive. Testing rates were higher among patients who were HBeAg positive, on antiviral therapy, or identified as Asian or Pacific Islander.
Conversely, testing was significantly less common among patients with high-risk alcohol use, past or current drug use, cirrhosis at diagnosis, or HCV coinfection. In contrast, HIV coinfection was associated with increased odds of being tested.
Among those tested, HDV positivity was more likely in patients with HCV coinfection, cirrhosis, or a history of drug use. On multivariable analysis, these factors were independent predictors of HDV positivity.
In the matched cohort of 71 HDV-positive patients and 140 HDV-negative controls, the incidence of cirrhosis was more than 3-fold higher in HDV-positive patients (4.39 vs 1.30 per 100,000 person-years; P less than .01), and hepatic decompensation was over 5 times more common (2.18 vs 0.41 per 100,000 person-years; P = .01). There was also a non-significant trend toward increased HCC risk in the HDV group.
“These findings align with existing studies and confirm that among a predominantly non-Asian US cohort of CHB patients, presence of concurrent HDV is associated with more severe liver disease progression,” the investigators wrote. “These observations, taken together with the low rates of HDV testing overall and particularly among high-risk individuals, emphasizes the need for greater awareness and novel strategies on how to improve HDV testing and diagnosis, particularly given that novel HDV therapies are on the near horizon.”
The study was supported by Gilead. The investigators disclosed additional relationships with Exact Sciences, GSK, Novo Nordisk, and others.
—according to new findings.
The low testing rate suggests limited awareness of HDV-associated risks in patients with CHB, and underscores the need for earlier testing and diagnosis, lead author Robert J. Wong, MD, of Stanford University School of Medicine, Stanford, California, and colleagues, reported.
“Data among US populations are lacking to describe the epidemiology and long-term outcomes of patients with CHB and concurrent HDV infection,” the investigators wrote in Gastro Hep Advances (2025 Oct. doi: 10.1016/j.gastha.2024.10.015).
Prior studies have found that only 6% to 19% of patients with CHB get tested for HDV, and among those tested, the prevalence is relatively low—between 2% and 4.6%. Although relatively uncommon, HDV carries a substantial clinical and economic burden, Dr. Wong and colleagues noted, highlighting the importance of clinical awareness and accurate epidemiologic data.
The present study analyzed data from the Veterans Affairs (VA) Corporate Data Warehouse between 2010 and 2023. Adults with CHB were identified based on laboratory-confirmed markers and ICD-9/10 codes. HDV testing (anti-HDV antibody and HDV RNA) was assessed, and predictors of testing were evaluated using multivariable logistic regression.
To examine liver-related outcomes, patients who tested positive for HDV were propensity score–matched 1:2 with CHB patients who tested negative. Matching accounted for age, sex, race/ethnicity, HBeAg status, antiviral treatment, HCV and HIV coinfection, diabetes, and alcohol use. Patients with cirrhosis or hepatocellular carcinoma (HCC) at base-line were excluded. Incidence of cirrhosis, hepatic decompensation, and HCC was estimated using competing risks Nelson-Aalen methods.
Among 27,548 veterans with CHB, only 16.1% underwent HDV testing. Of those tested, 3.25% were HDV positive. Testing rates were higher among patients who were HBeAg positive, on antiviral therapy, or identified as Asian or Pacific Islander.
Conversely, testing was significantly less common among patients with high-risk alcohol use, past or current drug use, cirrhosis at diagnosis, or HCV coinfection. In contrast, HIV coinfection was associated with increased odds of being tested.
Among those tested, HDV positivity was more likely in patients with HCV coinfection, cirrhosis, or a history of drug use. On multivariable analysis, these factors were independent predictors of HDV positivity.
In the matched cohort of 71 HDV-positive patients and 140 HDV-negative controls, the incidence of cirrhosis was more than 3-fold higher in HDV-positive patients (4.39 vs 1.30 per 100,000 person-years; P less than .01), and hepatic decompensation was over 5 times more common (2.18 vs 0.41 per 100,000 person-years; P = .01). There was also a non-significant trend toward increased HCC risk in the HDV group.
“These findings align with existing studies and confirm that among a predominantly non-Asian US cohort of CHB patients, presence of concurrent HDV is associated with more severe liver disease progression,” the investigators wrote. “These observations, taken together with the low rates of HDV testing overall and particularly among high-risk individuals, emphasizes the need for greater awareness and novel strategies on how to improve HDV testing and diagnosis, particularly given that novel HDV therapies are on the near horizon.”
The study was supported by Gilead. The investigators disclosed additional relationships with Exact Sciences, GSK, Novo Nordisk, and others.
FROM GASTRO HEP ADVANCES