Robert G. Gish Consultants, LLC

Hep D Virus Infection on Health-Related Quality of Life and Fatigue

2026-08-26T10:00:00+00:00

The Impact of Chronic Hepatitis D Virus Infection on Health-Related Quality of Life and Fatigue: A Real-World International Study

ABSTRACT
As little is known about the disease burden of chronic hepatitis D virus (HDV) infection, this study examined health-related quality of life (HRQoL) and fatigue at different disease stages. This was a real-world quantitative cross-sectional survey of patients in Germany, Italy, Spain and the USA. Patients were recruited via their treating physicians. Patients who had received bulevirtide for hepatitis B or treatment licensed for HDV were excluded. Of 211 patients, 41% were noncirrhotic (F0–F3); 20% had liver cirrhosis with normal function (compensated); 20% had liver cirrhosis (F4) with impaired function (decompensated); 19% had hepatocellular carcinoma (HCC). Mean (standard deviation; SD) age was 54.5 (11.5) years, 75% were male. ANOVA showed a significant decrease (indicating poorer HRQoL) in EQ-5D-3L visual analogue scale (VAS) scores and index values with worsening disease stage and increasing severity (all p < 0.0001). All domain scores of the Hepatitis Quality of Life Questionnaire v2 (except positive wellbeing) worsened with progressing disease and increasing symptom severity (all p ≤ 0.0001). Mean Fatigue Severity Scale (FSS) total scores also increased, indicating greater fatigue, with worsening of disease and increasing symptom severity (both p < 0.0001). HDV infection significantly impacts patients’ HRQoL and fatigue, particularly for patients at later disease stages. Treatments that slow disease progression, reducing the burden of HDV infection, are needed.

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Development of an HDV Identification Algorithm

2026-08-11T10:00:00+00:00

Development and External Validation of an Algorithm for Identifying HDV RNA positive Patients

Background and Aims:
Accurate detection and treatment of HDV-infected patients can reduce disease-related morbidity and mortality. This study developed and validated real-world evidence-based algorithms to detect RNA-positive HDV patients from administrative claims data.

Methods:
This retrospective observational study identified HBV and HDV patients from laboratory testing data linked to administrative claims (HealthVerity; 2015–2022), with external validation performed using electronic health records (TriNetX; 2005–2023). Both diagnosis-based and machine-learning algorithms were evaluated. Performance metrics included area under the receiver operating characteristic curve (AUROC), area under precision-recall curve, sensitivity, specificity, positive predictive value (PPV), and accuracy. Internal validation results showed that diagnosis code-based algorithms identified HDV RNA-positivity with ≥88% accuracy.

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APASL clinical practice guidelines

2026-07-03T10:00:00+00:00

APASL clinical practice guidelines on the management of chronic hepatitis B infection: a 2026 update

Globally, especially in the Asia Pacific region, chronic hepatitis B infection has led to an undesirable escalating morbidity and mortality with acute-on chronic liver failure, end-staged liver cirrhosis, and hepatocellular carcinoma. This has happened despite the past four decades of major scientific advances made in screening methods, vaccination strategies, highly effective low-cost anti-viral therapies, and surveillance strategies for early detection of hepatocellular carcinoma. To address this health threat, APASL has formed a Viral Elimination Taskforce to unite key opinion leaders from its member countries and regions. The ongoing shifts in hepatitis B epidemiology, socioeconomic changes, and advancements in technology are taken into consideration. With the conjoint efforts of all the members of the APASL Viral Elimination Taskforce, these clinical practice guidelines have been formulated aiming to facilitate healthcare professionals, policy-makers, and patients in making practical and cost-effective management decisions for chronic hepatitis B infection. Altogether, it provides recommendations in 13 major areas related to screening, vaccination, treatment, and HCC surveillance. The implementation of these clinical practice guidelines represents major APASL effort toward elimination of the disease burden due to chronic hepatitis B infection in Asia Pacific region.

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FDA Approves the HepQuant SHUNT® Liver Diagnostic Test

2026-06-26T10:00:00+00:00

FDA Approves the HepQuant SHUNT® Liver Diagnostic Test to Quantify Risk of Large Esophageal Varices in Adult Patients with Compensated Cirrhosis (Child Pugh Class A)

DENVER, Colo., June 23, 2026 —HepQuant announced that the U.S. Food and Drug Administration (FDA) has granted the premarket approval (PMA) for the HepQuant SHUNT® Liver Diagnostic Test. The test generates a Disease Severity Index (DSI) score which aids in identifying patients unlikely to require esophagogastroduodenoscopy (EGD) at the time of testing. A DSI score below the clinically validated threshold of 18.3 can be used in patients with compensated cirrhosis (Child Pugh Class A), age 22 years or older, undergoing screening or surveillance for esophageal varices to identify those patients unlikely to have large esophageal varices.

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Lonafarnib for chronic hepatitis delta

2026-06-10T10:00:00+00:00

Lonafarnib for chronic hepatitis delta: Clinical mechanism of action, development, and evolving role in combination therapy

Hepatitis D virus (HDV), the smallest known human RNA virus, is a defective, satellite virus that requires hepatitis B virus (HBV)-derived surface antigen (HBsAg) proteins for virion assembly and entry (Gopalakrishna et al., 2024). HDV superinfection occurs when a person with existing HBV infection subsequently becomes infected with HDV, resulting in the most severe form of chronic viral hepatitis, accelerating progression to cirrhosis, hepatic decompensation, hepatocellular carcinoma (HCC), and death (Gopalakrishna et al., 2024). Coinfection of HBV and HDV, ie, simultaneous infection, can result in fulminant hepatic failure, although most infected individuals can clear both HBV and HDV, if infected as adults. The original discovery of delta antigen in HBsAg carriers, and subsequent characterization of the delta agent as an RNA-containing particle associated with HBsAg, established HDV as a distinct viral pathogen dependent on HBV envelope proteins (Rizzetto et al., 1977, 1980). While HDV can replicate its genome autonomously inside the hepatocyte, the virus requires HBsAg, rather than complete HBV replication, to complete virion assembly and to facilitate transmission.

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Pruritus, Healthcare Utilization and Costs Among Individuals With PBC

2026-05-11T00:00:00+00:00

Association Between Pruritus and Healthcare Utilization and Costs Among Individuals With Primary Biliary Cholangitis

ABSTRACT

Background and Aims: Pruritus is a debilitating, under-prioritized symptom of primary biliary cholangitis (PBC). This study assessed its impact on healthcare resource utilization (HCRU) and costs in the US.

Methods: A retrospective cohort study of individuals with PBC was conducted using Komodo’s claims and laboratory data between September 1, 2017 and September 30, 2023. Individuals’ index date was a randomly selected medical event with (cases) or without pruritus diagnosis (controls) after initial PBC diagnosis. Participants were ≥ 18 years old with continuous insurance eligibility for ≥ 12 months before and after their index, excluding those on obeticholic acid during baseline. Negative binomial models estimated HCRU rate ratios, and linear models estimated incremental all-cause total costs (2024 USD) associated with pruritus, adjusting for baseline demographics and clinical characteristics.

Results: 10 077 patients with PBC and pruritus and 41 957 controls (PBC only) were identified. Regression-adjusted HCRU rate ratios for pruritus vs. controls were 1.69 (inpatient), 1.36 (outpatient), 1.65 (emergency), and 1.44 (prescription counts) and one-year adjusted healthcare costs averaged $39 949 for pruritus and $25 695 for controls, with an incremental cost of $14 254 (all p < 0.001). In sensitivity analyses, incremental costs ranged from $11 495 (using a broader definition of pruritus diagnosis or treatment) to $27 669 (using a stricter definition of pruritus diagnosis and treatment within ±90 days of diagnosis; both p < 0.001).

Conclusion: Pruritus significantly increases HCRU and costs in PBC, highlighting the economic argument for improved management. Further research should assess the effectiveness of novel PBC therapies in slowing liver disease progression and mitigating pruritus symptoms concomitantly.

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WHO Global hepatitis report 2026

2026-05-06T10:00:00+00:00

WHO Global hepatitis report 2026

Viral hepatitis is one of the world’s most important public health challenges. Hepatitis B virus (HBV) and hepatitis C virus (HCV) continue to cause chronic infection in hundreds of millions of people, leading to cirrhosis, liver cancer and over 1 million premature deaths each year, even though both infections are preventable and treatable. Together, HBV and HCV account for over 95% of global mortality caused by viral hepatitis, with hepatitis A virus (HAV), hepatitis D virus (HDV) and hepatitis E virus (HEV) accounting for the remainder.

People can be infected with viral hepatitis through exposure to infected blood (HBV, HCV and HDV) and other bodily fluids (HBV and HDV), contaminated water (HAV and HEV) and contaminated food (HAV). In highly endemic areas, most chronic HBV infections occur in children aged under 5 years, either through mother-to-child transmission at birth or horizontal transmission through person- to-person contact in the presence of open cuts and sores. The most common routes of HCV transmission are unsafe injections and medical procedures, unscreened blood transfusions, and sharing of needles and syringes among people who inject drugs. All forms of viral hepatitis infection can cause acute liver inflammation; however, HBV, HCV and HDV can progress to chronic infection, with those infected with HBV in infancy or early childhood (aged <5 years) being at the highest risk (about 95%).

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Priorities for a chronic hepatitis B functional cure treatment pathway

2026-01-13T10:00:00+00:00

A modified nominal group technique consensus to define implementation priorities for a chronic hepatitis B functional cure treatment pathway

BACKGROUND

Novel treatment strategies that aim to achieve FC for CHB are in development
Once these therapies targeting FC are approved, clinical pathways will need to be updated
The Futuring Liver Care (FLC) group was established to support clinical pathway transformations and improve outcomes for people living with CHB
- The FLC group is a GSK-organized international working group of 18 experts including hepatologists, gastroenterologists, infectious disease specialists, public health specialists, molecular virologists, and community advocates
In this study, we evaluated the level of consensus among a panel of the FLC group regarding the recommended clinical pathway for FC in CHB, as well as implementation priorities

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Magical thinking will not prevent future pandemics or improve public health

2026-01-08T10:00:00+00:00

Magical thinking will not prevent future pandemics or improve public health

The exact prevalence of hepatitis B in the US is unknown, with estimates between 660,000 and 2.2 million people. As many as 50% are unaware of their infection status, meaning that universal immunization to create population immunity is the best way to protect the population and to eliminate maternal-infant hepatitis B transmission. Hepatitis B vaccination at birth also protects children from infection through contact with infected caregivers and household members as well as in other settings which—prior to 1991—accounted for a substantial number of infections. As a physician who was a volunteer in the original efficacy trial for the recombinant hepatitis B vaccine in the mid-1980s, I have a particular interest in this vaccine and have followed it closely. It is exceedingly safe and highly efficacious.

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Broadening PEth testing for alcohol exposure in the Asia-Pacific region

2025-12-18T10:00:00+00:00

Broadening PEth testing for alcohol exposure in the Asia-Pacific region

Blood phosphatidylethanol (PEth) is a promising tool to objectively assess alcohol intake and was recommended in a recent position statement crafted by an expert panel. Beyond its diagnostic applications, PEth has also been shown to predict major adverse liver outcomes. Triangulated assessment using self-reporting, the AUDIT-C questionnaire, and PEth is recommended for patients with steatotic liver disease.

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