Robert G. Gish Consultants, LLC

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.

Read Full Article

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%).

Read Full Report

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

Download Poster

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.

Read Article

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.

Read Article

Strategies to Achieve Functional Cure in HBV: Focus on siRNA

2025-11-25T10:00:00+00:00

Strategies to Achieve Functional Cure in HBV: Focus on siRNA

Abstract
Purpose of Review Chronic hepatitis B (HBV) infection remains a major global contributor to liver disease, yet current antiviral therapies infrequently achieve a functional cure. This review highlights emerging data on 2 novel agents that are designed to suppress viral antigen expression and potentially restore immune control of the infection.

Recent Findings Imdusiran and bepirovirsen are 2 leading experimental therapies that target HBV RNA and have shown meaningful reductions in hepatitis B surface antigen and occasional instances of functional cure.

Summary The emergence of RNA-targeted therapies marks a pivotal advancement in HBV treatment, shifting the focus beyond viral suppression to include immune restoration. A strong, coordinated immune response is needed, as evidenced by seroconversion patterns in treatment-responsive individuals. Moving forward, successful HBV cure strategies will likely involve combination regimes, pairing RNA-targeted agents with nucleos(t)ide analogues

Read Article

Re: Removal of Vemlidy from CVS Health Formularies

2025-11-20T10:00:00+00:00

Letter: Re: Removal of Vemlidy from CVS Health Formularies

Dear Mr. Joyner, Dr. Compton-Phillips, and Mr. DeVaney,

We have been made aware that Aetna CVS Health and CVS Caremark are instituting changes to their formulary plan and removing Vemlidy (tenofovir alafenamide, TAF) as a covered medication for treating chronic hepatitis B effective January 1st, 2026.

We, as caregivers and clinical thought leaders, ask that CVS Health add tenofovir alafenamide (TAF, Vemlidy) back onto its treatment formulary for hepatitis B, allowing the decision regarding hepatitis B treatment to be left to healthcare providers and their patients. Every patient with hepatitis B should have access to the best treatment that meets their individual needs. Healthcare providers, with intimate knowledge of their patients’ healthcare needs, should have all current, front-line treatments available to prescribe.

For many people with hepatitis B, TAF is the best and only option for treatment. TAF is less likely to cause adverse effects on bone mineral density and renal dysfunctions than tenofovir disoproxil fumarate (TDF). By removing Vemlidy from the formulary plan, CVS Health is implementing a significant barrier to thousands of Americans at risk for these complications who may need and/or rely on this drug to manage their hepatitis B. The decision to remove Vemlidy as an option for individuals forces “non-medical switching,” where a patient must change medications for reasons other than their health. Non-medical switching is associated with poor health outcomes, and higher costs for patients, thereby decreasing accessibility of medications. A 2019 study by the Alliance for Patient Access found that 1 in 10 patients reported being hospitalized for complications after being switched off their preferred medication; and 40% stopped taking their medication completely. A 2017 study concluded that cost-motivated medication switches result in higher non-drug medical costs, such as doctor office visits, hospitalizations, and ER visits.

Download Letter

Patient Engagement as a HABIT

2025-11-10T10:00:00+00:00

Patient Engagement as a HABIT: Hope in Action – Breaking Barriers, Impactful Transitions

Questions and Answers for Barrier Assessment

What are the resources, processes and activities needed to conduct community-based HBV programming?
What role does a stakeholder committee play in conducting community-based HBV programming?
What impacts stakeholder participation and stakeholder committee success?
What successes can be achieved from community-based HBV programming?
What are the challenges facing enhanced community-based HBV programming, and what strategies can be used to overcome them?

Download Presentation

AASLD/IDSA Practice Guideline on Treatment of Chronic Hepatitis B

2025-11-04T10:00:00+00:00

AASLD/IDSA Practice Guideline on Treatment of Chronic Hepatitis B

Abstract

Background and Aims: Accumulating data related to prevention, surveillance and treatment of chronic hepatitis B (CHB) provided the impetus for this updated guideline, using the Grading of Recommendation Assessment, Development and Evaluation (GRADE) approach.

Methods: The guideline was developed in compliance with the National Academy of Medicine standards. The guideline panel developed structured questions following the Population, Intervention Comparison, Outcomes (PICO) framework. The panel addressed 6 PICO questions covering prevention (maternal to infant transmission and horizontal transmission), surveillance for liver cancer (among hepatitis B surface antigen positive (HBsAg) persons co-infected with hepatitis C virus, hepatitis D virus and/or human immunodeficiency viruses and after HBsAg loss) and treatment (HBsAg positive persons in immune-tolerant or indeterminate phases as well as withdrawal of antiviral therapy), providing evidence-based recommendations on these topics. Four systematic reviews of the literature were conducted, and two existing systematic reviews were utilized to support the recommendations in this practice guideline.

Conclusions: This evidence-based guideline provides updated recommendations to optimize the care of persons with CHB.

Download Paper

Best practices for screening, testing, diagnosing, and treating patients with hepatitis D

2025-10-09T10:00:00+00:00

Best practices for screening, testing, diagnosing, and treating patients with hepatitis D (delta) virus based on global expert review and recent guidelines

Abstract
Background
Hepatitis D virus (HDV) represents the most severe form of human viral hepatitis, associated with rapid progression to cirrhosis and increased liver-related mortality. Globally, an estimated 9-19 million individuals are anti-HDV positive. To ensure early detetion, current guidelines recommend screening all HBsAg-positive individuals or, at a minimum, those with defined risk factors.

Methods
This expert consensus paper updates the current landscape of HDV management. Recommendations were derived from a structured expert panel discussion, incorporating recent evidence and clinical guideline developments, with a focus on screening, diagnosis, and antiviral therapy.

Results
The panel emphasized the importance of systematic HDV screening in HBsAg-positive individuals. Therapeutic strategies aim at sustained HDV-RNA suppression and, ideally, HBV surface antigens (HBsAg) loss. Bulevirtide was recommended as a long-term monotherapy. Pegylated interferon alpha (PEG-IFNα), if used, should be limited to 48 weeks and tailored based on viral response and tolerability. Combination therapy with bulevirtide and PEG-IFNα may be considered in selected cases.

Conclusion
This consensus provides updated recommendations for the screening, diagnosis, and treatment of HDV infection, highlighting the role of bulevirtide and individualized therapeutic approaches. As the treatment landscape continues to evolve, combination regimens and novel agents currently under investigation may offer additional options in the near future.

Read Article