ArticleHepatology (Baltimore, Md.)2023
Guidance on treatment endpoints and study design for clinical trials aiming to achieve cure in chronic hepatitis B and D: Report from the 2022 AASLD-EASL HBV-HDV Treatment Endpoints Conference.
Article in Hepatology (Baltimore, Md.), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 61 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
61 citing papers in PubMed, 3 syntheses or guidelines pooled it, 101 citations in OpenAlex.
- A Systematic Review and Model-Based Meta-Analysis of Pegylated-Interferon-α-Induced HBsAg Loss in Chronic Hepatitis B Virus Infection.CPT: pharmacometrics & systems pharmacology · 2026Pooled it
- [Chinese expert consensus on clinical practice of chronic hepatitis B functional (clinical) cure].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2025Guideline
- The Post-Transcriptional Regulatory Element of Hepatitis B Virus: From Discovery to Therapy.Viruses · 2024Pooled it
- Immunomodulation by bepirovirsen may induce killing of infected hepatocytes (B-Together study).Hepatology international · 2026Trial
- Elebsiran and PEG-IFNα for chronic hepatitis B infection: a partially randomized, open-label, phase 2 trial.Nature medicine · 2026Trial
- Trial
- Article
- ANKRD11 deficiency reprograms CD8Nature immunology · 2026Article
- Occult hepatitis B virus infection.Nature reviews. Gastroenterology & hepatology · 2026Review
- Bepirovirsen induces innate immune proteins independent of HBV.Hepatology international · 2026Article
- Droplet Digital PCR Measurement of HBV DNA in On-Treatment Chronic HBV Patients: Association With HCC Development and Outcomes.Journal of viral hepatitis · 2026Article
- From Diagnosis to Durability: A Review of the European Bulevirtide Experience and Practical Learnings for CHD Management.Liver international : official journal of the International Association for the Study of the Liver · 2026Review
- A key role for the exoribonuclease XRN1 in regulating the hepatitis B viral transcriptome.iScience · 2026Article
- Topological Stability and Transcritical Bifurcations in a Target-Cell-Limited Model of HBV-HDV Viral Interference.Viruses · 2026Article
- Multiplex gene editing suppresses random integration of hepatitis B virus DNA in chronically infected liver.Molecular therapy. Nucleic acids · 2026Article
- Spatial-quantitative profiling of intrahepatic HBsAg heterogeneity and clustered distribution in chronic HBV infection.JHEP reports : innovation in hepatology · 2026Article
- Social determinants of health and quality of life among Korean Americans with chronic hepatitis B.BMC public health · 2026Article
- Hepatocyte-Targeted Drug Delivery Strategies for Chronic Hepatitis B: Overcoming Delivery Barriers Toward Functional Cure.Pharmaceutics · 2026Review
- Novel insights into chronic HBV infection.Nature reviews. Gastroenterology & hepatology · 2026Article
- Genotype-specific Response to 144-week Entecavir Therapy for HBeAg-positive Chronic Hepatitis B with a Particular Focus on Histological Improvement: A Prospective Study.Journal of clinical and translational hepatology · 2026Article
1 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
Abstract
Representatives from academia, industry, regulatory agencies, and patient advocacy groups convened under the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) in June 2022 with the primary goal of achieving consensus on chronic HBV and HDV treatment endpoints to guide clinical trials aiming to "cure" HBV and HDV. Conference participants reached an agreement on some key points. The preferred primary endpoint for phase II/III trials evaluating finite treatments for chronic hepatitis B (CHB) is a "functional" cure, defined as sustained HBsAg loss and HBV DNA less than the lower limit of quantitation (LLOQ) 24 weeks off-treatment. An alternate endpoint would be "partial cure" defined as sustained HBsAg level < 100 IU/mL and HBV DNA < LLOQ 24 weeks off-treatment. Clinical trials should initially focus on patients with HBeAg positive or negative CHB, who are treatment-naive or virally suppressed on nucleos(t)ide analogs. Hepatitis flares may occur during curative therapy and should be promptly investigated and outcomes reported. HBsAg loss would be the preferred endpoint for chronic hepatitis D, but HDV RNA < LLOQ 24 weeks off-treatment is a suitable alternate primary endpoint of phase II/III trials assessing finite strategies. For trials assessing maintenance therapy, the primary endpoint should be HDV RNA < LLOQ assessed at on-treatment week 48. An alternate endpoint would be ≥2 log reduction in HDV RNA combined with normalization of alanine aminotransferase level. Suitable candidates for phase II/III trials would be treatment-naiive or experienced patients with quantifiable HDV RNA. Novel biomarkers (hepatitis B core-related antigen [HBcrAg] and HBV RNA) remain exploratory, while nucleos(t)ide analogs and pegylated interferon still have a role in combination with novel agents. Importantly, patient input is encouraged early on in drug development under the FDA/EMA patient-focused drug development programs.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.