ArticleDrug safety2024
Consensus Guidelines: Best Practices for the Prevention, Detection and Management of Hepatitis B Virus Reactivation in Clinical Trials with Immunosuppressive/Immunomodulatory Therapy.
Article in Drug safety, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 14 citations in OpenAlex.
- Impact of Hepatitis B Virus Infection on the Efficacy and Safety of Pembrolizumab plus Chemotherapy for Advanced Biliary Tract Cancer in the KEYNOTE-966 Study.Cancer research communications · 2026Trial
- CGRP-targeted therapies for migraine and the risk of infection.Internal and emergency medicine · 2026Review
- HBV Serologic Testing Practices and Reactivation Outcomes Before Rituximab Initiation: A Retrospective Observational Study at an Academic Tertiary Care Centre.Journal of clinical medicine · 2026Article
- Review
- Article
- Chronic Hepatitis B: Current Management and Future Directions.Diseases (Basel, Switzerland) · 2025Review
- Hepatitis B reactivation with TNF-α inhibitors: assessing antiviral prophylaxis efficacy - protocol for systematic review and meta-analysis.Systematic reviews · 2025Article
- Clinical Audit of screening Latent TB, Hepatitis-C, and Occult Hepatitis-B in Rheumatoid arthritis' patients starting biologic or targeted synthetic DMARDS.Pakistan journal of medical sciences · 2025Article
- Drug-Induced Liver Injury in Patients With Chronic Liver Disease.Liver international : official journal of the International Association for the Study of the Liver · 2025Review
- Pharmacological considerations in pharmacotherapy of rheumatology patients with liver disease: a brief narrative review.Reumatologia · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 12 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Hepatitis B virus reactivation (HBVr) during and after immunosuppressive/immunomodulatory (IS/IM) therapy is associated with significant morbidity and mortality, including hepatic decompensation and acute liver failure. The risk of HBVr with IS/IM has been heterogeneous and often unpredictable. As a result, patients with active or previous HBV infection are often excluded from clinical drug trials of such agents. Thorough screening for HBV infection, antiviral prophylaxis, and careful monitoring for HBVr have proven to be effective in reducing the rate of HBVr and improving its outcome in the context of IS/IM. Therefore, safe enrollment and management of certain HBV-marker-positive patients in clinical trials is possible. There is a great, unmet need for consistent, evidence-based recommendations for best practices pertaining to enrollment, monitoring, and management of HBVr in clinical trial participants receiving IS/IM. The aim of these consensus guidelines is to provide a step-by-step blueprint to safely enroll, monitor and manage the patient with inactive chronic or resolved HBV in IS/IM clinical trials from the time of screening through to the end of post-treatment follow up.
Indexed as
Identifiers
What OpenQuestion holds
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.