Chronic Hepatitis B Finite Treatment: similar and different concerns with new drug classes.
Marion G PetersMan-Fung YuenNorah TerraultJohn FryPietro LamperticoEd GaneCarey HwangLuisa M StammMitchell LeusMala K MainiPatricia MendezIsabelle Lonjon-DomanecThomas BergSu WangPoonam MishraEric DonaldsonStephanie BuchholzVeronica MillerOliver LenzPublished in: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (2023)
Chronic hepatitis B, a major cause of liver disease and cancer, affects over 250 million people worldwide. Currently there is no cure, only suppressive therapies. Efforts to develop finite curative HBV therapies are underway, consisting of combinations of multiple novel agents +/- nucleos(t)ide reverse transcriptase inhibitors. The HBV Forum convened a webinar in July 2021, and subsequent working group discussions to address how and when to stop finite therapy for demonstration of sustained off-treatment efficacy and safety responses. Participants included leading experts in academia, clinical practice, pharmaceutical companies, patient representatives and regulatory agencies. This Viewpoint outlines areas of consensus within our multi-stakeholder group for stopping finite therapies in chronic Hepatitis B investigational studies, including trial design, patient selection, outcomes, biomarkers, pre-defined stopping criteria, pre-defined retreatment criteria, duration of investigational therapies, and follow up after stopping therapy. Future research of unmet needs are discussed.
Keyphrases
- hepatitis b virus
- clinical practice
- phase ii
- case report
- liver failure
- emergency department
- randomized controlled trial
- type diabetes
- study protocol
- papillary thyroid
- combination therapy
- rectal cancer
- current status
- metabolic syndrome
- skeletal muscle
- insulin resistance
- mesenchymal stem cells
- cell therapy
- lymph node metastasis
- childhood cancer