Chronic Hepatitis B Finite Treatment: Similar and Different Concerns With New Drug Classes

HBV Forum Stopping Finite Therapy Working Group

Research output: Contribution to journalReview articlepeer-review

4 Scopus citations

Abstract

Chronic hepatitis B, a major cause of liver disease and cancer, affects >250 million people worldwide. Currently there is no cure, only suppressive therapies. Efforts to develop finite curative hepatitis B virus (HBV) therapies are underway, consisting of combinations of multiple novel agents with or without nucleos(t)ide reverse-transcriptase inhibitors. The HBV Forum convened a webinar in July 2021, along with 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 Viewpoints article outlines areas of consensus within our multistakeholder group for stopping finite therapies in chronic hepatitis B investigational studies, including trial design, patient selection, outcomes, biomarkers, predefined stopping criteria, predefined retreatment criteria, duration of investigational therapies, and follow-up after stopping therapy. Future research of unmet needs are discussed.

Original languageEnglish (US)
Pages (from-to)983-990
Number of pages8
JournalClinical Infectious Diseases
Volume78
Issue number4
DOIs
StatePublished - Apr 15 2024

Keywords

  • HBV biomarkers
  • chronic hepatitis B
  • functional cure
  • new combination therapy
  • stopping finite therapy

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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