Related Experiment Video
Updated: Feb 25, 2026
04:11
Author Spotlight: Advancements and Challenges in Hepatitis B Virus Detection
Published on: December 15, 2023
4.9K
Hepatitis B cure: From discovery to regulatory approval
Anna S Lok1, Fabien Zoulim2, Geoffrey Dusheiko3
1Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, United States.
Journal of Hepatology
|August 6, 2017
Summary
Achieving a functional cure for chronic hepatitis B, defined by sustained loss of hepatitis B surface antigen, is a feasible goal. This requires developing new therapies and standardized assays to guide clinical trials toward improved patient outcomes.
Area of Science:
- Hepatology
- Virology
- Immunology
Background:
- Chronic hepatitis B (CHB) treatment currently requires long-term or lifelong therapy.
- Novel therapeutic strategies targeting hepatitis B virus (HBV) are under development, including entry inhibitors and immune modulators.
- Standardized efficacy and safety assessments are needed for new CHB treatments.
Purpose of the Study:
- To establish a consensus on treatment endpoints for clinical trials aimed at achieving a hepatitis B cure.
- To guide the development of novel antiviral and immune modulatory therapies for CHB.
- To define a feasible goal for hepatitis B cure.
Main Methods:
- A workshop involving key stakeholders was convened in September 2016.
- Consensus was developed on defining treatment endpoints for CHB cure.
- The feasibility of sterilizing cure versus functional cure was evaluated.
Main Results:
- A complete sterilizing cure (viral eradication) is considered unlikely to be feasible.
- A functional cure, characterized by sustained loss of hepatitis B surface antigen (HBsAg) with or without antibody seroconversion, is a feasible goal.
- This functional cure is associated with improved clinical outcomes.
Conclusions:
- Functional cure is the most achievable goal for hepatitis B treatment.
- Standardized assays for novel biomarkers should parallel the development of new therapies.
- Combination therapy involving antiviral and immune modulatory agents is likely necessary for functional cure, following initial monotherapy safety studies.
Related Concept Videos
01:15Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
39
PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
39
01:26Drug Discovery: Overview
12.2K
Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
12.2K
01:10Retrovirus Life Cycles
50.0K
Retroviruses have a single-stranded RNA genome that undergoes a special form of replication. Once the retrovirus has entered the host cell, an enzyme called reverse transcriptase synthesizes double-stranded DNA from the retroviral RNA genome. This DNA copy of the genome is then integrated into the host’s genome inside the nucleus via an enzyme called integrase. Consequently, the retroviral genome is transcribed into RNA whenever the host’s genome is transcribed, allowing the...
50.0K
01:25Drug Regulation
3.2K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
3.2K
01:26FDA Approved Drugs: Changes to Approved Drugs
291
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
291
01:29Microorganisms in Medicine and Therapeutics
1.2K
Microorganisms play a fundamental role in vaccine development, gene therapy, and therapeutic production. Their biological properties are harnessed to advance medicine and public health. Beyond immunization, microorganisms contribute to gut health, antibiotic synthesis, and genetic disease treatment.Live Attenuated and Inactivated VaccinesLive attenuated vaccines, such as the measles, mumps, and rubella (MMR) vaccine, utilize weakened forms of pathogens to closely resemble natural infections.
1.2K