Future Therapies for Functional Cure of Chronic HBV: Review of Investigational Drugs in Phase 1 and 2 Development
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HEPATITIS B (J LIM, SECTION EDITOR)
Future Therapies for Functional Cure of Chronic HBV: Review of Investigational Drugs in Phase 1 and 2 Development Lung-Yi Mak 1
&
Wai-Kay Seto 2,3
&
Man-Fung Yuen 1,2,3
# Springer Science+Business Media, LLC, part of Springer Nature 2019
Abstract Purpose of Review Treating patients with chronic hepatitis B (CHB) infection with long-term oral antiviral therapy or pegylated interferon is the current standard of care (SOC). However, functional cure, defined as sustained hepatitis B surface antigen (HBsAg) seroclearance that is associated with favorable clinical outcomes, is a rarely achieved treatment endpoint with the SOC. Recent Findings Remarkable advances in CHB therapy have been made in the recent years. This review was aimed to describe the different new treatment agents that are in the clinical phase of development. These include two main groups of agents that either target the viral replication cycle or enhance host immune control on the hepatitis B virus (HBV). The former group includes viral entry inhibitor, RNA gene silencers, core protein inhibitors, nucleic acid polymer, and monoclonal antibodies. The latter group includes toll-like receptor agonists, RIG-1/NOD2 agonist, therapeutic vaccines, and apoptosis inducer. Summary While some agents show promise in reduction of HBsAg levels and even HBsAg seroclearance, others are relatively modest in term of additional virological control effected by their different modes of action against HBV. These agents are in general well tolerated. Many upcoming new drugs against HBVare expected to enter phase II clinical trials. New challenge ahead would be the choice and duration of combination therapy to achieve a satisfactory rate of HBsAg seroclearance. Keywords Chronic hepatitis B virus . Antiviral therapy . Functional cure . Hepatitis B surface antigen
Introduction Chronic hepatitis B (CHB) infection affects 292 million individuals (3.9% of the global population) as of year 2016 [1]. The prevalence of CHB is highest in the Asia-Pacific region, but many other countries also have high CHB prevalence ranging from 3.3 to 6.1% such as the Eastern Mediterranean region and the African regions [2]. As of year 2015, 0.88 million deaths were related to CHB-related decompensation or hepatocellular carcinoma (HCC), which is comparable to This article is part of the Topical Collection on Hepatitis B * Man-Fung Yuen [email protected] 1
Department of Medicine, Queen Mary Hospital, 4/F, Professorial Block, Queen Mary Hospital, Pokfulam Road 102, High West, Hong Kong
2
Department of Medicine, The University of Hong Kong, Pok Fu Lam, Hong Kong
3
State Key Laboratory of Liver Research, The University of Hong Kong, Pok Fu Lam, Hong Kong
those due to malaria (0.44 million deaths) and human immunodeficiency virus infection (1.06 million deaths). In June 2016, the World Hepatitis Assembly adopted the Global Health Sector Strategy on viral hepatitis and formulated a global action plan to decrease the incidence of viral hepatitis infection
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