Methods for the treatment of hepatitis B and hepatitis D infections
Inventors
Bazinet, Michel • Vaillant, Andrew
Assignees
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Publication Number
US-9133458-B2
Publication Date
2015-09-15
Expiration Date
Abstract
It is disclosed a method for the treatment of hepatitis B (HBV) infection or HBV/hepatitis D (HDV) co-infection, the method comprising administering to a subject in need of treatment a first pharmaceutically acceptable agent that removes the hepatitis B surface antigen from the blood and a second pharmaceutically acceptable agent which stimulates immune function.
Core Innovation
The invention relates to a method for the treatment of hepatitis B infection or hepatitis B/hepatitis D co-infection. The method administers to a patient one or more first pharmaceutically acceptable agent or agents and one or more second pharmaceutically acceptable immunotherapeutic agent or agents, where the first agents comprise an oligonucleotide chelate complex and/or a nucleic acid polymer.
The oligonucleotide chelate complex comprises SEQ ID NOs. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20. The nucleic acid polymer consists of phosphorothioated oligonucleotides of 20–120 nucleotides, comprising repeats of the sequence AC, CA, UG, GU, TG, or GT.
The second agents are immunotherapeutic agents that stimulate immune function, including thymosin α1, interferons, Toll-like receptor agonists such as GS-9620, immunostimulatory oligonucleotides such as IMO-2055 and IMO-2125, and hormones such as DHEA. The invention states that circulating HBsAg suppresses immune signaling and inhibits immunotherapies, and that adding immunotherapy after or at the start of HBsAg removal provides unexpected synergy with rapid and high anti-HBsAg antibody responses and improved off-treatment immunological control.
Claims Coverage
The partial content provides one independent claim. The independent claim combines a first agent defined by specific oligonucleotide chelate complexes or a specified nucleic acid polymer, and a second agent defined by a listed set of immunotherapeutic agents.
Oligonucleotide chelate complex and/or nucleic acid polymer comprising repeat sequences
The method administers one or more first pharmaceutically acceptable agent or agents consisting of an oligonucleotide chelate complex comprising SEQ ID NOs. 1 through 20, or a nucleic acid polymer consisting of phosphorothioated oligonucleotides of 20–120 nucleotides comprising repeats of the sequence AC, CA, UG, GU, TG, or GT.
Immunotherapeutic agent selected from a listed set
The method administers one or more second pharmaceutically acceptable immunotherapeutic agent or agents consisting of thymosin α1, interferons, pegylated interferons, GS-9620, dehydroepiandrosterone, androstenediol, or androstenetriol.
Treating hepatitis B infection or hepatitis B/hepatitis D co-infection by co-administering first and second agents
A method for the treatment of hepatitis B infection or hepatitis B/hepatitis D co-infection, comprising administering to a patient in need of such treatment one or more first pharmaceutically acceptable agent or agents and one or more second pharmaceutically acceptable immunotherapeutic agent or agents.
The inventive concept is the coordinated administration of a specifically defined oligonucleotide chelate complex or phosphorothioated repeat nucleic acid polymer with an immunotherapeutic agent selected from the enumerated list for treating hepatitis B infection or hepatitis B/hepatitis D co-infection.
Stated Advantages
Provides unexpected synergy between HBsAg removal and subsequent or initial immunotherapy, with rapid and high anti-HBsAg antibody responses.
Improves off-treatment immunological control compared with HBsAg removal alone.
Addresses the limitation that HBsAg removal alone yields only partial immune recovery and viral rebound after stopping.
Documented Applications
Treatment of hepatitis B infection.
Treatment of hepatitis B/hepatitis D co-infection.
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