Project Grant R03AI201866

Award Date 7/1/26

Completion Date 6/30/28

Dollars Obligated $78K

Federal Agency

National Institute of Allergy and Infectious Diseases

Awardee

Baruch S. Blumberg Institute (NAYCKSJB7F68)

Federal Grant Program

93.855

Assistance Type

Project Grant

Place of Performance

Doylestown, PA 18901, USA

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IMPACT OF ANTIVIRAL THERAPY ON INFECTION AND REPLICATION DERIVED HEPATITIS B VIRUS DNA INTEGRATION - ABSTRACT HEPATITIS B VIRUS (HBV) CHRONICALLY INFECTS 254 MILLION PEOPLE WORLDWIDE AND ACCOUNTS FOR 1.1 MILLION DEATHS PER YEAR DUE TO CIRRHOSIS AND LIVER CANCER. CURRENTLY, THERE ARE TWO TYPES OF ANTIVIRAL DRUGS APPROVED TO TREAT CHRONIC HEPATITIS B (CHB) INCLUDING NUCLEOS(T)IDE ANALOGUES AND PEGYLATED INTERFERON-ALPHA, BUT CURE REMAINS RARE. DUE TO THE FACT THAT CHRONICITY OF HBV INFECTION AND INTRACELLULAR VIRAL REPLICATION IS ONLY INCOMPLETELY SUPPRESSED BY ANTIVIRALS, THE RATHER INFREQUENT VIRAL INTEGRATION CAN EVENTUALLY ACCUMULATE TO HIGH LEVEL OVER DECADES-LONG PRESENCE OF THE VIRUS. HIGH INTEGRATION BURDEN NOT ONLY WORSENS VIRAL PATHOGENESIS BY BEING EXTRA RESOURCES FOR HBV SURFACE ANTIGEN PRODUCTION, BUT ALSO DIRECTLY CONTRIBUTES TO TUMORIGENESIS BY DISRUPTING CHROMOSOME GENETIC STABILITY. THEREFORE, IT IS NOT SURPRISING THAT HBV INTEGRATION IS ASSOCIATED WITH MORE THAN 90% OF HBV-ASSOCIATED HCC. HOWEVER, SIGNIFICANT KNOWLEDGE GAP REMAINS IN THE FIELD WITH RESPECT TO THE EFFICACY OF DIFFERENT CLINICAL AND EXPERIMENTAL DRUGS IN BLOCK HBV INTEGRATION. ONE OF THE REASONS IS THAT THE VIROLOGICAL AND CLINICAL SIGNIFICANCE OF HBV INTEGRATION HAS LONG BEEN UNDERESTIMATED BUT ONLY RECENTLY BROUGHT INTO THE SPOTLIGHT. ANOTHER REASON IS THE LACK OF EFFICIENT AND ROBUST ASSAY TO MEASURE HBV INTEGRATION. WE RECENTLY MODIFIED THE TRADITIONAL HBV INTEGRATION ASSAY BY COMBINING IT WITH A COST-EFFECTIVE PCR AMPLICON BASED NEXT GENERATION SEQUENCING TECHNIQUE (AMPLICON-SEQ), WHICH REDUCES METHOD BIAS AND ENHANCES QUANTITATIVE POWER. THE PURPOSE OF THIS R03 GRANT APPLICATION ENTITLED "IMPACT OF ANTIVIRAL THERAPY ON INFECTION AND REPLICATION DERIVED HEPATITIS B VIRUS DNA INTEGRATION" IS TO ADDRESS THIS IMPORTANT KNOWLEDGE GAP BY USING OUR IMPROVED HBV INTEGRATION ASSAY TO CHARACTERIZE HOW ANTIVIRAL DRUGS TARGETING DISTINCT HBV REPLICATION STEPS IMPACT THE FREQUENCY AND PATTERN OF INTEGRATION. KNOWLEDGE GAINED THROUGH THIS STUDY WILL SHED LIGHT ON IMPROVING TREATMENT STRATEGIES TO REDUCE HBV INTEGRATION BURDEN AND MITIGATE THE RISK OF HCC.

Posted 7/1/26

Mod #	Description	ReasonForModification	Federal Obligation	Date
Not listed			$78.3k	7/1/26