競爭利益聲明 作者聲明以下可能被視為潛在競爭利益的經濟利益/個人關係： Ran Yan 和 Kathryn M. Kitrinos 是 Assembly Biosciences 的員工和股東。蔡大偉、Lea Ouyang、Richard Colonno 和 Qi Huang 在研究期間是 Assembly Biosciences 的員工和股東。作者: StephenW 时间: 2022-11-6 18:58
Development of a sensitive, multi-assay platform to monitor low levels of HBV DNA and pgRNA in patients with chronic Hepatitis B virus infection
Ran Yan 1 , Dawei Cai 2 , Lea Ouyang 2 , Richard Colonno 2 , Qi Huang 2 , Kathryn M Kitrinos 2
Affiliations
Affiliations
1
Assembly Biosciences, South San Francisco, CA, USA. Electronic address: [email protected].
2
Assembly Biosciences, South San Francisco, CA, USA.
HBV cure rates remain low despite prolonged nucleos(t)ide (NrtI) therapy, likely due to persistent residual viral replication and an inability to eliminate covalently closed circular DNA (cccDNA). Therapies with novel mechanisms of action against hepatitis B virus (HBV) are being explored with the goal of achieving sustained off-treatment response and a functional cure without requiring lifelong therapy. Recent studies have indicated that serum HBV DNA levels (a biomarker for viral replication) combined with serum pregenomic RNA (pgRNA) levels (a surrogate for intrahepatic cccDNA transcriptional activity), may provide a better prediction for the risk of liver-related complications. Current HBV DNA assays, such as the COBAS AmpliPrep/COBAS TaqMan HBV test v2.0, quantitate HBV DNA down to 20 IU/mL, but are not able to monitor loss of residual virus in patients on NrtI therapy. There are no commercially available assays approved to detect serum/plasma HBV pgRNA levels. We have developed a multi-assay panel of highly sensitive nucleic acid assays designed to monitor levels of HBV DNA, pgRNA and total nucleic acids (TNA, composite DNA+pgRNA) in clinical specimens and to monitor changes during treatment with new antiviral combination regimens.
Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ran Yan and Kathryn M. Kitrinos are employees and shareholders of Assembly Biosciences. Dawei Cai, Lea Ouyang, Richard Colonno, and Qi Huang were employees and shareholders of Assembly Biosciences during the study.