Standardized Hepatitis B Virus RNA Quantification in Untreated and Treated Chronic Patients: a Promising Marker of Infection Follow-Up

Cortese, María Francesca; Riveiro‐Barciela, Mar; Tabernero, David; Rodríguez-Algarra, Francisco; Sopena, Sara; Rando‐Segura, Ariadna; Roade, Luisa; Kuchta, Alison; Ferrer-Costa, Roser; Quer, Josep; Pacín, Beatriz; Vila, Marta; Casillas, Rosario; Garcia-Garcia, Selene; Esteban, Rafael; Pumarola, Tomás; Buti, María; Rodríguez‐Frías, Francisco

doi:10.1128/spectrum.02149-21

Cited by 5 publications

(4 citation statements)

References 36 publications

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“…This may be solved using a true HBV-RNA international standard (still lacking), which would enable reliable, reproducible HBV-RNA quantification. Recently, we compared HBV-DNA and HBV-RNA levels in 63 treatment-naïve patients with CHB (mostly HBeAg-negative) using a different approach [3] : HBV-DNA was quantified using the WHO international standard (IU/ml), and HBV-RNA using an armored HBV-RNA standard (copies/ml). To compare both magnitudes, HBV-DNA IU were converted into copies using the equivalent IU:copies.…”

Section: Letter To the Editor: Standardization Of Hbv-rna Assay For T...mentioning

confidence: 99%

“…Buti is on the speakers' bureau for Gilead and AbbVie. David Tabernero 1 Maria Francesca Cortese 1,2 Ariadna Rando-Segura 3,4 Maria Buti 1,5 Francisco Rodríguez-Frías Note: Differences were calculated by subtracting median HBV RNA (log 10 U/ml) from median HBV DNA (log 10 IU/ml), shown by Mak et al [1] in Table 1 for treatment-naïve patients and Table 3 for the baseline sample of nucleos(t)ide-treated patients.…”

Section: O N F L I C T O F I N T E R E S Tmentioning

confidence: 99%

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Letter to the editor: Standardization of HBV‐RNA assay for the different phases of chronic hepatitis B is essential

et al. 2021

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Section: Letter To the Editor: Standardization Of Hbv-rna Assay For T...mentioning

confidence: 99%

Section: O N F L I C T O F I N T E R E S Tmentioning

confidence: 99%

Letter to the editor: Standardization of HBV‐RNA assay for the different phases of chronic hepatitis B is essential

et al. 2021

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“…Considerable declines of serum HBV RNA were observed under long-term NAs treatment in the vast majority of current studies, and HBV RNA showed a much slower decline than serum HBV DNA, 8,57,59,65,69-83 which could be observed as early as 1 week after treatment. 8 gradually exceeded HBV DNA concentration during treatment, 69,71,72 and HBV RNA could remain detectable despite HBV DNA becoming undetectable in patients under persistent NAs therapy, 65,69,[76][77][78]80,[84][85][86] even in some patients achieving HBsAg clearance. 76,87,88 Contrary to the mainstream findings, it was observed that serum HBV RNA level showed a rise within 4 weeks after NA therapy and began to decline afterward.…”

Section: Dynami C Chang E S Of S Erum Hbv Rna Le Vel S Under Na S The...mentioning

confidence: 99%

Biogenesis of serum HBV RNA and clinical phenomena of serum HBV RNA in chronic hepatitis B patients before and after receiving nucleos(t)ide analogues therapy

Wu,

Yang,

Zheng

2024

Journal of Viral Hepatitis

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There are estimated 300 million people afflicted with chronic hepatitis B (CHB) worldwide. The risk of liver cirrhosis and hepatocellular carcinoma (HCC) increases considerably with chronic hepatitis B infection. While current therapeutics are effective in controlling hepatitis B virus (HBV) infection and disease progression, a cure for HBV infection remains unattainable due to an intranuclear replicative intermediate known as covalently closed circular DNA (cccDNA). It has recently been shown that serum HBV RNA is a non‐invasive biomarker that reflects cccDNA transcriptional activity. This review provides a comprehensive overview and the latest updates on the molecular characteristics and clinical significance of serum HBV RNA, such as species of serum HBV RNA, forms of serum HBV RNA carriers and predictive value for relapses in CHB patients after nucleos(t)ide analogues (NAs) discontinuation and development of liver fibrosis and HCC. Furthermore, we summarize standardized assays for testing serum HBV RNA, the dynamic changes of serum HBV RNA levels in treatment‐naïve CHB patients and those under NAs therapy, as well as the host and viral influencing factors of serum HBV RNA levels. Finally, we discuss the future perspectives in studies of serum HBV RNA.

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“…Recently, Roche has developed an automated assay on the cobas 6800/8800 platforms for the determination of HBV RNA levels in serum or plasma. 19 , 24 , 25 …”

Section: Introductionmentioning

confidence: 99%

Baseline serum HBV RNA is associated with the risk of hepatitis flare after stopping nucleoside analog therapy in HBeAg-negative participants

Thompson,

Jackson,

Bonanzinga

et al. 2023

Hepatology Communications

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Background and Aims: HBV RNA in peripheral blood reflects HBV cccDNA transcriptional activity and may predict clinical outcomes. The prospective Melbourne HBV-STOP trial studied nucleot(s)ide analog discontinuation in HBeAg-negative non-cirrhotic participants with long-term virological suppression. Ninety-six weeks after stopping treatment, the proportion of participants with virological relapse (HBV DNA > 2000 IU/mL), biochemical relapse (ALT > 2 × ULN and HBV DNA > 2000 IU/mL), or hepatitis flare (ALT > 5 × ULN and HBV DNA > 2000 IU/mL) was 89%, 58%, and 38%, respectively. We evaluated the ability of serum HBV RNA levels to predict these outcomes. Approach & Results: HBV RNA levels were measured using the Roche cobas 6800/8800 HBV RNA Investigational Assay. Sixty-five participants had baseline and longitudinal off-treatment specimens available for RNA testing. HBV RNA was detectable at baseline in 25% of participants and was associated with a higher risk of biochemical relapse (81% vs. 51%, p value 0.04) and hepatitis flare (63% vs. 31%, p value 0.04). Participants who had undetectable serum HBV RNA as well as HBsAg ≤ 100 IU/mL at baseline were less likely to experience virological relapse (4 of 9, 44%) than participants with detectable HBV RNA and HBsAg level > 100 IU/mL (15/15, 100%; p value 0.0009). Off-treatment levels of HBV RNA were correlated with HBV DNA and were associated with the risk of hepatitis flare. Conclusions: Serum HBV RNA may be a useful biomarker for guiding clinical decision-making before stopping nucleot(s)ide analog therapy. Baseline HBV RNA and HBsAg levels are associated with the risk of clinical relapse, hepatitis flare, and disease remission off-treatment.

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Standardized Hepatitis B Virus RNA Quantification in Untreated and Treated Chronic Patients: a Promising Marker of Infection Follow-Up

Abstract: This study focused on the quantification of circulating HBV RNA by using a standardized and sensitive assay. Thanks to this system we observed a higher difference between circulating HBV DNA and RNA than previously reported.

Cited by 5 publications

References 36 publications

Letter to the editor: Standardization of HBV‐RNA assay for the different phases of chronic hepatitis B is essential

Letter to the editor: Standardization of HBV‐RNA assay for the different phases of chronic hepatitis B is essential

Biogenesis of serum HBV RNA and clinical phenomena of serum HBV RNA in chronic hepatitis B patients before and after receiving nucleos(t)ide analogues therapy

Baseline serum HBV RNA is associated with the risk of hepatitis flare after stopping nucleoside analog therapy in HBeAg-negative participants

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