PMID- 32626831 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20200928 IS - 2471-254X (Electronic) IS - 2471-254X (Linking) VI - 4 IP - 7 DP - 2020 Jul TI - HBV-RNA Co-amplification May Influence HBV DNA Viral Load Determination. PG - 983-997 LID - 10.1002/hep4.1520 [doi] AB - Despite effective hepatitis B virus (HBV)-DNA suppression, HBV RNA can circulate in patients receiving nucleoside/nucleotide analogues (NAs). Current assays quantify HBV DNA by either real-time polymerase chain reaction (PCR), which uses DNA polymerase, or transcription-mediated amplification, which uses reverse-transcriptase (RT) and RNA polymerase. We assessed the effect of RT capability on HBV-DNA quantification in samples from three cohorts, including patients with quantified HBV RNA. We compared the HBV-DNA levels by real-time PCR (cobas HBV, Roche 6800/8800; Xpert HBV, Cepheid), transcription-mediated amplification (Aptima HBV, Hologic), and real-time PCR with added RT capability (cobas HBV+RT). In the first cohort (n = 45) followed over 192 weeks of NA therapy, on-treatment HBV-DNA levels were higher with cobas HBV+RT than cobas HBV (mean difference: 0.14 log(10) IU/mL). In a second cohort (n = 50) followed over 96 weeks of NA therapy, HBV-DNA viral load was significantly higher with the cobas HBV+RT and Aptima HBV compared with the cobas HBV test at all time points after initiation of NA therapy (mean difference: 0.65-1.16 log(10) IU/mL). A clinically significant difference was not detected between the assays at baseline. In a third cohort (n = 53), after a median of 2.2 years of NA therapy, we detected HBV RNA (median 5.6 log(10) copies/mL) in 23 patients (43.4%). Median HBV-DNA levels by Aptima HBV were 2.4 versus less than 1 log(10) IU/mL in samples with HBV RNA and without HBV RNA, respectively (P = 0.0006). In treated patients with HBV RNA, Aptima HBV measured higher HBV-DNA levels than Xpert HBV and cobas HBV. Conclusion: Tests including an RT step may overestimate HBV DNA, particularly in samples with low viral loads as a result of NA therapy. This overestimation is likely due to amplification of HBV RNA and may have an impact on clinical decisions. CI - (c) 2020 The Authors. Hepatology Communications published by Wiley Periodicals, Inc., on behalf of the American Association for the Study of Liver Diseases. FAU - Maasoumy, Benjamin AU - Maasoumy B AUID- ORCID: 0000-0002-3250-3177 AD - Department of Gastroenterology, Hepatology and Endocrinology Hannover Medical School Hannover Germany. AD - Center for Infection Research Hannover-Braunschweig site Braunschweig Germany. FAU - Geretti, Anna Maria AU - Geretti AM AD - Institute of Infection University of Liverpool Liverpool United Kingdom. FAU - Frontzek, Andre AU - Frontzek A AD - Labor Stein Monchengladbach Germany. FAU - Austin, Harrison AU - Austin H AD - Institute of Infection University of Liverpool Liverpool United Kingdom. FAU - Aretzweiler, Gudrun AU - Aretzweiler G AD - Labor Stein Monchengladbach Germany. FAU - Garcia-Alvarez, Monica AU - Garcia-Alvarez M AD - Hospital Universitario 12 de Octubre Madrid Spain. FAU - Leuchter, Susanne AU - Leuchter S AD - Labor Stein Monchengladbach Germany. FAU - Simon, Christian O AU - Simon CO AD - Roche Molecular Systems Pleasanton CA. FAU - Marins, Ed G AU - Marins EG AD - Roche Molecular Systems Pleasanton CA. FAU - Canchola, Jesse A AU - Canchola JA AD - Roche Molecular Systems Pleasanton CA. FAU - Cornberg, Markus AU - Cornberg M AD - Department of Gastroenterology, Hepatology and Endocrinology Hannover Medical School Hannover Germany. AD - Center for Infection Research Hannover-Braunschweig site Braunschweig Germany. AD - Center for Individualized Infection Medicine Hannover Germany. FAU - Delgado, Rafael AU - Delgado R AD - Hospital Universitario 12 de Octubre Madrid Spain. FAU - Wedemeyer, Heiner AU - Wedemeyer H AD - Department of Gastroenterology, Hepatology and Endocrinology Hannover Medical School Hannover Germany. AD - Essen University Hospital University of Duisburg-Essen Essen Germany. LA - eng PT - Journal Article DEP - 20200526 PL - United States TA - Hepatol Commun JT - Hepatology communications JID - 101695860 PMC - PMC7327219 EDAT- 2020/07/07 06:00 MHDA- 2020/07/07 06:01 PMCR- 2020/05/26 CRDT- 2020/07/07 06:00 PHST- 2019/08/12 00:00 [received] PHST- 2020/03/13 00:00 [revised] PHST- 2020/03/18 00:00 [accepted] PHST- 2020/07/07 06:00 [entrez] PHST- 2020/07/07 06:00 [pubmed] PHST- 2020/07/07 06:01 [medline] PHST- 2020/05/26 00:00 [pmc-release] AID - HEP41520 [pii] AID - 10.1002/hep4.1520 [doi] PST - epublish SO - Hepatol Commun. 2020 May 26;4(7):983-997. doi: 10.1002/hep4.1520. eCollection 2020 Jul.