scholarly journals Stability of hepatitis B virus pregenomic RNA in plasma specimens under various temperatures and storage conditions

PeerJ ◽  
2021 ◽  
Vol 9 ◽  
pp. e11207
Author(s):  
Pakkapon Rattanachaisit ◽  
Sirinporn Suksawatamnuay ◽  
Supachaya Sriphoosanaphan ◽  
Kessarin Thanapirom ◽  
Panarat Thaimai ◽  
...  
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Room Temperature ◽  
Plasma Samples ◽  
Freeze Thaw ◽  
B Virus ◽  
The Mean ◽  
Clinically Significant ◽  
The Stability ◽  
And Storage

Background Hepatitis B virus (HBV) pregenomic RNA (pgRNA) has gained increasing attention owing to its role in replication of covalently closed circular DNA (cccDNA) in HBV. This marker has the potential to be used in clinical programs aimed to manage HBV infections. However, several reports on HBV pgRNA levels in clinical cases have conflicting results. RNA is easily degraded when exposed to heat and other environmental stressors. However, the stability of HBV pgRNA, during blood sample collection before the standard automated quantification, has never been estimated. This study aimed to demonstrate the effect of two different temperature conditions and storage durations on the stability of HBV pgRNA. Method Blood from forty patients with chronic hepatitis B infection, who also showed evidence of active HBV DNA replication, was collected and processed within 2 h of collection. Plasma from each patient was divided and stored at 4 °C and 25 °C (room temperature) for six different storage durations (0, 2, 6, 12, 24, and 48 h) and subsequently transferred to −80 °C for storage. The effect of multiple cycles of freezing and thawing of plasma at −20 °C or −80 °C was evaluated using samples from ten patients. Quantification of pgRNA from the samples was performed simultaneously, using the digital polymerase chain reaction (dPCR) method. The differences in pgRNA levels at baseline and each time point were compared using generalized estimating equation (GEE). A change greater than 0.5 log10 copies/mL of pgRNA is considered clinically significant. Statistical analyses were conducted using Stata 16.0. Results The mean HBV pgRNA level in the initially collected plasma samples was 5.58 log10copies/mL (ranging from 3.08 to 8.04 log10 copies/mL). The mean pgRNA levels in samples stored for different time periods compared with the initial reference sample (time 0) significantly decreased. The levels of pgRNA for 6, 12, 24, and 48 h of storage reduced by −0.05 log10 copies/mL (95% confidence interval (CI) −0.095 to −0.005, p = 0.03), −0.075 log10 copies/mL (95% CI [−0.12 to −0.03], p = 0.001), −0.084 log10 copies/mL (95% CI [−0.13 to −0.039], p =  < 0.001), and −0.120 log10 copies/mL (95% CI [−0.17 to −0.076], p =  < 0.001), respectively. However, these changes were below 0.5 log10 copies/mL and thus were not clinically significant. Compared with the samples stored at 4 °C, there were no significant differences in pgRNA levels in samples stored at 25 °C for any of the storage durations (−0.01 log10 copies/mL; 95% CI [−0.708 to 0.689], p = 0.98). No significant difference in the levels of pgRNA was observed in the plasma samples, following four freeze-thaw cycles at −20 °C and −80 °C. Conclusion The plasma HBV pgRNA level was stable at 4 °C and at room temperature for at least 48 h and under multiple freeze-thaw cycles. Our results suggest that pgRNA is stable during the process of blood collection, and therefore results of pgRNA quantification are reliable.

scholarly journals Duck hepatitis B virus: a model to assess efficacy of disinfectants against hepadnavirus infectivity

1991 ◽  
Vol 106 (3) ◽  
pp. 435-443 ◽  
Author(s):  
S. M. Murray ◽  
J. S. Freiman ◽  
K. Vickery ◽  
D. Lim ◽  
Y. E. Cossart ◽  
...  
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Room Temperature ◽  
Virus Titre ◽  
Experimental Protocol ◽  
Duck Hepatitis B Virus ◽  
Duck Hepatitis ◽  
B Virus ◽  
Undiluted Serum ◽  
Sterile Filter

SUMMARYThe efficacy of three proprietary glutaraldehyde disinfectants and their component bases was assessed using the duck hepatitis B virus (DHBV) model. Inactivation of infectivity of undiluted serum containing 106·8ID50/ml DHBV was assessed after a mixture with an equal volume of disinfectant had stood at room temperature for 10 min. A dried spill of infectious serum was simulated using sterile filter paper disks, saturated with serum containing DHBV, dried and then exposed to test disinfectant for 10 min. Residual infectivity, and hence the reduction in virus titre, was determined by inoculation of dilutions of the treated samples into 1-day-old ducklings. A greater than 3 log10reduction in virus titre could be demonstrated for the disinfectants as well as for some of their component bases. Disinfectant activity varied according to the method of viral presentation but a reduction of exposure time from 10 to 2·5 min did not diminish activity. The experimental protocol permits a comparative and quantitative assessment of the efficacy of both established and new disinfectants.

Safety, tolerability, and pharmacokinetics of the novel hepatitis B virus capsid assembly modulator GST-HG141 in healthy Chinese subjects: a first-in-human single- and multiple-dose escalation trial

2021 ◽  
Author(s):  
Cuiyun Li ◽  
Min Wu ◽  
Hong Zhang ◽  
Jiajia Mai ◽  
Lizhi Yang ◽  
...  
Keyword(s):  
Steady State ◽  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Maximum Plasma ◽  
Capsid Assembly ◽  
Virus Capsid ◽  
B Virus ◽  
The Mean ◽  
Healthy Chinese ◽  
Chinese Subjects

Background: Hepatitis B virus capsid assembly modulators (HBV CAMs) are promising, clinically validated therapeutic agents for the treatment of chronic hepatitis B (CHB). The safety, tolerability, and pharmacokinetic (PK) profiles of GST-HG141, a novel HBV CAM, were evaluated in healthy Chinese volunteers. Method: This phase Ia study included two parts: a double-blinded, randomized, placebo-controlled single-ascending-dose (SAD) (50, 100, 200, 300, 400, or 500 mg) study comprising a food-effect investigation (300 mg), and a multiple-ascending-dose (MAD) (100 or 200 mg BID) study. Result: GST-HG141 reached the maximum plasma concentration (C max ) at 1.25–3.00 h (median T max ). The exposure exhibited a linear increase, while the mean half-life (t 1/2 ) ranged from 13.096 h to 22.121 h. The exposure of GST-HG141 (300 mg) was higher after food intake by about 2.4-fold. In the MAD study, steady-state was reached at around day 5, and the mean trough steady-state concentrations were 423 and 588 ng/mL for 50 and 100mg cohorts, respectively. The ratios of GST-HG141 accumulation were <1.5. GST-HG141 was well tolerated in healthy Chinese subjects. The rates of adverse events (AEs) in the GST-HG141 cohort did not differ from those of the placebo cohort. Conclusion: GST-HG141 was tolerated in healthy Chinese subjects. The safety and PK profiles of GST-HG141 support the further evaluation of its efficacy in individuals with CHB.

scholarly journals Dynamic Analysis of a Fractional-Order Model for Hepatitis B Virus with Holling II Functional Response

Complexity ◽  
2019 ◽  
Vol 2019 ◽  
pp. 1-13 ◽  
Author(s):  
Ruiqing Shi ◽  
Ting Lu ◽  
Cuihong Wang
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Fractional Order ◽  
Reproduction Number ◽  
Sufficient Conditions ◽  
Order Model ◽  
Fractional Order Model ◽  
B Virus ◽  
The Stability ◽  
Holling Ii Functional Response

In this paper, a fractional-order model is constructed to describe the transmission of Hepatitis B Virus (HBV). Firstly, the existence and uniqueness of positive solutions are proved. Secondly, the basic reproduction number and the sufficient conditions for the existence of two equilibriums are obtained. Thirdly, the stability of equilibriums are analyzed. After that, some numerical simulations are performed to verify the theoretical prediction. Finally, a brief discussion is presented.

scholarly journals Comparison of Telbivudine and Entecavir Therapy on Nephritic Function and Drug Resistance in Patients with Hepatitis B Virus-Related Compensated Cirrhosis

2016 ◽  
Vol 40 (1-2) ◽  
pp. 370-378 ◽  
Author(s):  
Huajiang Shen ◽  
Feng Ding ◽  
Zhiwei Wang ◽  
Fang Sun ◽  
Yafeng Yu ◽  
...  
Keyword(s):  
Drug Resistance ◽  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Function Method ◽  
Filtration Rate ◽  
Resistance Rate ◽  
Compensated Cirrhosis ◽  
B Virus ◽  
The Mean ◽  
The Impact

Background: To compare the impact of telbivudine (LDT) and entecavir (ETV) administration on nephritic function. Method: One hundred thirty patients diagnosed with hepatitis B virus (HBV)-related compensated cirrhosis were randomly divided into LDT (600 mg/d) or ETV (0.5 mg/d) groups. Results: The drug resistance rate was higher following LDT treatment compared to ETV treatment (16.9% vs. 1.5%, P=0.0006). The mean creatinine level decreased compared to baseline in the LDT group (0.81 vs. 0.94 mg/dl, P=0.000). The change in median glomerular filtration rate (eGFR) compared to baseline in the LTD and ETV groups was 22.3 and -3.3, respectively, at 2 years (P=0.000). In patients with mild nephritic injury (eGFR< 90 ml/min/1.73m2), the median eGFR increased by 28.0 ml/min/1.73m2 in the LDT group and decreased by 4.3 ml/min/1.73m2 in the ETV group (p=0.000). The eGFR in 88.5% of patients (23/26) from the LDT group increased > 90 ml/min/1.73m2. The percentage of patients with an eGFR > 90 ml/min/1.73m2 increased from 60.0% to 92.3% in the LDT group and from 64.6% to 69.2% in the ETV group. Conclusion: In patients with HBV-related compensated cirrhosis, LDT treatment was more effective in protecting nephritic function and was associated with a higher drug resistance rate, but did not contribute to a better outcome compared with ETV treatment.

scholarly journals EFFECT OF HEPATITIS-B VIRUS CO-INFECTION ON CD4 CELL COUNT AND LIVER FUNCTION OF HIV INFECTED PATIENTS

2019 ◽  
Vol 3 (7) ◽  
Author(s):  
Dr. Shakeel Ahamed ◽  
Dr. Geeta Parihar
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Liver Function ◽  
Cd4 Count ◽  
Abnormal Liver Function Test ◽  
Cd4 Cell Count ◽  
Keywords Hiv ◽  
Chronic Hepatitis B Virus ◽  
B Virus ◽  
The Mean

Background: Liver disease caused by chronic hepatitis B virus (HBV) is emerging as a significant cause of morbidity and mortality among human immunodeficiency virus (HIV)-infected individuals. Methods: This study is conducted in J. L. N. Medical College & Associated groups of Hospitals patients attending from ICTC (G). 500 samples are taken randomly from January 2018 to June 2018 Results: In the co-infected patients, ALT, AST and ALP were higher than normal. The mean serum level of ALT, AST and ALP were significantly higher in the co infected patients than in the HIV mono infected patients. The mean level of CD4+ count was significantly lower in the co infected patients than in the HIV mono infected patients. Conclusion: Hepatitis B virus co-infected HIV positive patients are more likely to have abnormal liver function test than the mono-infected patients. Keywords: HIV, Hepatitis B, CD4 count, co-infection

scholarly journals The Stability of Hepatitis B Virus Antigen and HBV-DNA Contents in Injectable Drug Solutions.

1999 ◽  
Vol 25 (6) ◽  
pp. 621-626
Author(s):  
RYO MATSUSHITA ◽  
MARIKO ASAHI ◽  
FUJIO ICHIMURA ◽  
TAKUMA HASHIMOTO ◽  
EIKI MATSUSHITA ◽  
...  
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Virus Antigen ◽  
Hbv Dna ◽  
Injectable Drug ◽  
B Virus ◽  
Dna Contents ◽  
The Stability

scholarly journals Effect of Multiple Freeze-Thaw Cycles on Hepatitis B Virus DNA and Hepatitis C Virus RNA Quantification as Measured with Branched-DNA Technology

1999 ◽  
Vol 37 (6) ◽  
pp. 1683-1686 ◽  
Author(s):  
Mel Krajden ◽  
James M. Minor ◽  
Oretta Rifkin ◽  
Lorraine Comanor
Keyword(s):  
Hepatitis C Virus ◽  
Hepatitis C ◽  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Hbv Dna ◽  
Hcv Rna ◽  
Freeze Thaw ◽  
Rna Quantification ◽  
B Virus ◽  
Rna Levels

Quantification of hepatitis B virus (HBV) DNA and hepatitis C virus (HCV) RNA often is performed in specimens that have been frozen and thawed more than once. To ensure optimal therapeutic and prognostic value, it is important to establish whether viral load measurements are affected by repeated freeze-thaw (FT) cycles. We therefore evaluated the effect of multiple FT cycles on HBV DNA and HCV RNA quantification by testing serum specimens subjected to one (baseline), two, four, and eight FT cycles with the appropriate Chiron Quantiplex assay. Linear regression analysis showed minor increases of 1.7% per FT cycle for both HBV DNA and HCV RNA. The rise in HCV RNA levels was more pronounced among low-concentration samples, since further analysis revealed an increase of 3.2% per FT cycle among samples with 0.2 to 3.86 Meq of HCV RNA per ml. Given that the coefficient of variation for the Quantiplex assays is generally 10 to 15%, the minor increases in HBV DNA and HCV RNA levels with progressive FT cycles for the specimens tested were recognized only because analysis of variance revealed a statistically significant trend (P < 0.05). Due to the minor statistical trend, the clinical impact for individual patient specimens is likely to be limited, but it may deserve further study. In conclusion, the concentration of HBV DNA and HCV RNA in serum specimens subjected to up to eight short-term FT cycles was stable.

scholarly journals Crystal structure, Hirshfeld analysis and a molecular docking study of a new inhibitor of the Hepatitis B virus (HBV): ethyl 5-methyl-1,1-dioxo-2-{[5-(pentan-3-yl)-1,2,4-oxadiazol-3-yl]methyl}-2H-1,2,6-thiadiazine-4-carboxylate

2020 ◽  
Vol 76 (1) ◽  
pp. 12-17 ◽  
Author(s):  
Alexandre V. Ivachtchenko ◽  
Sergiy M. Kovalenko ◽  
Dmitry V. Kravchenko ◽  
Oleg D. Mitkin ◽  
Vladimir V. Ivanov ◽  
...  
Keyword(s):  
Molecular Docking ◽  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Title Compound ◽  
Molecular Docking Study ◽  
Compound C ◽  
Potential System ◽  
B Virus ◽  
The Mean

The title compound, C15H22N4O5S, was prepared via alkylation of 3-(chloromethyl)-5-(pentan-3-yl)-1,2,4-oxadiazole in anhydrous dioxane in the presence of triethylamine. The thiadiazine ring has an envelope conformation with the S atom displaced by 0.4883 (6) Å from the mean plane through the other five atoms. The planar 1,2,4-oxadiazole ring is inclined to the mean plane of the thiadiazine ring by 77.45 (11)°. In the crystal, molecules are linked by C—H...N hydrogen bonds, forming chains propagating along the b-axis direction. Hirshfeld surface analysis and two-dimensional fingerprint plots have been used to analyse the intermolecular contacts present in the crystal. Molecular docking studies were use to evaluate the title compound as a potential system that interacts effectively with the capsid of the Hepatitis B virus (HBV), supported by an experimental in vitro HBV replication model.

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