scholarly journals Ropeginterferon alfa-2b every 2 weeks as a novel pegylated interferon for patients with chronic hepatitis B

2020 ◽  
Author(s):  
Yi-Wen Huang ◽  
Chao-Wei Hsu ◽  
Sheng-Nan Lu ◽  
Ming-Lung Yu ◽  
Chien-Wei Su ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Hbeag Seroconversion ◽  
Pegylated Interferon ◽  
Preliminary Evaluation ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Background Ropeginterferon alfa-2b is a novel mono-pegylated interferon that has only one major form as opposed to 8–14 isomers of other on-market pegylated interferon, allowing injection every two or more weeks with higher tolerability. It received European Medicines Agency and Taiwan marketing authorization in 2019 and 2020, for treatment of polycythemia vera. This phase I/II study aimed to have preliminary evaluation of safety and efficacy in chronic hepatitis B. Methods Thirty-one HBeAg-positive and 31 HBeAg-negative were stratified by HBeAg status and randomized at 1:1:1 ratio to q2w ropeginterferon alfa-2b 350 μg (group 1), q2w 450 μg (group 2) or q1w PEG-IFN alfa-2a 180 μg (group 3). Each patient received 48-week treatment (TW48) and 24-week post-treatment follow-up (FW24). Results The baseline demographics were comparable among the three groups, except for mean HBeAg in HBeAg-positive patients (2.90, 2.23, 2.99 log10 S/CO, respectively). Cumulative HBeAg seroconversion rate at follow-up period was 27.3% (3/11), 36.4% (4/11), and 11.1% (1/9) with time to HBeAg seroconversion starting from TW24, TW16, and TW48 in group 1, 2, and 3, respectively. The rate of HBV DNA < 2000 IU/mL and HBsAg levels < 1500 IU/mL at FW24 were comparable in all groups. Ropeginterferon alfa-2b (group 1 & 2) had numerically lower incidence of rash (9.5% and 4.5%) as compared to PEG-IFN alfa-2a (36.8%). Ropeginterferon alfa-2b 350 μg (group 1) had more ALT elevation (38.1%), however the rate was comparable in group 2 (9.1%) and group 3 (10.5%). Conclusion In this preliminary study, ropeginterferon alfa-2b, although in only half the number of injections, is as safe and effective as pegylated interferon alfa-2a for chronic hepatitis B. Graphic abstract

scholarly journals Prior Exposure to Lamivudine Increases Entecavir Resistance Risk in Chronic Hepatitis B Patients without Detectable Lamivudine Resistance

2014 ◽  
Vol 58 (3) ◽  
pp. 1730-1737 ◽  
Author(s):  
Jeong-Hoon Lee ◽  
Yuri Cho ◽  
Dong Hyeon Lee ◽  
Minjong Lee ◽  
Jeong-ju Yoo ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Tertiary Hospital ◽  
Lamivudine Resistance ◽  
Genotypic Resistance ◽  
Resistance Risk ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

ABSTRACTThe efficacy of entecavir (ETV) treatment in chronic hepatitis B (CHB) patients who were exposed to lamivudine (LAM) but had no detectable LAM resistance (LAM-R) is not well evaluated. In this study, we aimed to evaluate whether the probability of developing genotypic resistance to ETV in LAM-exposed patients with or without LAM-R is comparable to that in antiviral-naive patients. This retrospective cohort study included 500 consecutive patients with CHB who started ETV monotherapy at a single tertiary hospital in Korea. The patients were divided into three groups: nucleos(t)ide analogue (NA)-naive patients (group 1,n= 142), patients who were previously exposed to LAM and had no currently or previously detected LAM-R (group 2,n= 233), and patients with LAM-R when starting ETV (group 3,n= 125). The overall median ETV treatment duration was 48.7 months. The probabilities of virologic breakthrough were significantly increased not only in group 3 (hazard ratio [HR] = 14.4,P< 0.001) but also in group 2 (HR = 5.0,P< 0.001) compared to group 1. Genotypic ETV resistance (ETV-R) developed more frequently in group 2 (HR = 13.0,P= 0.013) as well as group 3 (HR = 43.9,P< 0.001) than in group 1: the probabilities of developing ETV-R in groups 1, 2, and 3 were <1.0%, 8.0%, and 28.2%, respectively, at month 48. The results of this study indicate that ETV-R occurred more frequently in LAM-exposed patients, even though they had no detectable LAM-R, than in NA-naive patients. Therefore, LAM-exposed CHB patients, regardless of the presence or absence of LAM-R, should be monitored more cautiously for the development of ETV-R during ETV monotherapy.

scholarly journals EFFICACY AND SAFETY OF OZONE THERAPY FOR PATIENTS WITH CHRONIC HEPATITIS B: A MULTICENTER, RANDOMIZED CLINICAL TRIAL

2018 ◽  
Vol 2 (2) ◽  
Author(s):  
Hong Yu ◽  
Pingyan Chen ◽  
Jilin Chen ◽  
Wei Dai ◽  
Zhimin Wu ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Hbeag Seroconversion ◽  
Virologic Response ◽  
Hbv Dna ◽  
Ozone Therapy ◽  
Group 2 ◽  
Medical Ozone ◽  
Group 1

Background: Ozone therapy has a long history. Some studies proved that ozone therapy was useful in treatment of virus hepatitis.Objective: To evaluate the efficacy and safety of new medical ozone therapy system for the treatment of chronic hepatitis B.Method One hundred eighty-nine patients with chronic hepatitis B were included in this open-label, phase 3 study, and randomly assigned to receive ozone autohemotherapy with experimental ozone generator TianYi (group 1) or with ozone generator Humares (group 2) or oral diammonium glycyrrhizinate capsules (group 3) in a 1:1:1 ratio for 12 weeks. The primary efficacy end point was sera HBV DNA level of less than 1×103 IU/ml or having a more than 2 log10 reduction in HBV DNA level at the end of 12 weeks treatment as compared to baseline HBV DNA level. Secondary end points included HBeAg seroconversion, biochemical response, and combined response.Results At the end of 12 weeks treatment, the proportion of patients reached the primary end point of virologic response in group 1, group 2, and group 3 were 22.4% (13/58, 95% CI, 12.5 to 35.3), 14.7 (9/61, 95% CI, 7.0 to 26.2) and 3.9% (2/51, 95% CI, 0.5 to 13.5), respectively (p=0.021) in the pre-protocol population. Virologic response occurred in more patients receiving ozone therapy with experimental device than patients receiving oral diammonium glycyrrhizinate capsules (mean difference 18.5%, 95% CI 6.3 to 31.5, p=0.005). However, there was no statistical difference in VR12 rates between the treatment of medical ozone therapy system with experimental device (group 1) and with Humares (group 2) (mean difference 7.7%, 95% CI -6.5 to 22.0, p=0.282). More HBeAg seroconversion in patients treated by Tianyi ozone therapy system than those treated by Humares ozone therapy device and oral diammonium glycyrrhizinate capsules (14.8%, 5.1% and 7.3%, respectively, P = 0.272). Higher biochemical response rate was observes in patients receiving ozone therapy than oral diammonium glycyrrhizinate capsules (31.6%, 36.7% and 24.0%, respectively, p = 0.359). The safety profile was similar for the three treatment groups and adverse events were .scare infrequent and mild.Conclusions: Ozone therapy had superior antiviral efficacy with a similar safety profile as compared with oral diammonium glycyrrhizinate capsules through week 12 treatment. Ozone therapy is also associated with normalized ALT and AST levels, demonstrating that ozone therapy could benefit the patients with chronic hepatitis B.

scholarly journals Comparison of Serum Hepatitis B Virus RNA Levels and Quasispecies Evolution Patterns between Entecavir and Pegylated-Interferon Mono-treatment in Chronic Hepatitis B Patients

2020 ◽  
Vol 58 (9) ◽  
Author(s):  
Xiao-qi Yu ◽  
Ming-jie Wang ◽  
De-min Yu ◽  
Pei-zhan Chen ◽  
Ming-yu Zhu ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Hbeag Seroconversion ◽  
Pegylated Interferon ◽  
Hbv Dna ◽  
Interferon Treatment ◽  
B Virus ◽  
Quasispecies Evolution ◽  
Rna Levels

ABSTRACT Hepatitis B virus (HBV) RNA may independently predict virological and serological response. This study aimed to compare dynamic changes in serum HBV RNA levels and HBV quasispecies evolution patterns between entecavir and pegylated-interferon mono-treatment in chronic hepatitis B patients and to determine the clinical significance during treatment. TaqMan real-time PCR was used for quantitative analysis. HBV RNA levels were retrospectively determined in serial serum samples from 178 chronic hepatitis B patients who received either entecavir or pegylated-interferon treatment. Both serum HBV DNA and RNA quasispecies were analyzed via next-generation sequencing. Receiver operating characteristics (ROC) analysis was performed to evaluate the prediction value of individual biomarkers for hepatitis B e antigen (HBeAg) seroconversion. Patients who received pegylated-interferon treatment showed stronger declines in HBV RNA levels than did those who received entecavir treatment. Serum HBV RNA levels were lower in patients with subsequent HBeAg seroconversion. At baseline, the level of HBV RNA was better than other indicators in predicting HBeAg seroconversion. Moreover, the predictive value of serum HBV RNA levels was better in the entecavir group. Baseline HBV RNA exhibited a significantly higher genetic diversity than HBV DNA and had a significant decline after 4 weeks of entecavir treatment. Higher baseline genetic diversity may result in a better outcome in pegylated-interferon-treated patients. Serum HBV RNA levels showed different decline kinetics, and HBV RNA quasispecies showed different evolution patterns in entecavir and pegylated-interferon mono-treatment. Taken together, serum HBV RNA may serve as a promising biomarker of HBeAg seroconversion in patients during antiviral treatment.

scholarly journals Genetic variation in the vitamin D pathway CYP2R1 gene predicts sustained HBeAg seroconversion in chronic hepatitis B patients treated with pegylated interferon: A multicenter study

PLoS ONE ◽  
2017 ◽  
Vol 12 (3) ◽  
pp. e0173263 ◽  
Author(s):  
Kessarin Thanapirom ◽  
Sirinporn Suksawatamnuay ◽  
Wattana Sukeepaisarnjareon ◽  
Tawesak Tanwandee ◽  
Phunchai Charatcharoenwitthaya ◽  
...  
Keyword(s):  
Vitamin D ◽  
Genetic Variation ◽  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Multicenter Study ◽  
Hbeag Seroconversion ◽  
Pegylated Interferon

scholarly journals Liver Histopathological Features Influencing HBeAg Seroconversion in Patients with HBeAg-positive Chronic Hepatitis B Treated with Pegylated Interferon α

2014 ◽  
Vol 3 (1) ◽  
pp. 10-15
Author(s):  
Yao-ren Hu ◽  
Hua-dong Yan ◽  
Guo-sheng Gao ◽  
Cheng-liang Zhu ◽  
Ji-fang Cheng
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Hbeag Seroconversion ◽  
Pegylated Interferon ◽  
Interferon Α ◽  
Binary Logistic Regression Analysis ◽  
Liver Inflammation ◽  
Histopathological Features ◽  
Positive Chronic Hepatitis

Abstract Objective To investigate the efficiency of pegylated interferon α therapy for patients with HBeAg-positive chronic hepatitis B (CHB) and explore whether liver histopathological features and other factors might influence HBeAg seroconversion. Methods Total of 80 HBeAg-positive CHB patients who received liver puncture were treated with pegylated interferon α once a week for 48 weeks. The rate of HBeAg seroconversion was determined after therapy, and the factors influencing HBeAg seroconversion were analyzed. Results The rate of HBeAg seroconversion was 30.00％ at the end of treatment. The rate of HBeAg seroconversion gradually increased with the elevation of liver inflammatory activity (χ2 = 9.170, P = 0.027). But liver fibrosis has little correlation with the rate of HBeAg seroconversion (χ2 = 5.917, P = 0.116). Except HBeAg, other baseline indexes including gender, age, serum ALT and serum HBV DNA 1evels had no statistical difference between the patients with HBeAg seroconversion and the patients without HBeAg seroconversion. By binary logistic regression analysis, liver inflammation and HBeAg were influencing factors for HBeAg seroconversion. Conclusions Pegylated interferon α therapy induces a higher rate of HBeAg seroconversion in HBeAg-positive chronic hepatitis B patients with severe liver inflammation, so the liver biopsies should be performed in time.

scholarly journals A new therapeutic option for chronic hepatitis B: Reduced dose and shorter duration of a combination therapy with pegylated interferon and entecavir

2019 ◽  
Vol 45 (3) ◽  
pp. 143-148
Author(s):  
Mamun Al Mahtab ◽  
Shahina Tabassum ◽  
Afzalun Nesa ◽  
Munira Jahan ◽  
Md. Sakirul Islam Khan ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Standard Dose ◽  
Pegylated Interferon ◽  
Hbv Dna ◽  
Control Group ◽  
Control Groups ◽  
Reduced Dose ◽  
Group 2 ◽  
Group 1

Background: Although several drugs are available for treatment of chronic hepatitis B (CHB), the outcome is still far from being satisfactory. The study was conducted to develop a therapeutic strategy for CHB by a combination therapy with reduced dose and duration of antiviral drugs. Objectives: Therapeutic effects of reduced dose and shorter duration of combination of pegylated interferon (Peg-IFN) and entecavir were evaluated in patients with CHB with two control groups. Methods: Fifty-four patients with CHB were treated with reduced dose of Peg-IFN (90 microgram in spite of standard dose of 180 microgram) and standard dose of entecavir (0.5 mg) for reduced duration of 24 weeks (Case of group). There were two control groups that adhered to inclusion and exclusion criteria. Patients of Control group-1 (n=50) received regular doses (180 microgram) of Peg-IFN, once weekly for 48 consecutive weeks. Patients of Control group-2 (n=50) were treated with regular does of entecavir (0.5 mg, daily) for 48 weeks. Results: The treatment regimens were safe for all patients. At the end of therapy (EOT), hepatitis B virus DNA negativity (HBV DNA <250 copies/mL) was found in 67%, 50% and 80% of patients of Control Group-1, Control group-2, and case group, respectively. HBV DNA negativity was found in more patients in cases (89% from 67%) 24 weeks after EOT. However, it declined in patients of Control group-1 (80% to 56%) and remained almost similar in Control group-2 (50% versus 56%). There was no significant difference in alanine transaminase (ALT) negativity and hepatitis E antigen (HBeAg) seronegativity among 3 groups at EOT and 24 weeks after EOT. Conclusion: A patient-friendlytherapeutic strategy with reduced dose of Peg-IFN and regular dose of entecavir for shortened duration for CHB patientshave been documented and it would be also cheap for usage of patients with CHB.

1012 TELBIVUDINE-INDUCED HBEAG SEROCONVERSION IN CHRONIC HEPATITIS B (CHB) IS DURABLE DURING 2 YEARS OFF-TREATMENT FOLLOW-UP

2010 ◽  
Vol 52 ◽  
pp. S391 ◽  
Author(s):  
Y.-F. Liaw ◽  
K. Wursthorn ◽  
S. Thongsawat ◽  
X.-Q. Zhou ◽  
S.G. Hwang ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Hbeag Seroconversion
Sign in / Sign up

Export Citation Format

Share Document