scholarly journals TDF Monotherapy Is Effective Regardless of Prior Nucleos(t)ide Analogue Treatment in Chronic Hepatitis B Patients in China

2017 ◽  
Vol 2017 ◽  
pp. 1-8
Author(s):  
Mingxing Huang ◽  
Guoli Lin ◽  
Hong Shi ◽  
Yuankai Wu ◽  
Yusheng Jie ◽  
...  

Background/Aims. Many patients had to transfer to tenofovir disoproxil fumarate (TDF) if there is other nucleos(t)ide analogue (NA) resistance. We aimed to investigate antiviral effects of TDF monotherapy between NA-naive and NA-experienced chronic hepatitis B (CHB) patients in China. Methods. A total of 102 NA-naive and NA-experienced CHB patients with TDF monotherapy (300 mg/day) were retrospectively analyzed for useful parameters up to 72 weeks. Results. There were 36 and 66 patients with matched HBV DNA baseline level in NA-naïve and NA-experienced group, respectively. There were no significant differences between NA-naïve and NA-experienced groups in HBV DNA levels (all P>0.05) and HBV DNA undetectable rates (all P>0.05) at all time points. At the end of follow-up, HBV DNA undetectable rates in NA-naïve and NA-experienced group were 96.2% (25/26) and 91.8% (45/49), respectively (P=0.476). Baseline HBV DNA level was the only independent predictor for HBV DNA negative time (P=0.018). In addition, 27.8% (5/18) and 11.4% (4/35) achieved HBeAg seroconversion at the end of the follow-up, respectively (P=0.133). Conclusions. TDF monotherapy was effective regardless of prior NA experienced. Baseline HBV DNA was a key predictive factor for HBV DNA negative time in TDF monotherapy.

Author(s):  
Yi-Wen Huang ◽  
Chao-Wei Hsu ◽  
Sheng-Nan Lu ◽  
Ming-Lung Yu ◽  
Chien-Wei Su ◽  
...  

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


2015 ◽  
Vol 2015 ◽  
pp. 1-12 ◽  
Author(s):  
Zhe Chen ◽  
Xiao Ma ◽  
Yanling Zhao ◽  
Jiabo Wang ◽  
Yaming Zhang ◽  
...  

Objective. To evaluate the efficacy and safety of Kushenin (KS) combined with nucleoside analogues (NAs) for chronic hepatitis B (CHB).Methods. Randomized controlled trials (RCTs) of KS combined with NAs for CHB were identified through 7 databases. Frequencies of loss of serum HBeAg, HBeAg seroconversion, undetectable serum HBV-DNA, ALT normalization, and adverse events at 48 weeks were abstracted by two reviewers. The Cochrane software was performed to assess the risk of bias in the included trials. Data were analyzed with Review Manager 5.3 software.Results. 18 RCTs involving 1684 subjects with CHB were included in the analysis. KS combined with NAs including lamivudine (LAM), entecavir (ETV), adefovir dipivoxil (ADV), and telbivudine (TLV) showed different degree of improvement in CHB indices. KS combined with NAs increased the frequency of loss of serum HBeAg, HBeAg seroconversion, undetectable HBV-DNA levels, and ALT normalization compared with single agents. It also decreased serum ALT and AST level after one-year treatment. However, KS combined with TLV did not show a significant difference in CHB indices. The side-effects of KS combined with NAs were light and of low frequency.Conclusion. KS combined with NAs improves the efficacy of NAs in CHB.


2000 ◽  
Vol 7 (2) ◽  
pp. 298-300 ◽  
Author(s):  
Harald H. Kessler ◽  
Sabine Preininger ◽  
Evelyn Stelzl ◽  
Elisabeth Daghofer ◽  
Brigitte I. Santner ◽  
...  

ABSTRACT The level of hepatitis B virus (HBV) DNA in serum reflects the replicative activity of HBV. To compare serum HBV DNA levels in different states of hepatitis B, 47 sera of patients with HBeAg-positive chronic hepatitis B, 4 sera of patients with HBeAg-negative chronic hepatitis B, 40 samples of patients after HBeAg seroconversion during alpha interferon treatment, 57 sera of inactive HBsAg carriers, and 42 sera of patients who had recovered from chronic hepatitis B more than 12 months prior to blood collection were checked for the presence of HBV DNA with the Amplicor HBV Monitor Test. In patients with HBeAg-positive chronic hepatitis B, the median of serum HBV DNA levels (8.3 × 108 copies/ml) was significantly higher than that for patients after HBeAg seroconversion (6.2 × 103 copies/ml) and than that for inactive HBsAg carriers (5.6 × 103 copies/ml). None of the patients who had recovered from hepatitis B had detectable HBV DNA in serum. Quantitative PCR proved to be a valuable tool for identification of different states of HBV infection. This technique was found to be a good method for determination of serum HBV DNA levels both for patients with HBeAg seroconversion and for inactive carriers who showed low viremia not detectable by conventional hybridization assays.


2020 ◽  
Vol 58 (9) ◽  
Author(s):  
Xiao-qi Yu ◽  
Ming-jie Wang ◽  
De-min Yu ◽  
Pei-zhan Chen ◽  
Ming-yu Zhu ◽  
...  

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.


2009 ◽  
Vol 53 (12) ◽  
pp. 5134-5140 ◽  
Author(s):  
Pham Thi Le Hoa ◽  
Nguyen Tien Huy ◽  
Le The Thu ◽  
Cao Ngoc Nga ◽  
Kazuhiko Nakao ◽  
...  

ABSTRACT The aim of the current study was to evaluate viral suppression following combined treatment with an S/pre-S1/pre-S2 vaccine and lamivudine in patients with chronic hepatitis B. We established a randomized, controlled clinical trial to compare the responses of three different treatment groups: those receiving vaccine monotherapy, lamivudine monotherapy, or combination treatment. Viral response was evaluated via hepatitis B virus (HBV) DNA suppression using different levels of classification. Seroconversion was evaluated via HBeAg loss, HBeAg seroconversion, HBsAg loss, and anti-HBs response. We found that the group receiving combination treatment demonstrated a significant increase in viral suppression over that for the lamivudine or vaccine monotherapy group, although the HBeAg seroconversion rate was not different. This enhanced suppression effect in the combination group was reversed after the discontinuation of vaccine treatment, suggesting that booster doses are required for a sustained viral response. Anti-HBs was detected in 55/120 vaccine recipients, but only 3 patients demonstrated HBsAg loss, indicating that the vaccine-induced anti-HBs was unable to completely neutralize HBsAg in the serum. At the study end point, anti-HBs responders showed significantly higher HBeAg seroconversion rates, greater suppression of HBV DNA levels, and a lower median reduction in HBV DNA levels than those of anti-HBs nonresponders. Our results suggest that combined treatment with the vaccine and lamivudine was significantly more effective than lamivudine monotherapy in the short term and was especially successful in producing viral suppression and an enhanced anti-HBs antibody response.


2015 ◽  
Vol 62 ◽  
pp. S545-S546
Author(s):  
W.P. Brouwer ◽  
H.L.-Y. Chan ◽  
M.R. Brunetto ◽  
M. Martinot-Peignoux ◽  
P. Arends ◽  
...  

2012 ◽  
Vol 1 (4) ◽  
pp. 216-223
Author(s):  
Zhen Ye ◽  
Min Zhao ◽  
He Jiao ◽  
Yang Feng ◽  
Ying-zi Li ◽  
...  

Objective To evaluate the therapeutic effects of telbivudine and entecavir on patients with chronic hepatitis B by meta-analysis method. Methods Databases including the Cochrane Library, PubMed, EMBASE and HighWire were searched from January 2008 to October 2012. Randomized controlled trials on treatment of chronic hepatitis B with telbivudine and entecavir were included. According to the Cochrane systematic reviews, the methodological quality of the included studies was evaluated and effective data was extracted from these studies and analyzed. Results Six studies were included eventually. The telbivudine group included 417 cases and the entecavir group included 396 cases. For 12-week antiviral treatment of chronic hepatitis B, the rate of undetectable HBV DNA was 39.1% with telbivudine and 38.6% with entecavir [OR = 1.04, 95% CI (0.62, 1.73), P > 0.05]; for treatment of HBeAg (+) hepatitis B, the HBeAg clearance rate was 23.8% with telbivudine and 3.8% with entecavir [OR= 8.07, 95% CI (2.69, 24.21), P < 0.05], and the HBeAg seroconversion rate was 6.7% with telbivudine and 3.8% with entecavir [OR = 4.95, 95% CI (1.60, 15.31), P < 0.05]; the ALT normalization rate was 54.3% with telbivudine and 58.5% with entecavir [OR = 0.84, 95% CI (0.49, 1.45), P > 0.05]; and for early-stage treatment, the incidence of adverse events was 17.2% with telbivudine and 22.0% with entecavir [OR = 0.66, 95% CI (0.33, 1.32), P > 0.05]. For 1-year antiviral treatment of chronic hepatitis B, the rate of undetectable HBV DNA was 79.4% with telbivudine and 89.7% with entecavir [OR = 0.46, 95% CI (0.28, 0.74), P < 0.05]; for treatment of HBeAg (+) hepatitis B, the HBeAg clearance rate was 28.9% with telbivudine and 15.6% with entecavir [OR = 2.21, 95% CI (1.06, 4.58), P < 0.05], and the HBeAg seroconversion rate was 31.2% with telbivudine and 18.5% with entecavir [OR = 2.31, 95% CI (1.23, 4.31), P < 0.05]; the ALT normalization rate was 85.8% with telbivudine and 84.9% with entecavir [OR = 0.90, 95% CI (0.29, 2.84), P > 0.05]; and the resistance rate was 6.0% with telbivudine and 0.76% with entecavir [OR = 5.71, 95% CI (1.67, 19.47), P < 0.05]. Conclusions For 1-year treatment of chronic hepatitis B, the difference in ALT normalization between telbivudine and entecavir was not statistically significant; and telbivudine was superior over entecavir in terms of HBeAg undetectable and HBeAg seroconversion; entecavir was superior over telbivudine in terms of HBV DNA undetectable and resistance; and both drugs had similar rates of adverse events in early-stage treatment and no severe adverse event was noted. Both telbivudine and entecavir are effective antiviral drugs against hepatitis B.


2015 ◽  
pp. 36-43
Author(s):  
Viet Thinh Nguyen ◽  
Van Huy Tran

Introduction: Assessing the histological character liver fibrosis by transient hepatic elastography (TE) by Fibroscan has several advantages when compared with liver biopsy and can indicate repeatedly; therefore it can help us to follow up the treatment of chronic hepatitis B. This study is aimed at assessing the biochemical, viral and liver elasticity responses in patients with chronic hepatitis B after 12 months of entecavir treatment. Methods: Prospective, open, non-controlled study. 75 patients over 16 years old were diagnosed with chronic hepatitis B and treated with Entecavir 0.5 mg orally 2 hours after meal during 12 months. Using Fibroscan to assess the liver fibrosis according to the METAVIR classification. Results: ALT decreased rapidly after 3 months of treatment. There were differences in ALT at baseline, compared with ALT at 3 months, 6 months and 12 months (p < 0.05). HBV-DNA responsed below detection thredsold is 32%, 54.7% and 84% after 3, 6, 12 months of treatment, respectively (p<0.05). The change in the Fibroscan value > 1KPa at 6 months was 53.3% after treatment, and this was lower than this proportion at 12 months (61.3%) (p<0.001). Conclusion: Fibroscan may be used as a mean to monitor the responses to HBV treatment besides the biochemical and viral responses. Key words: Chronic B hepatitis, Entecavir, Elastography, Fibroscan


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