HBV DNA Negative Conversion Rate Research Articles

Clinical Efficacy and Incidence of Adverse Reactions of Entecavir Combined with Long-Acting Interferon in Treating Hepatitis B

Objective: To explore and analyze the clinical efficacy and incidence of adverse reactions of entecavir combined with long-acting interferon in treating hepatitis B. Methods: The study was conducted from January 2020 to December 2022, and the research subjects were 69 hepatitis B patients admitted to our hospital. The patients were divided into a research group (n = 35) and a control group (n = 34). Patients in the control group were treated with entecavir, while patients in the study group were treated with entecavir combined with long-acting interferon. The antiviral efficacy, liver function indicators, clinical effectiveness, and incidence of adverse reactions were compared between the two groups. Results: The HBV-DNA negative conversion rate and HBeAg seroconversion rate of the patients in the study group were higher than those of the control group, and the virological breakthrough rate was lower than that of the control group (P < 0.05); the alanine transaminase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBIL) levels of the patients in the study group were all lower after treatment. In the control group, the albumin (ALB) level was higher than that in the control group (P < 0.05). The clinical effective rate of patients in the study group was higher than that in the control group (P < 0.05); there was no significant difference in the incidence of adverse reactions between the two groups (P > 0.05). Conclusion: The treatment effect of entecavir combined with long-acting interferon in patients with hepatitis B is significant. It can effectively antiviral and improve the liver function of patients. The incidence of adverse reactions is low and can be promoted and applied.

Evaluation of the efficacy of Biejia decoction pill combined with entecavir in the treatment of hepatitis B liver fibrosis/cirrhosis by VCTE

The vibration controlled transient elastography (VCTE) technique was used to assess the effectiveness of a Biejia Decoction pill in combination with Entecavir in the treatment of hepatitis B liver fibrosis/cirrhosis. We randomly selected 120 patients to receive entecavir and 119 patients to receive both entecavir and Biejia Decoction Pill, which both with hepatitis B liver fibrosis/cirrhosis visited the Second Affiliated Hospital of Nanchang University between January 2019 and February 2022. The observation group got ETV (entecavir) and Biejia Decoction pills, whereas the control group received only standard ETV antiviral medication. Based on the grading of the VCTE detection value (LSM) initially diagnosed for patients with hepatitis B liver fibrosis/cirrhosis, we divided the patients into two subgroups of liver fibrosis and cirrhosis. In addition, patients with liver fibrosis were divided into mild and moderate subgroups according to their VCTE values. Patients were measured for liver hardness after three, six, nine, and twelve months of treatment with VCTE. Biejia Decoction Pill combined with ETV on HBV liver fibrosis/cirrhosis was evaluated by comparing patients' changes in liver hardness and HBV-DNA negative conversion rates before and after treatment in each group at the same baseline. The LSM (liver elasticity value) of the observation group and the control group after treatment was lower than that before treatment, and the difference was statistically significant (P < 0.0001); The LSM of the observation group after treatment was significantly lower than that of the control group, and the difference was also statistically significant (P = 0.0005 < 0.05). In the subgroup of liver fibrosis, the number of patients with moderate and severe liver fibrosis who completely reversed liver fibrosis after treatment in the treatment group was far more than that in the control group, and the difference between the two groups was statistically significant (χ2 = 4.82 P = 0.028 < 0.05) 。 When the treatment course was more than 9 months, the negative conversion rate of patients in the observation group reached 87.4%, which was higher than that in the control group (70.8%), and the difference was statistically significant (P = 0.002 < 0.05); After 12 months of treatment, the negative conversion rate of patients in the observation group was as high as 95%, which was significantly higher than 76.67% in the control group (P < 0.001). The degree of liver fibrosis was significantly improved when Biejia Decoction Pill was combined with ETV in patients with liver fibrosis/cirrhosis due to hepatitis B. The virological response rate to HBV-DNA increased with the prolongation of treatment, and the Biejia Decoction Pill assists with entecavir in antiviral therapy.

Analysis of efficacy and factors influencing sequential combination therapy with tenofovir alafenamide fumarate after treatment with entecavir in chronic hepatitis B patients with low-level viremia

Objective: To observe the efficacy and factors influencing sequential or combined tenofovir alafenamide fumarate (TAF) after treatment with entecavir (ETV) in patients with chronic hepatitis B (CHB) with low-level viremia (LLV). Methods: 126 CHB cases treated with ETV antiviral therapy in the Department of Infectious Diseases of the First Affiliated Hospital of Nanchang University from January 2020-September 2022 were retrospectively collected. Patients were divided into a complete virologic response (CVR) group (n = 84) and a low-level viremia (LLV) group (n = 42) according to the HBV DNA level during treatment. Clinical characteristics and laboratory indicators of the two groups at baseline and 48 weeks were analyzed by univariate analysis. Patients in the LLV group were divided into three groups according to their continued antiviral treatment regimen until 96 weeks: continued use of ETV as a control group; replacement of TAF as a sequential group; and combination of ETV and TAF as a combined group. The data of the three groups of patients were analyzed by one-way analysis of variance for 48 weeks. HBV DNA negative conversion rate, HBeAg negative conversion rate, alanine aminotransferase (ALT), creatinine (Cr), and liver stiffness test (LSM) were compared among the three groups after 96 weeks of antiviral treatment. Multivariate logistic regression was used to analyze the independent factors influencing the occurrence of HBV DNA non-negative conversion in LLV patients at 96 weeks. Receiver operating characteristic curve (ROC) was used to evaluate the effectiveness of predicting the occurrence of HBV DNA non-negative conversion in LLV patients at 96 weeks. Kaplan-Meier was used to analyze the cumulative negative rate of DNA in LLV patients, and the Log-Rank test was used for comparison. HBV DNA and HBV DNA negative conversion rates during treatment were observed dynamically. Results: Univariate analysis showed statistically significant differences in age, BMI, HBeAg positivity rate, HBV DNA, HBsAg, ALT, AST, and LSM at baseline between the CVR group and the LLV group (P < 0.05). Univariate analysis of variance revealed no statistically significant difference among the three groups of LLV patients at 48 weeks (P > 0.05). HBV-DNA negative conversion rate in the sequential group and the combination group was significantly higher than that in the control group after 96 weeks of treatment (88.89% vs. 41.18%, 85.71% vs. 41.18%, χ (2) = 10.404, P = 0.006). HBeAg negative conversion rate was higher than that of the control group, with no statistically significant difference (P > 0.05).Compared with the control group, ALT, Cr, and LSM in the sequential group and the combined group were equally improved to varying degrees, with a statistically significant difference (P < 0.05). Subsequent use of ETV and HBV DNA at 48 weeks were independent risk factors for HBV DNA positivity at 96 weeks in LLV patients (P < 0.05). The AUC of HBV DNA at 48 weeks was 0.735 (95%CI: 0.578 ~ 0.891), the cut-off value was 2.63 log(10) IU/ml, and the sensitivity and specificity were 76.90% and 72.40%, respectively. DNA conversion rate was significantly lower in LLV patients receiving 48-week ETV and 48-week HBV DNA≥2.63 log10 IU/mL than in patients receiving sequential or combined TAF and 48-week HBV DNA < 2.63 log(10) IU/mL. HBV DNA negative conversion rates in the sequential group and combined group at 72 weeks, 84 weeks, and 96 weeks were higher than those in the control group during the period from 48 weeks to 96 weeks of continuous treatment, and the differences were statistically significant (P < 0.05). Conclusion: Sequential or combined TAF antiviral therapy could more effectively improve the 96-week CVR rate, as well as hepatic and renal function, and alleviate the degree of hepatic fibrosis in CHB patients with LLV following ETV treatment. Subsequent use of ETV and HBV DNA load at 48 weeks were independent predictors of HBV DNA positivity at 96 weeks in LLV patients.

Effects of Entecavir on Serum Hepatitis B Virus-DNA, Interferon-γ, and Pregenomic RNA in Patients with Chronic Hepatitis B Virus Infection

Background: Entecavir (ETV) has been widely used in the clinical treatment of the Hepatitis B Virus (HBV). However, whether ETV is helpful in the recovery of T cell immune function remains unclear. Objectives: We aimed to assess the effects of ETV on serum HBV-DNA, interferon-γ (IFN-γ), and pregenomic RNA (pgRNA) in patients with infection. Methods: The clinical data of 300 HBV patients admitted from January 2017 to January 2019 were retrospectively analyzed, of whom 193 cases administered with ETV were assigned to an observation group, and the remaining 107 untreated cases (who refused treatment) were assigned to a blank control group. Their liver function [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)], serum HBV markers [hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg)], IFN-γ, HBV-DNA, HBV pgRNA, negative conversion rates of HBeAg and HBV-DNA, and adverse reactions were compared. Results: The levels of HBsAg, IFN-γ, HBV-DNA, and HBV pgRNA were lower in the observation group than in the blank control group 12, 24, and 48 weeks after treatment (P &lt; 0.05). The HBeAg and HBV-DNA negative conversion rates of the observation group were higher than those of the blank control group 12, 24, and 48 weeks after treatment (P &lt; 0.05). Conclusions: Antiviral therapy with ETV can inhibit the replication of HBV-DNA, increase the HBV-DNA negative conversion rate, enhance immune function, and reduce the expression of HBV pgRNA in HBV patients.

Efficacy and safety of Fufang Biejia Ruangan Tablets as an adjuvant treatment for chronic hepatitis B liver fibrosis: A systematic review and meta-analysis.

Meta-analysis was used to evaluate the efficacy of Fufang Biejia Ruangan Tablets in the treatment of chronic hepatitis B (CHB) liver fibrosis. Databases, including PubMed, China Knowledge Network (CNKI), China Biomedical Database (CBM), Wan Fang, VIP database, Embase, and Cochrane Library were searched. The time was searched up to May 2022. The participant intervention comparator outcomes of this study were as follows: P, patients with CHB liver fibrosis; I, Fufang Biejia Ruangan Tablets; C, pharmacological placebo; O, the efficacy rate, alanine transaminase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), albumin (ALB), procollagen III protein (PIIIP), hyaluronic acid (HA), laminin (LN), collagen C type IV (IV-C), portal vein diameter, spleen thickness and HBV-DNA negative conversion rate. The Cochrane Risk of Bias tool, Begg's test and Egger's test were used to evaluate the methodological quality of eligible studies. A randomized controlled trial of Fufang Biejia Ruangan Tablets was used to treat CHB liver fibrosis. Three reviewers independently selected trials, extracted data, cross-checked, and performed methodological quality assessments. Data analysis was completed by Review Manager 5.3. Twenty-six studies with 2717 patients were included in the meta-analysis. The meta-analysis showed that Fufang Biejia Ruangan Tablets was effective by increasing the efficacy. Fufang Biejia Ruangan Tablets was more efficient in improving ALT, AST, TBIL, ALB, PIIIP, HA, LN, IV-C, portal vein diameter, spleen thickness, and HBV-DNA negative conversion rate with no serious adverse reactions. It was shown that Fufang Biejia Ruangan Tablets can effectively improve liver function and relieve liver fibrosis, but future research should focus on rigorously designed, multicenter, and large randomized controlled trials.

Exploring the effects of entecavir treatment on the degree of liver fibrosis in patients with non-alcoholic fatty liver combined with chronic hepatitis B in Tibet region

Objective: To explore the efficacy of entecavir antiviral therapy on the degree of liver fibrosis in patients with non-alcoholic fatty liver disease (NAFLD) combined with chronic hepatitis B (CHB) in Tibet region. Methods: HBeAg-positive CHB patients who were treated with entecavir in the outpatient and inpatient Department of Infectious Diseases of the Tibet Autonomous Region people's Hospital between January 2018 to December 2019 were retrospectively analyzed. Among the 140 subjects with CHB, 95 cases were CHB alone, and the other 45 cases were diagnosed as CHB combined with NAFLD by ultrasound. All patients were given entecavir 0.5 mg orally once daily on an empty stomach for 48 weeks. HBeAg negative conversion rate, blood glucose, blood lipid, liver function and the degree of liver fibrosis were compared between the two groups at the 12th, 24th and 48th weeks of treatment to evaluate the virological response. SPSS 19.0 statistical software was used to process the data. Measurement data were expressed as mean ± standard deviation (x¯±s). Descriptive statistical analysis was used for t-test, and the categorical variables were expressed as percentage (%) and χ2 test. A p-value < 0.05 was considered as statistically significant. Results: After 48 weeks of treatment, the HBeAg and HBV DNA negative conversion rate were significantly better in patients with CHB alone (group B) than CHB combined with NAFLD (group A), that is to say, HBeAg negative conversion rate in group A and B patients were 28.90% and 40%, respectively, and group B was better than group A. HBV DNA negative conversion rate was significantly elevated in group B (83.2%) than group A (64.4%), with statistical significance (P<0.05), and the difference between the both groups was statistically significant. Alanine aminotransferase level was significantly decreased in patients with CHB alone than patients with CHB combined with NAFLD. Aspartate aminotransferase/platelet ratio index was significantly decreased after treatment than before treatment in both group of patients, and the depletion was more pronounced in CHB alone group. Liver stiffness values were significantly decreased in patients with CHB combined with NAFLD than CHB alone group. Moreover, liver stiffness values was higher in group A than group B before treatment under the influence of fat attenuation factors, and the differences before treatment and after treatment were 3.50±4.66 and 2.05±2.53, respectively; however, group B was not affected by fat attenuation factors, so LSM value reduction in group A was more obvious, and the differences were statistically significant. There was no statistically significant difference in blood glucose and blood lipids levels before and after treatment between the two groups. Conclusion: NAFLD has a certain effect on antiviral therapy and liver fibrosis in patients with CHB, i.e., the effect of antiviral therapy in patients with CHB alone is better than patients with CHB combined with NAFLD. Patients with CHB combined with NAFLD when treated with antiviral therapy had a significantly greater degree of liver stiffness reduction than patients with CHB alone. Therefore, it is necessary to actively intervene the risk factors associated with NAFLD according to the actual situation of different individuals to improve clinical efficacy of antiviral therapy.

Antiviral Therapy with Entecavir following Antituberculosis Therapy Alleviates Liver Injury and Restores Innate Immunity in Tuberculosis Patients Coinfected with Hepatitis B Virus.

Objective Coinfection of tuberculosis (TB) and viral hepatitis may increase the risk of antituberculosis treatment-induced hepatotoxicity, which is regarded as a common cause of termination of the first-line antituberculosis drugs. The study aimed at investigating the protective effects of antiviral therapy on the liver and innate immunity in patients with TB-HBV coinfection. Methods A total of 100 patients with TB-HBV coinfection were recruited and split into antituberculosis and antiviral groups, 50 per group, according to odd or even date of hospital admission from December 2019 to October 2020. The patients in the anti-TB group received antituberculosis therapy, and those in the antiviral group received antiviral therapy. The clinical effectiveness; HBV-DNA negative conversion rate; liver function assessment involving alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBIL); immune function evaluation including CD4+, CD8+, CD4+/CD8+, and CD3+ T cells; inflammatory cytokines containing tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interferon-γ (IFN-γ); and intestinal microflora including bifidobacterium, lactobacillus, enterobacterium, enterococcus, and clostridium were main outcome measures after treatment. Results It was found that the total response rate in the antiviral group was significantly higher than the anti-TB group after treatment (χ2 = 3.157, P=0.017). There was a significant difference in HBV-DNA negative conversion rates between the antiviral group and anti-TB group (82% vs. 58%, χ2 = 6.384, P=0.001). The ALT, AST, and TBIL in the two groups were all increased after treatment (P < 0.05), but the antiviral group indicated a rise of the above indices compared to the anti-TB group (P < 0.05). The two groups showed a rise on the concentration of CD3+, CD4+, and CD4+/CD8+ T cells and a decline on the CD8+ T cells after treatment (P < 0.05), but these changes in the antiviral group were more evident to those in the anti-TB group (P < 0.05). There was an increase on the IFN-γ level and decrease on the TNF-α and IL-6 levels in both groups after treatment (P < 0.05), but the antiviral group revealed a higher level of IFN-γ with lower levels of TNF-α and IL-6 compared to the anti-TB group (P < 0.05). After treatment, the number of bifidobacteria and lactobacilli was increased, and the number of enterobacteria, enterococci, and clostridium were decreased in the two groups (P < 0.05), while these changes in the antiviral group were more remarkable compared to the anti-TB group (P < 0.05). There was no significant difference in the incidence of adverse reactions between the two groups (χ2 = 0.267, P=0.731). Conclusion Antiviral therapy for tuberculosis-HBV coinfected patients could inhibit HBV replication, providing protection against liver damage, improving innate immunity, and balancing intestinal microflora.

Short Term Efficacy of Entecavir in the Treatment of Decompensated Chronic Hepatitis B Cirrhosis

Objective: To explore the effect of entecavir on patients with decompensated chronic hepatitis B cirrhosis. Methods: From October 2007 to December 2019, 100 patients with decompensated chronic hepatitis B cirrhosis who were treated in our hospital were selected to carry out this study. The clinical data of the patients were analyzed. According to whether entecavir treatment was carried out, 100 patients were divided into two groups, 50 cases in the control group and 50 cases in the observation group. The control group was treated with conventional drugs, and the observation group was treated with entecavir. Liver function indexes, liver fibrosis indexes, HBV-DNA negative conversion rate and incidence of adverse reactions were compared between the two groups. Results: Compared with the control group, the liver function indexes of the observation group were lower, P &lt; 0.05; Compared with the control group, the observation group was better, P &lt; 0.05; The negative rate of HBV-DNA in the observation group was lower than that in the control group (P &lt; 0.05); There was no difference in the incidence of adverse reactions between the two groups, P &gt; 0.05. Conclusion: Entecavir can not only improve the liver function, but also enhance the short-term treatment effect, without increasing adverse reactions, and has high safety, which is worthy of recommendation.

Clinical Efficacy and Safety of Eight Traditional Chinese Medicine Combined with Entecavir in the Treatment of Chronic Hepatitis B Liver Fibrosis in Adults: A Network Meta-Analysis.

Background Traditional Chinese medicine (TCM) is used as an adjuvant drug for the treatment of chronic hepatitis B liver fibrosis and is used frequently. We still do not know which TCM has the best curative effect as an adjuvant drug. Therefore, we decided to use network meta-analysis to solve this problem. Methods We used the RevMan software (5.3) and Stata software (13.0) to achieve this network meta-analysis (NMA). The primary outcomes of this study were HA, LN, PCIII, and IV-C; the secondary outcomes of this study were AST, ALT, and HBV-DNA negative conversion rate, and the Cochrane risk-of-bias tool was used to assess the quality of the included studies. For all outcomes, the scissors funnel plot, Egger test, and Begg test were used to detect publication bias, and sensitivity analysis was used to investigate the stability of the results. And the meta-regression was used to explore the source of heterogeneity. Results A total of 34 articles were included in this study. The study involved a total of 3199 patients, of which 1578 were assigned to the control group and 1621 patients were assigned to the experimental group. The number of men and women is roughly equal, and the average age is about 43 years old. In addition, nine treatment strategies were involved in this study. The combination of TCM and entecavir can significantly improve the patients' HA, LN, PCIII, IV-C, AST, ALT, and HBV-DNA negative conversion rates. The comprehensive evaluation results showed that FHC combined with entecavir has more advantages than other treatment strategies. Conclusion For improving the HBV-DNA negative conversion rates, adding TCM to the therapeutic strategies does not seem to show absolute superiority. Finally, FHC combined with entecavir is the best therapeutic strategy.

A randomized controlled study on factors influencing the curative effect of sequential combined interferon and lamivudine therapy in children with immune-tolerant phase chronic hepatitis B

Objective: To investigate the curative effect of antiviral therapy and related factors influencing the curative affect in children with immune-tolerant phase chronic hepatitis B. Methods: From May 2014 to April 2015, 46 children with chronic hepatitis B, aged 1 to 16 years with immune-tolerant phase were enrolled as the treatment group. All cases in the treated group either received interferon alpha (3-5 MIU/m(2), once daily) in lamivudine combination (if HBV DNA decreased < 2 log(10)) or repeatedly received interferon-alpha alone (if HBV DNA decreased >2 log(10)) for 12 weeks. Interferon was discontinued at 72 weeks and followed-up period was continued with lamivudine for 24 weeks. At the same time, data of 23 cases of untreated children with immune-tolerant phase chronic hepatitis B were collected as the control group. The treatment group and the control group were divided into two age groups: 1-7 years old and 7-15 years old. Data measurements were compared using t-test, analysis of variance and single factor analysis methods, and the count data were analyzed by χ (2) test. Multiple logistic regression analysis was used to analyze the effects of different factors on response. Results: (1) There were 22 cases aged 1-7 years in the treatment group (47.8%) and 12 cases aged 1-7 years in the control group (52.2%). The cases of mother-to-child transmission (MTCT) in treatment and control group were 34 (73.9%) and 17 (73.9%), while children with normal baseline ALT in the treatment and control group were 18 (39.1%) and 10 (43.5%). (2) At the end of follow-up, 15 cases in the treatment group (32.6%) had HBeAg serological conversion. Among them, nine (19.6%) cases had HBsAg clearance or HB-Ag seroconversion with anti-HBs, and one (2.2%) case had HBsAg clearance, but both HBeAg and anti-HBe were positive. In the control group, one case had HBV DNA lower than the lower limit of detection level, and one case had HBeAg seroconversion without HBsAg clearance. (3) At the end of follow-up, the seroconversion rates of HBeAg in patients aged 1 to 7 years and patients aged 7 to 15 years were 45.5% and 20.8%, respectively (P = 0.078) and the clearance rates of HBsAg were 36.4% and 8.3% (P = 0.023). The serum conversion rates of normal and abnormal baseline alanine aminotransferase levels were 5.6% and 50.0% (P = 0.005), and the clearance rates of HBsAg were 5.6% and 32.1% (P = 0.077), respectively. There was no statistically significant difference in gender, mother-to-child transmission, HBV DNA genotyping and baseline HBsAg level in antiviral efficacy among children (P > 0.05). (4) HBsAg and HBeAg clearance occurred in 100% of patients at the end of follow-up who had HBsAg < 3 000 IU/ml at 24 weeks of treatment. (5) Multivariate logistic regression analysis showed that serum HBeAg conversion rate had relation with non-MTCT transmission and abnormal baseline alanine aminotransferase. Furthermore, HBsAg clearance rate was associated with the age of children. Conclusion: Sequential combination of interferon and lamivudine with a prolonged course can improve the HBV DNA negative conversion rate, HBeAg seroconversion rate, HBsAg loss rate and mild ALT abnormalities at baseline in children under the age of 7 years with immune-tolerant phase chronic hepatitis B.

Comparison of efficacy and safety between entecavir versus adefovir dipivoxil in the treatment of HBeAg positive chronic hepatitis B

Objective To compare the efficacy and safety of entecavir versus adefovir dipivoxil in the treatment of HBeAg positive chronic hepatitis B (CHB). Methods Ninety-six cases with HBeAg positive CHB were divided into ETV group and ADV group according to different medication.In addition to conventional treatment, ETV group received entecavir 0.5 mg/d, ADV group received adefovir dipivoxil 10 mg/d.HBV DNA negative conversion rate, alanine aminotransferase (ALT) recurrence rate and HBeAg negative conversion rate in 24 weeks, 48 weeks and 96 weeks were compared as well as the adverse reactions and liver function in 96 weeks. Results HBV DNA negative conversion rates in ETV group were significantly higher than those in ADV group in 24 weeks, 48 weeks and 96 weeks (24 weeks: 64.6%(31/48) vs.41.7%(20/48); 48 weeks: 83.3%(40/48) vs.52.1%(25/48); 96 weeks: 97.9%(47/48) vs.62.5%(30/48), χ2=5.06, 10.72, 18.96, P 0.05). There was no significant difference in HBeAg negative conversion rate between the two groups through treatment(χ2=0.07, 0.22, 0.44, P>0.05). After 96 weeks, ALT in both groups decreased significantly(t=13.56, 11.85, P 0.05). Conclusion Entecavir has a higher rate of HBV DNA negative conversion rate, ALT recurrence rate and HBeAg negative conversion rate in the treatment of HBeAg positive CHB.It is an ideal antiviral drug. Key words: Entecavir; Adefovir dipivoxil; HBeAg positive; Chronic hepatitis B; Efficacy

Efficacy and safety of Entecavir monotherapy switched from Lamivudine combined Adefovir Dipivoxil for chronic hepatitis B virus-related compensated liver cirrhosis

Objective: To observe the efficacy and safety of de novo combination of Lamivudine(LAM) and Adefovir Dipivoxil (ADV) therapy counter to Entecavir (ETV) monotherapy in patients with chronic hepatitis B (CHB)- related compensated liver cirrhosis. Methods: Patients with chronic hepatitis B-related compensated cirrhosis who were initially treated with LAM and ADV for more than 1 year were randomly assigned to two groups, one half replaced with ETV monotherapy, and the other half continued LAM and ADV co-therapy. Liver biochemistry, renal biochemistry, estimated glomerular filtration rate, alpha-fetoprotein, HBV serology markers and serum HBV DNA were measured every 3 months. Urine β2-microglobulin was measured every 6 months And retinol binding protein, followed up for 3 years. The mean values of the two groups were compared with t-test, and the rate of comparison was analyzed by x2 test. Results: A total of 580 cases were collected, 290 cases were replaced with ETV monotherapy, the other 290 patients continued to LAM and ADV combination therapy. In the ETV group, the rates of HBV DNA negative conversion at 1 year, 2 years and 3 years were 77.6%, 84.5% and 94.5% respectively, while the HBV DNA negative conversion rates at 1, 2 and 3 years in the LAM and ADV combination groups were 69.3%, 73.4% and 80.3% respectively. Among them, the negative rates of HBV DNA in the second year and the third year were P < 0.05, the difference was statistically significant. The 3-year cumulative gene-resistant rate in the ETV group was 1.4%, while the combined treatment was as high as 8.6%, and the difference was statistically significant in the two groups. The estimated value of serum creatinine and glomerular filtration rate in ETV group was followed by 3 years, and the baseline level was maintained, in the same group, the serum creatinine was higher than baseline, and the estimated value of glomerular filtration rate decreased. The results showed that there were 6.2%, 12.1%, 22.1% and 0, 0.3%, 1%, respectively, in 1, 2 and 3 years for the group of consecutive treatment and the replacement of ETV Group. The estimated glomerular filtration rate decreased by more than 30% compared with the baseline. The difference was statistically significant; the proportion of serum creatinine in the 1 year, 2 years and 3 years of the combined treatment group was 1.7%, 4.5% and 6.6%, compared with the baseline rise of > 50 μmol/l, and the ETV group was replaced in the 1 year, The values of 2 and 3 years were 0,0,0.7%, of which the 2nd and 3rd years were statistically significant; the proportion of microalbuminuria and retinol-binding protein in patients with combined treatment group was also significantly higher than that of Β2-m ETV Group. Conclusion: The initial combination of LAM and ADV therapy is inferior in terms of ETV monotherapy. Single therapy with ETV increase the rate of viral response, reduce the incidence of drug resistance, and also reduce the incidence of renal impairment in patients with chronic hepatitis B -related compensated liver cirrhosis.

Fuzheng Huayu capsule as an adjuvant treatment for HBV-related cirrhosis: A systematic review and meta-analysis.

Fuzheng Huayu (FZHY) capsule, a formulated traditional Chinese medicine product with 6 Chinese herbs, is widely used for HBV-related cirrhosis as an adjuvant treatment. However, the efficacy of FZHY capsule for HBV-induced cirrhosis did not be comprehensively proved by systematic analysis. Our current analysis was aimed to assess the efficacy and safety of FZHY capsule by an evidence-based method. Databases, including China National Knowledge Infrastructure, Wangfang, VIP medicine information system, Pubmed, Embase, and Cochrane Library, were searched, and the randomized controlled trials of FZHY capsule were used for the treatment of HBV-associated liver cirrhosis. Meta-analysis was performed by Review Manager 5.3. The efficacy rate, alanine transaminase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), albumin (ALB), Procollagen III protein (PIIIP), hyaluronic acid (HA), laminin (LN), Collagen C Type IV (IV-C), Child-Pugh score, portal vein diameter, spleen thickness, HBeAg negative conversion rate, and HBV-DNA negative conversion rate were systematically assessed. The Cochrane Risk of Bias tool was used to evaluate the methodological quality of eligible studies. Nineteen studies with 1,769 patients were included in the meta-analysis. Compared to conventional treatment, FZHY capsule was effective by increasing the efficacy. FZHY capsule was more efficient in improving ALT, AST, TBIL, PIIIP, HA, LN, IV-C, Child-Pugh grading score, portal vein diameter, spleen thickness, and HBV-DNA negative conversion rate with no serious adverse reactions. Nevertheless, a variety of well-designed randomized controlled trials are needed to confirm these findings since small samples were applied in the previous studies.

Spleen, liver and kidney-strengthening formula combined with polyethylene glycol interferon in treatment of chronic hepatitis B

To observe the clinical efficacy of spleen, liver and kidney-strengthening formula combined with polyethylene glycol interferon in the treatment of HBeAg positive chronic hepatitis B(HP-HBV).One hundred and twenty-six patients with HP-HBV, who were treated in the hospital from June 2012 to December 2014, were selected and injected with polyethylene glycol interferon α-2a(or α-2b). The treatment course for the patients lasted for 24 weeks. Base on the level of HBV-DNA, patients are divided into response group and poor response group. According to random number table, the poor response group were randomized into control group and test group. Patients in the control group were injected with polyethylene glycol interferon α-2a(or α-2b), and patients in the test group were treated with spleen, liver and kidney-strengthening formula combined with polyethylene glycol interferon. Clinical efficacies of the 2 groups were observed, and changes in the level of HBeAg, ALT and HBV-DNA were observed before treatment and at the 24th week after treatment, and virological and serological response, biochemical responses, integral clinical symptoms and signs, adverse reactions were observed after 48 weeks of treatment.After 24 weeks of treatment, the response group was significantly better than the poor response group in HBeAg, ALT and the level of HBV-DNA(P<0.05). After 48 weeks of treatment, there was statistical significance in HBV-DNA negative conversion rate, HBeAg negative conversion rate between the 2 groups(P<0.05), and the test group was better in the two indicators. And the test group was significantly lower than the control group in clinical symptoms and signs score at the 48th week after treatment(P<0.05), with a significantly lower adverse reaction rate than the control group(P<0.05).Combination of spleen, liver and kidney-strengthening formula and polyethylene glycol interferon α-2a was effective and safe in the treatment of chronic hepatitis B, and so worth promoting in clinic.

Meta-analysis of the efficacy and safety of nucleotide/nucleoside analog monotherapy for hepatitis B virus-associated glomerulonephritis.

Antiviral monotherapy is recommended for hepatitis B virus-associated glomerulonephritis (HBV-GN) treatment. Although considered superior to interferon-α in several respects, nucleotide/nucleoside analog (NA) monotherapy has not been studied. This metaanalysis evaluates the efficacy and safety of NA monotherapy for treating HBV-GN. We searched for controlled clinical trials of NA monotherapy for HBVGN in the MEDLINE, Embase, Cochrane Library, Chinese BioMedical Literature on disc, Chinese National Knowledge Infrastructure, and Wanfang databases. Primary outcome measures were proteinuria remission, HBV-DNA negative conversion rate, and hepatitis B e-antigen (HBeAg) clearance. Secondary outcome measures were variations in proteinuria, serum albumin, alanine aminotransferase (ALT), and serum creatinine (Scr). Ten trials involving 325 patients were included: four randomized controlled trials, two cohort clinical trials, and four self-controlled studies. Based on the fixed-effects model, we found significant proteinuria remission rate improvement in the NA group (relative risk (RR): 3.60, 95% confidence interval (CI): 1.99 – 6.50), negative conversion rate of HBV-DNA (RR: 2.20, 95% CI: 1.55 – 3.13), and clearance of HBeAg (RR: 4.49, 95% CI: 1.29 – 15.67). Improvement in ALT (mean difference (MD): 56.60, 95% CI: 50.41 – 62.79) was found with the fixedeffects model, and a slight decrease in Scr (MD: 25.25, 95% CI: –17.11 – 67.61, p = 0.24) was shown. HBV-GN proteinuria remission with elevated serum albumin, decreased HBV replication, and improved HBeAg clearance could be achieved using NA monotherapy. Furthermore, NA monotherapy may protect renal function in HBV-GN patients by preventing Scr elevation.

Clinical investigation of entecavir combined with adefovir dipivoxil in the treatment of lamivudine-resistant hepatitis B cirrhosis

Objective To investigate the clinical effect of entecavir combined with adefovir dipivoxil in the treatment of lamivudine-resistant hepatitis B cirrhosis, to provide a reference for clinical treatment. Methods 117 cases of liver cirrhosis with lamivudine resistance were selected, they were divided into the control group and the observation group according to treatment.60 cases in the observation group used entecavir and adefovir combination therapy, 57 cases in the control group was given lamivudine combined with adefovir dipivoxil.The HBeAg conversion rate, HBV-DNA negative rate, liver function, liver function Child-pugh score were compared between two groups. Results After treatment for 24 weeks, 48 weeks, the HBV-DNA negative conversion rates in the observation group were 75.00%, 95.00%, which were higher than those in the control group, the differences were statistically significant (χ2=4.251, P=0.024; χ2=4.535, P=0.018). In the observation group, ALB, ALT, TBiL, PT improved better than the control group, the differences were statistically significant(t=4.229, P=0.025; t=6.214, P=0.008; t=5.514, P=0.014; t=5.233, P=0.017). After treatment, CTP of the observation group was (7.15 ± 1.05) points, which was significantly lower than the control group (8.86 ± 1.47) points, the difference was statistically significant (t=5.874, P=0.010). The incidence rate of adverse reactions between the two groups showed no statistically significant difference(P>0.05). Conclusion Entecavir combined with adefovir dipivoxil therapy has good effect for lamivudine-resistant liver cirrhosis, which will help to improve liver function, inhibit HBV replication, it is worthy of clinical application. Key words: Liver cirrhosis; Entecavir; Adefovir dipivoxil; Lamivudine

Clinical effect of telbivudine in pregnant patients with e antigen-negative chronic hepatitis B

Objective To investigate clinical effect of telbivudine used in e antigen-negative chronic hepatitis B pregnant patients, to provide a reference for clinical treatment. Methods 90 pregnant patients with chronic hepatitis B e antigen-negative were selected, they were divided into two groups, 50 patients in the control group and 40 patients in the observation group.The observation group used telbivudine treatment, the control group used the compound glycyrrhizin treatment.Before and after treatment, HBV DNA levels, negative rate, serum ALT levels, pregnancy outcome were compared between the two groups. Results After treatment, HBV-DNA in the two groups was significantly decreased compared with before treatment, before treatment, the HBV-DNA of the control group was (6.37±1.18)mL, 6 weeks after delivery was (5.49±1.21)mL; before treatment, the HBV-DNA of the observation group was (6.31±1.21)mL, 6 weeks after delivery was (0.23±0.04)mL.The difference was statistically significant (t=8.154, P<0.01). In the observation group, before birth, six weeks after childbirth HBV-DNA were (0.21±0.05)lg copy/mL, (0.23±0.04)lg copy/mL, which were significantly lower than those of the control group, the differences were significant (t=19.257, P=0.000; t=8.154, P=0.000).4 weeks, 8 weeks after treatment, six weeks after childbirth, the HBV-DNA negative conversion rates of the control group were 52.00%, 60.00%, 88.00%, which were significantly lower than the observation group (χ2=177.61, 142.41, 184.58, P<0.01). Compared with before treatment, ALT levels after treatment were significantly decreased in the two groups (t=29.665, P<0.01). Before birth, six weeks after birth, ALT levels in the observation group were (12.58±2.58)U/L, (18.44±3.43)U/L, which were significantly lower than the control group (t=54.251, P=0.000; t=29.665, P=0.000). The incidence rate of adverse pregnancy of the observation group was 14.00%, compared with the control group the difference was not statistically significant (χ2=0.524, P=0.493). Conclusion Telbivudine in the treatment of gestational e antigen-negative chronic hepatitis B pregnant patients has good clinical effect, it can help to control hepatitis activity and reduce virus levels, which is worthy of clinical application. Key words: Hepatitis B, chronic; Telbivudine; Pregnancy; E antigen

Relationship between HBV genotypes/sub-genotypes of hepatitis B virus and antiviral therapy

Objective To investigate the relationship between the genotype/sub-genotype and antiviral treatment. Methods The clinical data of 159 patients with chronic HBV infections were collected, who were treated by adefovir dipivoxil(10mg/d)or entecavir(0.5mg/d)according to the disease's conditions. The genotypes and subtypes of hepatitis B virus were determined by Nested polymerase chain reaction(nt PCR). The levels of serum HBVDNA replication, ALT levels and HBV serologic markers were detected pre or post-treatment 24 weeks,48 weeks. Observed the relationship between the HBV genotypes/sub-genotypes and the antiviral efficacy of adefovir dipivoxil or entecavir treatment. Results After 24 weeks of adefovir dipivoxil therapy,ALT normalization rate of subgenotype Ba and subgenotype C2 was 66.7%vs 66.2%(χ2=0.74,P>0.05),HBeAg negative conversion rate of two subgenotypes was 27.3%vs 23.1%(χ2=0.10,P>0.05),HBVDNA negative conversion rate of two sub genotype Ba and subgenotype C2 was 33.3%vs 30.9%(χ2=0.03,P>0.05),respectively.After treatment for 48 weeks,ALT normalization rates of subgenotype Ba and subgenotype C2 were 83.3%vs 82.4%(χ2=0.01,P>0.05),HBeAg negative conversion rates of two subgenotypes were 45.5%vs 34.4%(χ2=0.49,P>0.05),HBVDNA negative conversion rates of two subgenotypes were 58.3%vs 48.5%(χ2=0.39,P>0.05).After 24 weeks of entecavir therapy,ALT normalization rates of subgenotype Ba and subgenotype C2 were 71.4%vs 69.6%(χ2=0.02,P>0.05),HBeAg negative conversion rates of two subgenotypes were 33.3%vs 30.8%(χ2=0.03,P>0.05),HBVDNA negative conversion rates of two subgenotypes were 42.9%vs 39.3%(χ2=0.06,P>0.05),respectively. After treatment for 48 weeks,ALT normali zation rates of subgenotype Ba and subgenotype C2 were 85.7%vs 83.9% (χ2=0.03,P>0.05),HBeAg negative conversion rates of two subgenotypes were 50.0%vs 44.9%(χ2=0.10, P>0.05),HBVDNA negative conversion rates of two subgenotypes were 71.4%vs 67.8%(χ2=0.07,P>0.05). Conclusion The study showed that genotype C(C2)is a predominant HBV genotype among people with chronic HBV infections in Shanxi province.HBV subgenotypes Ba and C2 have no significant difference in virologic, biochemical, and immunologic response to ADV or ETV. Key words: Chronic Hepatitis B; Genotype; Adefovir Dipivoxil; Entecavir

Clinical efficacy of adefovir and lamivudine in the treatment of chronic hepatitis B

Objective To study the clinical curative effect of adefovir and lamivudine in the treatment of chronic hepatitis B .Methods 68 patients with chronic hepatitis B were randomly divided into the treatment group and control group,34 cases in each group.The treatment group was treated with adefovir and lamivudine for 48 weeks,the control group was treated by lamivudine for 48 weeks.12,24,36,48 weeks after treatment ,the changes of liver func-tion,ALT index in HBV DNA,HBV DNA and the changes of serum HBeAg negative rate ,HBeAg/HBeAb seroconver-sion rate and adverse reaction were observed and compared .Results With the extension of treatment time ,ALT,HBV DNA in the two groups were gradually decreased , there were significant differences before and after treatment （ t=4.63,4.65,P〈0.05）.24,36,48 weeks after treatment,ALT,HBV DNA in the treatment group were significantly lower than those in the control group[ALT （89.9 ±16.7） U/L,（60.1 ±13.8） U/L,（44.6 ±8.9） U/L vs （90.7 ± 17.6） U/L,（72.0 ±14.1） U/L,（61.3 ±24.5） U/L;HBV DNA （4.92 ±1.44） U/L,（3.35 ±1.37） U/L,（2.53 ± 1.31） U/L vs （5.02 ±1.41） U/L,（3.69 ±1.40） U/L,（3.02 ±1.35） U/L],there were significant differences between two groups（F=4.32,4.56.4.76,all P〈0.05）.After treatment,the HBV DNA and HBeAg negative con-version rate,HBeAg/HBeAb seroconversion rate in two groups were increased significantly ,the differences were statis-tically significant（χ2 =4.63,4.36,4.21,4.27,4,35,4.23,all P〈0.05）.At the 24th week of treatment,the serolog-ical markers of HBV had no significant difference , but after 24 weeks, serum markers in the treatment group （67.65%,32.35%,26.47%,85.29%,38.23%,35.29%） were obviously higher than those in the control group , the differences between the two groups were significant （χ2 =4.43,4.73,4.23,4.32,4.34,4.46,4.76,4.34,4.22, 4.29,4.34,4.45,all P〈0.05）.Conclusion Adefovir and lamivudine combination therapy in the treatment of chro-nic hepatitis B has obvious clinical effect ,has no serious adverse reactions ,which is suitable for clinical application . Key words: Adefovir dipivoxil; Lamivudine; Hepatitis B,chronic

A clinical study on hepatitisi B vaccine triple-therapy in chronic hepatitis B virus infection

Event Abstract Back to Event A clinical study on hepatitisi B vaccine triple-therapy in chronic hepatitis B virus infection Bang-FU Wu1, 2* and Jiang-Ying Yang2 1 Southern Medical University Renkang Hospital, Gastroenterology and Hepatology Center, China 2 Guangzhou Pubang Bio-Immunological Tech Research Institute, China Aims: To observe the clinical efficacy of the admixture of hepatitis B vaccine, rhGM-CSF and BCG polysaccharide ucleic acid(for short: hepatitis B vaccine triple-therapy) combined with adefovir dipivoxil in the patients of chronic hepatitis B virus(HBV) infection. Methods: 18 HBeAg positive chronic hepatitis B(CHB) patients, 11 HBeAg positive chronic HBV carriers, 5 HBeAg negative CHB patients, 2 HBeAg negative chronic HBV carriers and 12 inactive HBsAg carriers were recruited in the study. Hepatitis B vaccine containing 20µg HBsAg, rhGM-CSF 100µg and BCG polysaccharide nucleic acid 2ml were mixed. And then the admixture injected hypodermically to the patient once every two weeks for 12 practices applications totally. Adefovir dipivoxil was taken 10mg daily for 33 patients those HBVDNA>10000 copy/ml. Quantitative HBVM(TRFIA) and HBVDNA were evaluated at week 0, 12, and 24. Results: At week 12 and 24, HBeAg seroconversion rate were 13.79%(4/29) and 27.59%(8/29) respectively, HBVDNA negative conversion rate were 37.14%(13/35), and 60.00%(21/35), HBsAg negative conversion rate were 2.08%(1/48) and 6.25%(3/48), HBsAb positive conversion rate were 16.67%(8/48) and 37.50%(18/48), HBsAg seroconversion rate were 2.08%(1/48) and 6.25%(3/48). The rate of adverse effect was 50.17%. The adverse effect include fever, headache, ache all over, bellyache, urticaria and hives, dyspnea, and tumefaction ache in the injection site after injected the admixture. Conclusions: The hepatitis B vaccine triple-therapy in combination with adefovir dipivoxil can be considered as a efficient approach for patients of chronic HBV infection, which may effectively inhibit the viral replication, improve the production of HBsAb and HBeAb, and increase HBeAg seroconversion rate. Keywords: Hepatitis B virus (HBV), Chronic hepatitis B (CHB), Hepatitis B vaccine, Chronic HBV carriers, rhGM-CSF Conference: 15th International Congress of Immunology (ICI), Milan, Italy, 22 Aug - 27 Aug, 2013. Presentation Type: Abstract Topic: Translational immunology and immune intervention Citation: Wu B and Yang J (2013). A clinical study on hepatitisi B vaccine triple-therapy in chronic hepatitis B virus infection. Front. Immunol. Conference Abstract: 15th International Congress of Immunology (ICI). doi: 10.3389/conf.fimmu.2013.02.00895 Copyright: The abstracts in this collection have not been subject to any Frontiers peer review or checks, and are not endorsed by Frontiers. They are made available through the Frontiers publishing platform as a service to conference organizers and presenters. The copyright in the individual abstracts is owned by the author of each abstract or his/her employer unless otherwise stated. Each abstract, as well as the collection of abstracts, are published under a Creative Commons CC-BY 4.0 (attribution) licence (https://creativecommons.org/licenses/by/4.0/) and may thus be reproduced, translated, adapted and be the subject of derivative works provided the authors and Frontiers are attributed. For Frontiers’ terms and conditions please see https://www.frontiersin.org/legal/terms-and-conditions. Received: 20 Jun 2013; Published Online: 22 Aug 2013. * Correspondence: Prof. Bang-FU Wu, Southern Medical University Renkang Hospital, Gastroenterology and Hepatology Center, Dongguan, Guangdong, 523952, China, bangfu.wu@163.com Login Required This action requires you to be registered with Frontiers and logged in. To register or login click here. Abstract Info Abstract The Authors in Frontiers Bang-FU Wu Jiang-Ying Yang Google Bang-FU Wu Jiang-Ying Yang Google Scholar Bang-FU Wu Jiang-Ying Yang PubMed Bang-FU Wu Jiang-Ying Yang Related Article in Frontiers Google Scholar PubMed Abstract Close Back to top Javascript is disabled. Please enable Javascript in your browser settings in order to see all the content on this page.