Dataset Information

A Randomized Controlled Trial of Glycyrrhizin Plus Tenofovir vs. Tenofovir in Chronic Hepatitis B with Severe Acute Exacerbation.

ABSTRACT:

Objectives

Severe acute exacerbation (SAE) of chronic hepatitis B (CHB) may progress to liver failure with high potential mortality despite the prompt treatment with nucleos(t)ide analogs. This study aimed to evaluate the efficacy and safety of glycyrrhizin in the treatment of CHB with SAE.

Methods

Sixty patients with SAE of CHB were randomly treated with tenofovir plus intravenous glycyrrhizin (group A, n=30) or with tenofovir alone (group B, n=30). Primary end points were the improvement of serum levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and model for end-stage liver disease (MELD) score. Secondary end point was overall mortality or receipt of liver transplantation by week 24.

Results

Patients in group A had significant reductions of serum AST and ALT levels from baseline at days 3, 5, 8, and 15 than those in group B (all P<0.05). The MELD score significantly decreased since week 1 in the group A patients, whereas there were no changes relative to baseline in group B patients at weeks 1 and 2. By week 24, one (3.3%) of group A patients and four (13.3%) of group B patients died (n=3) or received liver transplantation (n=1) (P=0.177). Multivariate analysis identified baseline MELD score (P=0.021) as an independent factor for mortality or receipt of liver transplantation. There were no differences in the rates of grade 3 hypertension, hypokalemia and ascites between two groups.

Conclusions

Early introduction of glycyrrhizin can be safe and helpful for patients with SAE of CHB.

SUBMITTER: Hung CH

PROVIDER: S-EPMC5518952 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Publications

A Randomized Controlled Trial of Glycyrrhizin Plus Tenofovir vs. Tenofovir in Chronic Hepatitis B with Severe Acute Exacerbation.

Hung Chao-Hung CH Kee Kwong-Ming KM Chen Chih-Hung CH Tseng Po-Lin PL Tsai Ming-Chao MC Chen Chien-Hung CH Wang Jing-Houng JH Chang Kuo-Chin KC Kuo Yuan-Hung YH Yen Yi-Hao YH Hu Tsung-Hui TH Lu Sheng-Nan SN

Clinical and translational gastroenterology 20170629 6

<h4>Objectives</h4>Severe acute exacerbation (SAE) of chronic hepatitis B (CHB) may progress to liver failure with high potential mortality despite the prompt treatment with nucleos(t)ide analogs. This study aimed to evaluate the efficacy and safety of glycyrrhizin in the treatment of CHB with SAE.<h4>Methods</h4>Sixty patients with SAE of CHB were randomly treated with tenofovir plus intravenous glycyrrhizin (group A, n=30) or with tenofovir alone (group B, n=30). Primary end points were the im ...[more]

PMID: 28662023

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Project description:AimTo make efficacy and safety comparison of telbivudine-raodmap and tenofovir-roadmap in hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) patients.MethodsThis was the first prospective, randomised, two-arm, open-label, non-inferiority study in HBeAg-negative CHB patients that compared telbivudine and tenofovir administered as per roadmap concept. Patients were treated up to 24 wk and, depending on virologic response, continued the same therapy or received add-on therapy up to 104 wk. Eligible patients received an additional 52 wk of treatment in the extension period (i.e., up to 156 wk). Patients who developed virologic breakthrough (VB) while on monotherapy also received add-on therapy. The primary efficacy endpoint was the rate of patients achieving hepatitis B virus (HBV) DNA < 300 copies/mL at week 52. Secondary efficacy endpoints included the rates of HBV DNA < 300 and < 169 copies/mL, HBV DNA change from baseline, alanine aminotransferase normalisation, hepatitis B surface antigen (HBsAg) loss, HBsAg seroconversion, VB, and emergence of resistance at various timepoints throughout the study. Safety and estimated glomerular filtration rate (eGFR) were also analysed.ResultsA total of 241 patients were randomised. Non-inferiority of telbivudine arm to tenofovir arm was demonstrated at week 52 (± 7 d window), with over 91% of patients in each treatment arm achieving HBV DNA level < 300 copies/mL. Both arms were similar in terms of key secondary efficacy variables at weeks 104 and 156. The percentage of patients achieving HBV DNA < 300 copies/mL remained high and was similar in the telbivudine and tenofovir arms at both weeks 104 and 156. Over 82% of patients in both arms achieved alanine aminotransferase normalisation at week 52, and this percentage remained high at weeks 104 and 156. Telbivudine treatment progressively reduced serum HBsAg levels from baseline while no change was reported in quantitative HBsAg during therapy with tenofovir. Both treaments showed acceptable safety profiles. The telbivudine arm showed eGFR improvement unlike the tenofovir arm.ConclusionEfficacy was shown for both telbivudine-roadmap and tenofovir-roadmap regimens in HBeAg-negative CHB patients over 156 wk. Telbivudine arm was associated with renal improvement.

Project description:ImportanceEntecavir and tenofovir disoproxil fumarate have comparable efficacy in achieving surrogate end points, including virologic response, and are equally recommended as first-line treatments for patients with chronic hepatitis B (CHB). However, it is unclear whether treatment with these drugs is associated with equivalent clinical outcomes, especially development of hepatocellular carcinoma (HCC).ObjectiveTo compare entecavir and tenofovir in terms of the risk of HCC and death or liver transplant in patients with CHB infection.Design, setting, and participantsA nationwide historical population cohort study involving treatment-naive adult patients with CHB who started treatment with entecavir (n = 11 464) or tenofovir disoproxil fumarate (n = 12 692) between January 1, 2012, and December 31, 2014, using data from the Korean National Health Insurance Service database. As validation, a hospital cohort of patients with CHB treated with entecavir (n = 1560) or tenofovir (n = 1141) in a tertiary referral center between January 1, 2010, and December 31, 2016, were analyzed. Nationwide cohort data were retrieved from January 1, 2010, to December 31, 2016, and hospital cohort data from January 1, 2010, to October 31, 2017.Main outcomes and measuresCumulative incidence rates of HCC and death and transplant rates.ResultsAmong the population cohort of 24 156, the mean (SD) age was 48.9 (9.8) years, and 15 120 patients (62.6%) were male. Among the hospital cohort of 2701, the mean (SD) age was 48.8 (10.5) years and 1657 patients (61.3%) were male. In the population cohort, the annual incidence rate of HCC was significantly lower in the tenofovir group (0.64 per 100 person-years [PY]) than in the entecavir group (1.06 per 100 PY). By multivariable-adjusted analysis, tenofovir therapy was associated with a significantly lower risk of HCC (hazard ratio [HR], 0.61; 95% CI, 0.54-0.70) and all-cause mortality or transplant (HR, 0.77; 95% CI, 0.65-0.92) compared with entecavir. The tenofovir group also showed a significantly lower risk of HCC in the 10 923-pair propensity score-matched population cohort (HR, 0.62; 95% CI, 0.54-0.70) and 869-pair propensity score-matched hospital cohort (HR, 0.68; 95% CI, 0.46-0.99) compared with the entecavir group.Conclusions and relevanceThis study suggests that tenofovir treatment was associated with a significantly lower risk of HCC compared with entecavir treatment in a population-based cohort of adults with CHB; these findings were validated in a hospital cohort. Given the poor prognosis of patients with HCC, these findings may have considerable clinical implications in prevention of this cancer in patients with CHB infection.

Dataset Information

A Randomized Controlled Trial of Glycyrrhizin Plus Tenofovir vs. Tenofovir in Chronic Hepatitis B with Severe Acute Exacerbation.

Objectives

Methods

Results

Conclusions

Publications

A Randomized Controlled Trial of Glycyrrhizin Plus Tenofovir vs. Tenofovir in Chronic Hepatitis B with Severe Acute Exacerbation.

Similar Datasets

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