scholarly journals Tenofovir disoproxil fumarate for the treatment of chronic hepatitis B infection

2010 ◽  
Vol 14 (Suppl 1) ◽  
pp. 23-28
Author(s):  
J Jones ◽  
J Colquitt ◽  
J Shepherd ◽  
P Harris ◽  
K Cooper
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Treatment Strategy ◽  
Tenofovir Disoproxil Fumarate ◽  
Cost Effective ◽  
Complete Response ◽  
Treatment Comparison ◽  
Appropriate Treatment ◽  
Significant Difference

This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of tenofovir disoproxil fumarate for the treatment of chronic hepatitis B, in accordance with the licensed indication, based upon the evidence submission from Gilead to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal process. The submitted clinical evidence included two international randomised controlled trials (RCTs) comparing tenofovir with adefovir, and a mixed treatment comparison (MTC) using Bayesian methodology to compare tenofovir with other nucleos(t)ide analogues using direct and indirect RCT evidence. There were no statistically significant differences between tenofovir and adefovir in overall adverse events although, in hepatitis B ‘e’ antigen (HBeAg)-positive patients, there was a higher incidence of mild nausea in the tenofovir treatment group. The primary outcome, ‘complete response’, was a composite end point defined as histology response and hepatitis B virus DNA below 400 copies/ml. For both HBeAg-positive and HBeAg-negative patients, a significantly greater proportion had a complete response after 48 weeks with tenofovir than with adefovir. There was no statistically significant difference in histological response in either group of patients compared with adefovir. The MTC could only generate results for HBeAg positive nucleos(t)ide naive patients as there was insufficient evidence for other subgroups. The probability of achieving undetectable HBV DNA with tenofovir was found to be significantly higher than that for all other treatments considered in the analysis at the 0.05 level. The analysis demonstrated that there is a 98% probability that tenofovir is the most potent nucleos(t)ide in terms of this outcome. The manufacturer’s submission concluded that tenofovir is a cost-effective option as first-line treatment. For HBeAg-positive patients, tenofovir followed by lamivudine has an incremental cost-effective ratio (ICER) of £9940 per quality-adjusted life-year (QALY) gained, compared with lamivudine followed by tenofovir. A more appropriate treatment strategy of tenofovir followed by tenofovir plus lamivudine has an ICER of £13,619 per QALY gained, compared with lamivudine followed by tenofovir. For HBeAg-negative patients, tenofovir followed by lamivudine has an ICER of £9811 per QALY gained, compared with best supportive care. A more clinically appropriate treatment strategy of tenofovir followed by tenofovir plus lamivudine has an ICER of £13,854 per QALY gained, compared with tenofovir followed by lamivudine. The ERG uncovered a number of errors in the submission and these ICERs approximately doubled when the analysis was corrected and reran. The guidance issued by NICE on 22 July 2009 states that tenofovir disoproxil, within its marketing authorisation is recommended as an option for the treatment of people with chronic HBe-Ag-positive or HBe-Ag-negative hepatitis B in whom antiviral treatment is indicated.

scholarly journals Real-World Single-Center Comparison of the Safety and Efficacy of Entecavir, Tenofovir Disoproxil Fumarate, and Tenofovir Alafenamide in Patients with Chronic Hepatitis B

Intervirology ◽  
2021 ◽  
pp. 1-10
Author(s):  
Sara Jeong ◽  
Hyun Phil Shin ◽  
Ha Il Kim
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Real World ◽  
Tenofovir Disoproxil Fumarate ◽  
Antiviral Effect ◽  
Incidence Rates ◽  
Duration Of Treatment ◽  
Significant Difference ◽  
Tenofovir Alafenamide

<b><i>Introduction:</i></b> Chronic hepatitis B (CHB) is a major cause of chronic liver diseases and tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), and entecavir (ETV) are recommended as primary treatments. This study aimed to evaluate the efficacy and safety of ETV, TDF, and TAF in a real-world clinical setting. <b><i>Methods:</i></b> In this retrospective cohort study, a total of 363 CHB patients who were treated with ETV (<i>n</i> = 163), TDF (<i>n</i> = 154), or TAF (<i>n</i> = 46) from July 2007 to September 2019 were enrolled. <b><i>Results:</i></b> Median patient age was 51 years and 66.4% of patients were male. Median duration of treatment with ETV, TDF, or TAF was 49.0 months (interquartile range, 27.0–74.0 months). In terms of safety, cholesterol was mildly increased in the ETV and TAF groups and significantly lowered in the TDF group than baseline (<i>p</i> &#x3c; 0.001). There was no significant difference in liver cirrhosis-related complications among the 3 groups at 48 weeks (<i>p</i> = 0.235). Hepatitis B e antigen seroconversion, complete virological response, and alanine aminotransferase normalization at 48 weeks as measures of treatment efficacy were not significantly different among the 3 groups (<i>p</i> = 0.142, 0.538, and 0.520, respectively). There was also no significant difference in cumulative incidence rate of hepatocellular carcinoma (HCC) between the ETV and TDF groups (<i>p</i> = 0.894). <b><i>Conclusions:</i></b> ETV, TDF, and TAF were safe antiviral agents and showed similar antiviral effect for CHB at 48 weeks. Cirrhosis-related complications and annual HCC incidence rates did not differ significantly between the ETV and TDF groups over the 48 week follow-up period.

scholarly journals Tenofovir Disoproxil Fumarate Is Superior to Entecavir in Reducing Hepatitis B Surface Antigen for Chronic Hepatitis B in China: 2-Year Comprehensive Comparative Result of a Matched Comparative Study

2021 ◽  
Vol 8 ◽  
Author(s):  
Sisi Yang ◽  
Xueqing Ma ◽  
Chengwei Cai ◽  
Huanqiu Wang ◽  
Fenqiang Xiao ◽  
...  
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Subgroup Analysis ◽  
Tenofovir Disoproxil Fumarate ◽  
Hepatitis B Surface Antigen ◽  
Inspection Time ◽  
Hbsag Level ◽  
Hbsag Seroclearance ◽  
Significant Difference

Aim: Tenofovir disoproxil fumarate (TDF) and entecavir (ETV) are equally recommended as the first-line antiviral treatments for chronic hepatitis B (CHB) at present. We aimed to compare the long-term efficacy and safety between ETV and TDF therapy in CHB patients who had not received nucleoside analog treatment.Method: In this single-center retrospective study, 414 patients who received ETV (290 patients) or TDF (124 patients) therapy at our center from January 2017 to May 2019 were included. To reduce the imbalance of baseline variables, propensity score matching (PSM) was employed to yield 124 pairs of patients at a ratio of 1:1 based on the treatment regimen.Result: After PSM, the cumulative rate of patients who achieved complete virological response (CVR) was not different by drug therapy at each inspection time (1, 3, 6, 12, 18, and 24 months). Subgroup analysis on HBeAg status and level of HBV DNA demonstrated that evolution of proportion of achieving CVR was not significantly different between groups. Despite the insignificant incidence of HBsAg seroclearance in either group, patients in TDF group achieved higher on-treatment HBsAg decline at each inspection time (1, 3, 6, 9, 12, 18, and 24 months), 0.39, 0.51, 0.61, 0.64, 0.68, 0.76, and 0.91 log IU/mL, respectively; while the corresponding reduction were 0.27, 0.37, 0.40, 0.45, 0.48, 0.55, and 0.66 log IU/mL in ETV group (p &lt; 0.05). In subgroup analysis, we found that the significant difference still existed in patients with high baseline HBsAg level (&gt;3 log IU/mL). Additionally, the proportion of patients who achieved on-treatment HBsAg decline &gt;1 log IU/mL in TDF and ETV group was 33.3 and 17.1% (p &lt; 0.01) at the 12th month, 44.4 and 29.5% (p = 0.03) at the 24th month, respectively. Mean increase in serum creatinine from baseline was 0.10 and 0.08 mg/dL in TDF and ETV group (p = 0.11), with no patient experienced acute kidney injury.Conclusions: TDF has higher potency in reducing HBsAg than ETV in this study. Considering the effect still existed in patients with high HBsAg level (&gt;3 log IU/mL), TDF might be a superior therapeutic regimen combining with its relatively safety.

scholarly journals Efficacy and Safety of Tenofovir Disoproxil Orotate in Chronic Hepatitis B Patients Previously Treated with Tenofovir Disoproxil Fumarate: Multicenter, Open-Label, Prospective Study

2021 ◽  
Vol 10 (23) ◽  
pp. 5628
Author(s):  
Young Chang ◽  
Sang-Gyune Kim ◽  
Soung-Won Jeong ◽  
Jae-Young Jang ◽  
Jeong-Ju Yoo ◽  
...  
Keyword(s):  
Renal Function ◽  
Chronic Hepatitis ◽  
Hepatitis B ◽  
Adverse Events ◽  
Chronic Hepatitis B ◽  
Tenofovir Disoproxil Fumarate ◽  
Efficacy And Safety ◽  
Open Label ◽  
Significant Difference ◽  
The Mean

Background/Aim: We aimed to demonstrate the efficacy and safety of tenofovir disoproxilorotate (TDO) compared with that of tenofovir disoproxil fumarate (TDF) in patients with chronic hepatitis B. Methods: This multicenter, open-label, prospective clinical trial (KCT0004185) was conducted to evaluate the efficacy and safety of TDO on switching from TDF for 24 weeks in virologically suppressed chronic hepatitis B patients. The primary efficacy endpoint was the maintenance of virologic response. Safety was assessed by evaluating major adverse events, changes in renal function, and occurrence of hepatocellular carcinoma (HCC). Results: TDO treatment was not inferior in terms of virological response when compared with that on TDF treatment, with a noninferiority margin of −10% (risk difference, −3.17%; 95% confidence interval, −7.5%–1.15%). The biological response of TDO was also comparable to that of TDF, with no significant difference in the proportion of patients with normalized alanine transaminase levels. After 24 weeks of treatment, hepatitis B core-related antigen (HBcrAg) significantly decreased to a mean titer of 3.91 log U/mL from 4.15 log U/mL at baseline (p = 0.01). There were no cases of grade 3 or higher adverse events and HCC. The mean estimated glomerular filtration rate increased from 91.09 mL/min to 93.34 mL/min (p = 0.056), and the mean serum level of phosphorus increased from 3.33 mg/dL to 3.44 mg/dL (p = 0.045), suggesting improvement in renal function with TDO treatment. Conclusion: In patients with chronic hepatitis B, the efficacy of TDO was noninferior to that of TDF, with a significant decrease in the HBcrAg titer and improved renal function.

Torres Strait Islanders‘ understandings of chronic hepatitis B and attitudes to treatment

2016 ◽  
Vol 22 (4) ◽  
pp. 316 ◽  
Author(s):  
Elayne Anderson ◽  
Jeanne Ellard ◽  
Jack Wallace
Keyword(s):  
Chronic Hepatitis ◽  
Liver Cancer ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Cost Effective ◽  
Cancer Surveillance ◽  
Indigenous Australians ◽  
Remote Communities ◽  
Torres Strait

Indigenous Australians are disproportionally affected by hepatitis B compared with non-Indigenous Australians. The higher prevalence of hepatitis B among Indigenous Australians has been linked to an increased incidence of liver cancer in this population. There is evidence that comprehensive programs of hepatitis B virus management, which include liver cancer surveillance and appropriate antiviral therapy, offer a cost-effective approach to reduce the incidence of liver cancer in Australia. This paper reports on data from the first study investigating understandings of hepatitis B and attitudes to treatment among Torres Strait Islanders living with chronic hepatitis B. Forty-two participants completed an interview questionnaire. Participants typically had an unclear understanding of hepatitis B and reported significant gaps in monitoring and follow up. A majority of participants indicated a willingness to use treatment if required. The findings of this study suggest the need for a new service delivery model that is appropriate to remote communities such as the Torres Strait Islands, to improve hepatitis B follow up, disease monitoring and management, and where appropriate, the uptake of treatment.

scholarly journals ANALYSIS OF PLATELET COUNT ON FIBROSIS DEGREE IN CHRONIC HEPATITIS B PATIENTS

2018 ◽  
Vol 24 (2) ◽  
pp. 165
Author(s):  
Hairul Anwar ◽  
Mutmainnah Mutmainnah ◽  
Ibrahim Abdul Samad
Keyword(s):  
Chronic Hepatitis ◽  
Platelet Count ◽  
Hepatitis B ◽  
Chronic Hepatitis B ◽  
Complete Blood Count ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Significant Difference ◽  
B Virus ◽  
Spearman Correlation Test

Chronic hepatitis B is an infectious liver disease caused by hepatitis B virus that persist for more than 6 months. Fibrosis is a result of fibrogenesis which is the formation of connective tissue (scarring) caused by liver tissue damage. Liver damage will affect the production of thrombopoetin causing disturbances in the balance between destruction and production of platelet resulting in decreased platelet counts. This study was a retrospective cross-sectional study by taking the data from medical records of chronic hepatitis B patients who were tested for complete blood count and fibroScan at the Dr.Wahidin Sudirohusodo Hospital Makassar from January 2014 to July 2016. The result showed a total of 323 chronic B hepatitis patients, 99 with severe fibrosis, 84 with moderate fibrosis and 140 with mild fibrosis. The Spearman correlation test showed a significant correlation between the platelet count and the degree of fibrosis (p <0.001) and showed a positive correlation between both of them with a very strong correlation (r = 0.802). The Kruskal-Wallis test showed a significant difference between platelet count and the degree of fibrosis (p<0.001). The conclusion is that a decreased platelet count is a sign of an increase in the degree of fibrosis in chronic hepatitis B patients. It is suggested to perform another study with larger samples based on the degree of fibrosis. 

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