Tenofovir monotherapy versus tenofovir and entecavir combination therapy in adefovir-resistant chronic hepatitis B patients with multiple drug failure: results of a randomised trial

Lim, Young Suk; Yoo, Byung Chul; Byun, Kwan Soo; Kwon, So Young; Kim, Yoon Jun; An, Jihyun; Lee, Han Chu; Lee, Yung Sang

doi:10.1136/gutjnl-2014-308435

Cited by 81 publications

(95 citation statements)

References 47 publications

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“…Thus, entecavir and tenofovir are equally effective. Combination of entecavir and tenofovir showed no additional benefit in a randomized study in patients with multiple drug failure, although only 18% of patients were cirrhotic [43]. …”

Section: Treatment Of Chronic Hepatitis B and Decompensated Cirrhosismentioning

confidence: 99%

Management of HBV and HBV/HDV-Associated Liver Cirrhosis

Siederdissen

Cornberg

2016

Visc Med

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Background: Chronic hepatitis B virus (HBV) infection and hepatitis delta virus (HDV) co-infection lead to liver cirrhosis, hepatic decompensation, and hepatocellular carcinoma (HCC). Methods: We review the current knowledge of the management of HBV mono-infection and HBV/HDV co-infection with a special emphasis on liver cirrhosis. Results: Treatment options for chronic hepatitis B are pegylated interferon (PEG-IFN) alfa and nucleos(t)ide analogues (NUC). PEG-IFN is a finite option to achieve hepatitis B surface antigen loss in compensated cirrhosis. However, this goal is rare. NUC are potent to achieve HBV DNA suppression but long-term treatment is mandatory in most cases. Long-term treatment with NUC can lead to reversion of liver cirrhosis, improve liver function, prevent liver transplantation, and reduces but does not eliminate the risk for development of HCC. Treatment options for hepatitis D are limited to PEG-IFN. Although late relapse is common, treatment with PEG-IFN reduces disease progression. However, new treatments are urgently needed for HDV infection. Conclusion: Early treatment of chronic hepatitis B and D is important to prevent complications of cirrhosis. HCC surveillance remains important in patients with cirrhosis.

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Section: Treatment Of Chronic Hepatitis B and Decompensated Cirrhosismentioning

confidence: 99%

Management of HBV and HBV/HDV-Associated Liver Cirrhosis

Siederdissen

Cornberg

2016

Visc Med

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“…Therefore, rtV191I mutation may be the new resistance site to LAM. Since rt224I/V has never been reported before [13,[22][23][24][25][26], further observation of these patients might address the question whether these mutations are associated with other nucleoside analogue resistance or affect the outcome of the disease.…”

Section: Discussionmentioning

confidence: 99%

Hepatitis B virus pre-existing drug resistant mutation is related to the genotype and disease progression

Wang

Han

Duan

et al. 2017

J Infect Dev Ctries

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Introduction: Previous studies have indicated that the drug-resistant mutations of hepatitis B virus (HBV) are a major obstacle to antiviral therapy. However, it is still unclear whether there are pre-existent resistance mutations in patients with HBV infection and the relationship between drug-resistant mutation, genotypes, and progression of hepatitis B disease. Methodology: A total of 357 treatment-naïve patients with HBV infection were involved in this retrospective study. The drug-resistant mutations of HBV reverse transcriptase domain were screened by direct gene sequencing. Results: Lamivudine (LAM) resistance was detected in 8 patients (3.7%) with chronic hepatitis B (CHB), 13 (11.7%) patients with liver cirrhosis (LC), and 6 (21.4%) patients with hepatocellular carcinoma (HCC). Adefovir(ADV)-resistant mutations were detected in 10 (4.6%) patients with CHB, 15 (13.5%) patients with LC and 4 (14.5%) patients with HCC. Both LAM and ADV resistant mutations were detected in 2 patients (0.9%) with CHB, 1 patient (0.9%) with LC and 1 patient (3.6%) with HCC. Significant differences (p <0.01) were observed in the drug-resistance rates among patients with CHB, LC and HCC. Meanwhile, all the drug-resistant mutations were found in patients with HBV genotype C. Conclusions: This study demonstrated higher risk of pre-existing drug-resistant mutations in patients with HBV genotype C comparing to patients with HBV genotype B. Likewise, increasing prevalence of pre-existing drug-resistant mutations was shown, alongside with the progression of the disease.

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“…A recently published study on long-term TDF treatment found no resistance detectable throughout a 7-year period [16] . Real-life studies have proven TDF retains significant activity against HBV virus in pretreated subjects with resistance to LAM, adefovir, or entecavir [17,18] . Our findings demonstrate that TDF provides a reasonable treatment modality not only for treatment-naïve HBV patients, but also for rescuing treatment-experienced cases with a high rate of genotypic resistance.…”

Section: Discussionmentioning

confidence: 99%

Two-year Single-Center Real-Life Data of Tenofovir Disoproxil Fumarate Treatment for Chronic Hepatitis B Patients in Taiwan

Lee

Yang

et al. 2016

Journal of Gastroenterology and Hepatology Research

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AIM: Chronic infection with hepatitis B virus (CHB) is a worldwide disease. The aim of this study was to evaluate the treatment efficacy and renal tolerability of Tenofovir disoproxil fumarate (TDF) in patients with CHB. METHODS: Data from patients were retrospectively collected from January 2012 to September 2014. The inclusion criteria included CHB, high serum HBV DNA, high serum alanine aminotransferase (ALT), and persistent use of TDF for at least one year. The exclusion criteria included HCV or HIV coinfection. The therapeutic efficacy was recorded at screening and every 6 months thereafter. RESULTS: Among all 100 enrolled subjects, 28 and 24 patients were HBe-positive and treatment-experienced, respectively. The 2-year biochemical response (ALT less than 40 U/L) was 95% to Journal of Gastroenterology and Hepatology Research100%, virologic response (HBV DNA < 20 IU/mL) was 86% to 98%, and serologic response (HBeAg seroloss) was 33%. No cases with HBsAg clearance were detectable. No significant difference existed between treatment-naïve and -experienced patients, but those with positive HBe had a poor virological response compared with the negative HBe group (P = 0.043). There was no significant change in renal function. CONCLUSION: TDF treatment was considered as a efficient, safe and well tolerated therapy to CHB individuals.

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Tenofovir monotherapy versus tenofovir and entecavir combination therapy in adefovir-resistant chronic hepatitis B patients with multiple drug failure: results of a randomised trial

Abstract: NCT01639066.

Cited by 81 publications

References 47 publications

Management of HBV and HBV/HDV-Associated Liver Cirrhosis

Management of HBV and HBV/HDV-Associated Liver Cirrhosis

Hepatitis B virus pre-existing drug resistant mutation is related to the genotype and disease progression

Two-year Single-Center Real-Life Data of Tenofovir Disoproxil Fumarate Treatment for Chronic Hepatitis B Patients in Taiwan

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