519 Entecavir is superior to lamivudine for the treatment of chronic hepatitis B (CHB): Results of a phase 3 Chinese study (ETV-023) in nucleoside-naïve patients

Yao, G.; Chen, C.; Lu, Wenjian; Ren, Hongye; Wang, Y.; Xu, Dongming; Jiang, Meng; Liu, J.; Macdonald, Laurie

doi:10.1016/s0168-8278(06)80519-2

Cited by 7 publications

(11 citation statements)

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“…Comparing the efficacy of treatment is difficult; however, some comparative studies have been performed. Both entecavir and telbivudine proved superior efficacy over lamivudine after 1 year of treatment [13,15,63,64] . Direct comparison of telbivudine or adefovir for 52 wk showed superior efficacy on viral and biochemical parameters for telbivudine, but resistance was not assessed [65] .…”

Section: Treatment With Nucleoside/ Nucleotide Analoguesmentioning

confidence: 96%

“…Presuming study randomisation led to an equal distribution of both viral and host factors, it is to be expected that more potent drugs are able to suppress viral replication in subjects with suboptimal suppression. Entecavir and telbivudine proved their superior potency over lamivudine in a head to head comparison and for telbivudine this observation also has been made in comparison with adefovir [13,15,[63][64][65] . In adefovir treatment failures the more potent drug tenofovir showed good viral suppression [93] .…”

Section: Management Of Treatment Failures To Nucleos(t)ide Analoguesmentioning

confidence: 99%

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Future prospectives for the management of chronic hepatitis B

Leemans

Janssen

Man³

2007

WJG

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Chronic hepatitis B virus infection affects about 400 million people around the globe and causes approximately one million deaths a year. Since the discovery of interferon-α as a therapeutic option the treatment of hepatitis B has evolved fast and management has become increasingly complicated. T h e a m o u n t o f v ira l re p l ic a t io n re f le c t e d in t he viral load (HBV-DNA) plays an important role in the development of cirrhosis and hepatocellular carcinoma. The current treatment modalities for chronic hepatitis B are immunomodulatory (interferons) and antiviral suppressants (nucleoside and nucleotide analogues) all with their own advantages and limitations. An overview of the treatment efficacy for both immunomodulatory as antiviral compounds is provided in order to provide the clinician insight into the factors influencing treatment outcome. With nucleoside or nucleotide analogues suppression of viral replication by 5-7 log10 is feasible, but not all patients respond to therapy. Known factors influencing treatment outcome are viral load, ALT levels and compliance. Many other factors which might influence treatment are scarcely investigated. Identifying the factors associated with response might result in stopping rules, so treatment could be adapted in an early stage to provide adequate treatment and avoid the development of resistance. The efficacy of compounds for the treatment of mutant virus and the crossresistance is largely unknown. However, genotypic and phenotypic testing as well as small clinical trials provided some data on efficacy in this population. Discontinuation of nucleoside or nucleotide analogues frequently results in viral relapse; however, some patients have a sustained response. Data on the risk factors for relapse are necessary in order to determine when treatment can be discontinued safely. In conclusion: chronic hepatitis B has become a treatable disease; however, much research is needed to tailor therapy to an individual patient, to predict the sustainability of response and determine the best treatment for those failing treatment.

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Section: Treatment With Nucleoside/ Nucleotide Analoguesmentioning

confidence: 96%

Section: Management Of Treatment Failures To Nucleos(t)ide Analoguesmentioning

confidence: 99%

Future prospectives for the management of chronic hepatitis B

Leemans

Janssen

Man³

2007

WJG

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“…In this study, patients were randomized to receive entecavir, 0.5 mg/day, plus placebo (n 5 261) or lamivudine, 100 mg/day, plus placebo (n 5 258) for 48 weeks. At week 48, a higher proportion of patients in the entecavir group than in the lamivudine group achieved the composite end point of HBV DNA level o0.7 mEq/ml by bDNA assay and an ALT level of o1.25 Â ULN (90% vs 67%; Po0.0001) (29). The overall mean reduction in HBV DNA level was greater in patients treated with entecavir than in patients treated with lamivudine ( À 5.9 vs À 4.3 log 10 copies/ml; Po0.0001).…”

Section: Anti-hbv Agents Licensed Since 2005mentioning

confidence: 98%

“…The efficacy of entecavir has also been studied in nucleoside-naı¨ve and lamivudine-refractory Chinese patients with CHB. Data from a randomized, double-blind, multicenter, phase III study comparing entecavir and lamivudine in Chinese nucleoside-naı¨ve patients were recently reported (29). In this study, patients were randomized to receive entecavir, 0.5 mg/day, plus placebo (n 5 261) or lamivudine, 100 mg/day, plus placebo (n 5 258) for 48 weeks.…”

Section: Anti-hbv Agents Licensed Since 2005mentioning

confidence: 99%

New therapies for chronic hepatitis B infection

Chang

Jia

Omata

et al. 2006

Liver International

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Conventional pharmacotherapeutic approaches to the management of chronic hepatitis B virus (HBV) infection are compromised by drug resistance and a failure to achieve sustained HBV DNA suppression. Low rates of seroconversion to hepatitis B e antigen‐negative status and loss of hepatitis B surface antigen, as well as the potential for the development of adverse effects, are additional problems. Two agents, entecavir and the pegylated interferon (peginterferon) α‐2a, have recently been added to the therapeutic armamentarium for the management of chronic hepatitis B (CHB). Data from clinical trials indicate that these newly licensed drugs may offer advantages over conventional treatments such as lamivudine and, possibly, adefovir. In addition, several novel agents in late‐stage clinical development, specifically telbivudine and clevudine, have also shown encouraging results in patients with CHB infection. This review summarizes the current clinical experience with these new agents, focusing on data in Asian populations, and discusses the implications of the data for CHB management.

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“…At week 52, HBV DNA level decreased by 5.9 vs. 4.3 log 10 copies/ml in entecavir and lamivudine groups, respectively (P \ 0.0001); undetectable HBV DNA in 76 vs. 43% (P \ 0.0001), HBeAg seroconversion rates 15 vs. 18% (NS). In another phases II and III trials in China involving 876 Chinese patients, efficacy, minimal drug resistance emergence, good safety profile, and good tolerability were reported [100][101][102].…”

Section: Entecavirmentioning

confidence: 99%

Recent data on treatment of chronic hepatitis B with nucleos(t)ide analogues

Leung

2008

Hepatol Int

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Forty years ago in 1967, Professor Blumberg discovered the Australian Antigen, later known as the hepatitis B surface antigen, and was awarded the Nobel Prize. This discovery enables the diagnosis of hepatitis B virus (HBV) infection and defines its epidemiology. Viral hepatitis B infection affects global health situation, and chronic hepatitis B (CHB) is particularly serious in the Asia-Pacific region. HBV vaccines created the first breakthrough in HBV prevention. Through universal HBV vaccination program for the newborns, promoted since the mid-1980s, the main route that perpetuates chronic infection from mother to child is curbed. Most children and young adults now have immunity against HBV infection. The next breakthrough comes with therapy for CHB. This prevents progression to cirrhosis and hepatocellular carcinoma. Standard interferon therapy with modest efficacy has been largely replaced by therapy with nuclos(t)ide analogues or pegylated interferons alfa-2a and -2b. Lamivudine was approved by the FDA USA in 1998, followed by adefovir dipivoxil in 2002, entecavir in 2005, and telbivudine in 2006. Clevudine, tenofovir, and many promising candidates are in different stages of development and clinical trial. This paper critically reviews recent data published or presented since the APASL Consensus and Guideline Update of 2005. Clinical efficacy mostly in patients with raised serum alanine aminotransferase will be analyzed.

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519 Entecavir is superior to lamivudine for the treatment of chronic hepatitis B (CHB): Results of a phase 3 Chinese study (ETV-023) in nucleoside-naïve patients

Cited by 7 publications

References 0 publications

Future prospectives for the management of chronic hepatitis B

Future prospectives for the management of chronic hepatitis B

New therapies for chronic hepatitis B infection

Recent data on treatment of chronic hepatitis B with nucleos(t)ide analogues

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