Four-Year Entecavir Treatment in Nucleoside-Naïve HBeAg(+) Patients: Results from Studies ETV-022 and -901

Han, S.; Chang, Ting-Chen; Chao, You‐Chen; Yoon, Soo-Young; Gish, R. G.; Cheinquer, Hugo; Carrilho, F.; Zhang, H.; Brett‐Smith, Helena; Spiegelmacher, N.; Schwendel, Anke; Pichl, T.; Reeb, I.; Hindes, R.

doi:10.1055/s-0028-1089821

Cited by 14 publications

(19 citation statements)

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“…Of 167 patients in the cohort, 86% (144) completed 96 weeks in the follow-up study for a total of 2.5-3 years of entecavir therapy, and only one patient discontinued treatment due to resistance emergence. In both global long-term studies of entecavir and in the present study, continuation of therapy beyond 2 years resulted in approximately 90% of patients achieving or maintaining HBV-DNA levels below the PCR assay limit of detection of 300-400 copies/ml [32]. These results were consistent with the results of a sensitivity analysis (last observation carried forward), in which 85% of patients achieved HBV-DNA <400 copies/ml on their last HBV-DNA observation.…”

Section: Discussionsupporting

confidence: 90%

Long-term use of entecavir in nucleoside-naïve Japanese patients with chronic hepatitis B infection

Yokosuka

Takaguchi

Fujioka

et al. 2010

Journal of Hepatology

113

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Section: Discussionsupporting

confidence: 90%

Long-term use of entecavir in nucleoside-naïve Japanese patients with chronic hepatitis B infection

Yokosuka

Takaguchi

Fujioka

et al. 2010

Journal of Hepatology

113

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“…[12][13][14][15][16] Follow-up of patients treated in clinical trials beyond 48 weeks demonstrated durable viral suppression. [17][18][19][20] Viral kinetic studies of nucleoside analogs have shown a biphasic decay in HBV DNA. [21][22][23] A 12-week study showed that a higher dose (30 mg/day) than the currently approved 10-mg daily dose of ADV suppressed HBV DNA replication to a greater extent.…”

mentioning

confidence: 99%

Early hepatitis B virus DNA reduction in hepatitis B e antigen-positive patients with chronic hepatitis B: A randomized international study of entecavir versus adefovir

et al. 2008

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This study was undertaken to compare the early antiviral activity and viral kinetic profiles of entecavir (ETV) versus adefovir (ADV) in hepatitis B e antigen positive nucleoside-naïve adults with chronic hepatitis B (CHB). Sixty-nine nucleoside-naïve CHB patients with baseline HBV DNA of 10 8 copies/mL or more were randomized 1:1 to open-label treatment with entecavir 0.5 mg/day or adefovir 10 mg/day for a minimum of 52 weeks. The primary efficacy analysis compared mean reduction in HBV DNA at week 12 adjusted for baseline levels using linear regression. Entecavir was superior to adefovir for mean change from baseline in HBV DNA at week 12 (؊6.23 log 10 copies/mL versus ؊4.42 log 10 copies/mL, respectively; mean difference ؊1.58 log 10 copies/mL; P < 0.0001). Both drugs demonstrated biphasic viral kinetics, with a first phase of rapid decline lasting 10 days. A significant difference favoring ETV was reached at day 10 (day 10 ETV؊ADV difference estimate: ؊0.66 log 10 copies/mL; 95% CI [؊0.30, ؊0.01]). Early virological response was found to be predictive of subsequent virological response, with those having lower HBV DNA levels at day 10 being more likely to achieve HBV DNA of less than 300 copies/mL at week 48. In addition, there was considerably less variability in the extent of HBV DNA reductions in patients treated with entecavir versus adefovir. Both the mean decrease in serum HBV DNA and the proportion of patients achieving HBV DNA less than 300 copies/mL were greater in entecavir-treated than adefovir-treated patients at weeks 2, 4, 8, 12, 24, and 48. At week 48, one (3%) ETV-treated versus 15 (47%) ADV-treated patients had HBV DNA of 10 5 copies/mL or more. Both antivirals were well tolerated. Conclusion: Entecavir therapy resulted in earlier and superior reduction in HBV DNA compared with adefovir in nucleoside-naïve HBeAg-positive patients with CHB. (HEPATOLOGY 2009;49:72-79.)

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“…The results on 146 HBeAg-positive CHB after 192 weeks of entecavir therapy were presented in AASLD 2007. Ninety-eight of 108 (91%) achieved HBV DNA \300 copies/ml, 96 of 112 (86%) had ALT normalization, patients continued to experience HBeAg loss and seroconversion, reaching 39 of 96 (41%) and 15 of 96 (16%), respectively [99].…”

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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Four-Year Entecavir Treatment in Nucleoside-Naïve HBeAg(+) Patients: Results from Studies ETV-022 and -901

Cited by 14 publications

References 0 publications

Long-term use of entecavir in nucleoside-naïve Japanese patients with chronic hepatitis B infection

Long-term use of entecavir in nucleoside-naïve Japanese patients with chronic hepatitis B infection

Early hepatitis B virus DNA reduction in hepatitis B e antigen-positive patients with chronic hepatitis B: A randomized international study of entecavir versus adefovir

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

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