Virologic, serologic, and biochemical outcomes through 2 years of treatment with entecavir and lamivudine in nucleoside-naïve Chinese patients with chronic hepatitis B: a randomized, multicenter study

Yao, Guangbi; Chen, ChengWei; Lu, WeiLun; Ren, Hong; Tan, Deming; Wang, Yuming; Xu, Dong; Liu, Jessica; Xu, Dong; Llamoso, Cyril

doi:10.1007/s12072-008-9088-8

Cited by 22 publications

(18 citation statements)

References 19 publications

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“…Safety findings for the first 2 years of the study have been published elsewhere [10,11]. In general, the safety of entecavir was comparable with that of lamivudine.…”

Section: Resultsmentioning

confidence: 76%

“…Chronic hepatitis B is highly prevalent in China. The results of entecavir trials performed in China are encouraging as they have demonstrated superior efficacy of entecavir compared with lamivudine in Chinese patients, with comparable safety and tolerability [8,10,11]. Persistently elevated HBV DNA levels increase the risk of development of cirrhosis and hepatocellular carcinoma in persons with CHB [14], and this relationship remains consistent when both baseline and follow‐up HBV DNA and ALT values are taken into consideration [15].…”

Section: Discussionmentioning

confidence: 99%

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Virological, serological and biochemical outcomes through 3 years of entecavir treatment in nucleoside‐naive Chinese chronic hepatitis B patients

Yao¹,

Ren²,

Xu³

et al. 2010

Journal of Viral Hepatitis

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SUMMARY. Hepatitis B virus (HBV) infection has a high prevalence in China. Entecavir has shown superior efficacy over lamivudine in Chinese nucleoside-naive chronic hepatitis B (CHB) patients over 48 weeks, with continued clinical benefit to 96 weeks. The present study evaluates the long-term efficacy of entecavir in Chinese CHB patients who continued entecavir treatment for 144 weeks. Patients receiving either entecavir 0.5 mg/day (n = 258) or lamivudine 100 mg/day (n = 261) entered the initial 96-week randomized, doubleblind, controlled efficacy study. Patients who did not achieve a consolidated response [HBV DNA <0.7 MEq/mL; alanine aminotransferase (ALT) <1.25 · upper limit of normal; and if hepatitis B e antigen (HBeAg) positive at baseline, loss of HBeAg for ‡24 weeks] or who experienced viral breakthrough or relapse entered a 48-week entecavir rollover study. A total of 160 patients received continuous entecavir for 144 weeks; of these, 89% had undetectable serum HBV DNA, 86% showed ALT normalization, 20% reported HBeAg loss and 8% experienced HBeAg seroconversion. The cumulative rates of HBeAg loss and seroconversion were 36% and 27% at Week 144, respectively. The development of resistance was low, with three patients up to Week 96 and an additional two patients in Weeks 96-144 showing evidence of associated genotypic mutations. Entecavir was well tolerated. Adverse event rates were similar to those in lamivudine-treated patients, but patients receiving entecavir experienced fewer ALT flares. This study demonstrates that entecavir provides durable, long-term suppression of HBV DNA and ALT normalization in Chinese CHB patients, and is associated with low rates of emerging resistance. The results are consistent with the findings using entecavir globally and in Japan.

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“…Safety findings for the first 2 years of the study have been published elsewhere [10,11]. In general, the safety of entecavir was comparable with that of lamivudine.…”

Section: Resultsmentioning

confidence: 76%

Section: Discussionmentioning

confidence: 99%

Virological, serological and biochemical outcomes through 3 years of entecavir treatment in nucleoside‐naive Chinese chronic hepatitis B patients

Yao¹,

Ren²,

Xu³

et al. 2010

Journal of Viral Hepatitis

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“…While, high rates of resistance in nucleoside-naïve patients during 5 years of lamivudine therapy, rates of phenotypic resistance were 17, 40, 57, 67 and 69% respectively Keeffe et al, 2006). These findings supported the selection of entecavir as a primary therapy that enabled prolonged treatment with potent viral suppression and minimal resistance, but we could not conduct this metaanalysis because the studies of comparing the efficacy of entecavir and lamivudine for chronic hepatitis B treatment which exceeded 96 weeks were rare (Gish et al, 2007;Yao et al, 2008;Chang et al, 2008).…”

Section: Discussionmentioning

confidence: 86%

Comparison of the efficacy of entecavir and lamivudine in the treatment of chronic hepatitis B: A meta-analysis

Liu¹,

Zhang#²,

Cheng³

et al. 2011

Afr. J. Biotechnol.

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Some researches demonstrate that entecavir increases the incidence of virological and biochemical responses compared to lamivudine, although, they have shown inconsistent response rates. A metaanalysis was conducted to compare the efficacy of entecavir and lamivudine for chronic hepatitis B treatment. Two independent researchers identified pertinent clinical controlled trials. Our analysis includes nine case-control studies, which had 1251 entecavir groups and 1188 lamivudine groups. Analyses were performed with STATA version 9.0. Rates of virology and biochemical responses and HBeAg clearance and seroconversion were used as primary efficacy measures. Greater virological and biochemical responses rates were observed with entecavir to lamivudine after treatment of 48 weeks (odds ratio (OR) = 3.422, 95% confidence intervals (CI) = 2.349 -4.985, P = 0.000; OR = 2.173, 95% CI = 1.462 -3.230, P = 0.000, respectively), but no statistically significant differences were observed between cases and controls for clearance and seroconversion of HBeAg (P > 0.05). Safety and adverse-event profiles were similar in the two groups. In conclusion, this meta-analysis suggested that entecavir increases the incidence of virological and biochemical responses compared with lamivudine after treatment for 48 weeks.

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“…However, in an earlier study comparing entecavir and lamivudine, entecavir demonstrated similar virologic, biochemical, and serologic outcomes in nucleos(t)ide-naïve Chinese patients with CHB 24. Although a higher proportion of patients treated with entecavir achieved HBV DNA <300 copies/mL (79% versus 46%; P <0.0001), similar proportions of entecavir-treated and lamivudine-treated patients achieved confirmed ALT normalization and HBeAg seroconversion, and the safety profile was similar between the groups.…”

Section: Entecavir Versus Lamivudinementioning

confidence: 91%

Clinical utility of entecavir for chronic hepatitis B in Chinese patients

Wang

2013

DDDT

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The People’s Republic of China has one of the highest rates of hepatitis B virus (HBV) infection. This review summarizes recent data from studies of entecavir, one of the recommended first-line oral therapies for treating chronic hepatitis B, in Chinese HBV-infected patients. Long-term treatment with entecavir is efficacious and well tolerated, and studies comparing entecavir with other nucleos(t)ide therapies, such as lamivudine, adefovir, and telbivudine, demonstrate superior antiviral effects for entecavir therapy and comparable safety profiles. Entecavir monotherapy and combination treatment with other nucleos(t) ide analogs has been shown to be efficacious in the treatment of lamivudine-resistant and adefovir-resistant patients with HBV infection, as well as in patients with multidrug-resistant disease. Entecavir has also been shown to be effective in patients with HBV-associated clinical morbidity, including cirrhosis and liver failure, as well as in preventing recurrence of HBV following liver transplantation and in preventing reactivation of HBV after immunosuppres-sive therapy. Although the cost of anti-HBV therapy is a particular concern in the People’s Republic of China, a number of studies have recently demonstrated that entecavir (particularly long-term therapy) represents a more cost-effective treatment strategy compared with other nucleos(t)ide therapies. Further research is required to assess the effects of entecavir combination therapy on hepatitis B surface antigen clearance, and in drug-resistant patients in the People’s Republic of China.

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Virologic, serologic, and biochemical outcomes through 2 years of treatment with entecavir and lamivudine in nucleoside-naïve Chinese patients with chronic hepatitis B: a randomized, multicenter study

Cited by 22 publications

References 19 publications

Virological, serological and biochemical outcomes through 3 years of entecavir treatment in nucleoside‐naive Chinese chronic hepatitis B patients

Virological, serological and biochemical outcomes through 3 years of entecavir treatment in nucleoside‐naive Chinese chronic hepatitis B patients

Comparison of the efficacy of entecavir and lamivudine in the treatment of chronic hepatitis B: A meta-analysis

Clinical utility of entecavir for chronic hepatitis B in Chinese patients

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