Safety and efficacy of entecavir for the treatment of chronic hepatitis B

Osborn, Melissa

doi:10.2147/idr.s4188

Cited by 24 publications

(22 citation statements)

References 68 publications

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“…The rtM204V/I mutation, lamivudine's signature mutation, is necessary but not sufficient for entecavirresistance, causing an 8-to 10-fold decrease in susceptibility to entecavir compared with wild-type HBV. Other mutations at positions rtT184, rtS202, and rtM250 confer additional decreases in entecavir susceptibility [25,27,28]. In the present study, two patients (Patients #3 and 5) with mutations at position rtM204V/I, without rtT184, rtS202, or rtM250 mutations, showed emergence of VBT, as did one patient (Patient #4) with an rtA181T mutation, which was first reported in a LAM-treated patient [29].…”

Section: Discussionsupporting

confidence: 69%

Long-term continuous entecavir therapy in nucleos(t)ide-naïve chronic hepatitis B patients

Ono

Suzuki

Kawamura

et al. 2012

Journal of Hepatology

154

107

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Section: Discussionsupporting

confidence: 69%

Long-term continuous entecavir therapy in nucleos(t)ide-naïve chronic hepatitis B patients

Ono

Suzuki

Kawamura

et al. 2012

Journal of Hepatology

154

107

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“…Compared with other available nucleos(t)ide analogs, ETV achieves more potent HBV DNA suppression than all agents except perhaps TDF, which is equivalent 12. Our previous study 13 has shown that ETV had better rate of virologic response, lower incidence of resistance, commensurable safety as well as seroconversion rate when compared to LAM, ADV, LdT.…”

Section: Discussionmentioning

confidence: 94%

Efficacy of Entecavir Treatment for up to 5 Years in Nucleos(t)ide-Naïve Chronic Hepatitis B Patients in Real Life

Luo¹,

Li²,

Wu³

et al. 2013

Int. J. Med. Sci.

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Objective: To analyze the efficacy and safety of entecavir (ETV) treatment for up to 5 years in nucleos(t)ide-naïve chronic hepatitis B patients in real life.Methods: We retrospectively analyzed 230 nucleos(t)ide naïve chronic hepatitis B patients who received ETV 0.5 mg/day monotherapy for at least 3 months, of whom 113 were HBeAg positive and 117 were HBeAg negative. The primary endpoints was cumulative probability of achieving a virological response (undetectable serum HBV DNA, <100IU/mL). Secondary endpoints were rates of ALT normalization (ALT < upper limit of normal), HBeAg seroconversion, resistance, and safety.Results: The median follow-up duration was 27.5 months (3-73 months) and mean age was 42 years. With 230, 214, 180, 142, 88, 42 and 11 patients followed-up for at least 3 months,6 months, 1, 2, 3, 4 and 5 years, respectively. In all, Incremental increases were observed in the rates of undetectable HBV DNA. 67.0%, 85.0%, 89.4%, 94.4%, 95.5%, 97.6%, 100% had undetectable HBV DNA at month 3, month 6, 1 year, 2 years, 3 years, 4 years and 5 years. Proportions of patients achieving normal ALT were 73.9%, 85.5%, 82.8%, 89.4%, 80.7%, 85.7%, 100%, respectively. The rate of HBeAg seroconversion reached 21.4% and 15.4% at year2, 3, respectively. One patient achieved HBsAg seroclearance after 1 year, and achieved anti-HBs seroconversion at year 3. Of 180 patients, HBV DNA was detectable (partial virological response, PVR) in 19 patients at year 1 of follow-up, twelve of 14 (85.7%) patients with PVR need more than 1 year of continuous ETV therapy to achieved VR. At baseline, no ETV-resistance was detected in 25 ETV-naïve patients. One patient developed ETV-resistance mutations due to noncompliance. No serious adverse event was reported.Conclusion: Long-term ETV treatment of nucleos(t)ide-naïve was effective and safe in real life. Adjustment of ETV monotherapy in nucleos(t)ide-naïve patients with a partial virological response at 1 year may be unnecessary.

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“…It blocks HBV replication by inhibiting HBV polymerase, the DNA strand via reverse transcription elongation, and Ye XG et al . Entecavir and lamivudine for HBV cirrhosis Removing the inferior quality trials [13,15,17] DNA-dependent plus-strand DNA synthesis [25] . ETV has the advantage of a higher rate of HBV DNA suppression, low drug-resistance and high safety, especially in LAM-resistant CHB patients [26] .…”

Section: Discussionmentioning

confidence: 99%

Effects of entecavir and lamivudine for hepatitis B decompensated cirrhosis: Meta-analysis

Su²

2013

WJG

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AIM:To compare the effects of entecavir (ETV) and lamivudine (LAM) for the treatment of hepatitis B decompensated cirrhosis using a meta-analysis. METHODS:We conducted a literature search for all eligible studies published prior to May 30, 2013 using PUBMED, MEDLINE, EMBASE, the China National Knowledge Infrastructure (CNKI), the VIP database, the Wanfang database and the Cochrane Controlled Trial Register. Randomized controlled trials (RCTs) comparing ETV with LAM for the treatment of hepatitis B decompensated cirrhosis were included. The data were analyzed with Review Manager Software 5.0.2. We used RR as an effect measure, and reported its 95%CI. The meta-analysis was performed using either a fixed-effect or random-effect model, based on the absence or presence of significant heterogeneity. Two reviewers assessed the risk of bias and extracted data independently and in duplicate. The analysis was executed using the main outcome parameters including hepatitis B virus (HBV) DNA undetectability, HBV DNA level, hepatitis B e antigen (HBeAg) seroconversion, alanine aminotransferase (ALT) level, albumin level, total bilirubin (TBIL) level, prothrombin time activity (PTA) level, Child-Turcotte-Pugh (CTP) score, mortality, drugresistance, and adverse reactions. Meta-analysis of the included trials and subgroup analyses were conducted to examine the association between pre-specified characteristics and the therapeutic effects of the two agents. RESULTS:Thirteen eligible trials (873 patients in total) were included and evaluated for methodological quality and heterogeneity. Of these studies, all had baseline comparability, 12 of them reported baseline values of the two treatment groups in detail. Following various treatment durations (12, 24, 36, 48 and > 48 wk), both ETV and LAM significantly reduced HBV DNA level, however, reductions were greater in the ETV group (MD = -0.66, 95%CI: -0.83-0.50, P < 0.00001), (MD = -0.93, 95%CI: -1.36-0.51, P < 0.0001), (MD = -1.4, 95%CI: -1.78-1.01, P < 0.00001), (MD = -1.18, 95%CI: -1.90-0.46, P = 0.001), (MD = -0.14, 95%CI: -0.17-0.11, P < 0.00001, respectively). At 12, 24 and 48 wk of treatment, ETV had a significant effect on the rate of HBV DNA undetectability (RR = 1.55, 95%CI:1.22-1.99, P = 0.0004), (RR = 1.25, 95%CI: 1.13-1.38, P < 0.0001), (RR = 1.2, 95%CI: 1.10-1.32, P < 0.0001, respectively). Although HBeAg seroconversion in the ETV group was more pronounced than that in the LAM group at 24 wk (27.90% vs 26.19%) and 48 wk (31.52% vs 25.00%) of treatment, there was no statistically significant difference between them (RR = 1.49, 95%CI: 0.98-2.28, P = 0.07), (RR = 1.27, 95%CI: 0.98-1.65, P = 0.07, respectively). Following various treatment durations, both the ETV group and the LAM group showed significantly improved liver function (ALT, AIB, TBIL, PTA and CTP levels) and reduced mortality (ETV 6.37%, LAM 7.89%). The effects in the ETV group (0.33%) were statistically lower than those in the LAM group (14.33%) regarding the rate of drug-resistance (RR Although there...

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Safety and efficacy of entecavir for the treatment of chronic hepatitis B

Cited by 24 publications

References 68 publications

Long-term continuous entecavir therapy in nucleos(t)ide-naïve chronic hepatitis B patients

Long-term continuous entecavir therapy in nucleos(t)ide-naïve chronic hepatitis B patients

Efficacy of Entecavir Treatment for up to 5 Years in Nucleos(t)ide-Naïve Chronic Hepatitis B Patients in Real Life

Effects of entecavir and lamivudine for hepatitis B decompensated cirrhosis: Meta-analysis

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