Telbivudine versus Lamivudine in Patients with Chronic Hepatitis B

Lai, Ching–Lung; Gane, Edward; Liaw, Yun–Fan; Hsu, Chao‐Wei; Thongsawat, Satawat; Wang, Yuming; Chen, Yagang; Heathcote, E. Jenny; Rasenack, J.; Bzowej, Natalie; Naoumov, Nikolai V.; Bisceglie, Adrian M. Di; Zeuzem, Stefan; Moon, Young Myoung; Goodman, Zachary; Chao, George; Constance, Barbara Fielman; Brown, Nathaniel

doi:10.1056/nejmoa066422

Cited by 719 publications

(733 citation statements)

References 41 publications

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“…In contrast, HBeAg seroconversion rates reported with older oral nucleos(t)ide analogues (NAs; lamivudine and adefovir) have been considerably lower (12-16%), though the rate in patients with a baseline ALT of more than five times the upper limit of normal (ULN) was more than 50% [49]. Week 24 HBV-DNA level during NA therapy is also predictive of HBeAg seroconversion [22,48]. In addition, a retrospective analysis of HBeAg seroconversion involving 98 HBeAg-positive patients with genotype C CHB who were treated with lamivudine, the cumulative relapse rates at 1 and 2 years post-treatment were 37.5 and 49.2%, respectively, and most relapses were accompanied by an elevation in ALT levels (94%) and reappearance of HBeAg (81%) [50].…”

Section: Treatment-induced Hbeag Seroconversion and Disease Progressionmentioning

confidence: 99%

“…The GLOBE study, conducted in 20 countries, compared these two antiviral agents in 1,367 patients (921 HBeAg positive) [22]. A similarly designed study was conducted in China and enrolled 332 patients (290 HBeAg positive) [52].…”

Section: Treatment-induced Hbeag Seroconversion and Disease Progressionmentioning

confidence: 99%

“…Studies have shown that profound and sustained suppression of HBV replication is a critical factor in achieving the goals of anti-HBV therapy, including improvement of liver histology and reduction in liver disease progression [4][5][6][7][19][20][21][22][23][24]. However, HBeAg seroconversion is still considered to be an important end point in the management of HBeAg-positive patients with CHB.…”

Section: Introductionmentioning

confidence: 99%

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HBeAg seroconversion as an important end point in the treatment of chronic hepatitis B

2009

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During the natural history of chronic hepatitis B virus (HBV) infection, the loss of serum hepatitis B e antigen (HBeAg) and the development of anti-HBe antibodies (HBeAg seroconversion) mark a transition from the immune-active phase of disease to the inactive carrier state. This review examines the evidence from natural history and cohort studies on the relationship between HBeAg seroconversion and disease progression. The role of HBeAg seroconversion as an important milestone in the management of HBeAg-positive patients with chronic hepatitis B (CHB), as well as the advantages and disadvantages of administering a finite course of therapy for HBeAg-positive CHB, is also discussed. The evidence from natural history and cohort studies indicates that spontaneous or treatment-induced HBeAg seroconversion is associated with lower rates of disease progression to cirrhosis and hepatocellular carcinoma, a potential of hepatitis B surface antigen seroconversion, and improved survival rates. Updated guidelines developed by major liver associations recommend stopping oral therapy for HBeAgpositive patients who achieve sustained HBeAg seroconversion with polymerase chain reaction-undetectable HBV-DNA on two separate occasions for 6 or more months apart, taking into consideration the individual's clinical and virologic response to therapy, as well as the severity of liver disease. Thus, early induction of HBeAg seroconversion with interferon-based therapy or oral nucleos(t)ide analogues has important clinical and socioeconomic implications for the management of CHB.

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Section: Treatment-induced Hbeag Seroconversion and Disease Progressionmentioning

confidence: 99%

Section: Treatment-induced Hbeag Seroconversion and Disease Progressionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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HBeAg seroconversion as an important end point in the treatment of chronic hepatitis B

2009

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“…On the basis of our observations, we suggest LAM as a preemptive treatment in onco-hematologic HBsAg-positive patients with a high probability of cure after first line treatment and as a preventative measure in HBV occult carriers undergoing ICT. While new drugs, such as Entecavir [6], are more powerful and faster acting, they might be more useful when longer lasting or repeated treatments are required as they provide protection against the development of drug resistance. Whichever antiviral drug is administered, an extended follow-up term, for HBV reactivation, is recommended after ICT discontinuation.…”

Section: Letter To the Editormentioning

confidence: 99%

Is management with lamivudine always the appropriate choice for HBV patients with onco-hematologic diseases?

et al. 2008

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“…27 who continued to receive treatment showed a response from the second to the fi fth year. 16 The reduction in HBV DNA was 88.3% 15 after the fi rst year of treatment with telbivudina and 82.0% in the second year. 19 Due to limited data available on the time of treatment, we used the conservative estimate of 15% rate of reaction to treatment from the sixth to the fi nal year of the cohort, which corresponds to the lowest rate of response to treatment using one drug (adefovir).…”

Section: Methodsmentioning

confidence: 99%

Custo-efetividade dos análogos de nucleosídeos/nucleotídeos para hepatite crônica B

et al. 2012

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OBJECTIVE:To conduct a cost-effectiveness analysis of drug alternatives with rescue therapy in case of relapse due to viral resistance for the treatment of patients with chronic hepatitis B (CHB). METHODS:Hypothetical cohort of patients with CHB, HBeAg-negative, without clinical or histological evidence of cirrhosis, detectable HBV DNA, histological diagnosis of the disease, positive serum HBsAg for longer than six months, high levels of alanine aminotransferase (ALT) (twice as high as the upper limit of normality) and mean age of 40 years. A Markov model was developed for chronic hepatitis B (HBeAg-negative) with a 40-year time horizon. Costs and benefi ts were discounted at 5%. Annual rates of disease progression, costs due to complications and the effi cacy of medicines were obtained from the literature. One-way and probabilistic sensitivity analysis evaluated uncertainties. RESULTS:Initiation of treatments with entecavir resulted in an increase of 0.35 discounted life-years gained compared to lamivudine. The incremental cost-effectiveness ratio was R$ 16,416.08 per life-years gained. In the sensitivity analysis, the incremental cost-effectiveness ratio was more sensitive to variation in the probability of transition from chronic hepatitis B to compensated cirrhosis, discount rate and medicine prices (± 10%). In the probabilistic sensitivity analysis, the acceptability curve showed that beginning treatment with entecavir was the most cost-effective alternative in comparison with the use of lamivudine. CONCLUSIONS:The availability of entecavir is economically attractive as part of early treatment for patients with chronic hepatitis B without HIV co-infection. Cost-effectiveness: chronic hepatitis B Almeida AM et al Chronic hepatitis B (CHB) is a serious public health problem which affects between 350 and 400 million people worldwide. 2 A population based prevalence study of hepatitis B infection in Brazil revealed endemic levels > 1% across all the capital cities of each region and of the Federal District. The overall prevalence of HbsAg in the Brazilian state capitals was 0.37% (95%CI 0.25;0.50). The prevalence of this marker was 0.055% (95%CI 0.012;0.10) in the ten to 19 year old age group and of 0.6% (95%CI 0.41;0.78) for the 20 to 69 year old age group. The North showed the highest results for both age groups. a Treatment, when prescribed, is critical in avoiding progression and complications of the disease such as compensated cirrhosis, decompensated cirrhosis and hepatocellular carcinoma. a Treatment costs become signifi cantly higher with the high morbidity and mortality of patients in advanced stages of the disease, as serious hepatic complications increase the complexity of treatment and the risk of death. 23 In Brazil, until 2009, the guidelines from advocated interferon and lamivudine for the treatment of CHB. Currently, drugs such as adefovir, entecavir and tenofovir are also included. b A systematic review 1 showed adefovir, entecavir and telbivudina effectiveness to be similar to or grea...

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Telbivudine versus Lamivudine in Patients with Chronic Hepatitis B

Cited by 719 publications

References 41 publications

HBeAg seroconversion as an important end point in the treatment of chronic hepatitis B

HBeAg seroconversion as an important end point in the treatment of chronic hepatitis B

Is management with lamivudine always the appropriate choice for HBV patients with onco-hematologic diseases?

Custo-efetividade dos análogos de nucleosídeos/nucleotídeos para hepatite crônica B

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