51 Optimal virologic and clinical efficacy at one year is associated with maximal early HBV suppression in nucleoside-treated hepatitis B patients

Zeuzem, Stefan; Lai, CL; Gane, Ed; Yf, Liaw; Thongsawat, Satawat; Ym, Wang; Chen, Y; Heathcote, Jenny; Rasenack, J; Bzowej, Natalie; Naoumov, Nikolai V.; Chao, George; Fielman, B.; Brown, Nathaniel

doi:10.1016/s0168-8278(06)80052-8

Cited by 8 publications

(10 citation statements)

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“…Similar trends were observed for HBeAgnegative patients with complete viral suppression at week 24 and for the subset of patients with baseline HBV DNA <7 log 10 copies/mL and those in this subset with complete viral suppression at 24 weeks (Table 5b) [21][22][23]. In a study comparing telbivudine to adefovir (n = 135), HBV DNA <300 copies/mL after 24 weeks of therapy was also shown to be associated with improved efficacy at 1 year with a higher rate of HBeAg seroconversion (41% vs 13%), ALT normalization (95% vs 81%) and complete viral suppression (95% vs 22%) [32,33].…”

Section: Hbv Dna Levels At 24 Weeks Of Therapysupporting

confidence: 71%

“…For HBeAg-positive patients from the initial intentionto-treat (ITT) population, those with baseline HBV DNA <9 log 10 copies/mL plus ALT ‡2· ULN who achieved complete viral suppression (HBV DNA £300 copies/mL) at week 24 appear to have better outcomes after 104 weeks of telbivudine compared with the overall ITT or subgroup population (Table 5a) [21][22][23]. Similar trends were observed for HBeAgnegative patients with complete viral suppression at week 24 and for the subset of patients with baseline HBV DNA <7 log 10 copies/mL and those in this subset with complete viral suppression at 24 weeks (Table 5b) [21][22][23].…”

Section: Hbv Dna Levels At 24 Weeks Of Therapymentioning

confidence: 99%

“…In a smaller study of primarily non-Asian patients, those with HBV DNA <100 copies/mL at week 24 had a reduced rate of viral resistance and were the only patients to subsequently clear their HBeAg [20]. Analysis from the GLOBE trial comparing the efficacy of telbivudine and lamivudine also provided additional information on early viral suppression at week 24 and treatment outcomes at week 104 for lamivudine [21][22][23]. In HBeAg-positive patients treated with lamivudine, the HBeAg seroconversion and resistance rates at week 104 were 25% and 40%, respectively, in the overall study population [23].…”

Section: Hbv Dna Levels After 24 Weeks Of Lamivudine Therapymentioning

confidence: 99%

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Chronic hepatitis B: early viral suppression and long‐term outcomes of therapy with oral nucleos(t)ides

Nguyen¹,

Keeffe²

2009

Journal of Viral Hepatitis

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Chronic hepatitis B is a serious health problem worldwide with a substantial minority of patients experiencing premature death due to end-stage liver disease and/or hepatocellular carcinoma. Antiviral therapy may help prevent complications of chronic hepatitis B, and seven agents are currently approved in many countries. Of these agents, five are nucleos(t)ide analogs that all have a risk of antiviral drug resistance with long-term use. Efforts have been made in the recent years to prevent or to reduce the risk of viral resistance in patients treated with oral nucleos(t)ides as the majority of these patients will require therapy for 3-5 years or longer. One approach is to identify patients who would most likely develop antiviral resistance on long-term therapy using predictors obtainable early in the course of treatment, when intervention with new or additional therapy can be instituted. The most important predictors of treatment outcomes are serum HBV DNA levels at baseline and during the first 6 months of therapy. The purpose of this synopsis is to review the recent literature regarding the importance of serum HBV DNA levels in association with treatment outcomes in chronic hepatitis B, particularly the association of complete viral suppression early in the course of oral therapy with long-term treatment outcomes, particularly the incidence of antiviral drug resistance.

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Section: Hbv Dna Levels At 24 Weeks Of Therapysupporting

confidence: 71%

Section: Hbv Dna Levels At 24 Weeks Of Therapymentioning

confidence: 99%

Section: Hbv Dna Levels After 24 Weeks Of Lamivudine Therapymentioning

confidence: 99%

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Chronic hepatitis B: early viral suppression and long‐term outcomes of therapy with oral nucleos(t)ides

Nguyen¹,

Keeffe²

2009

Journal of Viral Hepatitis

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“…In a multivariate analysis, a lower HBV DNA level at week 24 was the best predictor of clinical and virologic efficacy responses at week 52, irrespective of HBeAg serostatus [7]. Among patients who were HBV DNA-negative by PCR at week 24, 90% were HBV DNA-negative (\300 copies/ml) at week 52, and\1% developed resistance [9]. More recently, the 2-year analysis of GLOBE data demonstrated that week 24 viral suppression is correlated with maintained viral suppression at 2 years.…”

Section: Telbivudinementioning

confidence: 96%

“…Guidelines for the management of CHB address the criteria for patient selection, the objectives and timing of therapy, and the advantages and disadvantages of available treatment options, but little information is available on treatment monitoring and strategies for optimizing patient outcomes [1][2][3][4][5]. Emerging evidence from clinical studies of antiviral agents suggest that on-treatment serum levels of hepatitis B virus (HBV) DNA are predictive of treatment response [6][7][8][9]. Based on these findings, a panel of international experts has proposed an algorithm for optimizing treatment response that relies on the on-treatment monitoring of HBV DNA levels [10].…”

Section: Introductionmentioning

confidence: 99%

Current approaches for treating chronic hepatitis B: when to start, what to start with, and when to stop

Chang

Suh

2008

Hepatol Int

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The natural course of hepatitis B virus (HBV) infection is variable, and chronic hepatitis B (CHB) disease exhibits itself through a spectrum of clinical manifestations. These factors contribute to the challenges faced when managing patients who live with HBV infection. Furthermore, conventional treatment options (e.g., interferon alfa-2a, lamivudine, and adefovir) are moderately effective and can be associated with problems, such as poor tolerability (interferon alfa-2a) and the development of drug resistance (lamivudine). Over the last 5 years, several antiviral agents including entecavir, peginterferon alfa-2a, and telbivudine which are more efficacious and have improved tolerability over previous drugs have become available. The availability of novel antiviral agents and advances in understanding resistance patterns of antiviral agents has resulted in refinement of CHB treatment recommendations and guidelines. More recently, evidence from clinical trials suggests the central importance of virologic suppression as an indicator of treatment outcome and the predictive value of on-treatment HBV DNA levels in response to antiviral therapy. This review highlights the goals of therapy and clinical experience with therapies that are newly licensed or in the late stages of clinical development. Current approaches for treating CHB and new strategies for optimizing response to therapy are also discussed.

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HBeAg and hepatitis B virus DNA as outcome predictors during therapy with peginterferon alfa-2a for HBeAg-positive chronic hepatitis B

et al. 2008

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T he goal of therapy in patients with chronic hepatitis B is the prevention of cirrhosis, hepatocellular carcinoma, and hepatitis B virus (HBV)-related mortality. 1 However, it is difficult to assess these outcomes during short-term clinical trials because of the prolonged natural history of chronic hepatitis B. Surrogate endpoints are used for assessing the efficacy of anti-HBV drugs. Reduction in hepatitis B virus deoxyribonucleic acid (HBV DNA) is an excellent measure of antiviral efficacy. However, a decrease in HBV DNA Abbreviations: HBeAg, hepatitis B e antigen; HBV, hepatitis B virus; NPV, negative predictive value. From the

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51 Optimal virologic and clinical efficacy at one year is associated with maximal early HBV suppression in nucleoside-treated hepatitis B patients

Cited by 8 publications

References 0 publications

Chronic hepatitis B: early viral suppression and long‐term outcomes of therapy with oral nucleos(t)ides

Chronic hepatitis B: early viral suppression and long‐term outcomes of therapy with oral nucleos(t)ides

Current approaches for treating chronic hepatitis B: when to start, what to start with, and when to stop

HBeAg and hepatitis B virus DNA as outcome predictors during therapy with peginterferon alfa-2a for HBeAg-positive chronic hepatitis B

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