Tenofovir Disoproxil Fumarate versus Adefovir Dipivoxil for Chronic Hepatitis B

Marcellin, Patrick; Heathcote, E. Jenny; Buti, Marı́a; Gane, Ed; Man, Robert A. de; Krastev, Zahary; Germanidis, G.; Lee, Sam S; Flisiak, Robert; Kaita, Kelly; Manns, Michael P.; Kotzev, Iskren; Tchernev, К.; Buggisch, Peter; Weilert, Frank; Kurdas, Oya Ovung; Shiffman, Mitchell L.; Trinh, Huy N.; Washington, Mary Kay; Sorbel, J.; Anderson, Jane; Snow–Lampart, Andrea; Mondou, Elsa; Quinn, Joe; Rousseau, Franck

doi:10.1056/nejmoa0802878

Cited by 1,089 publications

(1,076 citation statements)

References 37 publications

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“…Viral suppression occurred in HBeAg-negative patients receiving ADV for 48 weeks was 63% with no amino acid substitutions within the HBV DNA polymerase associated with phenotypic resistance [22]. These data show that for HBeAg-negative CHB patients, de novo combination treatment of LAM ?…”

Section: Discussionmentioning

confidence: 73%

De novo combination of lamivudine and adefovir versus entecavir monotherapy for the treatment of naïve HBeAg-negative chronic hepatitis B patients

Wang

Chen²,

Cao

et al. 2011

Hepatol Int

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Purpose Either combination treatment or monotherapy using agents with a high genetic barrier are recommended for hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB). The aim of this study was to compare effect of naïve HBeAg-negative CHB patients with either de novo combination of lamivudine (LAM) and adefovir dipivoxil (ADV) or entecavir (ETV) monotherapy. Methods HBeAg-negative CHB patients (n = 71) with ALT levels between 2 and 10 times the upper normal limit and HBV DNA levels [10 4 copies/mL were enrolled. Patients were treated with either LAM 100 mg plus ADV 10 mg per day (n = 31) or ETV 0.5 mg per day (n = 40) for 48 weeks. Results The average reduction in HBV DNA level compared with baseline were 5.16 ± 1.69 log in the LAM ? ADV group and 5.36 ± 1.70 log in the ETV group by week 48 (P = 0.624). The virological response (VR) rates were 80.65 and 77.5%, the biochemical response (BR) rates were 93.55 and 90.00% at week 48 in the LAM ? ADV and ETV groups, respectively. There was no significant difference in the VR and BR between the two groups. During the 48-week treatment period, virological breakthrough and serious side effects were not noted in any patient. Conclusions Both LAM ? ADV combination therapy and ETV monotherapy are effective in naïve HBeAgnegative CHB patients, but further studies are needed to obtain long-term results.

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Section: Discussionmentioning

confidence: 73%

De novo combination of lamivudine and adefovir versus entecavir monotherapy for the treatment of naïve HBeAg-negative chronic hepatitis B patients

Wang

Chen²,

Cao

et al. 2011

Hepatol Int

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“…Tenofovir disoproxil fumarate (TDF) is a highly potent drug active against a broad spectrum of viral infections, including human immunodeficiency virus (HIV-1) and HBV [8]. Recently, its high potency and lasting antiviral effect were confirmed by two randomized trials, mostly in treatment-naive HBV monoinfected, HBeAg-positive, and HBeAg-negative patients [9].…”

Section: Introductionmentioning

confidence: 99%

Successful switch to tenofovir after suboptimal response to entecavir in an immunocompromised patient with chronic hepatitis B and without genotypic hepatitis B virus resistance

et al. 2011

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We report a case of an immunocompromised patient affected by chronic hepatitis B virus (HBV) with high basal HBV viremia ([8 log 10 IU/ml) who failed an entecavir regimen, despite the absence of primary or secondary drug resistance mutations. The patient achieved sustained virological success (serum HBV DNA \12 IU/ ml) when tenofovir was added to the treatment. This case highlights the difficulty in choosing an optimal therapy in such specific conditions and supports the concept of tailoring therapy (including combination regimens) on the basis of the particular conditions of each individual patient.

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“…The registration trials for TDF required a estimated glomerular filtration rate (eGFR) [70 ml/min, absence of anemia, neutropenia, and liver decompensation or presence of unstable comorbidities [3]. In practice, patient complexity can be greater, comorbidities not always optimized, and adherence less assured.…”

mentioning

confidence: 99%

“…For most clinicians, peginterferon is infrequently considered due to the greater complexity of monitoring, higher frequency of adverse effects and patient preference, which narrows the treatment options to TDF or entecavir. In the registration trials of treatment-naïve patients with chronic hepatitis B, both TDF and entecavir demonstrated high rates of on-treatment HBV DNA suppression and low rates of viral resistance coupled with excellent safety [3,4]. Given that TDF and entecavir have been approved therapies for HBV for more than a decade, data derived from ''real-world'' cohort studies have helped fill knowledge gaps regarding the use of these drugs in clinical practice.…”

mentioning

confidence: 99%

Real-World Experiences with Tenofovir Disoproxil Fumarate: Is this the “B-Ticket”?

Terrault

2016

Dig Dis Sci

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The preferred options for treatment of chronic hepatitis B viral (HBV) infection in countries without resource constraints are peginterferon, entecavir, or tenofovir disoproxil fumarate (TDF) [1,2]. For most clinicians, peginterferon is infrequently considered due to the greater complexity of monitoring, higher frequency of adverse effects and patient preference, which narrows the treatment options to TDF or entecavir. In the registration trials of treatment-naïve patients with chronic hepatitis B, both TDF and entecavir demonstrated high rates of on-treatment HBV DNA suppression and low rates of viral resistance coupled with excellent safety [3,4]. Given that TDF and entecavir have been approved therapies for HBV for more than a decade, data derived from ''real-world'' cohort studies have helped fill knowledge gaps regarding the use of these drugs in clinical practice. In the case of TDF, the issues of particular interest include: (1) the efficacy of TDF across a wider spectrum of patients including those less adherent than patients in clinical trials, and (2) the risks associated with longer-term use of TDF, especially the frequency of viral resistance and the risk of renal and bone toxicity.Patients participating in clinical trials are a select group-typically healthier than many patients in the clinic, with fewer comorbidities and higher rates of adherence. The registration trials for TDF required a estimated glomerular filtration rate (eGFR) [70 ml/min, absence of anemia, neutropenia, and liver decompensation or presence of unstable comorbidities [3]. In practice, patient complexity can be greater, comorbidities not always optimized, and adherence less assured. Understanding how antivirals perform under these less than ideal circumstances is important. The ideal ''real-world'' study would prospectively enroll consecutive patients and account for all patients at study end, provide intent-to-treat as well as perprotocol analyses, and include details of treatment failures, including reasons for treatment discontinuation. The ''realworld'' cohorts included in this issue of Digestive Diseases and Sciences-GEMINIS from Germany [5] and VIREAL from France [6]-partially meet these high standards. Regardless, some important practical messages can be gleaned from their analyses.The VIREAL and GEMINIS cohorts enrolled [800 patients from diverse practice settings who were newly initiated on TDF therapy [5,6]. Treatment-naïve and experienced subjects were included, with a substantial proportion of the treatment-experienced patients transitioning from another nucleos(t)ide analog therapy to TDF and having low or undetectable HBV DNA levels at the time of TDF initiation. Hypertension, diabetes, renal disease, cardiovascular diseases, and other comorbidities were present in *40 % of patients [5] with up to 28 % having eGFR \90 ml/min [6]. Although the intent of the study was to follow patients for 3 years, both cohorts suffered from patient attrition, leading to incomplete reporting of virologic and safety data. The primary...

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Tenofovir Disoproxil Fumarate versus Adefovir Dipivoxil for Chronic Hepatitis B

Abstract: Among patients with chronic HBV infection, tenofovir DF at a daily dose of 300 mg had superior antiviral efficacy with a similar safety profile as compared with adefovir dipivoxil at a daily dose of 10 mg through week 48. (ClinicalTrials.gov numbers, NCT00116805 and NCT00117676.)

Cited by 1,089 publications

References 37 publications

De novo combination of lamivudine and adefovir versus entecavir monotherapy for the treatment of naïve HBeAg-negative chronic hepatitis B patients

De novo combination of lamivudine and adefovir versus entecavir monotherapy for the treatment of naïve HBeAg-negative chronic hepatitis B patients

Successful switch to tenofovir after suboptimal response to entecavir in an immunocompromised patient with chronic hepatitis B and without genotypic hepatitis B virus resistance

Real-World Experiences with Tenofovir Disoproxil Fumarate: Is this the “B-Ticket”?

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