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New approaches in the management of chronic hepatitis B: role of tenofovir.

Reijnders JG, LA Janssen H - Infect Drug Resist (2009)

Bottom Line: TDF was superior to adefovir dipivoxil (ADV) in both nucleos(t)ide-naïve HBeAg-positive and HBeAg-negative HBV patients, and appeared to be one of the most potent antiviral agents so far.In addition, several reports showed that TDF was also effective in the nucleos(t)ide-experienced population, although conflicting results have been presented concerning patients with genotypic resistance to ADV.As treatment with TDF may be associated with nephrotoxicity, all TDF-treated patients should be monitored for renal function at baseline and periodically thereafter.

View Article: PubMed Central - PubMed

Affiliation: Department of Gastroenterology and Hepatology, Erasmus University Medical Center Rotterdam, The Netherlands.

ABSTRACT
In the field of HIV management, tenofovir disoproxil fumarate (TDF) plays a pivotal role and has been demonstrated to be a safe and well-tolerated antiviral agent. Recent data showed the efficacy of TDF in the treatment of chronically hepatitis B virus (HBV)-infected patients. TDF was superior to adefovir dipivoxil (ADV) in both nucleos(t)ide-naïve HBeAg-positive and HBeAg-negative HBV patients, and appeared to be one of the most potent antiviral agents so far. In addition, several reports showed that TDF was also effective in the nucleos(t)ide-experienced population, although conflicting results have been presented concerning patients with genotypic resistance to ADV. TDF seems to have a good resistance profile as well. The rtA194T mutation in association with lamivudine resistance may confer resistance to TDF, although both in vivo and in vitro studies regarding this mutation demonstrate conflicting results. As treatment with TDF may be associated with nephrotoxicity, all TDF-treated patients should be monitored for renal function at baseline and periodically thereafter. While the relative roles of interferon vs nucleos(t)ide analogues (NA) as initial anti-HBV therapy remains unclear, TDF will probably become one of the key factors in HBV management both as first-choice NA for nucleos(t)ide-naïve patients and as rescue therapy for nucleos(t)ide-experienced patients.

No MeSH data available.


Related in: MedlinePlus

Study design of two randomized trials comparing the efficacy of tenofovir to adefovir in both HBeAg-positive and HBeAg-negative chronic hepatitis B patients. At or after week 72 there is an option to initiate emtricitabine–tenofovir combination therapy for confirmed HBV DNA > 400 copies/mL. Current follow-up is up to 96 weeks of treatment.Abbreviations: HBeAg, hepatitis B e antigen.
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f2-idr-2-013: Study design of two randomized trials comparing the efficacy of tenofovir to adefovir in both HBeAg-positive and HBeAg-negative chronic hepatitis B patients. At or after week 72 there is an option to initiate emtricitabine–tenofovir combination therapy for confirmed HBV DNA > 400 copies/mL. Current follow-up is up to 96 weeks of treatment.Abbreviations: HBeAg, hepatitis B e antigen.

Mentions: The results of two international phase III clinical trials, in which the efficacy of TDF is compared with ADV, have recently been presented (Figure 2).22,28 One study studied HBeAg-positive nucleos(t)ide-naïve patients, the second at HBeAg-negative nucleos(t)ide-naïve patients. Both trials used a 2:1 randomization for patients to receive either TDF 300 mg/day or ADV 10 mg/day. Primary efficacy was evaluated at 48 weeks. The primary endpoint was the combined presence of HBV DNA levels below 400 copies/mL and histological improvement, defined as a ≥2-point reduction in Knodell necroinflammatory score without worsening fibrosis. After 48 weeks all eligible subjects with a week 48 biopsy were switched to open-label TDF monotherapy for up to an additional 8 years.


New approaches in the management of chronic hepatitis B: role of tenofovir.

Reijnders JG, LA Janssen H - Infect Drug Resist (2009)

Study design of two randomized trials comparing the efficacy of tenofovir to adefovir in both HBeAg-positive and HBeAg-negative chronic hepatitis B patients. At or after week 72 there is an option to initiate emtricitabine–tenofovir combination therapy for confirmed HBV DNA > 400 copies/mL. Current follow-up is up to 96 weeks of treatment.Abbreviations: HBeAg, hepatitis B e antigen.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3108728&req=5

f2-idr-2-013: Study design of two randomized trials comparing the efficacy of tenofovir to adefovir in both HBeAg-positive and HBeAg-negative chronic hepatitis B patients. At or after week 72 there is an option to initiate emtricitabine–tenofovir combination therapy for confirmed HBV DNA > 400 copies/mL. Current follow-up is up to 96 weeks of treatment.Abbreviations: HBeAg, hepatitis B e antigen.
Mentions: The results of two international phase III clinical trials, in which the efficacy of TDF is compared with ADV, have recently been presented (Figure 2).22,28 One study studied HBeAg-positive nucleos(t)ide-naïve patients, the second at HBeAg-negative nucleos(t)ide-naïve patients. Both trials used a 2:1 randomization for patients to receive either TDF 300 mg/day or ADV 10 mg/day. Primary efficacy was evaluated at 48 weeks. The primary endpoint was the combined presence of HBV DNA levels below 400 copies/mL and histological improvement, defined as a ≥2-point reduction in Knodell necroinflammatory score without worsening fibrosis. After 48 weeks all eligible subjects with a week 48 biopsy were switched to open-label TDF monotherapy for up to an additional 8 years.

Bottom Line: TDF was superior to adefovir dipivoxil (ADV) in both nucleos(t)ide-naïve HBeAg-positive and HBeAg-negative HBV patients, and appeared to be one of the most potent antiviral agents so far.In addition, several reports showed that TDF was also effective in the nucleos(t)ide-experienced population, although conflicting results have been presented concerning patients with genotypic resistance to ADV.As treatment with TDF may be associated with nephrotoxicity, all TDF-treated patients should be monitored for renal function at baseline and periodically thereafter.

View Article: PubMed Central - PubMed

Affiliation: Department of Gastroenterology and Hepatology, Erasmus University Medical Center Rotterdam, The Netherlands.

ABSTRACT
In the field of HIV management, tenofovir disoproxil fumarate (TDF) plays a pivotal role and has been demonstrated to be a safe and well-tolerated antiviral agent. Recent data showed the efficacy of TDF in the treatment of chronically hepatitis B virus (HBV)-infected patients. TDF was superior to adefovir dipivoxil (ADV) in both nucleos(t)ide-naïve HBeAg-positive and HBeAg-negative HBV patients, and appeared to be one of the most potent antiviral agents so far. In addition, several reports showed that TDF was also effective in the nucleos(t)ide-experienced population, although conflicting results have been presented concerning patients with genotypic resistance to ADV. TDF seems to have a good resistance profile as well. The rtA194T mutation in association with lamivudine resistance may confer resistance to TDF, although both in vivo and in vitro studies regarding this mutation demonstrate conflicting results. As treatment with TDF may be associated with nephrotoxicity, all TDF-treated patients should be monitored for renal function at baseline and periodically thereafter. While the relative roles of interferon vs nucleos(t)ide analogues (NA) as initial anti-HBV therapy remains unclear, TDF will probably become one of the key factors in HBV management both as first-choice NA for nucleos(t)ide-naïve patients and as rescue therapy for nucleos(t)ide-experienced patients.

No MeSH data available.


Related in: MedlinePlus