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Adefovir Drug Resistance

Is There Resistance to Hepsera?

Drug resistance is a primary concern of infectious disease specialists around the world. Any virus can develop drug resistance, and may even develop resistance to more than one drug. Resistance occurs when viruses acquire ways to survive the effects of the drugs that were designed to weaken them. Resistance to antiviral drugs presents an obstacle to providing effective long-term treatment of viral diseases, such as chronic hepatitis B.

Hepsera® was studied in clinical trials to find out whether or not resistance would develop. Through 144 weeks (about 3 years), resistance mutations were identified that may reduce the effectiveness of Hepsera. After 3 years of continuous treatment, 4/100 patients developed resistance to Hepsera in clinical trials.

In clinical trials, Hepsera was found to work well in people who had hepatitis B virus that was resistant to the currently approved chronic hepatitis B treatment, lamivudine.


Outcomes of Patients with Hepatitis B Who Developed Viral Breakthrough or Resistance to Antiviral Therapy While on Liver Transplant Waiting List
 1/16/07

Occurrence of Adefovir-Resistance Mutations in Lamivudine-Resistant Hepatitis B Patients
- 6/13/06

Adefovir Add-on Therapy after Emergence of Lamivudine Resistance Is Effective and Unlikely to Result in Resistance to Adefovir in HIV-HBV Coinfected Patients - 11/16/05


Treatment with Tenofovir Results in a Rapid Decrease of HBV-DNA Viral Load in Patients with Resistance or Sub-optimal Response to Adefovir - 11/16/05

Tenofovir Appears Highly Effective as Salvage Therapy for HBV Patients with Suboptimal Response to Adefovir - 11/16/05


Resistance to Adefovir Dipivoxil (Hepsera) Can Be Associated with Significant Virologic Breakthough and Fatal Hepatic Decompensation
- 5/27/05

Adefovir Dipivoxil (Hepsera) and Lamivudine (Epivir-HBV) Combination Therapy Prevents Emergence of ADV Resistance Mutations in Patients with LAM-Resistant HBV - 5/16/05

Incidence and Predictors of Adefovir Resistance during 4 Years of Adefovir Therapy - 4/24/05

After 144 Weeks of Adefovir Therapy in Chronic HBV Patients, Drug Resistance Emerges with Low Frequency - 4/16/04

In Vitro Characterization and Molecular Modeling Analysis of a Novel Adefovir Resistance Mutation, rtN236T, in the HBV Polymerase - 4/16/04


Resistance Surveillance after Hepsera Treatment of Liver Transplantation Patients with Epivir-HBV-resistant HBV - 10/29/03







































































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FDA-approved
Monotherapies for HBV

Baraclude
  (entecavir)
 Epivir-HBV
  (lamivudine; 3TC)
Intron A
  (interferon alfa-2b)
Hepsera
  (adefovir dipivoxil)
Pegasys
  (peginterferon alfa-2a)
Tyzeka
  (telbivudine)

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