Risk
Factors for Hepatitis Flares After Discontinuing Adefovir Hepatitis
"flares," or severe alanine aminotransferase
(ALT) elevations, are a recognized risk for patients stopping antiviral therapy
for HBV. A retrospective analysis presented at the recent Digestive Disease Week
2006 conference in Los Angeles looked at factors that predict post-treatment hepatitis
exacerbation after discontinuing adefovir
(Hepsera).
The analysis included data from 40 HBeAg-negative
chronic hepatitis B patients with compensated liver disease participating in a
registration trial (Study 438) in which they switched from 10 mg once-daily adefovir
to placebo during the second year. At baseline, median age was 47 years, ALT was
2.1 times the upper limit of normal (x ULN), and serum HBV
DNA was 7.16 log copies/mL. Results  | After
stopping adefovir, 13 patients experienced post-treatment flares with ALT greater
than 10 x ULN; one of these also experienced grade 3 bilirubin elevation, but
no patients developed concurrent albumin or prothrombin time abnormalities. | | Most
hepatitis exacerbations (9 out of 13, or 69%) occurred within 13 weeks after adefovir
discontinuation. | | 12
out of 13 patients who experienced post-treatment flares never achieved HBV DNA
below 400 copies/mL during adefovir therapy. | | A
regression analysis including a variety of demographic and disease-related factors
found that only baseline HBV viral load was a significant predictor of post-treatment
hepatitis exacerbation (P = 0.006). | | In
a multivariate analysis, however, duration of HBV DNA suppression was highly predictive
of ALT flares (P = 0.005), while baseline HBV DNA was only marginally correlated
(P = 0.060). |
|
Conclusion
The
authors concluded that the incidence of post-treatment hepatitis exacerbation
was "significantly increased among patients who had no or a short duration
of HBV DNA < 400 copies/mL in the first year of treatment and was marginally
correlated with higher baseline viral load."
6/09/06 Reference
Y
Murata, S Arterburn, C Pang, E Mondou, F Rousseau. Predictive factors for exacerbation
of hepatitis B after discontinuation of oral therapy in HBeAg-negative patients.
Abstract 481. Digestive Disease Week 2006. May 20-25, 2006. Los Angeles, California.
Additional
Hepsera Articles posted on HIV and Hepatitis.com
Adefovir
Rapidly
Suppresses HBV in HBeAg-negative Patients Who Develop Resistance to Lamivudine
Efficacy
and Tolerability of Adefovir- versus Tenofovir-based Combination Therapy
Regimens in a Cohort of Individuals with Chronic Hepatitis B
In
Comparison to Adefovir, the Efficacy of Tenofovir Seems Unchanged by the
Presence of Lamivudine-resistant HBV
Experimental
HBV Drug Pradefovir: Safety, Tolerability, Antiviral Activity, and Pharmacokinetics
Five-year
Treatment with Adefovir Results in Regression of Liver Fibrosis in Patients
with HBeAg-negative Chronic Hepatitis B
Adefovir
Add-on Therapy after Emergence of Lamivudine Resistance Is Effective and Unlikely
to Result in Resistance to Adefovir in HIV-HBV Coinfected Patients
A
Cost-Effectiveness Analysis of Treatment Alternatives for Hepatitis B Cirrhosis
Long-term
Treatment with Adefovir Dipivoxil Is More Cost Effective Than Lamivudine for HBeAg-negative
Patients with Chronic Hepatitis B
Effective
Treatment Does Not Reach HBV Patients in the Netherlands Due to Lack of Use by
Specialists of Treatment Guidelines
Adefovir
Alone or in Combination with Ongoing Lamivudine in Patients with Decompensated
Liver Disease and Lamivudine-resistant Hepatitis B Virus
Resistance
to Adefovir Dipivoxil (Hepsera) Can Be Associated with Significant Virologic
Breakthough and Fatal Hepatic Decompensation
Adefovir
Dipivoxil Demonstrates Sustained Efficacy in HBeAg-negative Chronic Hepatitis
B Patients
Increasing
Serologic, Virologic and Biochemical Response Over Time to Adefovir Dipivoxil
(ADV) 10 mg in HBeAg+ Chronic Hepatitis B Patients
Pegylated
Interferon Alfa-2b (PegIntron) and Adefovir Dipivoxil (Hepsera) Combination
Therapy in Chronic Hepatitis B (CHB) Patients Leads to a Strong Suppression of
cccDNA and High Rates of HBe and HBs Seroconversion
Predictors
of a Poor Outcome in Patients Treated with Adefovir for Reactivation of
Chronic Hepatitis B Due to Lamivudine-resistant HBV Mutants
|
