Hepatitis B
Conditions
Keywords
Hepatitis B, HBV, Treatment
Brief summary
We propose a largely retrospective study with short-term prospective follow-up in a subgroup of patients who have not yet been treated with 48 weeks of entecavir following partial response to adefovir. The aim of the study is to describe sequential virologic response to adefovir and entecavir.
Detailed description
Amendment was made, and approved by WIRB in January 2009, to this protocol: We propose a largely retrospective study with short-term prospective follow-up in a subgroup of patients who have not yet been treated with 96 weeks of entecavir following adefovir treatment. The aim of the study is to describe sequential virologic response to adefovir and entecavir.
Interventions
DRUGEntecavir
0.5 or 1 mg dose qd
Sponsors
Bristol-Myers Squibb
Pacific Health Foundation
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
KEY INCLUSION CRITERIA: * Age 18 years or older * All genders and ethnicity * Positive HBsAg * HBeAg positive and negative * Pretreatment HBV DNA of 10,000 copies/mL or higher (for purposes of this study, both copies and equivalent IU measurements will be recorded and analyzed) * Patients who are switched to, or prescribed, entecavir after treatment with adefovir for at least 12 weeks by the providing physician. * Patients with and without prior lamivudine exposure will be enrolled but enrollment of lamivudine experienced cases will be limited to no more than 30 patients total KEY
Exclusion criteria
* Patients who refused to consent to the study * Patients younger than 18 * Vulnerable subjects such as pregnant women, prisoners, employees, patients with significant cognitive deficits. * Patients with prior exposure to another nucleoside for more than 2 weeks. Those with prior exposure to lamivudine will be enrolled under conditions detailed above. * HIV co-infection * HCV co-infection * HDV co-infection * Recipients of solid organ transplantation * Patients who receive high-dose steroid (60 mg/d or higher and for longer than 10 days)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA PCR after 12 weeks of entecavir from the time of medication switching: percent of patients with <2log drop in HBV DNA and percent of patients with complete viral suppression during adefovir versus during entecavir. | 48 weeks or after |
Secondary
| Measure | Time frame |
|---|---|
| HBV DNA PCR after 24 weeks of entecavir from the time of medication switching. | 48 weeks or after |
| HBV DNA PCR after 48 weeks of entecavir from the time of medication switching. | 48 weeks or after |
| BR and CR at 24 and 48 weeks of therapy with entecavir. | 48 weeks or after. |
| BR and CR for longer duration of therapy if available. | 48 weeks or after. |
Countries
United States
Outcome results
None listed