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Hepatitis B Virus (HBV) Viral Suppression by Entecavir in Adefovir Partial Responders
Trial ID: NCT00704106
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.
HBV Viral Suppression by Entecavir in Adefovir Partial Responders
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)
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mindie H. Nguyen, MD