Hepatitis B Virus (HBV) Viral Suppression by Entecavir in Adefovir Partial Responders (ADVPR)

Pacific Health Foundation

Status: Completed

Conditions: Hepatitis B

Treatments: Drug: Entecavir

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00704106

PHF008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

60 participants in 4 patient groups

Group 1

Description:

Persistent viremia after 48 weeks or longer.

Treatment:

Drug: Entecavir

Group 2

Description:

\<2 log IU/mL drop from initial HBVDNA after 12 weeks of adefovir

Treatment:

Drug: Entecavir

Group 3

Description:

Patients who responded to adefovir and were switched to entecavir.

Treatment:

Drug: Entecavir

Group 4

Description:

Patients with 160 copies/mL (100 IU/mL) or higher at the time of medication switch.

Treatment:

Drug: Entecavir