Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum

Mylan

Status and phase

Completed

Phase 4

Conditions

Chronic Hepatitis B Infection

Treatments

Drug: Tenofovir disoproxil fumarate

Other: Historical Data

Study type

Interventional

Funder types

Industry

Identifiers

NCT05355467

Mylan-Ricovir-TW-01

Details and patient eligibility

About

This is a phase IV, open label, historical controlled comparative study to evaluate the efficacy and safety of Ricovir® in maintaining durability of viral response in CHB patients who have been treated with Viread® and have undetectable HBV DNA in serum by real-time polymerase chain reaction (PCR) assay.

Enrollment

40 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Ricovir® Group

Inclusion Criteria:

Male or female aged more than 20 years old;
CHB patients who have been treated with Viread® for more than 1 year;
Serum HBV DNA level is undetectable (not detected or <20 IU/mL) at screening;
Informed consent must be obtained before the commencement of any screening procedures or study drugs

Exclusion Criteria:

Patients with active HCC or other types of malignancy;
Patients with impaired renal function (defined as eGFR ≦ 30 mL/min/1.73m2);
Patients with hepatitis A (HAV), hepatitis C (HCV), hepatitis D (HDV) or human immunodeficiency virus (HIV) coinfection;
Patients with alcohol dependence or addiction;
Patients with autoimmune hepatitis;
Patients with primary biliary cholangitis (PBC);
Pregnancy, planning on getting pregnant, or breast-feeding;
History of allergy, hypersensitivity, intolerance, or experiencing severe adverse reactions to tenofovir or any ingredient of the study drug;
Not suitable for participating in this trial at the investigator's discretion.

Historical Control Group

Eligible individuals will be obtained from the TCVGH historical database based on matching (1:1) in terms of age (±5 years) and gender. To be eligible for the study, subjects must meet all of the following criteria:

Male or female aged more than 20 years old;
CHB patients who had been treated with Viread® for more than 1 year;
Patients who had discontinued Viread® therapy for at least 24 weeks during the period from January 2014 to December 2021 and had undetectable HBV DNA (not detected or <20 IU/mL) in serum at the time of discontinuation;
Patients who have the data of HBV DNA level 24 weeks after the time of discontinuation, with a time window of +4 weeks is allowed;
The informed consent requirement will be waived based on the approval of IRB.