Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir

Uijeongbu St. Mary Hospital

Status and phase: Unknown; Phase 3

Conditions: Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48

Treatments: Drug: Tenofovir Disoproxil Fumarate; Drug: lamivudine plus adefovir combination

Study type: Interventional

Funder types: Other

Identifiers

NCT03236584

UC15MISI0099

Details and patient eligibility

About

Little is known about efficacy of switching to tenofovir monotherapy for lam-resistant chronic hepatitis B patients who achieved a complete virological response to lamivudine plus adefovir. This study was to investigate the efficacy of switching to tenofovir monotherapy for lamivudine -resistant chronic hepatitis B patients with undetectable hepatitis B virus DNA while on lamivudine plus adefovir combination therapy

Enrollment: 76 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HBsAg (+) for > 6 months age >19 years antiviral resistance to LAM (rtL180M and/or M204V/I) currently receiving LAM plus ADV for more than 12 months HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval

Exclusion criteria

• Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

lamivudine adefovir

Active Comparator group

Treatment:

Drug: lamivudine plus adefovir combination

tenofovir

Experimental group

Treatment:

Drug: Tenofovir Disoproxil Fumarate