Entecavir Plus Adefovir in Lamivudine-Resistant Patients

Bristol-Myers Squibb

Overview

Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant chronic hepatitis B infection

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Hepatitis B, Chronic

Interventions

LamivudineDRUG

Tablets, Oral, 100mg, once daily, 48-96 weeks depending on response

EntecavirDRUG

Tablets, Oral, 1mg, once daily, 48-96 weeks depending on response

AdefovirDRUG

Tablets, Oral, 10mg, once daily, 48-96 weeks depending on response

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * CHB HBeAg(+) Subject with Lamivudine treatment history must have LVDr substitution at rtM204V/I * Naïve to nucleoside/nucleotide analogues except for LVD * HBV DNA \> 17,200 IU/mL * Compensated liver function * Serum ALT \<10 × ULN Exclusion Criteria: * Women who are pregnant or breastfeeding * Evidence of decompensated cirrhosis * Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)

Outcomes

Primary Outcomes

The proportion of patients with HBV DNA < 50 IU/mL at W48

Time frame: Week 48

Secondary Outcomes

The proportion of patient with HBV DNA < 50 IU/mL at W 96

Time frame: Week 96

Mean reduction of HBV DNA at W 48 & 96

Time frame: Week 48 and 96

The proportion of subjects with ALT normalization at W 48 & 96

Time frame: Week 48 & Week 96

The proportion of subjects achieved HBeAg loss, seroconversion, HBsAg loss and seroconversion at W48 & 96

Time frame: Week 48 & 96

Safety

Time frame: Week 48 and Week 96

Resistance

Time frame: Week 48 & Week 96

Data from ClinicalTrials.gov

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