Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Naive CHB Patients in China

Completed

Brief Summary: To compare the effectiveness, in a real world practice setting in tier 2 cities of China, of Entecavir (ETV) monotherapy and Lamivudine (LAM) based therapies (including LAM monotherapy, de novo LAM + Adefovir \[ADV\] combination, and early add-on of ADV) among chronic hepatitis B (CHB) patients who are naive to NUC at enrollment to this study

Detailed Description: Sampling Method: Consecutive patient sampling

Biospecimen Retention: Blood samples for HBV viral load testing along the treatment period of this study

Recruitment & Eligibility

Inclusion Criteria

CHB patients, or CHB patients with compensated cirrhosis, as defined by the current Chinese guidelines
Male or female
≥ 18 years of age
Either Hepatitis B e antigen (HBeAg) positive or negative
Naïve to NUC (defined as no previous exposure to NUC treatment as based on patient self-report)
Has compensated liver disease
Patients with compensated cirrhosis
Patients who consent to participate in this study
Local residents with medical reimbursement coverage preferred

Exclusion Criteria

Co-infected with hepatitis C virus (HCV)
CHB patients with decompensated cirrhosis, liver failure, hepatocellular carcinoma, or any other types of malignancy at the screening phase
CHB patients who are being treated by interferon therapy within 6 months immediately prior to the screening phase of this study
CHB patients with a confirmed pregnancy

Primary Outcome Measures

Name	Time	Method
Proportion of patients who achieve virology response (defined as HBV DNA < 300 copies/mL) by ETV monotherapy in comparison with LAM-based therapy	48 weeks after initial NUC antiviral therapy	Virology response is defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) \< 300 copies/mL by a highly sensitive assay such as Roche COBAS or Abbott Real Time Polymerase chain reaction (PCR) performed in a one central laboratory

Secondary Outcome Measures

Name	Time	Method
Mean HBV DNA reductions after 48 weeks of treatment from baseline for ETV and LAM-based therapy patients (stratifying by the 3 LAM-based subgroups)	Baseline (Day 1) and 48 weeks
Proportion of patients who achieve virology response by ETV in comparison with LAM-based therapy after 24 weeks and 96 weeks of treatment (stratifying by the 3 LAM based subgroups)	24 weeks and 96 weeks
Proportion of patients who modify their initial treatment options to manage suboptimal response or resistance after 24 weeks, 48 weeks, and 96 weeks of treatment among all treatment options	24 weeks, 48 weeks and 96 weeks
Proportion of patients who achieve virology response among other treatment options, including ADV, LdT, and combinations of NUCs, after 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks of treatment	24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks	HBV DNA levels at week 24 will be analyzed at the laboratories of hospitals where the patients are treated while evaluation of HBV DNA levels after 48 and 96 weeks of treatment will be conducted at the central laboratory
Cumulative incidence of patients who develop viral breakthrough and/or genotypic resistance	24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks
Cumulative incidence of clinical outcome (eg, HCC, death, decompensated cirrhosis) in ETV arm versus LAM-based and other treatment arms	48 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks

Locations (3): Local institution
🇨🇳
Hangzhou, Zhejiang, China
Local Institution
🇨🇳
Ningbo, Zhejiang, China
Local Instution
🇨🇳
Fushun, Liaoning, China

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