Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients

Study Overview
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Brief Summary
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This study evaluates generic emtricitabine(FTC) plus adefovir dipivoxil in Chinese naive HBV related cirrhosis patients. Patients were divided into 2 groups: compensated HBV related cirrhosis patients and decompensated HBV related cirrhosis patients.

Detailed Description
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Generic emtricitabine(FTC) has been approved for treatment of naive chronic hepatitis B(CHB) patients in China. Yet data are limited for this agent plus adefovir dipivoxil in cirrhosis patients. The investigators design this trial to test the effect of FTC plus adefovir dipivoxil in Chinese naive compensated and decompensated HBV related cirrhosis patients.

Official Title
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Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients

Conditions
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Hepatitis B, Chronic, Fibrosis

Intervention / Treatment
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* Drug: Emtricitabine plus adefovir dipivoxil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dignosed cirrhosis patients HBsAg positive for more than 6 months HBV DNA detectable Nucleoside/nucleotide naive patients Exclusion Criteria: Diagnosed HCC with AFP and ultrasound, CT or MRI Creatine >130μmol/L or Ccr < 70mL/min Hemoglobin <100g/L Coinfected with HAV,HEV,HCV,HDV or HIV ANA > 1:100 Uncontrolled cardiovascular diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer; Drug abuse or alcohol addiction Previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine Long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial Underwent liver transplantation or liver transplantation in schedule Allergic to nucleoside or nucleotide analogues Pregnancy or in breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: compensated HBV related cirrhosis patients<br>Chinese naive compensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks | Drug: Emtricitabine plus adefovir dipivoxil<br>* emtricitabine plus adefovir dipivoxil were given to each patients for 96 weeks<br>* Other names: Brand name of emtricitabine：Huierding;|
| Experimental: decompensated HBV related cirrhosis patients<br>Chinese naive decompensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks | Drug: Emtricitabine plus adefovir dipivoxil<br>* emtricitabine plus adefovir dipivoxil were given to each patients for 96 weeks<br>* Other names: Brand name of emtricitabine：Huierding;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| virological response rate | HBV DNA < 500 copies/ml | week 96 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA negativity rate | HBV DNA < 500 copies/ml | week 24, 48 and 72 | 
| HBV DNA decrease level | HBV DNA decrease compared with baseline（log10 copies/ml） | week24, 48, 72 and 96 | 
| biochemical response | ALT normalization | week 24,48,72 and 96 | 
| HBeAg loss | HBeAg loss in HBeAg positive group | week 24,48,72 and 96 | 
| HBeAg seroconversion | HBeAg seroconversion in HBeAg positive group | week 24,48,72 and 96 | 
| HBeAg reversion | HBeAg positive in Baseline HBeAg negativie group patients | week 24,48,72 and 96 | 
| HBsAg loss | HBsAg loss in both group | week 24,48,72 and 96 | 
| HBsAg seroconversion | HBsAg loss and anti-HBs positive | week 24,48,72 and 96 | 
| HBV genetic resistance to emtricitabine and adefovir | HBV genetic resistance to emtricitabine and adefovir | week 24,48,72 and 96 | 
| adverse event | type and rate of adverse events;type and rate of severe adverse event | week 24,48,72 and 96 | 
| incidence of HCC | incidence of HCC in both groups | week 24,48,72 and 96 | 
| change of MELD score and Child-Pugh score | change of MELD score and Child-Pugh score in both groups | week 24,48,72 and 96 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adefovir dipivoxil, Hepatitis B virus, Cirrhosis, Emtricitabine