Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver

Pilot Study to Assess the Antiviral Activity and Safety of Besifovir Dipivoxil 150mg and L-carnitine 660mg Compared to Tenofovir Alafenamide 25mg in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver

Pilot study to assess the antiviral activity and safety of Besifovir dipivoxil 150mg and L-carnitine 660mg compared to Tenofovir Alafenamide 25mg in chronic hepatitis B patients with Nonalcoholic fatty liver

Inclusion Criteria:

• 20 years of age and older, Male or female patients
• Chronic hepatitis B patients with Nonalcoholic fatty liver
• Patients who use oral anti-diabetic drug or drugs for hyperlipemia without any change in drug dosage within 2 month before screening visit
• Patients who have been explained about the trial and agreed to the consent
• Patients who agree with the approved method of contraception during the clinical trial

Exclusion Criteria:

• Patients with hepatitis C virus, hepatitis D virus or human immunodeficiency virus
• Patients who has a history of liver transplantation or Child-Pugh score >=8
• Alpha-fetoprotein (AFP) > 50 ng/mL or Hepatocellular Carcinoma (HCC) patients
• Patients who have taken Besifovir or Vemlidy
• Among the patients treated with immunosuppressive drug within 6 months before screening, suspected case of the declined immunity in the opinion of the investigator
• Chronic alcoholism (Significant alcohol consumption: male > 210 g/week, female> 140 g/week)
• Patients who take drugs that can cause hepatic steatosis
• Patient diagnosed with a malignant tumor within 5 years before screening or relapsed patient
• Patients with uncontrolled diabetes mellitus (HbA1c > 9%) or using insulin
• Patients who participate in other clinical trials or is supposed to do so during the study period
• Pregnant or breast-feeding women or women who have plan to be pregnant.
• Patients with a history of hypersensitivity to the test drug or the components of the test drug
• Patients with moderate or severe renal impairment
• Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
• History within the past one years or presence of drug abuse or alcoholism.
• Patient has serious disease judged by investigator such as heart failure, renal failure, and pancreatitis
• Patient has liver diseases except chronic hepatitis B (i.e. hematochromatosis, alcoholic liver disease, nonalcoholic fatty liver disease, alpha-1 antitrypsin deficiency etc.)
• Patient has history of organ transplantation
• Patient concerned about the decline in daily activity or not able to understand the objectives and methods due to the psychiatric problems
• Patients who are considered to be unacceptable in this study under the opinion of the investigator.