A Multicenter, Open-label, Single Arm Trial for the Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels with a Comparison to Matched Historical Controls (ATTACH)
Multicenter, Open-label, Single arm Trial with Matched Historical controls. Male and female adults with compensated liver cirrhosis due to chronic hepatitis B virus infection who have low-level viremia. To assess the efficacy of Tenofovir Alafenamide (TAF) in reducing liver-related events (hepatocellular carcinoma, liver-related events and death, decompensated liver cirrhosis) in cirrhotic chronic hepatitis B patients with low-level viremia compared with matched historical controls.
• Willing and able to provide written informed consent prior to study entry
• Age ≥30 years and ≤80 years at the time of screening
• Chronic hepatitis B infection defined as HBsAg (+) or HBV DNA (+) for at least 6 months prior to the Screening visit, or medical records indication a chronic hepatitis B virus infection by meeting all of the following criteria at the time of screening. (1) HBsAg (+), (2) HBV DNA (+), and (3) HBcAb IgM (-)
• Either HBeAg (+) or HBeAg (-)
• Serum HBV DNA levels ≥20 IU/mL and \<2,000 IU/mL at the time of screening
• Evidence of liver cirrhosis defined as meeting any of the following criteria:
‣ Radiological evidence of liver cirrhosis by ultrasound, CT, or MRI
⁃ Platelet count \<150,000 /mm3
⁃ Presence of esophageal or gastric varices by endoscopy in 2 years before the timing of screening
⁃ Clinically significant portal hypertension
⁃ Fibroscan ≥12.0 kPa (if the test was done in 6 months before the time of screening)
• Estimated creatinine clearance ≥30 ml/min (by calculation of creatinine clearance or using the CKD-EPI equation)
• Ability to comply with all study requirements