This is a retrospective, prospective, noninterventive, multicenter registry study. Patients diagnosed with HDV infection (based on positive HDV RNA) were included in this study and were followed up for at least 5 years to evaluate their disease progression and clinical outcomes (including death, liver transplantation, hepatocellular carcinoma \[hcc\], liver decompensation, and cirrhosis) during the 5-year follow-up period. All patients were followed up at least once a year after they were included in the study. It was in 2016 HDV infection first reported in China. Since January 1, 2016, all patients diagnosed with HDV infection can be enrolled in this study and evidence confirming the diagnosis (including but not limited to HDV RNA test reports and medical records, etc.) must be delivered. The main test results (including serum HDV RNA, ALT, and tests to determine the presence of liver cirrhosis, decompensation of liver function, and liver cancer such as B-ultrasound and FibroScan) of these patients each year from diagnosis to enrollment should be collected and filled in the case report form (CRF). Follow-up data of patients with serum anti-HDV positive and HDV RNA negative can be recorded and followed up on this platform, with informed consent of the patients is required. Patients whose serum HBV RNA turn positive during the follow-up period will be included in the follow-up cohort of the study.
Study Type
OBSERVATIONAL
Enrollment
1,000
Bejing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
The incidence of death of patients infected with HDV during 5-year follow-up
HDV means hepatitis D virus
Time frame: 5 years
The incidence of liver transplantation of patients infected with HDV during 5-year follow-up
HDV means hepaitis D virus
Time frame: 5 years
The incidence of hepatocellular carcinoma of patients infected with HDV during 5-year follow-up
HDV means hepaitis D virus
Time frame: 5 years
The incidence of liver decompensation of patients infected with HDV during 5-year follow-up
liver decompensation means ascites, variceal bleeding, or hepatic encephalopathy
Time frame: 5 years
The incidence of cirrhosis of patients infected with HDV during 5-year follow-up
Patients who developed cirrhosis in the absence of cirrhosis at baseline by liver biopsy or noninvasive testing
Time frame: 5 years
Demographic characteristics of HDV-infected individuals using baseline data
Demographic characteristics: age, sex, height, weight, nationality, main residence, economic level.
Time frame: 1 year
Epidemiological characteristics of HDV-infected individuals using baseline data
Risk factors for infection/possible route of infection, HDV genotype
Time frame: 1 year
Serum HDV RNA levels of patients infected with HDV
HDV means hepaitis D virus
Time frame: 5 years
Serum HBV DNA levels of patients infected with HDV
HBV means hepaitis B virus, HDV means hepaitis D virus
Time frame: 5 years
HBsAg concentration levels of patients infected with HDV
HBsAg means Hepatitis B surface antigen，HDV means hepaitis D virus
Time frame: 5 years
Serum alanine aminotransferase concentration levels of patients infected with HDV
HDV means hepaitis D virus
Time frame: 5 years
Serum total bilirubin concentration levels of patients infected with HDV
HDV means hepaitis D virus
Time frame: 5 years
Serum albumin levels concentration levels of patients infected with HDV
HDV means hepaitis D virus
Time frame: 5 years
Child-Pugh scores of patients infected with HDV
The Child-Pugh classification is a universal scoring system of the degree of liver failure in patients with cirrhosis. Variables measured by this system include ascites, encephalopathy, serum albumin, bilirubin, and prothrombin time. Traditionally, the Child-Pugh class (A, B, or C) has been used as a predictive index for operative mortality rate in adult patients undergoing portosystemic shunting procedures. The estimated 1- and 5-year survival rates are 95% and 75% for patients with Child-Pugh class B, and 85% and 50% for patients with Child-Pugh class C.
Time frame: 5 years
The incidence of death of chronic HDV-infected patients with persistently normal ALT
HDV means hepaitis D virus, ALT means alanine aminotransferase
Time frame: 5 years
The incidence of liver transplantation of chronic HDV-infected patients with persistently normal ALT
HDV means hepaitis D virus, ALT means alanine aminotransferase
Time frame: 5 years
The incidence of hepatocellular carcinoma (HCC) of chronic HDV-infected patients with persistently normal ALT
HDV means hepaitis D virus, ALT means alanine aminotransferase
Time frame: 5 years
The incidence of liver decompensation of chronic HDV-infected patients with persistently normal ALT
HDV means hepaitis D virus, ALT means alanine aminotransferase
Time frame: 5 years
The incidence of cirrhosis of chronic HDV-infected patients with persistently normal ALT
HDV means hepaitis D virus, ALT means alanine aminotransferase
Time frame: 5 years
The proportion of patients with HDV RNA negative conversion of patients receiving antiviral therapies
HDV RNA negative conversion means HDV RNA\< lower limit of quantification（LLOQ）
Time frame: 5 years
The proportion of patients with a >2lg IU/mL HDV RNA decline of patients receiving antiviral therapies
The proportion of patients with a HDV RNA decrease of greater than 2log IU/mL
Time frame: 5 years
Changes in serum HDV RNA during treatment and after discontinuation
HDV means hepatitis D virus
Time frame: 5 years
The proportion of patients with ALT normalization of patients receiving antiviral therapies
ALT means alanine aminotransferase，ALT normalization means ALT \<ULN
Time frame: 5 years
Combined response rate of patients with antiviral therapy
Combined response means HDV RNA \<LLOQ and ALT\<ULN
Time frame: 5 years
Number of patients with abnormal laboratory values and/or adverse events that are related to antiviral treatment
Number of patients with adverse events, sever adverse events, abnormal laboratory parameters, and drug combinations
Time frame: 5 years
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