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The goal of this observational study is to determine the prevalence of hepatitis D virus (HDV) and the distribution of the HDV genotype in patients with chronic hepatitis B infection. It will also identify factors related to hepatitis D virus infection, such as characteristics of the study sample, vaccination history, drug use affecting hepatitis, family factors, environment, and lifestyle.
This study will be conducted at Tam Anh General Hospital, Bach Mai Hospital and Tam Anh TP. Ho Chi Minh General Hospital.
Participants will be interviewed directly through a questionnaire to collect some information related to epidemiological risk factors. A blood sample will also be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic hepatitis B virus infection |
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of hepatitis D virus (HDV) in patients with chronic hepatitis B infection | The method of estimating prevalence based on the assumption of binary distribution will be applied to the entire study sample and each subgroup. The prevalence rate will be estimated by dividing the number of positive cases by the sample size. The 95% confidence interval of the prevalence will be calculated based on the binary distribution assumption. Prevalence will be estimated for each sex, age, and disease group (chronic hepatitis B, chronic hepatitis B with hepatocellular carcinoma, and cirrhosis). | Day 0 after recruitment |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of the HDV genotype in patients with chronic hepatitis B infection | Testing for differences in genotypic distribution between disease groups will be analyzed using the Chi-squared test. The difference is statistically significant with p < 0.05. | Day 0 after recruitment |
| Factors related to hepatitis D virus infection |
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Inclusion Criteria:
Exclusion Criteria:
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Patients ≥ 16 years old with chronic hepatitis B, with hepatocellular carcinoma and cirrhosis or not, should be examined and treated at the Gastroenterology - Hepatobiliary Center of Bach Mai Hospital, Tam Anh General Hospital and Tam Anh TP. Ho Chi Minh General Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Loc Tho Truong, MSc | Contact | +842871026789 | 1668 | loctt@tamri.vn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bach Mai General Hospital | Recruiting | Hà Nội | Northern Vietnam | 100000 | Vietnam |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Blood
The determination of the association between risk factors and HDV will be analyzed across the total study sample. The multivariate logistic regression method will be applied in determining the variables related to the probability of HDV infection. In this analysis, HDV infection (positive or negative) is the dependent variable; Independent variables include factors that reflect demography, lifestyle, environment, occupation, clinical history (including vaccinations), and history of drug use. There are many independent variables and these variables can be correlated, determining which one affects HDV infection is a major challenge. To solve this problem, we will apply the Bayesian Model Averaging method in the R library. Based on the results of this analysis, a prognostic model of the risk of HDV infection will be established. |
| Day 0 after recruitment |
| Tam Anh General Hospital | Recruiting | Hà Nội | Northern Vietnam | 100000 | Vietnam |
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| Tam Anh TP. Ho Chi Minh General Hospital | Recruiting | Ho Chi Minh City | Southern Vietnam | 700000 | Vietnam |
|
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |