Chronic Hepatitis b
Conditions
Keywords
Chronic Hepatitis b, Antiviral treatment
Brief summary
China has the world's largest burden of hepatitis B virus (HBV) infection and will be a major contributor towards the global elimination of hepatitis B disease by 2030. One of the main issues in the management of patients with chronic HBV infection (CHB) is to maximize the individuals who need the treatment engaged and retained in care. However, our investigation revealed that 21.1% patients were treatment eligible but not treated based on Chinese 2019 CHB treatment guidelines, while only 213 (13.9%) patients were indicated-but-not-treated according to AASLD 2018 Hepatitis B guidance in a real-life cohort study. To maximize the individuals who need the treatment engaged and retained in care, integrated intervention strategies to address these treatment barriers are urgently needed. Therefore, we aim to propose a study to narrow the gap between in accordance with guidelines and consent to treat CHB population in EAST of China.
Interventions
OTHERIntegrated intervention strategies
Implementation of integrated intervention strategies to reduce the proportion of indicated-but-not-treated CHB patients.
Sponsors
Gilead Sciences
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Positive HBV surface antigen (HBsAg) for 6 months or more; 2. Elevated ALT levels (\>1×ULN) and detectable HBV DNA; 3. Treatment-naïve; 4. Willing to attend this study and able to provide the written informed consent.
Exclusion criteria
1. Co-infection with other viral hepatitis and human immunodeficiency virus; 2. Concurrent with other chronic liver diseases, including primary biliary cirrhosis, autoimmune hepatitis, alcoholic hepatitis, nonalcoholic fatty hepatitis, and hereditary metabolic liver disease; 3. Patients with liver cirrhosis; 4. Coexistence of hepatocellular carcinoma and other malignant tumor; 5. Underwent liver transplantation before the enrollment; 6. Severe cardiac, renal, respiratory, hematological, or psychiatric illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of indicated-but-not-treated CHB patients. | 18 months | The proportion of indicated-but-not-treated CHB patients. |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of lost to follow-up in CHB patients. | 18 months |
| The frequency of follow-up visit in CHB patients. | 18 months |
Countries
China
Contacts
Primary ContactRui Huang, M.D., Ph.D
Backup ContactChao Wu, M.D., Ph.D
Outcome results
None listed