CHB
Conditions
Interventions
Research Group 1 (For patients treated with TMF, the generic name of the drug is Amitiniofovir tablets, the product name is Hengmu, the specification is 25mg, the manufacturer is Changzhou Haosen Phar
Control group 1 (Patients treated with TAF, generic name of the drug: Propenovir Fumarate Tablets, specification: 25mg, manufacturer: unlimited, generic drug requires consistency evaluation, once dail
Research Group 2 (Patients treated with TMF combined with ETV, TMF drug generic name: Amitiniofovir tablets, drug trade name: Hengmu, specification: 25mg, manufacturer: Changzhou Haosen Pharmaceutical
ETV drug generic name: Entecavir, specification: 0.5mg, manufacturer: unlimited, generic drugs require consistency evaluation. TMF is taken orally once a day, 25mg per day, for a course of 48 weeks. E
Control group 2 (For patients treated with TAF combined with ETV, the generic name of TAF drug is propafenone fumarate tenofovir tablets, specification: 25mg, manufacturer: unlimited, generic drugs re
ETV drug generic name: Entecavir, specification: 0.5mg, manufacturer: unlimited, generic drugs require consistency evaluation. TAF is taken orally once a day, 25mg per day, for a course of 48 weeks. E
Sponsors
Beijing You'an Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Queue 1: (1) Age = 65 years old, gender not limited; (2) Meets the diagnostic criteria for decompensated chronic hepatitis B cirrhosis in China's "Diagnosis and Treatment Guidelines for Cirrhosis (2019 Edition)" and "Prevention and Treatment Guidelines for Chronic Hepatitis B (2022 Edition)"; (3) HBsAg positive; (4) Patients who meet the indications for HBV antiviral therapy; (5) Newly diagnosed patients need to be HBV DNA positive; (6) Patients receiving monotherapy with TMF or TAF for HBV infection. Queue 2: (1) Age range: 18-64 years old, gender not limited; (2) Meets the diagnostic criteria for chronic hepatitis B in China's "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)"; (3) HBsAg positive; (4) Patients who have developed resistance, virological breakthrough, hypoviremia, and poor response to nucleoside (acid) analogues after treatment; (5) ETV combined with TMF or TAF treatment for patients.
Exclusion criteria
Exclusion criteria: Queue 1: (1) Patients treated with Peg IFN or other HBV drugs in combination; (2) Peg IFN treated patients; (3) Pregnant or lactating women; (4) Patients with combined infections of HAV, HCV, HDV, HEV, HIV virus, drug-induced liver injury, autoimmune liver disease (AIH, PBC, PSC), alcoholic liver disease, liver cancer, and liver transplantation; (5) Patients with incomplete observation data; (6) Patients who did not take medication according to the drug instructions. Queue 2: (1) Patients treated with Peg IFN or other HBV drugs in combination; (2) Peg IFN treated patients; (3) Patients with decompensated cirrhosis; (4) Pregnant or lactating women; (5) Patients with combined infections of HAV, HCV, HDV, HEV, HIV virus, drug-induced liver injury, autoimmune liver disease (AIH, PBC, PSC), alcoholic liver disease, liver cancer, and liver transplantation; (6) Patients with incomplete observation data; (7) Patients who did not take medication according to the drug instructions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA; | — |
Countries
China
Contacts
Public ContactQiu Xinye
Beijing You'an Hospital, Capital Medical University
Outcome results
None listed