Chronic Viral Hepatitis B With Delta-Agent
Conditions
Brief summary
The goal of this observational study is to evaluate the effectiveness of the carnitine-orotate complex and biphenyl dimethyl dicarboxylate in the adjuvant therapy of chronic hepatitis D in real clinical practice: a prospective cohort study
Interventions
None listed
Sponsors
Kazakh Association of Internal Medicine Specialists
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Inclusion criteria
* Patients of both sexes aged 18 to 75 years who are citizens of the Republic of Kazakhstan; * An established diagnosis of CGD (chronic viral hepatitis B with the delta agent); * Patients who have contraindications to taking peg-INF-alpha2a and/or have failed treatment with peg-INF-alpha2a; * Compensated liver disease ≤ CPT A (6 points); * Patients without severe concomitant diseases; * Patients who do not receive other adjuvant therapy (metabolic therapy drugs, essential phospholipids, ursodeoxycholic acid, glycyrrhizic acid, ademetionine and others); * Patients who voluntarily signed the informed consent form.
Exclusion criteria
* Patients taking COC for more than 4 weeks before inclusion in the study; * Patients with contraindications to the COC; * Decompensated liver disease severity class \> CPT A6; * Patients taking peg-IFN-alpha 2a; * Alcohol abuse according to the AUDIT-c questionnaire; * Pregnancy and lactation; * Patients with coinfection with HIV, HCV; * GFR ≤ 15 ml/min/1.73 m2; * Exclude patients with significant biochemical activity (ALT, AST more than 10 ULN) and total bilirubin more than 2 norms; * Patients with other causes of liver damage; * Drug addict people; * Malignant formations of the liver and other organs (in history and currently) or a clinically significant increase in alpha-fetoprotein more than 5 times or more; * Patient takes part in an interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Normalization of ALT levels during adjuvant CGD therapy at 12 months among study participants taking and not taking COC and BDD | at 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Dynamics of the level of fibrosis during adjuvant CGD therapy at 6 and 12 months among study participants taking and not taking COCs AND BDD | at 6 and 12 months |
| Viral load during adjuvant CGD therapy at 6 and 12 months among study participants taking and not taking COC and BDD | at 6 and 12 months |
| Adherence to COC and BDD therapy against the background of adjuvant CGD therapy among study participants taking and not taking COCs and BDD | up to 12 months since enrollment |
| Normalization of ALT levels during adjuvant CGD therapy at 6 months among study participants taking and not taking COCs AND BDD | at 6 months |
| Incidence of adverse and serious unexpected adverse reactions associated with the use of COC and BDD | up to 12 months since enrollment |
| Satisfaction of patients with CGD with combination therapy of COCs and BDD | up to 12 months since enrollment |
| Dynamics of changes in the total score of the quality of life questionnaire | up to 12 months since enrollment |
Countries
Kazakhstan
Outcome results
None listed