Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
1. Treatment adherence (Good adherence: 80% or more of administrations, Fair adherence: Between 60% and 70% of administrations, Poor adherence: 50% or less administrations). Measurement time: At the end of treatment.
2. Percentage of HBsAg loss or reduction (Percentage of patients with HBsAg loss or reduction. Values will be recorded according to the established unit (IU/ml)). Measurement time: At baseline, at six months, at one year, and annually for up to 5 years.
Key secondary outcomes:
1. Quality of Life (Chronic Liver Disease Questionnaire, CLDQ). Measurement time: At baseline and, one year after.
2. Percentage of patients with HBV DNA below the limit of detection (Values will be recorded according to the established unit (IU/mL)). Measurement time points: At baseline, at six months, at one year, and annually up to five years.
3. Percentage of HBeAg and/or HBsAg loss and/or seroconversion (HBeAg: Positive or negative (dichotomous response); anti-HBeAg: Positive or negative (dichotomous response); anti-HBs: Positive or negative (dichotomous response)). Measurement time: At baseline, at six months, at one year, and annually up to five years.
4. Mean Logarithmic Reduction of HBV DNA (Values will be recorded according to the established unit (IU/mL)). Measurement time: At baseline, at six months, at one year, and annually up to five years.
5. Biochemical response defined by sustained normalization of ALT (Values will be recorded using the established unit (U/L), categorized as: normal, abnormal not clinically significant, abnormal clinically significant, and not performed, according to the defined normal reference ranges). Measurement time: At baseline, at six months, at one year, and annually up to five years.
6. Response to liver fibrosis (APRI (Relationship between ASAT levels and platelet count) and FIB-4 (Calculated from age, platelet count and ASAT and ALAT levels) indices; Transient elastography (Fibroscan). Results are reported in kPa. The degree of fibrosis will be determined from F0 to F4, taking into account the results obtained by each of the methods evaluated. F4 being the exclusion criterion for the inclusion of the patient in the study). Measurement time: At baseline, at six months, at one year, and annually up to five years.
7. Adverse Events –AE (Adverse events occurring during the study will be recorded, including those related to findings from the physical examination. It will measure: Occurrence of any AE(yes/no); Description of the AE (Name of the adverse event); Duration of the AE (Difference in dates between onset and resolution); Intensity of the AE (Mild, Moderate, Severe); Severity of the AE (Serious, Not serious); Action taken regarding the investigational treatment (No change, Dose modification, Temporary interruption, Permanent discontinuation); Outcome of the AE (Recovered, Improved, Ongoing, With squeals); Causality relationship (Very likely; Likely Possible; Unlikely; Not related; Not assessable)). Measurement time: From the treatment started until 30 days after the last immunization.