Immune-tolerant patients with chronic hepatitis B (CHB) awaiting assisted reproduction (AR) are required to initiate antiviral therapy due to laboratory safety. Additionally, rapid virus elimination is suggested to faciliate timely performance of AR. However, no consensus is reached regarding the antiviral therapy in this group. This study aimed to explore the efficacy and safety of tenofovir (TDF) and telbivudine (LdT) in this population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
tenofovir and telbivudine administered at least 48 weeks
tenofovir administered at least 48 weeks
Fuzhou General Hospital, Xiamen Univ
Fuzhou, Fujian, China
Percentage of Participants With HBV DNA < 500 Copies/mL at Week 12
Time frame: week 12
Percentage of Participants With HBV DNA < 500 Copies/mL at Week 24, 36 and 48
Time frame: Week 24, 36 and 48
Number of Participants With Normal Alanine Aminotransferase (ALT) at Week 12, 24, 36 and 48
Time frame: Week 12, 24, 36 and 48
Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 12, 24, 36 and 48
Time frame: Week 12, 24, 36 and 48
Number of Participants With Seroconversion to Antibody Against HBeAg (AntiHBe) at Week 12, 24, 36 and 48
Time frame: Week 12, 24, 36 and 48
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12, 24, 36 and 48
Time frame: Week 12, 24, 36 and 48
Number of Participants With Seroconversion to Antibody to HBsAg (AntiHBs) at Week 12, 24, 36 and 48
Time frame: Week 12, 24, 36 and 48
Occurrence of HBV Resistance Mutations
Time frame: Baseline to Week 48
off-treatment recurrence of HBV
Time frame: Week 72 to 96
Down syndrome Occurrence
Time frame: week 13 of pregnancy
Fetal Malformations Occurrence
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Time frame: week 26 of pregnancy