Studies have shown that the HBeAg seroconversion rate of HBeAg positive chronic hepatitis B with tenofovir for one year's treatment was 17.8% and the negative conversion rate of their HBeAg and HBV DNA were 20.0% and 97.6%. The HBeAg Seroconversion rate of these patients was lower.Clinically, most patients need to take tenofovir for a long time, which may cause serious complications such as renal function damage,with decreased therapy compliance and Increased cost of treatment.In the course of tenofovir treatment, it is common that HBV-DNA negative patients with HBeAg Being down poor or staying at a low positive level for a long time keep taking the medicine. Therefore, it is Significant to Increase the HBeAg seroconversion rate of tenofovir during the clinical treatment. Telbivudine has a strong antiviral effect.Studies have shown that the HBeAg seroconversion rate of HBeAg positive CHB for one year was 25%, which was higher than other nucleosides, and it could also improve the damaged renal function to a certain extent.The HBeAg seroconversion rate of patients with poor response to tenofovir for 12 months could be still poor if for 24 months . Therefore, this study is to observe the efficacy of these patients combined with telbivudine.
This is an open, multicenter, exploratory and real-world clinical study. It will be carried out in patients with poor response (HBV DNA \> 2x103iu / ml) to tenofovir for 12 months. After one -week screening period, patients will be randomly assigned 1:1 to control and experimental groups. The control group takes tenofovir for 12 months while the experimental group takes tenofovir combined with telbivudinefor 12months .
Study Type
OBSERVATIONAL
Enrollment
200
TDF combined with telbivudine (LDT) for 12 months
TDF monotherapy was continued for 12 months
Chaoshuang Lin
Guangzhou, China
RECRUITINGHBeAg seroconversion rates
HBeAg seroconversion rates at 12 months after tenofovir plus telbivudine treatment
Time frame: 12months
HBeAg seroconversion rates
HBeAg seroconversion rates at 24 months after tenofovir plus telbivudine treatment
Time frame: 24months
HBeAg negative rate
HBeAg negative rate of tenofovir combined with telbivudine treatment at 12 and 24 months
Time frame: 12 and 24months
ALT normalization rate
ALT normalization rate of tenofovir combined with telbivudine treatment at 12 and 24 months
Time frame: 12 and 24months
Renal function index
Renal function index of tenofovir combined with telbivudine treatment at 12 and 24 months
Time frame: 12 and 24months
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