Real World Study About Anti-viral Regimen Adjustment on Achieving Complete Response in CHB Patients
- Conditions
- Sustained Virologic ResponseHepatitis B, Chronic
- Interventions
- Other: only monitoringOther: monitoring and regimen change if necessaryDrug: regimen change
- Registration Number
- NCT04724785
- Brief Summary
In the treatment of chronic hepatitis B (CHB), viral suppression is closely related to disease progression, and the lower the viral load, the lower the risk of progression to cirrhosis and hepatocellular carcinoma (HCC). In addition, a considerable number of patients in China are still using non-first-line antiviral therapy, such as adefovir dipivoxil, lamivudine, and telbivudine (ADV/LAM/LdT). About 25% of patients who received entecavir(ETV) treatment for more than half a year and confirmed that their DNA had turned negative by non-high-precision detection methods still had low viremia (LLV,DNA\>20 IU/ml,IU=international unit), and LLV patients were twice as likely to develop HCC as patients with complete viral response.Patients who have received ETV or second-line NA(LAM/ADV/LdT) treatment for more than half a year to 1 year and confirmed HBV-DNA\>10IU/ml by high-precision detection method are recommended to adjust the treatment plan in order to reduce the DNA load below 10IU/ml as soon as possible. It is up to the doctor, in consultation with the patient, to decide whether or not to make the adjustment.
- Detailed Description
In our hospital, about 150 patients are screened for HBV-DNA every day. Therefore, 54 million patients will be tested for HBV-DNA within one year, of which 30% are estimated to be HBV-DNA ≥10 IU. These patients will be informed to the Department of Infectious Diseases of the Second Affiliated Hospital of Chongqing Medical University for follow-up, and will be randomly divided into three groups according to 1:1. Patients in all three groups will be educated about hepatitis B virus infection and antiviral treatment, and the treatment regimen will be adjusted according to whether their HBV DNA is ≥10 IU/ml or not. Patients in group 1: patients with persistant low level HBV DNA (\<10 IU/ml). Patients in group 2: HBV-DNA≥10 IU/ml, receiving HBV-related education and being advised by the doctor to change or to add another NA. Patients in group 2: patients with persistant HBV DNA (\>10 IU/ml) but refuse to change the regimen. Patients in group 3: patients with persistant HBV DNA (\>10 IU/ml) and agree to change the regimen. Educational methods include videos, including an introduction to hepatitis B virus (disease profile, infection, outcome, HBV infection, vertical transmission and other risk factors) for 5 minutes, brochures with relevant information and consultations with physicians and nurses.
All patients with chronic hepatitis B(CHB) receiving ETV or second-line NA(LAM/ADV/LdT) treatment for more than six months to one year will receive HBV-DNA detection, and patients with HBV-DNA≥10 IU/ml will be informed and recommended to adjust the treatment regimen so that the actual prevalence of HBV-DNA load \< 10 IU/ml in Chongqing HBV cohort could be obtained . The investigators estimated that 30% of the patients had HBV-DNA≥ 10 IU/ml, so there were about 16,200 patients had HBV-DNA≥ 10 IU/ml among 54,000 patients a year. These patients will be diagnosed with LLV and will undergo a treatment regimen adjustment, with a recommendation to switch to or use a different type of nucleos(t)ide analogue (NA) for anti-viral treatment.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10000
- any patients treated with ETV\LAM\ADF\LDT\TDF\TAF.【ADV=adefovir dipivoxil, LAM=lamivudine, and LdT=telbivudine , TAF =Tenofovir alafenamide Fumarate, ETV=Entecavir and TDF=Tenofovir disoproxil fumarate 】
- with a expected life span <48 weeks
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description patients with persistant low level HBV DNA (<10 IU/ml) only monitoring No further intervention(s) to be administered except for monitoring of HBV DNA viraemia patients with persistant HBV DNA (>10 IU/ml) but refuse to change the regimen monitoring and regimen change if necessary All patients with CHB receiving ETV or second-line NA(LAM/ADV/LdT) treatment for more than six months to one year will receive HBV-DNA detection, and patients with HBV-DNA≥10 IU/ml will be informed and recommended to adjust the treatment regimen. If those patients refuse to change the regimen which they are using , No further intervention(s) to be administered except for monitoring of HBV DNA viraemia until those patients change their idea patients with persistant HBV DNA (>10 IU/ml) and agree to change the regimen regimen change All patients with CHB receiving ETV or second-line NA(LAM/ADV/LdT) treatment for more than six months to one year will receive HBV-DNA detection, and patients with HBV-DNA≥10 IU/ml will be informed and recommended to adjust the treatment regimen.They will change their regimen according one which they are using.
- Primary Outcome Measures
Name Time Method The proportion of patients who received a complete virologic response (HBV DNA<10IU/ml) at 24 weeks after therapy adjustment. 24 weeks The proportion of patients who received a complete virologic response (HBV DNA\<10IU/ml) at 24 weeks after therapy adjustment.
- Secondary Outcome Measures
Name Time Method The proportion of patients with complete virologic response (HBV DNA<10IU/ml) at 12 weeks, 48 weeks and 96 weeks after therapy adjustment. 12 weeks, 48 weeks ,96 weeks The proportion of patients with complete virologic response (HBV DNA\<10IU/ml) at 12 weeks, 48 weeks and 96 weeks after therapy adjustment.
he proportion of patients with normal Alanine transaminase（ALT） at baseline and at each follow-up time point baseline,12 weeks,48 weeks,96 weeks he proportion of patients with normal Alanine transaminase（ALT ）at baseline and at each follow-up time point
Changes of estimated glomerularfiltrationratee(GFR) compared with baseline at each follow-up time point. baseline,12 weeks,48 weeks,96 weeks Changes of estimated glomerularfiltrationratee(GFR) compared with baseline at each follow-up time point.
Changes of bone mass density（BMD) compared with baseline at each follow-up time point. baseline,12 weeks,48 weeks,96 weeks Changes of bone mass density (BMD) compared with baseline at each follow-up time point.
Changes of serum creatinine(SCr）compared with baseline at each follow-up time point. baseline,12 weeks,48 weeks,96 weeks Changes of serum creatinine(SCr) compared with baseline at each follow-up time point.
Trial Locations
- Locations (1)
The second affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China